Plasma Cell MyelomaPhase 3NCT05561387
Comparing Combinations of Drugs to Treat Newly Diagnosed Multiple Myeloma (NDMM) When a Stem Cell Transplant is Not a Medically Suitable Treatment
A Phase 3 study testing Bortezomib, Daratumumab and Hyaluronidase-fihj and Dexamethasone in people with Plasma Cell Myeloma, run by SWOG Cancer Research Network at 397 sites in United States.
Trial summary
This phase III trial compares three-drug induction regimens followed by double-or single-drug maintenance therapy for the treatment of newly diagnosed multiple myeloma in patients who are not receiving a stem cell transplant and are considered frail or intermediate-fit based on age, comorbidities, and functional… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Plasma Cell Myeloma
- What is being tested?
- Bortezomib, Daratumumab and Hyaluronidase-fihj and Dexamethasone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 510 participants
- Where
- 397 sitesUnited States
- Study dates
- 12 Oct 2023to 30 May 2031
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Participants must have documented multiple myeloma satisfying standard International Myeloma Working Group (IMWG) diagnostic criteria within 28 days prior to registration
- Participants must have measurable disease within 28 days prior to registration as defined by any of the following:
- Immunoglobulin (Ig) G myeloma (serum monoclonal paraprotein [M-protein] level >= 0.5 gram/deciliter [g/dL] or urine M-protein level >= 200 milligram[mg]/24 hours[hrs]); OR
- IgA, IgM, IgD, or IgE multiple myeloma (serum M-protein level >= 0.2 g/dL or urine M-protein level >= 200 mg/24 hrs); OR
- Light chain multiple myeloma (serum immunoglobulin free light chain >= 10 mg/dL and abnormal serum immunoglobulin kappa lambda free light chain ratio)
- All disease must be assessed and documented on the baseline/pre-registration tumor assessment form
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- Participants must have a calculated myeloma frailty index (Myeloma Frailty Score Calculator; http://www.myelomafrailtyscorecalculator.net/) categorized as frail or intermediate fit (regardless of age) within 28 days prior to registration
- For Participants Meeting "Frail" Status:
- Participants with any degree of kidney dysfunction are allowed; however, participants on dialysis are not eligible
- For Participants Meeting "Frail" Status:
- Hemoglobin >= 7 g/dL (must be performed within 28 days prior to registration)
- Note: growth factor and transfusion utilization are allowed if cytopenias are considered secondary to bone marrow involvement from MM)
- For Participants Meeting "Frail" Status:
- Platelets >= 50 x 10^9/L (must be performed within 28 days prior to registration)
- Note: growth factor and transfusion utilization are allowed if cytopenias are considered secondary to bone marrow involvement from MM)
- For Participants Meeting "Frail" Status:
- Absolute neutrophil count (ANC) >= 0.75 x10^9/L (must be performed within 28 days prior to registration)
- Note: growth factor and transfusion utilization are allowed if cytopenias are considered secondary to bone marrow involvement from MM)
- For Participants Meeting "Intermediate Fit" Status, one or more of the following criteria must be present:
- Kidney dysfunction showing calculated creatinine clearance (CrCl) <30 ml/min.
- Actual lab serum creatinine value with a minimum of 0.7 mg/dL.
- Participants must have bone marrow function assessed and meet the below criteria ranges:
- Hemoglobin between 7-8 g/dL, OR
- Platelets between 50-75 x10^9/L, OR
- ANC between 0.75-1 x10^9/L
- Note: growth factor and transfusion utilization are allowed as long as cytopenias are considered secondary to bone marrow involvement from MM)
- Revised International Staging System (R-ISS) stage III disease
- Note: All labs must be performed within 28 days prior to registration
- Participants must have a complete medical history and physical exam within 28 days prior to registration
- Participants must have whole body imaging within 60 days prior to registration. The recommended method of imaging is a positron emission tomography/computed tomography (PET/CT); a low-dose whole body CT scan or whole-body magnetic resonance imaging (MRI) or skeletal survey should be done only if a PET/CT scan cannot be done or is non-feasible. This must be documented in the comments section of the Onstudy form.
- Total bilirubin =< 2 times institutional upper limit of normal (ULN) unless history of Gilbert's disease. Participants with history of Gilbert's disease must have total bilirubin =< 5 x institutional ULN (within 28 days prior to registration)
- Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) =< 3 × institutional ULN (within 28 days prior to registration)
- Participants must have adequate cardiac function, as assessed by the treating physician within 14 days prior to registration. Participants with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, must have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification and must not be assessed as class 3 or 4
- Participants with known diabetes must show evidence of controlled disease within 14 days prior to registration. Uncontrolled diabetes is defined as: A glycosylated hemoglobin (Hg)A1C > 7
- Participants with known human immunodeficiency virus (HIV)-infection must be receiving anti-retroviral therapy and have an undetectable viral load test on the most recent test result obtained, within 6 months prior to registration
- All participants with evidence of chronic hepatitis B virus (HBV) infection must have undetectable HBV viral load on suppressive therapy within 28 days prior to registration
- Participants with a history of hepatitis C virus (HCV) infection must have been treated and cured. For participants with HCV infection who are currently on treatment, participant must have an undetectable HCV viral load within 28 days prior to registration
- Participants must have an Eastern Cooperative Oncology Group (ECOG)/Zubrod performance status score of 0-2 (Note: Participants with ECOG/Zubrod performance score [PS] 3, especially where the deterioration of PS is considered secondary to the MM diagnosis, will be allowed)
- Participants must be offered the opportunity to participate in specimen banking. With participant consent, specimens must be collected and submitted via the Southwest Oncology Group (SWOG) specimen tracking system
- Participants who are able to complete the patient-reported outcomes measures in English or Spanish must agree to participate in the PRO portion of the study
- Participants must be informed of the investigational nature of this study and must sign and give informed consent in accordance with institutional and federal guidelines. For participants with impaired decision-making capabilities, legally authorized representatives may sign and give informed consent on behalf of study participants in accordance with applicable federal, local, and Central Institutional Review Board (CIRB) regulations
Who cannot join
- Participants must not have received any prior systemic therapy for multiple myeloma with the exception of any one or more of the following:
- An emergency use of a short course of corticosteroids (equivalent of dexamethasone 160 mg) any time before registration, or
- Up to one complete cycle of a non-daratumumab and hyaluronidase-fihj containing anti-myeloma regimen (1 cycle = 21 or 28 days depending on the regimen being used), or
- Localized palliative radiation therapy for multiple myeloma, as long as the radiation therapy is completed at least 3 days prior to starting the systemic treatment as per the study protocol.
- Participants must not have evidence of grade 4 peripheral neuropathy prior to study registration
- Participants must not have uncontrolled blood pressure within 14 days prior to registration. Uncontrolled blood pressure: systolic blood pressure (SBP) > 140 mmHg or diastolic blood pressure (DBP) > 90 mmHg. Participants are permitted to be receiving multiple anti-hypertensive medications (unless otherwise indicated in the study). All blood pressure measurements within the 14 days prior to registration must be SBP =< 140 and DBP =< 90. A participant with a single blood pressure elevation who upon rechecking has a normal blood pressure will remain eligible at the discretion of the registering investigator.
- Participants must not have a prior or concurrent malignancy whose natural history or treatment (in the opinion of the treating physician) has the potential to interfere with the safety or efficacy assessment of the investigational regimen.
- Participants must not be pregnant or nursing. Individuals who are of reproductive potential must have agreed to use an effective contraceptive method with details provided as a part of the consent process. A person who has had menses at any time in the preceding 24 consecutive months or who has semen likely to contain sperm is considered to be of "reproductive potential." In addition to routine contraceptive methods, "effective contraception" also includes refraining from sexual activity that might result in pregnancy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) including hysterectomy, bilateral oophorectomy, bilateral tubal ligation/occlusion, and vasectomy with testing showing no sperm in the semen.
Trial locations and contacts
397 sites in 1 country. Contact the study team or a site near you to ask about taking part.
300 sites in 1 country
United States300 sites, 292 recruiting
- Recruiting
Avera Cancer Institute-Aberdeen
Aberdeen, South Dakota, 57401
Site Public Contact, 605-622-8700, oncregulatory@avera.org
Xavier Andrade-Gonzalez
- Recruiting
Providence Regional Cancer System-Aberdeen
Aberdeen, Washington, 98520
Site Public Contact, 360-412-8958, deidre.dillon@providence.org
Charles W. Drescher
- Recruiting
Riverwood Healthcare Center
Aitkin, Minnesota, 56431
Site Public Contact, 218-786-3308, CancerTrials@EssentiaHealth.org
Bret E. Friday
- Recruiting
Lovelace Medical Center-Saint Joseph Square
Albuquerque, New Mexico, 87102
Site Public Contact, 505-272-0530, AYost@nmcca.org
Shashank Cingam
- Recruiting
University of New Mexico Cancer Center
Albuquerque, New Mexico, 87102
Site Public Contact, 505-925-0348, HSC-ClinicalTrialInfo@salud.unm.edu
Shashank Cingam
- Recruiting
Presbyterian Kaseman Hospital
Albuquerque, New Mexico, 87110
Site Public Contact, 505-559-6113, WBurman@phs.org
Shashank Cingam
- Recruiting
Lehigh Valley Hospital-Cedar Crest
Allentown, Pennsylvania, 18103
Site Public Contact, 610-402-9543, Morgan_M.Horton@lvhn.org
Elie G. Dib
- Recruiting
Saint Anthony's Health
Alton, Illinois, 62002
Site Public Contact, 618-463-5623
Jay W. Carlson
- Recruiting
Anchorage Associates in Radiation Medicine
Anchorage, Alaska, 98508
Site Public Contact, 907-212-6871, AKPAMC.OncologyResearchSupport@providence.org
Charles W. Drescher
- Recruiting
Anchorage Radiation Therapy Center
Anchorage, Alaska, 99504
Site Public Contact, 907-212-6871, AKPAMC.OncologyResearchSupport@providence.org
Charles W. Drescher
- Recruiting
Alaska Breast Care and Surgery LLC
Anchorage, Alaska, 99508
Site Public Contact, 907-212-6871, AKPAMC.OncologyResearchSupport@providence.org
Charles W. Drescher
- Recruiting
Alaska Oncology and Hematology LLC
Anchorage, Alaska, 99508
Site Public Contact, 907-212-6871, AKPAMC.OncologyResearchSupport@providence.org
Charles W. Drescher
- Recruiting
Alaska Women's Cancer Care
Anchorage, Alaska, 99508
Site Public Contact, 907-212-6871, AKPAMC.OncologyResearchSupport@providence.org
Charles W. Drescher
- Recruiting
Anchorage Oncology Centre
Anchorage, Alaska, 99508
Site Public Contact, 907-212-6871, AKPAMC.OncologyResearchSupport@providence.org
Charles W. Drescher
- Recruiting
Katmai Oncology Group
Anchorage, Alaska, 99508
Site Public Contact, 907-212-6871, AKPAMC.OncologyResearchSupport@providence.org
Charles W. Drescher
- Recruiting
Providence Alaska Medical Center
Anchorage, Alaska, 99508
Site Public Contact, 907-212-6871, AKPAMC.OncologyResearchSupport@providence.org
Charles W. Drescher
- Recruiting
Mission Cancer and Blood - Ankeny
Ankeny, Iowa, 50023
Site Public Contact, 515-282-2921
Richard L. Deming
- Recruiting
Saint Joseph Mercy Hospital
Ann Arbor, Michigan, 48106
Site Public Contact, 734-712-7251, MCRCwebsitecontactform@stjoeshealth.org
Elie G. Dib
- Recruiting
Langlade Hospital and Cancer Center
Antigo, Wisconsin, 54409
Site Public Contact, 715-623-9869, Juli.Alford@aspirus.org
Andrew J. Huang
- Recruiting
ThedaCare Regional Cancer Center
Appleton, Wisconsin, 54911
Site Public Contact, 920-364-3604, ResearchDept@thedacare.org
Yazhini Vallatharasu
- Recruiting
Mission Hope Medical Oncology - Arroyo Grande
Arroyo Grande, California, 93420
Site Public Contact, 720-874-1881, ResearchInstituteInquiries@CommonSpirit.org
Shahzad Siddique
- Recruiting
Duluth Clinic Ashland
Ashland, Wisconsin, 54806
Site Public Contact, 218-786-3308, CancerTrials@EssentiaHealth.org
Bret E. Friday
- Recruiting
Northwest Wisconsin Cancer Center
Ashland, Wisconsin, 54806
Site Public Contact, 218-786-3308, CancerTrials@EssentiaHealth.org
Bret E. Friday
- Recruiting
Rocky Mountain Regional VA Medical Center
Aurora, Colorado, 80045
Site Public Contact, 888-336-8262
Jessica D. McDermott
- Recruiting
Rush - Copley Medical Center
Aurora, Illinois, 60504
Site Public Contact, 630-978-6212, Cancer.Research@rushcopley.com
Maria T. Grosse-Perdekamp
- Recruiting
Saint Louis Cancer and Breast Institute-Ballwin
Ballwin, Missouri, 63011
Site Public Contact, 314-251-7058
Jay W. Carlson
- Recruiting
Greater Baltimore Medical Center
Baltimore, Maryland, 21204
Site Public Contact, 443-849-3706
Ari H. Elman
- Recruiting
Flaget Memorial Hospital
Bardstown, Kentucky, 40004
Site Public Contact, 720-874-1881, ResearchInstituteInquiries@CommonSpirit.org
Shahzad Siddique
- Recruiting
Bronson Battle Creek
Battle Creek, Michigan, 49017
Site Public Contact, 616-391-1230, crcwm-regulatory@crcwm.org
Kathleen J. Yost
- Recruiting
Essentia Health - Baxter Clinic
Baxter, Minnesota, 56425
Site Public Contact, 218-828-2880
Bret E. Friday
- Recruiting
Indu and Raj Soin Medical Center
Beavercreek, Ohio, 45431
Site Public Contact, 937-528-2900, clinical.trials@daytonncorp.org
Howard M. Gross
- Recruiting
PeaceHealth Saint Joseph Medical Center
Bellingham, Washington, 98225
Site Public Contact, 360-788-8223
Charles W. Drescher
- Recruiting
Sanford Joe Lueken Cancer Center
Bemidji, Minnesota, 56601
Site Public Contact, 218-333-5000, OncologyClinicalTrialsFargo@sanfordhealth.org
Daniel Almquist
- Recruiting
Saint Charles Health System
Bend, Oregon, 97701
Site Public Contact, 541-706-2909, nosall@stcharleshealthcare.org
Charles W. Drescher
- Recruiting
Lehigh Valley Hospital - Muhlenberg
Bethlehem, Pennsylvania, 18017
Site Public Contact, 610-402-9543, Morgan_M.Horton@lvhn.org
Elie G. Dib
- Recruiting
University of Iowa Healthcare Cancer Services Quad Cities
Bettendorf, Iowa, 52722
Site Public Contact, 563-355-7733, kedaprile@rccqc.com
Hira Shaikh
- Recruiting
Sanford Bismarck Medical Center
Bismarck, North Dakota, 58501
Site Public Contact, 701-323-5760, OncologyClinicalTrialsFargo@sanfordhealth.org
Daniel Almquist
- Recruiting
Saint Joseph Medical Center
Bloomington, Illinois, 61701
Site Public Contact, 309-243-3605, andersonj@illinoiscancercare.com
Bryan A. Faller
- Recruiting
Illinois CancerCare-Bloomington
Bloomington, Illinois, 61704
Site Public Contact, 309-243-3605, andersonj@illinoiscancercare.com
Bryan A. Faller
- Recruiting
Saint Elizabeth Boardman Hospital
Boardman, Ohio, 44512
Site Public Contact, 937-528-2900, clinical.trials@daytonncorp.org
Howard M. Gross
- Recruiting
Prisma Health Cancer Institute - Spartanburg
Boiling Springs, South Carolina, 29316
Site Public Contact, 864-241-6251
Suzanne R. Fanning
- Recruiting
Saint Luke's Cancer Institute - Boise
Boise, Idaho, 83712
Site Public Contact, 208-381-2774, eslinget@slhs.org
Charles W. Drescher
- Recruiting
Central Care Cancer Center - Bolivar
Bolivar, Missouri, 65613
Site Public Contact, 913-948-5588, aroland@kccop.org
Jay W. Carlson
- Recruiting
Essentia Health Saint Joseph's Medical Center
Brainerd, Minnesota, 56401
Site Public Contact, 218-786-3308, CancerTrials@EssentiaHealth.org
Bret E. Friday
- Recruiting
Cox Cancer Center Branson
Branson, Missouri, 65616
Site Public Contact, 417-269-4520
Jay W. Carlson
- Recruiting
Harrison Medical Center
Bremerton, Washington, 98310
Site Public Contact, 720-874-1881, ResearchInstituteInquiries@CommonSpirit.org
Shahzad Siddique
- Recruiting
Saint Joseph Mercy Brighton
Brighton, Michigan, 48114
Site Public Contact, 734-712-7251, MCRCwebsitecontactform@stjoeshealth.org
Elie G. Dib
- Recruiting
Trinity Health IHA Medical Group Hematology Oncology - Brighton
Brighton, Michigan, 48114
Site Public Contact, 734-712-7251, MCRCwebsitecontactform@stjoeshealth.org
Elie G. Dib
- Recruiting
Providence Saint Joseph Medical Center/Disney Family Cancer Center
Burbank, California, 91505
Site Public Contact, 818-847-4793, Najee.Boucher@providence.org
Charles W. Drescher
- Recruiting
Minnesota Oncology - Burnsville
Burnsville, Minnesota, 55337
Site Public Contact, 952-993-1517, mmcorc@healthpartners.com
David M. King
- Recruiting
Loyola Center for Health at Burr Ridge
Burr Ridge, Illinois, 60527
Site Public Contact, 708-216-9000
Patrick A. Hagen
- Recruiting
Cambridge Medical Center
Cambridge, Minnesota, 55008
Site Public Contact, 952-993-1517, mmcorc@healthpartners.com
David M. King
- Recruiting
Marshall Cancer Center
Cameron Park, California, 95682
Site Public Contact, 530-672-7050, cancerservices@marshallmedical.org
Aaron Rosenberg
- Recruiting
Illinois CancerCare-Canton
Canton, Illinois, 61520
Site Public Contact, 309-243-3605, andersonj@illinoiscancercare.com
Bryan A. Faller
- Recruiting
Saint Joseph Mercy Canton
Canton, Michigan, 48188
Site Public Contact, 734-712-7251, MCRCwebsitecontactform@stjoeshealth.org
Elie G. Dib
- Recruiting
Trinity Health IHA Medical Group Hematology Oncology - Canton
Canton, Michigan, 48188
Site Public Contact, 734-712-7251, MCRCwebsitecontactform@stjoeshealth.org
Elie G. Dib
- Recruiting
Saint Francis Medical Center
Cape Girardeau, Missouri, 63703
Site Public Contact, 573-334-2230, sfmc@sfmc.net
Bryan A. Faller
- Recruiting
Southeast Cancer Center
Cape Girardeau, Missouri, 63703
Site Public Contact, 573-651-5550
Bryan A. Faller
- Recruiting
Memorial Hospital of Carbondale
Carbondale, Illinois, 62902
Site Public Contact, 618-457-5200, clinical.research@sih.net
Bryan A. Faller
- Recruiting
IU Health North Hospital
Carmel, Indiana, 46032
Site Public Contact, 317-278-5632, iutrials@iu.edu
Attaya Suvannasankha
- Recruiting
Mercy Cancer Center - Carmichael
Carmichael, California, 95608
Site Public Contact, 720-874-1881, ResearchInstituteInquiries@CommonSpirit.org
Shahzad Siddique
- Recruiting
Mercy San Juan Medical Center
Carmichael, California, 95608
Site Public Contact, 916-556-3301, OncologyResearch@DignityHealth.org
Shahzad Siddique
- Recruiting
Caro Cancer Center
Caro, Michigan, 48723
Site Public Contact, 989-907-8411, lori.srebinski@ascension.org
Elie G. Dib
- Recruiting
SIH Cancer Institute
Carterville, Illinois, 62918
Site Public Contact, 618-985-3333, clinical.research@sih.net
Bryan A. Faller
- Recruiting
Illinois CancerCare-Carthage
Carthage, Illinois, 62321
Site Public Contact, 309-243-3605, andersonj@illinoiscancercare.com
Bryan A. Faller
- Recruiting
Physicians' Clinic of Iowa PC
Cedar Rapids, Iowa, 52402
Site Public Contact, 319-297-2900
Bharat Jenigiri
- Recruiting
Dayton Physicians LLC-Miami Valley South
Centerville, Ohio, 45459
Site Public Contact, 937-528-2900, clinical.trials@daytonncorp.org
Howard M. Gross
- Recruiting
Centralia Oncology Clinic
Centralia, Illinois, 62801
Site Public Contact, 217-876-4762, morganthaler.jodi@mhsil.com
Bryan A. Faller
- Recruiting
Saint Mary's Hospital
Centralia, Illinois, 62801
Site Public Contact, protocols@swog.org
Jay W. Carlson
- Recruiting
Providence Regional Cancer System-Centralia
Centralia, Washington, 98531
Site Public Contact, 360-412-8958, deidre.dillon@providence.org
Charles W. Drescher
- Recruiting
West Virginia University Charleston Division
Charleston, West Virginia, 25304
Site Public Contact, 304-388-9944
Ahmed A. Khalid
- Recruiting
Saint Joseph Mercy Chelsea
Chelsea, Michigan, 48118
Site Public Contact, 734-712-7251, MCRCwebsitecontactform@stjoeshealth.org
Elie G. Dib
- Recruiting
Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital
Chelsea, Michigan, 48118
Site Public Contact, 734-712-7251, MCRCwebsitecontactform@stjoeshealth.org
Elie G. Dib
- Recruiting
Marshfield Clinic-Chippewa Center
Chippewa Falls, Wisconsin, 54729
Site Public Contact, 800-782-8581, oncology.clinical.trials@marshfieldresearch.org
Seth O. Fagbemi
- Recruiting
Good Samaritan Hospital - Cincinnati
Cincinnati, Ohio, 45220
Site Public Contact, 720-874-1881, ResearchInstituteInquiries@CommonSpirit.org
Shahzad Siddique
- Recruiting
Oncology Hematology Care Inc-Kenwood
Cincinnati, Ohio, 45236
Site Public Contact, 937-528-2900, clinical.trials@daytonncorp.org
Howard M. Gross
- Recruiting
Bethesda North Hospital
Cincinnati, Ohio, 45242
Site Public Contact, 720-874-1881, ResearchInstituteInquiries@CommonSpirit.org
Shahzad Siddique
- Recruiting
TriHealth Cancer Institute-Westside
Cincinnati, Ohio, 45247
Site Public Contact, 720-874-1881, ResearchInstituteInquiries@CommonSpirit.org
Shahzad Siddique
- Recruiting
TriHealth Cancer Institute-Anderson
Cincinnati, Ohio, 45255
Site Public Contact, 720-874-1881, ResearchInstituteInquiries@CommonSpirit.org
Shahzad Siddique
- Recruiting
Clackamas Radiation Oncology Center
Clackamas, Oregon, 97015
Site Public Contact, 503-215-2614, CanRsrchStudies@providence.org
Charles W. Drescher
- Recruiting
Providence Cancer Institute Clackamas Clinic
Clackamas, Oregon, 97015
Site Public Contact, 503-215-2614, CanRsrchStudies@providence.org
Charles W. Drescher
- Recruiting
Hematology Oncology Consultants-Clarkston
Clarkston, Michigan, 48346
Site Public Contact, 734-712-7251, MCRCwebsitecontactform@stjoeshealth.org
Elie G. Dib
- Recruiting
Newland Medical Associates-Clarkston
Clarkston, Michigan, 48346
Site Public Contact, 734-712-7251, MCRCwebsitecontactform@stjoeshealth.org
Elie G. Dib
- Recruiting
Medical Oncology and Hematology Associates-West Des Moines
Clive, Iowa, 50325
Site Public Contact, 515-241-3305
Richard L. Deming
- Recruiting
Mercy Cancer Center-West Lakes
Clive, Iowa, 50325
Site Public Contact, 515-358-6613, cancerresearch@mercydesmoines.org
Richard L. Deming
- Recruiting
Penrose-Saint Francis Healthcare
Colorado Springs, Colorado, 80907
Site Public Contact, 720-874-1881, ResearchInstituteInquiries@CommonSpirit.org
Shahzad Siddique
- Recruiting
Rocky Mountain Cancer Centers-Penrose
Colorado Springs, Colorado, 80907
Site Public Contact, 720-874-1881, ResearchInstituteInquiries@CommonSpirit.org
Shahzad Siddique
- Recruiting
Saint Francis Cancer Center
Colorado Springs, Colorado, 80923
Site Public Contact, 720-874-1881, ResearchInstituteInquiries@CommonSpirit.org
Shahzad Siddique
- Recruiting
MD Anderson in The Woodlands
Conroe, Texas, 77384
Site Public Contact, 866-632-6789, askmdanderson@mdanderson.org
Jing Christine Ye
- Recruiting
Mercy Hospital
Coon Rapids, Minnesota, 55433
Site Public Contact, 952-993-1517, mmcorc@healthpartners.com
David M. King
- Recruiting
Bay Area Hospital
Coos Bay, Oregon, 97420
Site Public Contact, 541-269-8392, cherie.cox@bayareahospital.org
Charles W. Drescher
- Recruiting
Commonwealth Cancer Center-Corbin
Corbin, Kentucky, 40701
Site Public Contact, 720-874-1881, ResearchInstituteInquiries@CommonSpirit.org
Shahzad Siddique
- Suspended
Alegent Health Mercy Hospital
Council Bluffs, Iowa, 51503
- Recruiting
Greater Regional Medical Center
Creston, Iowa, 50801
Site Public Contact, 515-358-6613, cancerresearch@mercydesmoines.org
Richard L. Deming
- Recruiting
Northwest Cancer Center - Main Campus
Crown Point, Indiana, 46307
Site Public Contact, 219-310-2550
Maria T. Grosse-Perdekamp
- Recruiting
Carle at The Riverfront
Danville, Illinois, 61832
Site Public Contact, 800-446-5532, Research@Carle.com
Maria T. Grosse-Perdekamp
- Recruiting
Geisinger Medical Center
Danville, Pennsylvania, 17822
Site Public Contact, 570-271-5251, HemonCCTrials@geisinger.edu
Joseph J. Vadakara
- Recruiting
Dayton Physician LLC-Miami Valley Hospital North
Dayton, Ohio, 45415
Site Public Contact, 937-528-2900, clinical.trials@daytonncorp.org
Howard M. Gross
- Recruiting
Cancer Care Specialists of Illinois - Decatur
Decatur, Illinois, 62526
Site Public Contact, 217-876-4762, morganthaler.jodi@mhsil.com
Bryan A. Faller
- Recruiting
Decatur Memorial Hospital
Decatur, Illinois, 62526
Site Public Contact, 217-876-4762, morganthaler.jodi@mhsil.com
Bryan A. Faller
- Recruiting
Essentia Health - Deer River Clinic
Deer River, Minnesota, 56636
Site Public Contact, 218-786-3308, CancerTrials@EssentiaHealth.org
Bret E. Friday
- Suspended
Porter Adventist Hospital
Denver, Colorado, 80210
- Recruiting
Smilow Cancer Hospital-Derby Care Center
Derby, Connecticut, 06418
Site Public Contact, 203-785-5702, canceranswers@yale.edu
Elan Gorshein
- Recruiting
Mercy Medical Center - Des Moines
Des Moines, Iowa, 50314
Site Public Contact, 515-358-6613, cancerresearch@mercydesmoines.org
Richard L. Deming
- Recruiting
Mission Cancer and Blood - Laurel
Des Moines, Iowa, 50314
Site Public Contact, 515-241-3305
Richard L. Deming
- Recruiting
Ascension Saint John Hospital
Detroit, Michigan, 48236
Site Public Contact, 313-343-3166, karen.forman@ascension.org
Elie G. Dib
- Recruiting
Essentia Health Saint Mary's - Detroit Lakes Clinic
Detroit Lakes, Minnesota, 56501
Site Public Contact, 218-786-3308, CancerTrials@EssentiaHealth.org
Bret E. Friday
- Recruiting
Illinois CancerCare-Dixon
Dixon, Illinois, 61021
Site Public Contact, 815-285-7800
Bryan A. Faller
- Recruiting
Essentia Health Cancer Center
Duluth, Minnesota, 55805
Site Public Contact, 218-786-3308, CancerTrials@EssentiaHealth.org
Bret E. Friday
- Recruiting
Essentia Health Saint Mary's Medical Center
Duluth, Minnesota, 55805
Site Public Contact, 218-786-3308, CancerTrials@EssentiaHealth.org
Bret E. Friday
- Recruiting
Miller-Dwan Hospital
Duluth, Minnesota, 55805
Site Public Contact, 218-786-3308, CancerTrials@EssentiaHealth.org
Bret E. Friday
- Recruiting
Mercy Medical Center
Durango, Colorado, 81301
Site Public Contact, 720-874-1881, ResearchInstituteInquiries@CommonSpirit.org
Shahzad Siddique
- Recruiting
Southwest Oncology PC
Durango, Colorado, 81301
Site Public Contact, 720-874-1881, ResearchInstituteInquiries@CommonSpirit.org
Shahzad Siddique
- Recruiting
Northwest Oncology LLC
Dyer, Indiana, 46311
Site Public Contact, 219-924-8178
Maria T. Grosse-Perdekamp
- Recruiting
Prisma Health Cancer Institute - Easley
Easley, South Carolina, 29640
Site Public Contact, 864-522-2066, Kim.Williams3@prismahealth.org
Suzanne R. Fanning
- Recruiting
Great Lakes Cancer Management Specialists-Doctors Park
East China, Michigan, 48054
Site Public Contact, 313-343-3166, karen.forman@ascension.org
Elie G. Dib
- Recruiting
Pocono Medical Center
East Stroudsburg, Pennsylvania, 18301
Site Public Contact, 610-402-9543, Morgan_M.Horton@lvhn.org
Elie G. Dib
- Recruiting
Marshfield Medical Center-EC Cancer Center
Eau Claire, Wisconsin, 54701
Site Public Contact, 800-782-8581, oncology.clinical.trials@marshfieldresearch.org
Seth O. Fagbemi
- Recruiting
Fairview Southdale Hospital
Edina, Minnesota, 55435
Site Public Contact, 952-993-1517, mmcorc@healthpartners.com
David M. King
- Recruiting
Swedish Cancer Institute-Edmonds
Edmonds, Washington, 98026
Site Public Contact, 206-215-3086, PCRC-NCORP@Swedish.org
Charles W. Drescher
- Recruiting
Carle Physician Group-Effingham
Effingham, Illinois, 62401
Site Public Contact, 800-446-5532, Research@carle.com
Maria T. Grosse-Perdekamp
- Recruiting
Crossroads Cancer Center
Effingham, Illinois, 62401
Site Public Contact, 217-876-4762, morganthaler.jodi@mhsil.com
Bryan A. Faller
- Recruiting
Mercy Cancer Center - Elk Grove
Elk Grove, California, 95758
Site Public Contact, 720-874-1881, ResearchInstituteInquiries@CommonSpirit.org
Shahzad Siddique
- Recruiting
Essentia Health - Ely Clinic
Ely, Minnesota, 55731
Site Public Contact, 218-365-7900
Bret E. Friday
- Recruiting
Illinois CancerCare-Eureka
Eureka, Illinois, 61530
Site Public Contact, 309-243-3605, andersonj@illinoiscancercare.com
Bryan A. Faller
- Recruiting
Providence Regional Cancer Partnership
Everett, Washington, 98201
Site Public Contact, 425-261-3529, marilyn.birchman@providence.org
Charles W. Drescher
- Recruiting
Exeter Hospital
Exeter, New Hampshire, 03833
Site Public Contact, 800-439-3837
Cocav A. Rauwerdink
- Recruiting
Smilow Cancer Hospital Care Center-Fairfield
Fairfield, Connecticut, 06824
Site Public Contact, 203-785-5702, canceranswers@yale.edu
Elan Gorshein
- Recruiting
Essentia Health Cancer Center-South University Clinic
Fargo, North Dakota, 58103
Site Public Contact, 218-786-3308, CancerTrials@EssentiaHealth.org
Bret E. Friday
- Recruiting
Sanford South University Medical Center
Fargo, North Dakota, 58103
Site Public Contact, 701-234-6161
Daniel Almquist
- Recruiting
Southpointe-Sanford Medical Center Fargo
Fargo, North Dakota, 58103
Site Public Contact, 605-312-3320
Daniel Almquist
- Recruiting
Sanford Medical Center Fargo
Fargo, North Dakota, 58104
Site Public Contact, 800-437-4010
Daniel Almquist
- Recruiting
Sanford Broadway Medical Center
Fargo, North Dakota, 58122
Site Public Contact, 701-323-5760, OncologyClinicalTrialsFargo@sanfordhealth.org
Daniel Almquist
- Recruiting
Sanford Roger Maris Cancer Center
Fargo, North Dakota, 58122
Site Public Contact, 701-234-6161, OncologyClinicalTrialsFargo@sanfordhealth.org
Daniel Almquist
- Recruiting
Parkland Health Center - Farmington
Farmington, Missouri, 63640
Site Public Contact, 314-996-5569
Bryan A. Faller
- Recruiting
Armes Family Cancer Center
Findlay, Ohio, 45840
Site Public Contact, 937-528-2900, clinical.trials@daytonncorp.org
Howard M. Gross
- Recruiting
Blanchard Valley Hospital
Findlay, Ohio, 45840
Site Public Contact, 937-528-2900, clinical.trials@daytonncorp.org
Howard M. Gross
- Recruiting
Orion Cancer Care
Findlay, Ohio, 45840
Site Public Contact, 937-528-2900, clinical.trials@daytonncorp.org
Howard M. Gross
- Recruiting
Genesee Cancer and Blood Disease Treatment Center
Flint, Michigan, 48503
Site Public Contact, 810-762-8038, wstrong@ghci.org
Elie G. Dib
- Recruiting
Genesee Hematology Oncology PC
Flint, Michigan, 48503
Site Public Contact, 810-762-8038, wstrong@ghci.org
Elie G. Dib
- Recruiting
Genesys Hurley Cancer Institute
Flint, Michigan, 48503
Site Public Contact, 810-762-8038, wstrong@ghci.org
Elie G. Dib
- Recruiting
Hurley Medical Center
Flint, Michigan, 48503
Site Public Contact, 810-762-8038, wstrong@ghci.org
Elie G. Dib
- Recruiting
Holy Cross Hospital
Fort Lauderdale, Florida, 33308
Site Public Contact, eileen.georgi@holy-cross.com
Elie G. Dib
- Recruiting
Mercy Hospital Fort Smith
Fort Smith, Arkansas, 72903
Site Public Contact, 800-378-9373
Jay W. Carlson
- Recruiting
Essentia Health - Fosston
Fosston, Minnesota, 56542
Site Public Contact, 218-786-3308, CancerTrials@EssentiaHealth.org
Bret E. Friday
- Recruiting
Dayton Physicians LLC-Atrium
Franklin, Ohio, 45005
Site Public Contact, 937-528-2900, clinical.trials@daytonncorp.org
Howard M. Gross
- Active, not recruiting
Unity Hospital
Fridley, Minnesota, 55432
- Recruiting
Saint Luke's Cancer Institute - Fruitland
Fruitland, Idaho, 83619
Site Public Contact, 208-381-2774, eslinget@slhs.org
Charles W. Drescher
- Recruiting
Illinois CancerCare-Galesburg
Galesburg, Illinois, 61401
Site Public Contact, 309-243-3605, andersonj@illinoiscancercare.com
Bryan A. Faller
- Recruiting
Western Illinois Cancer Treatment Center
Galesburg, Illinois, 61401
Site Public Contact, 309-344-2831
Bryan A. Faller
- Recruiting
Central Care Cancer Center - Garden City
Garden City, Kansas, 67846
Site Public Contact, 913-948-5588, aroland@kccop.org
Jay W. Carlson
- Recruiting
Smilow Cancer Hospital Care Center at Glastonbury
Glastonbury, Connecticut, 06033
Site Public Contact, 203-785-5702, canceranswers@yale.edu
Elan Gorshein
- Recruiting
Helen DeVos Children's Hospital at Spectrum Health
Grand Rapids, Michigan, 49503
Site Public Contact, 616-267-1925, crcwm-regulatory@crcwm.org
Kathleen J. Yost
- Recruiting
Spectrum Health at Butterworth Campus
Grand Rapids, Michigan, 49503
Site Public Contact, 616-391-1230, crcwm-regulatory@crcwm.org
Kathleen J. Yost
- Recruiting
Trinity Health Grand Rapids Hospital
Grand Rapids, Michigan, 49503
Site Public Contact, 616-391-1230, crcwm-regulatory@crcwm.org
Kathleen J. Yost
- Recruiting
Central Care Cancer Center - Great Bend
Great Bend, Kansas, 67530
Site Public Contact, 913-948-5588, aroland@kccop.org
Jay W. Carlson
- Recruiting
Dayton Physicians LLC-Wayne
Greenville, Ohio, 45331
Site Public Contact, 937-528-2900, clinical.trials@daytonncorp.org
Howard M. Gross
- Recruiting
Wayne Hospital
Greenville, Ohio, 45331
Site Public Contact, 937-528-2900, clinical.trials@daytonncorp.org
Howard M. Gross
- Recruiting
Prisma Health Cancer Institute - Butternut
Greenville, South Carolina, 29605
Site Public Contact, 864-241-6251
Suzanne R. Fanning
- Recruiting
Prisma Health Cancer Institute - Faris
Greenville, South Carolina, 29605
Site Public Contact, 864-241-6251
Suzanne R. Fanning
- Recruiting
Prisma Health Cancer Institute - Eastside
Greenville, South Carolina, 29615
Site Public Contact, 864-241-6251
Suzanne R. Fanning
- Recruiting
Smilow Cancer Hospital Care Center at Greenwich
Greenwich, Connecticut, 06830
Site Public Contact, 203-785-5702, canceranswers@yale.edu
Elan Gorshein
- Recruiting
Prisma Health Cancer Institute - Greer
Greer, South Carolina, 29650
Site Public Contact, 864-241-6251
Suzanne R. Fanning
- Recruiting
Academic Hematology Oncology Specialists
Grosse Pointe Woods, Michigan, 48236
Site Public Contact, 313-343-3166, karen.forman@ascension.org
Elie G. Dib
- Recruiting
Great Lakes Cancer Management Specialists-Van Elslander Cancer Center
Grosse Pointe Woods, Michigan, 48236
Site Public Contact, 313-343-3166, karen.forman@ascension.org
Elie G. Dib
- Recruiting
Smilow Cancer Hospital Care Center - Guilford
Guilford, Connecticut, 06437
Site Public Contact, 203-785-5702, canceranswers@yale.edu
Elan Gorshein
- Recruiting
Smilow Cancer Hospital Care Center at Saint Francis
Hartford, Connecticut, 06105
Site Public Contact, 203-785-5702, canceranswers@yale.edu
Elan Gorshein
- Recruiting
Essentia Health-Hayward Clinic
Hayward, Wisconsin, 54843
Site Public Contact, 218-786-3308, CancerTrials@EssentiaHealth.org
Bret E. Friday
- Recruiting
Lehigh Valley Hospital-Hazleton
Hazleton, Pennsylvania, 18201
Site Public Contact, 610-402-9543, Morgan_M.Horton@lvhn.org
Elie G. Dib
- Recruiting
Essentia Health Hibbing Clinic
Hibbing, Minnesota, 55746
Site Public Contact, 218-786-3308
Bret E. Friday
- Recruiting
Edward Hines Jr VA Hospital
Hines, Illinois, 60141
Site Public Contact, 708-202-8387
Kathleen W. Phelan
- Recruiting
Northwest Cancer Center - Hobart
Hobart, Indiana, 46342
Site Public Contact, 219-947-1795
Maria T. Grosse-Perdekamp
- Recruiting
Saint Mary Medical Center
Hobart, Indiana, 46342
Site Public Contact, 219-836-6875, CancerResearch@COMHS.org
Maria T. Grosse-Perdekamp
- Recruiting
Loyola Medicine Homer Glen
Homer Glen, Illinois, 60491
Site Public Contact, 708-216-9000
Patrick A. Hagen
- Recruiting
Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center
Houston, Texas, 77030
Site Public Contact, 713-798-1354, burton@bcm.edu
Tareq Abuasab
- Recruiting
Ben Taub General Hospital
Houston, Texas, 77030
Site Public Contact, 713-873-2000
Tareq Abuasab
- Recruiting
M D Anderson Cancer Center
Houston, Texas, 77030
Site Public Contact, 877-632-6789, askmdanderson@mdanderson.org
Jing Christine Ye
- Recruiting
Michael E DeBakey VA Medical Center
Houston, Texas, 77030
Site Public Contact, 800-553-2278
Quillan Huang
- Recruiting
MD Anderson West Houston
Houston, Texas, 77079
Site Public Contact, 877-632-6789, askmdanderson@mdanderson.org
Jing Christine Ye
- Recruiting
Indiana University/Melvin and Bren Simon Cancer Center
Indianapolis, Indiana, 46202
Site Public Contact, 317-278-5632, iutrials@iu.edu
Attaya Suvannasankha
- Recruiting
Saint Catherine Hospital
Indianapolis, Indiana, 46312
Site Public Contact, protocols@swog.org
Maria T. Grosse-Perdekamp
- Recruiting
Essentia Health - International Falls Clinic
International Falls, Minnesota, 56649
Site Public Contact, 218-283-9431
Bret E. Friday
- Recruiting
University of Iowa/Holden Comprehensive Cancer Center
Iowa City, Iowa, 52242
Site Public Contact, 800-237-1225
Hira Shaikh
- Recruiting
Swedish Cancer Institute-Issaquah
Issaquah, Washington, 98029
Site Public Contact, 206-215-3086, PCRC-NCORP@Swedish.org
Charles W. Drescher
- Recruiting
Mayo Clinic in Florida
Jacksonville, Florida, 32224-9980
Site Public Contact, 855-776-0015
Sikander Ailawadhi
- Recruiting
Essentia Health - Jamestown Clinic
Jamestown, North Dakota, 58401
Site Public Contact, 218-786-3308, CancerTrials@EssentiaHealth.org
Bret E. Friday
- Recruiting
Capital Region Southwest Campus
Jefferson City, Missouri, 65109
Site Public Contact, 573-632-4851, amy.franken@health.missouri.edu
Bryan A. Faller
- Recruiting
Freeman Health System
Joplin, Missouri, 64804
Site Public Contact, 417-347-4030, LJCrockett@freemanhealth.com
Jay W. Carlson
- Recruiting
Mercy Hospital Joplin
Joplin, Missouri, 64804
Site Public Contact, 417-556-3074, esmeralda.carrillo@mercy.net
Jay W. Carlson
- Recruiting
Jupiter Medical Center
Jupiter, Florida, 33458
Site Public Contact, 561-745-5768
Ryan H. Devine
- Recruiting
Bronson Methodist Hospital
Kalamazoo, Michigan, 49007
Site Public Contact, 616-391-1230, crcwm-regulatory@crcwm.org
Kathleen J. Yost
- Recruiting
West Michigan Cancer Center
Kalamazoo, Michigan, 49007
Site Public Contact, 616-391-1230, crcwm-regulatory@crcwm.org
Kathleen J. Yost
- Recruiting
Ascension Borgess Cancer Center
Kalamazoo, Michigan, 49009
Site Public Contact, 616-391-1230, crcwm-regulatory@crcwm.org
Kathleen J. Yost
- Recruiting
Borgess Medical Center
Kalamazoo, Michigan, 49048
Site Public Contact, 616-391-1230, crcwm-regulatory@crcwm.org
Kathleen J. Yost
- Recruiting
Research Medical Center
Kansas City, Missouri, 64132
Site Public Contact, 913-948-5588, aroland@kccop.org
Suman Kambhampati
- Recruiting
CHI Health Good Samaritan
Kearney, Nebraska, 68847
Site Public Contact, 720-874-1881, ResearchInstituteInquiries@CommonSpirit.org
Shahzad Siddique
- Recruiting
Kadlec Clinic Hematology and Oncology
Kennewick, Washington, 99336
Site Public Contact, 509-783-4637, research@kadlecmed.org
Charles W. Drescher
- Recruiting
Greater Dayton Cancer Center
Kettering, Ohio, 45409
Site Public Contact, 937-528-2900, clinical.trials@daytonncorp.org
Howard M. Gross
- Recruiting
Kettering Medical Center
Kettering, Ohio, 45429
Site Public Contact, 937-528-2900, clinical.trials@daytonncorp.org
Howard M. Gross
- Recruiting
Illinois CancerCare-Kewanee Clinic
Kewanee, Illinois, 61443
Site Public Contact, 309-243-3605, andersonj@illinoiscancercare.com
Bryan A. Faller
- Recruiting
Gundersen Lutheran Medical Center
La Crosse, Wisconsin, 54601
Site Public Contact, 608-775-2385, cancerctr@gundersenhealth.org
David E. Marinier
- Recruiting
Providence Regional Cancer System-Lacey
Lacey, Washington, 98503
Site Public Contact, 360-412-8958, deidre.dillon@providence.org
Charles W. Drescher
- Recruiting
Marshfield Clinic - Ladysmith Center
Ladysmith, Wisconsin, 54848
Site Public Contact, 800-782-8581, oncology.clinical.trials@marshfieldresearch.org
Seth O. Fagbemi
- Recruiting
Saint Anthony Hospital
Lakewood, Colorado, 80228
Site Public Contact, 720-874-1881, ResearchInstituteInquiries@CommonSpirit.org
Shahzad Siddique
- Recruiting
University of Michigan Health - Sparrow Lansing
Lansing, Michigan, 48912
Site Public Contact, 517-364-3712, harsha.trivedi@umhsparrow.org
Elie G. Dib
- Recruiting
MD Anderson League City
League City, Texas, 77573
Site Public Contact, 877-632-6789, askmdanderson@mdanderson.org
Jing Christine Ye
- Recruiting
Geisinger Medical Oncology-Lewisburg
Lewisburg, Pennsylvania, 17837
Site Public Contact, 570-374-8555, HemonCCTrials@geisinger.edu
Joseph J. Vadakara
- Recruiting
Saint Joseph Hospital
Lexington, Kentucky, 40504
Site Public Contact, 720-874-1881, ResearchInstituteInquiries@CommonSpirit.org
Shahzad Siddique
- Recruiting
Saint Joseph Radiation Oncology Resource Center
Lexington, Kentucky, 40504
Site Public Contact, 720-874-1881, ResearchInstituteInquiries@CommonSpirit.org
Shahzad Siddique
- Recruiting
Saint Joseph Hospital East
Lexington, Kentucky, 40509
Site Public Contact, 720-874-1881, ResearchInstituteInquiries@CommonSpirit.org
Shahzad Siddique
- Suspended
Saint Elizabeth Regional Medical Center
Lincoln, Nebraska, 68510
- Recruiting
CARTI Cancer Center
Little Rock, Arkansas, 72205
Site Public Contact, 501-906-4199, Research@CARTI.com
Jay W. Carlson
- Suspended
John L McClellan Memorial Veterans Hospital
Little Rock, Arkansas, 72205
- Recruiting
University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205
Site Public Contact, 501-686-8274
Samer Al Hadidi
- Suspended
Littleton Adventist Hospital
Littleton, Colorado, 80122
- Recruiting
Trinity Health Saint Mary Mercy Livonia Hospital
Livonia, Michigan, 48154
Site Public Contact, 734-712-7251, MCRCwebsitecontactform@stjoeshealth.org
Elie G. Dib
- Recruiting
Saint Joseph London
London, Kentucky, 40741
Site Public Contact, 720-874-1881, ResearchInstituteInquiries@CommonSpirit.org
Shahzad Siddique
- Recruiting
Longmont United Hospital
Longmont, Colorado, 80501
Site Public Contact, 720-874-1881, ResearchInstituteInquiries@CommonSpirit.org
Shahzad Siddique
- Recruiting
PeaceHealth Saint John Medical Center
Longview, Washington, 98632
Site Public Contact, 360-514-2016, kmakin-bond@peacehealth.org
Charles W. Drescher
- Recruiting
Illinois CancerCare-Macomb
Macomb, Illinois, 61455
Site Public Contact, 309-243-3605, andersonj@illinoiscancercare.com
Bryan A. Faller
- Recruiting
Great Lakes Cancer Management Specialists-Macomb Medical Campus
Macomb, Michigan, 48044
Site Public Contact, 313-343-3166, karen.forman@ascension.org
Elie G. Dib
- Recruiting
Fairview Clinics and Surgery Center Maple Grove
Maple Grove, Minnesota, 55369
Site Public Contact, 952-993-1517, mmcorc@healthpartners.com
David M. King
- Recruiting
Minnesota Oncology Hematology PA-Maplewood
Maplewood, Minnesota, 55109
Site Public Contact, 952-993-1517, mmcorc@healthpartners.com
David M. King
- Recruiting
Saint John's Hospital - Healtheast
Maplewood, Minnesota, 55109
Site Public Contact, 952-993-1517, mmcorc@healthpartners.com
David M. King
- Recruiting
Saint Mary's Oncology/Hematology Associates of Marlette
Marlette, Michigan, 48453
Site Public Contact, 989-907-8411, lori.srebinski@ascension.org
Elie G. Dib
- Recruiting
Marshfield Medical Center-Marshfield
Marshfield, Wisconsin, 54449
Site Public Contact, 800-782-8581, oncology.clinical.trials@marshfieldresearch.org
Seth O. Fagbemi
- Recruiting
Sovah Health Martinsville
Martinsville, Virginia, 24115
Site Public Contact, 276-666-7489, sharon.hubbard@lpnt.net
Ana M. Ventura
- Recruiting
Fremont - Rideout Cancer Center
Marysville, California, 95901
Site Public Contact, 530-749-4400
Aaron Rosenberg
- Recruiting
Carle Physician Group-Mattoon/Charleston
Mattoon, Illinois, 61938
Site Public Contact, 800-446-5532, Research@carle.com
Maria T. Grosse-Perdekamp
- Recruiting
Loyola University Medical Center
Maywood, Illinois, 60153
Site Public Contact, 708-226-4357
Patrick A. Hagen
- Recruiting
Rogue Valley Medical Center
Medford, Oregon, 97504
Site Public Contact, 541-789-4673, research@asante.org
Alison D. Savage
- Recruiting
Aspirus Medford Hospital
Medford, Wisconsin, 54451
Site Public Contact, 715-847-2353, Beth.Knetter@aspirus.org
Andrew J. Huang
- Recruiting
Marjorie Weinberg Cancer Center at Loyola-Gottlieb
Melrose Park, Illinois, 60160
Site Public Contact, 708-450-4554
Patrick A. Hagen
- Recruiting
Mercy UC Davis Cancer Center
Merced, California, 95340
Site Public Contact, 720-874-1881, ResearchInstituteInquiries@CommonSpirit.org
Shahzad Siddique
- Recruiting
Saint Luke's Cancer Institute - Meridian
Meridian, Idaho, 83642
Site Public Contact, 208-381-2774, eslinget@slhs.org
Charles W. Drescher
- Recruiting
Abbott-Northwestern Hospital
Minneapolis, Minnesota, 55407
Site Public Contact, 952-993-1517, mmcorc@healthpartners.com
David M. King
- Recruiting
Hennepin County Medical Center
Minneapolis, Minnesota, 55415
Site Public Contact, 952-993-1517, mmcorc@healthpartners.com
David M. King
- Recruiting
Health Partners Inc
Minneapolis, Minnesota, 55454
Site Public Contact, 952-993-1517, mmcorc@healthpartners.com
David M. King
- Recruiting
Marshfield Clinic-Minocqua Center
Minocqua, Wisconsin, 54548
Site Public Contact, 800-782-8581, oncology.clinical.trials@marshfieldresearch.org
Seth O. Fagbemi
- Recruiting
Saint Patrick Hospital - Community Hospital
Missoula, Montana, 59802
Site Public Contact, 406-327-3118, amy.hanneman@providence.org
Charles W. Drescher
- Recruiting
Monticello Cancer Center
Monticello, Minnesota, 55362
Site Public Contact, 952-993-1517, mmcorc@healthpartners.com
David M. King
- Recruiting
Essentia Health - Moose Lake Clinic
Moose Lake, Minnesota, 55767
Site Public Contact, 218-485-4481
Bret E. Friday
- Recruiting
Saint Joseph Mount Sterling
Mount Sterling, Kentucky, 40353
Site Public Contact, 720-874-1881, ResearchInstituteInquiries@CommonSpirit.org
Shahzad Siddique
- Recruiting
Good Samaritan Regional Health Center
Mount Vernon, Illinois, 62864
Site Public Contact, 618-242-4600
Jay W. Carlson
- Recruiting
The Community Hospital
Munster, Indiana, 46321
Site Public Contact, 219-836-3349
Maria T. Grosse-Perdekamp
- Recruiting
Women's Diagnostic Center - Munster
Munster, Indiana, 46321
Site Public Contact, 219-934-8869, mnicholson@comhs.org
Maria T. Grosse-Perdekamp
- Recruiting
Trinity Health Muskegon Hospital
Muskegon, Michigan, 49444
Site Public Contact, 616-391-1230, crcwm-regulatory@crcwm.org
Kathleen J. Yost
- Recruiting
Saint Luke's Cancer Institute - Nampa
Nampa, Idaho, 83686
Site Public Contact, 208-381-2774, eslinget@slhs.org
Charles W. Drescher
- Recruiting
Providence Queen of The Valley
Napa, California, 94558
Site Public Contact, 707-521-3830
Charles W. Drescher
- Recruiting
Marshfield Medical Center - Neillsville
Neillsville, Wisconsin, 54456
Site Public Contact, 800-782-8581, oncology.clinical.trials@marshfieldresearch.org
Seth O. Fagbemi
- Recruiting
Smilow Cancer Center/Yale-New Haven Hospital
New Haven, Connecticut, 06510
Site Public Contact, 203-785-5702, canceranswers@yale.edu
Elan Gorshein
- Recruiting
Yale University
New Haven, Connecticut, 06520
Site Public Contact, 203-785-5702, canceranswers@yale.edu
Elan Gorshein
- Recruiting
Cancer Center of Western Wisconsin
New Richmond, Wisconsin, 54017
Site Public Contact, 952-993-1517, mmcorc@healthpartners.com
David M. King
- Recruiting
New Ulm Medical Center
New Ulm, Minnesota, 56073
Site Public Contact, 952-993-1517, mmcorc@healthpartners.com
David M. King
- Recruiting
NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center
New York, New York, 10032
Site Public Contact, 212-342-5162, cancerclinicaltrials@cumc.columbia.edu
Divaya Bhutani
- Recruiting
Providence Newberg Medical Center
Newberg, Oregon, 97132
Site Public Contact, 503-215-2614, CanRsrchStudies@providence.org
Charles W. Drescher
- Recruiting
Corewell Health Lakeland Hospitals - Niles Hospital
Niles, Michigan, 49120
Site Public Contact, 616-391-1230
Kathleen J. Yost
- Recruiting
Yale-New Haven Hospital North Haven Medical Center
North Haven, Connecticut, 06473
Site Public Contact, 203-785-5702, canceranswers@yale.edu
Elan Gorshein
- Recruiting
Cancer and Hematology Centers of Western Michigan - Norton Shores
Norton Shores, Michigan, 49444
Site Public Contact, 616-391-1230, connie.szczepanek@crcwm.org
Kathleen J. Yost
- Recruiting
Cancer Care Center of O'Fallon
O'Fallon, Illinois, 62269
Site Public Contact, 217-876-4762, morganthaler.jodi@mhsil.com
Bryan A. Faller
- Recruiting
HSHS Saint Elizabeth's Hospital
O'Fallon, Illinois, 62269
Site Public Contact, 217-876-4762, morganthaler.jodi@mhsil.com
Bryan A. Faller
- Not yet recruiting
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104
Site Public Contact, 405-271-8777, ou-clinical-trials@ouhsc.edu
Manu Pandey
- Recruiting
Mercy Hospital Oklahoma City
Oklahoma City, Oklahoma, 73120
Site Public Contact, 405-752-3402
Jay W. Carlson
- Recruiting
Alegent Health Immanuel Medical Center
Omaha, Nebraska, 68122
Site Public Contact, 720-874-1881, ResearchInstituteInquiries@CommonSpirit.org
Shahzad Siddique
- Recruiting
Alegent Health Bergan Mercy Medical Center
Omaha, Nebraska, 68124
Site Public Contact, 720-874-1881, ResearchInstituteInquiries@CommonSpirit.org
Shahzad Siddique
- Recruiting
Alegent Health Lakeside Hospital
Omaha, Nebraska, 68130
Site Public Contact, 720-874-1881, ResearchInstituteInquiries@CommonSpirit.org
Shahzad Siddique
- Recruiting
Creighton University Medical Center
Omaha, Nebraska, 68131
Site Public Contact, 720-874-1881, ResearchInstituteInquiries@CommonSpirit.org
Shahzad Siddique
- Recruiting
Providence Willamette Falls Medical Center
Oregon City, Oregon, 97045
Site Public Contact, 503-215-2614, CanRsrchStudies@providence.org
Charles W. Drescher
- Recruiting
Lake Regional Hospital
Osage Beach, Missouri, 65065
Site Public Contact, 573-302-2768, clinicaltrials@lakeregional.com
Jay W. Carlson
- Recruiting
Illinois CancerCare-Ottawa Clinic
Ottawa, Illinois, 61350
Site Public Contact, 309-243-3605, andersonj@illinoiscancercare.com
Bryan A. Faller
- Suspended
Midlands Community Hospital
Papillion, Nebraska, 68046
- Recruiting
Essentia Health - Park Rapids
Park Rapids, Minnesota, 56470
Site Public Contact, 218-786-3308, CancerTrials@EssentiaHealth.org
Bret E. Friday
- Suspended
Parker Adventist Hospital
Parker, Colorado, 80138
- Recruiting
Illinois CancerCare-Pekin
Pekin, Illinois, 61554
Site Public Contact, 309-243-3605, andersonj@illinoiscancercare.com
Bryan A. Faller
- Recruiting
Illinois CancerCare-Peoria
Peoria, Illinois, 61615
Site Public Contact, 309-243-3605, andersonj@illinoiscancercare.com
Bryan A. Faller
- Recruiting
Methodist Medical Center of Illinois
Peoria, Illinois, 61636
Site Public Contact, 309-243-3605, andersonj@illinoiscancercare.com
Bryan A. Faller
- Recruiting
Illinois CancerCare-Peru
Peru, Illinois, 61354
Site Public Contact, 309-243-3605, andersonj@illinoiscancercare.com
Bryan A. Faller
- Recruiting
Valley Radiation Oncology
Peru, Illinois, 61354
Site Public Contact, 815-664-4141
Bryan A. Faller
- Recruiting
Cancer Center at Saint Joseph's
Phoenix, Arizona, 85004
Site Public Contact, 720-874-1881, ResearchInstituteInquiries@CommonSpirit.org
Shahzad Siddique
- Recruiting
21st Century Oncology-Pontiac
Pontiac, Michigan, 48341
Site Public Contact, 248-858-6215, Emily.Crofts@trinity-health.org
Elie G. Dib
- Recruiting
Hope Cancer Center
Pontiac, Michigan, 48341
Site Public Contact, 734-712-7251, MCRCwebsitecontactform@stjoeshealth.org
Elie G. Dib
- Recruiting
Newland Medical Associates-Pontiac
Pontiac, Michigan, 48341
Site Public Contact, 734-712-7251, MCRCwebsitecontactform@stjoeshealth.org
Elie G. Dib
- Recruiting
Saint Joseph Mercy Oakland
Pontiac, Michigan, 48341
Site Public Contact, 734-712-7251, MCRCwebsitecontactform@stjoeshealth.org
Elie G. Dib
- Recruiting
Providence Portland Medical Center
Portland, Oregon, 97213
Site Public Contact, 503-215-2614, CanRsrchStudies@providence.org
Charles W. Drescher
- Recruiting
Providence Saint Vincent Medical Center
Portland, Oregon, 97225
Site Public Contact, 503-215-2614, CanRsrchStudies@providence.org
Charles W. Drescher
- Recruiting
Illinois CancerCare-Princeton
Princeton, Illinois, 61356
Site Public Contact, 309-243-3605, andersonj@illinoiscancercare.com
Bryan A. Faller
- Recruiting
Fairview Northland Medical Center
Princeton, Minnesota, 55371
Site Public Contact, 952-993-1517, mmcorc@healthpartners.com
David M. King
- Recruiting
Saint Mary Corwin Medical Center
Pueblo, Colorado, 81004
Site Public Contact, 720-874-1881, ResearchInstituteInquiries@CommonSpirit.org
Shahzad Siddique
- Recruiting
Saint Charles Health System-Redmond
Redmond, Oregon, 97756
Site Public Contact, 541-706-2909
Charles W. Drescher
- Recruiting
Corewell Health Reed City Hospital
Reed City, Michigan, 49677
Site Public Contact, 616-391-1230, crcwm-regulatory@crcwm.org
Kathleen J. Yost
- Recruiting
Ascension Saint Mary's Hospital
Rhinelander, Wisconsin, 54501
Site Public Contact, 715-847-2353, Beth.Knetter@aspirus.org
Andrew J. Huang
- Recruiting
Marshfield Medical Center-Rice Lake
Rice Lake, Wisconsin, 54868
Site Public Contact, 800-782-8581, oncology.clinical.trials@marshfieldresearch.org
Seth O. Fagbemi
- Recruiting
Reid Health
Richmond, Indiana, 47374
Site Public Contact, 937-528-2900, clinical.trials@daytonncorp.org
Howard M. Gross
- Recruiting
Virginia Cancer Institute
Richmond, Virginia, 23229
Site Public Contact, 804-287-3000, smoore@vacancer.com
Hashim Mann
- Recruiting
VCU Massey Cancer Center at Stony Point
Richmond, Virginia, 23235
Site Public Contact, ctoclinops@vcu.edu
Hashim Mann
- Recruiting
Virginia Commonwealth University/Massey Cancer Center
Richmond, Virginia, 23298
Site Public Contact, CTOclinops@vcu.edu
Hashim Mann
- Recruiting
Presbyterian Rust Medical Center/Jorgensen Cancer Center
Rio Rancho, New Mexico, 87124
Site Public Contact, 505-559-6113, WBurman@phs.org
Shashank Cingam
- Recruiting
North Memorial Medical Health Center
Robbinsdale, Minnesota, 55422
Site Public Contact, 952-993-1517, mmcorc@healthpartners.com
David M. King
- Recruiting
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
Site Public Contact, 855-776-0015
Sikander Ailawadhi
- Recruiting
University of Rochester
Rochester, New York, 14642
Site Public Contact, 585-275-5830
Paul M. Barr
About this study
Official title: A Phase III Randomized Trial for Newly Diagnosed Multiple Myeloma (NDMM) Patients Considered Frail or in a Subset of "Intermediate Fit" Comparing Upfront Three-Drug Induction Regimens Followed by Double or Single-Agent Maintenance
This phase III trial compares three-drug induction regimens followed by double-or single-drug maintenance therapy for the treatment of newly diagnosed multiple myeloma in patients who are not receiving a stem cell transplant and are considered frail or intermediate-fit based on age, comorbidities, and functional status. Treatment for multiple myeloma includes initial treatment (induction) which is the first treatment a patient receives for cancer followed by ongoing treatment (maintenance) which is given after initial treatment to help keep the cancer from coming back. There are three combinations of four different drugs being studied. Bortezomib is one of the drugs that may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Lenalidomide works by helping bone marrow to produce normal blood cells and killing cancer cells. Anti-inflammatory drugs, such as dexamethasone, lower the body's immune response and are used with other drugs in the treatment of some types of cancer. Daratumumab and hyaluronidase-fihj is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. Patients receive 1 of 3 combinations of these drugs for treatment to determine which combination of study drugs works better to shrink and control multiple myeloma.
Read the detailed description
PRIMARY OBJECTIVES:
- To compare progression-free survival (PFS) in frail or selected intermediate fit newly diagnosed multiple myeloma (NDMM) participants treated with bortezomib with lenalidomide and dexamethasone at reduced dosing (VRd-Lite) induction followed by lenalidomide maintenance (Arm 1) versus daratumumab and hyaluronidase-fihj with lenalidomide and dexamethasone (DRd) induction followed by lenalidomide maintenance (Arm 2).
II. To compare overall survival (OS) in frail or selected intermediate fit NDMM participants treated with VRd-Lite induction followed by lenalidomide maintenance (Arm 1) versus DRd induction followed by lenalidomide and daratumumab and hyaluronidase-fihj maintenance (Arm 3).
SECONDARY OBJECTIVES:
- To compare PFS in Arm 1 versus Arm 3 II. To compare OS in Arm 1 versus Arm 2. III. To compare PFS in Arm 2 versus 3. IV. To compare the overall response rate (ORR) of Arm 1 against the ORR of Arm 2 and Arm 3.
- To compare the safety of Arm 1 with the safety of Arm 2 and Arm 3. VI. To explore veinous thrombo-embolism (VTE) incidence in participants receiving lenalidomide during induction across the three study arms.
VII. To describe median time to response (complete response [CR] or better per International Myeloma Working Group [IMWG] criteria, very good partial response [VGPR] or better per IMWG criteria, partial response [PR] or better per IMWG criteria) on the three study arms.
PRIMARY QUALITY OF LIFE (QOL) OBJECTIVE:
- To compare patient-reported global health status between treatment arms (Arm 1 versus the combination of Arms 2 and 3) at 9 months after randomization (end of induction therapy) using the European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life Questionnaire (QLQ-C30).
SECONDARY QOL OBJECTIVE:
II. To compare longitudinal changes in global health status between treatment arms (Arm 1 versus the combination of Arms 2 and 3) from baseline to 9 months after randomization (end of induction therapy).
PATIENT REPORTED OUTCOMES-COMMON TERMINOLOGY CRITERIA FOR ADVERSE EVENTS (PRO-CTCAE) OBJECTIVE:
- To compare selected patient-reported outcome symptoms using PRO-CTCAE items among the 3 study arms.
ADDITIONAL OBJECTIVES:
- To compare the rate of minimal residual disease (MRD) by clonoSEQ after 9 cycles of induction in Arm 1 versus Arm 2 and Arm 3, respectively.
II. To compare the rate of MRD conversion after 1 year of maintenance in participants who were MRD positive after induction in Arm 1 versus Arm 2 and Arm 3, respectively.
III. To compare the rate of sustained MRD negativity at time points of post-induction, post-1 year maintenance in Arm 1 versus Arm 2 and Arm 3, respectively.
BANKING OBJECTIVES:
- To bank specimens for future correlative studies.
OUTLINE: Patients are randomized to 1 of 3 arms.
ARM I (VRd-Lite):
INDUCTION CYCLES 1-9: Patients receive bortezomib subcutaneously (SC) on days 1, 8, 15, and 22 of each cycle, lenalidomide orally (PO) on days 1-21 of each cycle, and dexamethasone PO on days 1, 8, 15, and 22 of each cycle. Treatment repeats every 28 days for up to 9 cycles in the absence of disease progression or unacceptable toxicity.
MAINTENANCE CYCLES 10+: Patients receive lenalidomide PO on days 1-21 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
ARM II (DRd-R):
INDUCTION CYCLES 1-9: Patients receive daratumumab and hyaluronidase-fihj SC on days 1, 8, 15, and 22 of cycles 1-2, days 1 and 15 of cycles 3-6, and day 1 of cycles 7-9, lenalidomide PO on days 1-21 of each cycle, and dexamethasone PO on days 1, 8, 15, and 22 of each cycle. Treatment repeats every 28 days for up to 9 cycles in the absence of disease progression or unacceptable toxicity.
MAINTENANCE CYCLES 10+: Patients receive lenalidomide PO on days 1-21 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
ARM III (DRd-DR):
INDUCTION CYCLES 1-9: Patients receive daratumumab and hyaluronidase-fihj SC on days 1, 8, 15, and 22 of cycles 1-2, days 1 and 15 of cycles 3-6, and day 1 of cycles 7-9, lenalidomide PO on days 1-21 of each cycle, and dexamethasone PO on days 1, 8, 15, and 22 of each cycle. Treatment repeats every 28 days for up to 9 cycles in the absence of disease progression or unacceptable toxicity.
MAINTENANCE CYCLES 10+: Patients receive daratumumab and hyaluronidase-fihj SC on day 1 of each cycle and lenalidomide PO on days 1-21 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every 3 months for 1 year, every 6 months for 2 years, and then annually for up to 10 years.
- Conditions
- Plasma Cell Myeloma
- Being tested
- Bortezomib, Daratumumab and Hyaluronidase-fihj, Dexamethasone, Lenalidomide, Quality-of-Life Assessment
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BortezomibDrug
Also called [(1R)-3-Methyl-1-[[(2S)-1-oxo-3-phenyl-2-[(pyrazinylcarbonyl)amino]propyl]amino]butyl]boronic Acid, LDP 341, MLN341, PS-341
Given SC
Daratumumab and Hyaluronidase-fihjDrug
Also called DARA Co-formulated with rHuPH20, DARA/rHuPH20, Daratumumab + rHuPH20, Daratumumab with rHuPH20
Given SC
DexamethasoneDrug
Also called Aacidexam, Adexone, Aknichthol Dexa, Alba-Dex
Given PO
LenalidomideDrug
Also called CC-5013, CC5013, CDC 501, Revlimid
Given PO
Quality-of-Life AssessmentOther
Also called Quality of Life Assessment
Ancillary studies
Questionnaire AdministrationOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| Arm I (VRd-Lite) | Active comparator | INDUCTION CYCLES 1-9: Patients receive bortezomib SC on days 1, 8, 15, and 22 of each cycle, lenalidomide PO on days 1-21 of each cycle, and dexamethasone PO on days 1, 8, 15, and 22 of each cycle. Treatment repeats every 28 days for up to 9 cycles in the absence of disease progression or unacceptable toxicity.
MAINTENANCE CYCLES 10+: Patients receive lenalidomide PO on days 1-21 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Receives: Drug: Bortezomib; Drug: Dexamethasone; Drug: Lenalidomide; Other: Quality-of-Life Assessment; Other: Questionnaire Administration |
| Arm II (DRd-R) | Experimental | INDUCTION CYCLES 1-9: Patients receive daratumumab and hyaluronidase-fihj SC on days 1, 8, 15, and 22 of cycles 1-2, days 1 and 15 of cycles 3-6, and day 1 of cycles 7-9, lenalidomide PO on days 1-21 of each cycle, and dexamethasone PO on days 1, 8, 15, and 22 of each cycle. Treatment repeats every 28 days for up to 9 cycles in the absence of disease progression or unacceptable toxicity.
MAINTENANCE CYCLES 10+: Patients receive lenalidomide PO on days 1-21 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Receives: Drug: Daratumumab and Hyaluronidase-fihj; Drug: Dexamethasone; Drug: Lenalidomide; Other: Quality-of-Life Assessment; Other: Questionnaire Administration |
| Arm III (DRd-DR): | Experimental | INDUCTION CYCLES 1-9: Patients receive daratumumab and hyaluronidase-fihj SC on days 1, 8, 15, and 22 of cycles 1-2, days 1 and 15 of cycles 3-6, and day 1 of cycles 7-9, lenalidomide PO on days 1-21 of each cycle, and dexamethasone PO on days 1, 8, 15, and 22 of each cycle. Treatment repeats every 28 days for up to 9 cycles in the absence of disease progression or unacceptable toxicity.
MAINTENANCE CYCLES 10+: Patients receive daratumumab and hyaluronidase-fihj SC on day 1 of each cycle and lenalidomide PO on days 1-21 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Receives: Drug: Daratumumab and Hyaluronidase-fihj; Drug: Dexamethasone; Drug: Lenalidomide; Other: Quality-of-Life Assessment; Other: Questionnaire Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression free survival (PFS) of Arm 1 versus (vs.) Arm 2
Analysis of each of the dual primary endpoints will be performed using a stratified log-rank test for comparison between arms. The analyses will be stratified according to frailty score (frail vs. intermediate fit), presence of one or more high-risk abnormalities by fluorescence in situ hybridization (iFISH) (yes vs. no), and prior therapy (yes vs. no). All eligible participants will be considered in analyses of the dual primary endpoints, according to their assigned arm at randomization.
Measured: From date of randomization to date of first documentation of progression or symptomatic deterioration, or death due to any cause, or assessed up to 10 years
Overall survival (OS) of Arm 1 vs. Arm 3
Analysis of each of the dual primary endpoints will be performed using a stratified log-rank test for comparison between arms. The analyses will be stratified according to frailty score (frail vs. intermediate fit), presence of one or more high-risk abnormalities by iFISH (yes vs. no), and prior therapy (yes vs. no). All eligible participants will be considered in analyses of the dual primary endpoints, according to their assigned arm at randomization.
Measured: From date of randomization to date of death due to any cause, or assessed up to 10 years
Secondary outcomes (9)
PFS
Analysis of PFS and OS endpoints will be performed using a stratified log-rank test for comparison between arms, with stratification according to frailty score (frail vs. intermediate fit) presence of one or more high-risk abnormalities by iFISH (yes vs. no) and prior therapy (yes vs. no).
Measured: From date of randomization to date of first documentation of progression or symptomatic deterioration, or death due to any cause, or assessed up to 10 years
OS
Analysis of PFS and OS endpoints will be performed using a stratified log-rank test for comparison between arms, with stratification according to frailty score (frail vs. intermediate fit) presence of one or more high-risk abnormalities by iFISH (yes vs. no) and prior therapy (yes vs. no).
Measured: From date of randomization to date of death due to any cause, or assessed up to 10 years
Overall response rate (ORR)
ORR is defined as the percentage of participants achieving a best response of partial response (PR) or better while on study. ORR will be reported with a binomial confidence interval. Time to response will be analyzed using the cumulative incidence competing risks method.
Measured: Up to 10 years
Time to complete response (CR)
All eligible participants will be considered in analyses of the secondary endpoints, according to their assigned arm at randomization, and with participants who go off-study prior to response assessment considered as non-responders for the analysis of response rate and as censored at the time of removal from study for the analysis of time to response. Time to response will be analyzed using the cumulative incidence competing risks method.
Measured: The time from the date of registration to the date of the first documented incidence of a response of CR or better, assessed up to 10 years
Time to very good partial response (VGFR)
All eligible participants will be considered in analyses of the secondary endpoints, according to their assigned arm at randomization, and with participants who go off-study prior to response assessment considered as non-responders for the analysis of response rate and as censored at the time of removal from study for the analysis of time to response. Time to response will be analyzed using the cumulative incidence competing risks method.
Measured: The time from the date of registration to the date of the first documented incidence of a response of VGPR or better, assessed up to 10 years
Time to PR
All eligible participants will be considered in analyses of the secondary endpoints, according to their assigned arm at randomization, and with participants who go off-study prior to response assessment considered as non-responders for the analysis of response rate and as censored at the time of removal from study for the analysis of time to response. Time to response will be analyzed using the cumulative incidence competing risks method.
Measured: The time from the date of registration to the date of the first documented incidence of a response of PR or better, assessed up to 10 years
Minimal residual disease (MRD)
The rate of MRD negativity will be calculated at each timepoint as the number of patients who are MRD negative divided by the number of patients who were eligible, analyzable and assessable for clinical response assessment at that timepoint. Rates of MRD negativity will be compared using a two-arm binomial test.
Measured: At 9 months of induction therapy and 1 year of maintenance therapy
Patient report out comes (PRO) quality-of-life (QOL)
We will use the European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 (version 3). This instrument includes questions broadly applicable to all cancer patients, assessing 5 functional domains (physical, role, cognitive, emotional, social) and 8 symptoms (fatigue, pain, nausea/vomiting, dyspnea, loss of appetite, insomnia, constipation, diarrhea), together with financial problems and global quality of life.
Measured: At baseline and months 1, 3, 9, and 18 after randomization
Patient-reported toxicity (PRO-Common Terminology Criteria for Adverse Events [CTCAE])
PRO-CTCAE is intended to enhance the quality of adverse event data reporting in clinical trials, provide data that complements and extends the information provided by clinician reporting using CTCAE, represent the patient perspective of the experience of symptomatic adverse events (AEs), and improve detection of potentially serious adverse events. Descriptive statistics will be used to summarize selected PRO-CTCAEs tabulated at each cycle overall and by arm. We will examine the extent to which PRO-CTCAEs with provider reported AEs are correlated and evaluate differences in incidence and worst severity.
Measured: At baseline, at each treatment cycle up to month 18 from randomization, and at discontinuation of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2022
- Study start12 Oct 2023
- Primary completion30 May 2031 (estimated)
- Study completion30 May 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Plasma Cell MyelomaStudies of the same condition, open and under way.
- More trials run by SWOG Cancer Research NetworkThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 510 participants (estimated)
Sponsor and investigators
- Lead sponsor
- SWOG Cancer Research Network
- Sponsor type
- Research network
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Sikander Ailawadhi, Principal investigator, SWOG Cancer Research Network
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05561387
- Sponsor's protocol ID
- S2209
- Other IDs
- NCI-2022-05722, S2209, S2209, U10CA180888
- Status last verified
- Jun 2026
- First submitted
- 27 Sep 2022
- Last updated
- 10 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III Randomized Trial for Newly Diagnosed Multiple Myeloma (NDMM) Patients Considered Frail or in a Subset of "Intermediate Fit" Comparing Upfront Three-Drug Induction Regimens Followed by Double or Single-Agent Maintenance
- ClinicalTrials.gov ID
- NCT05561387
- Acronym / sponsor ID
- S2209
- Conditions
- Plasma Cell Myeloma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 510 participants (estimated)
- Lead sponsor
- SWOG Cancer Research NetworkResearch network
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 12 Oct 2023 (actual)
- Primary completion
- 30 May 2031 (estimated)
- Study completion
- 30 May 2031 (estimated)
- First posted
- 30 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This phase III trial compares three-drug induction regimens followed by double-or single-drug maintenance therapy for the treatment of newly diagnosed multiple myeloma in patients who are not receiving a stem cell transplant and are considered frail or intermediate-fit based on age, comorbidities, and functional status. Treatment for multiple myeloma includes initial treatment (induction) which is the first treatment a patient receives for cancer followed by ongoing treatment (maintenance) which is given after initial treatment to help keep the cancer from coming back. There are three combinations of four different drugs being studied. Bortezomib is one of the drugs that may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Lenalidomide works by helping bone marrow to produce normal blood cells and killing cancer cells. Anti-inflammatory drugs, such as dexamethasone, lower the body's immune response and are used with other drugs in the treatment of some types of cancer. Daratumumab and hyaluronidase-fihj is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. Patients receive 1 of 3 combinations of these drugs for treatment to determine which combination of study drugs works better to shrink and control multiple myeloma.
Detailed description
PRIMARY OBJECTIVES:
- To compare progression-free survival (PFS) in frail or selected intermediate fit newly diagnosed multiple myeloma (NDMM) participants treated with bortezomib with lenalidomide and dexamethasone at reduced dosing (VRd-Lite) induction followed by lenalidomide maintenance (Arm 1) versus daratumumab and hyaluronidase-fihj with lenalidomide and dexamethasone (DRd) induction followed by lenalidomide maintenance (Arm 2).
II. To compare overall survival (OS) in frail or selected intermediate fit NDMM participants treated with VRd-Lite induction followed by lenalidomide maintenance (Arm 1) versus DRd induction followed by lenalidomide and daratumumab and hyaluronidase-fihj maintenance (Arm 3).
SECONDARY OBJECTIVES:
- To compare PFS in Arm 1 versus Arm 3 II. To compare OS in Arm 1 versus Arm 2. III. To compare PFS in Arm 2 versus 3. IV. To compare the overall response rate (ORR) of Arm 1 against the ORR of Arm 2 and Arm 3.
- To compare the safety of Arm 1 with the safety of Arm 2 and Arm 3. VI. To explore veinous thrombo-embolism (VTE) incidence in participants receiving lenalidomide during induction across the three study arms.
VII. To describe median time to response (complete response [CR] or better per International Myeloma Working Group [IMWG] criteria, very good partial response [VGPR] or better per IMWG criteria, partial response [PR] or better per IMWG criteria) on the three study arms.
PRIMARY QUALITY OF LIFE (QOL) OBJECTIVE:
- To compare patient-reported global health status between treatment arms (Arm 1 versus the combination of Arms 2 and 3) at 9 months after randomization (end of induction therapy) using the European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life Questionnaire (QLQ-C30).
SECONDARY QOL OBJECTIVE:
II. To compare longitudinal changes in global health status between treatment arms (Arm 1 versus the combination of Arms 2 and 3) from baseline to 9 months after randomization (end of induction therapy).
PATIENT REPORTED OUTCOMES-COMMON TERMINOLOGY CRITERIA FOR ADVERSE EVENTS (PRO-CTCAE) OBJECTIVE:
- To compare selected patient-reported outcome symptoms using PRO-CTCAE items among the 3 study arms.
ADDITIONAL OBJECTIVES:
- To compare the rate of minimal residual disease (MRD) by clonoSEQ after 9 cycles of induction in Arm 1 versus Arm 2 and Arm 3, respectively.
II. To compare the rate of MRD conversion after 1 year of maintenance in participants who were MRD positive after induction in Arm 1 versus Arm 2 and Arm 3, respectively.
III. To compare the rate of sustained MRD negativity at time points of post-induction, post-1 year maintenance in Arm 1 versus Arm 2 and Arm 3, respectively.
BANKING OBJECTIVES:
- To bank specimens for future correlative studies.
OUTLINE: Patients are randomized to 1 of 3 arms.
ARM I (VRd-Lite):
INDUCTION CYCLES 1-9: Patients receive bortezomib subcutaneously (SC) on days 1, 8, 15, and 22 of each cycle, lenalidomide orally (PO) on days 1-21 of each cycle, and dexamethasone PO on days 1, 8, 15, and 22 of each cycle. Treatment repeats every 28 days for up to 9 cycles in the absence of disease progression or unacceptable toxicity.
MAINTENANCE CYCLES 10+: Patients receive lenalidomide PO on days 1-21 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
ARM II (DRd-R):
INDUCTION CYCLES 1-9: Patients receive daratumumab and hyaluronidase-fihj SC on days 1, 8, 15, and 22 of cycles 1-2, days 1 and 15 of cycles 3-6, and day 1 of cycles 7-9, lenalidomide PO on days 1-21 of each cycle, and dexamethasone PO on days 1, 8, 15, and 22 of each cycle. Treatment repeats every 28 days for up to 9 cycles in the absence of disease progression or unacceptable toxicity.
MAINTENANCE CYCLES 10+: Patients receive lenalidomide PO on days 1-21 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
ARM III (DRd-DR):
INDUCTION CYCLES 1-9: Patients receive daratumumab and hyaluronidase-fihj SC on days 1, 8, 15, and 22 of cycles 1-2, days 1 and 15 of cycles 3-6, and day 1 of cycles 7-9, lenalidomide PO on days 1-21 of each cycle, and dexamethasone PO on days 1, 8, 15, and 22 of each cycle. Treatment repeats every 28 days for up to 9 cycles in the absence of disease progression or unacceptable toxicity.
MAINTENANCE CYCLES 10+: Patients receive daratumumab and hyaluronidase-fihj SC on day 1 of each cycle and lenalidomide PO on days 1-21 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every 3 months for 1 year, every 6 months for 2 years, and then annually for up to 10 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm I (VRd-Lite) | Active comparator | Drug: Bortezomib, Drug: Dexamethasone, Drug: Lenalidomide, Other: Quality-of-Life Assessment, Other: Questionnaire AdministrationINDUCTION CYCLES 1-9: Patients receive bortezomib SC on days 1, 8, 15, and 22 of each cycle, lenalidomide PO on days 1-21 of each cycle, and dexamethasone PO on days 1, 8, 15, and 22 of each cycle. Treatment repeats every 28 days for up to 9 cycles in the absence of disease progression or unacceptable toxicity. MAINTENANCE CYCLES 10+: Patients receive lenalidomide PO on days 1-21 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. |
| Arm II (DRd-R) | Experimental | Drug: Daratumumab and Hyaluronidase-fihj, Drug: Dexamethasone, Drug: Lenalidomide, Other: Quality-of-Life Assessment, Other: Questionnaire AdministrationINDUCTION CYCLES 1-9: Patients receive daratumumab and hyaluronidase-fihj SC on days 1, 8, 15, and 22 of cycles 1-2, days 1 and 15 of cycles 3-6, and day 1 of cycles 7-9, lenalidomide PO on days 1-21 of each cycle, and dexamethasone PO on days 1, 8, 15, and 22 of each cycle. Treatment repeats every 28 days for up to 9 cycles in the absence of disease progression or unacceptable toxicity. MAINTENANCE CYCLES 10+: Patients receive lenalidomide PO on days 1-21 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. |
| Arm III (DRd-DR): | Experimental | Drug: Daratumumab and Hyaluronidase-fihj, Drug: Dexamethasone, Drug: Lenalidomide, Other: Quality-of-Life Assessment, Other: Questionnaire AdministrationINDUCTION CYCLES 1-9: Patients receive daratumumab and hyaluronidase-fihj SC on days 1, 8, 15, and 22 of cycles 1-2, days 1 and 15 of cycles 3-6, and day 1 of cycles 7-9, lenalidomide PO on days 1-21 of each cycle, and dexamethasone PO on days 1, 8, 15, and 22 of each cycle. Treatment repeats every 28 days for up to 9 cycles in the absence of disease progression or unacceptable toxicity. MAINTENANCE CYCLES 10+: Patients receive daratumumab and hyaluronidase-fihj SC on day 1 of each cycle and lenalidomide PO on days 1-21 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (41 listed)
- Participants must have documented multiple myeloma satisfying standard International Myeloma Working Group (IMWG) diagnostic criteria within 28 days prior to registration
- Participants must have measurable disease within 28 days prior to registration as defined by any of the following:
- All disease must be assessed and documented on the baseline/pre-registration tumor assessment form
- Participants must have a calculated myeloma frailty index (Myeloma Frailty Score Calculator; http://www.myelomafrailtyscorecalculator.net/) categorized as frail or intermediate fit (regardless of age) within 28 days prior to registration
- For Participants Meeting "Frail" Status:
Key exclusion criteria (8 listed)
- Participants must not have received any prior systemic therapy for multiple myeloma with the exception of any one or more of the following:
- Participants must not have evidence of grade 4 peripheral neuropathy prior to study registration
- Participants must not have uncontrolled blood pressure within 14 days prior to registration. Uncontrolled blood pressure: systolic blood pressure (SBP) > 140 mmHg or diastolic blood pressure (DBP) > 90 mmHg. Participants are permitted to be receiving multiple anti-hypertensive medications (unless otherwise indicated in the study). All blood pressure measurements within the 14 days prior to registration must be SBP =< 140 and DBP =< 90. A participant with a single blood pressure elevation who upon rechecking has a normal blood pressure will remain eligible at the discretion of the registering investigator.
- Participants must not have a prior or concurrent malignancy whose natural history or treatment (in the opinion of the treating physician) has the potential to interfere with the safety or efficacy assessment of the investigational regimen.
- Participants must not be pregnant or nursing. Individuals who are of reproductive potential must have agreed to use an effective contraceptive method with details provided as a part of the consent process. A person who has had menses at any time in the preceding 24 consecutive months or who has semen likely to contain sperm is considered to be of "reproductive potential." In addition to routine contraceptive methods, "effective contraception" also includes refraining from sexual activity that might result in pregnancy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) including hysterectomy, bilateral oophorectomy, bilateral tubal ligation/occlusion, and vasectomy with testing showing no sperm in the semen.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BortezomibAlso: [(1R)-3-Methyl-1-[[(2S)-1-oxo-3-phenyl-2-[(pyrazinylcarbonyl)amino]propyl]amino]butyl]boronic Acid, LDP 341, MLN341, PS-341Given SC | Drug | Arm I (VRd-Lite) |
| Daratumumab and Hyaluronidase-fihjAlso: DARA Co-formulated with rHuPH20, DARA/rHuPH20, Daratumumab + rHuPH20, Daratumumab with rHuPH20Given SC | Drug | Arm II (DRd-R), Arm III (DRd-DR): |
| DexamethasoneAlso: Aacidexam, Adexone, Aknichthol Dexa, Alba-DexGiven PO | Drug | Arm I (VRd-Lite), Arm II (DRd-R), Arm III (DRd-DR): |
| LenalidomideAlso: CC-5013, CC5013, CDC 501, RevlimidGiven PO | Drug | Arm I (VRd-Lite), Arm II (DRd-R), Arm III (DRd-DR): |
| Quality-of-Life AssessmentAlso: Quality of Life AssessmentAncillary studies | Other | Arm I (VRd-Lite), Arm II (DRd-R), Arm III (DRd-DR): |
| Questionnaire AdministrationAncillary studies | Other | Arm I (VRd-Lite), Arm II (DRd-R), Arm III (DRd-DR): |
Primary outcome
Progression free survival (PFS) of Arm 1 versus (vs.) Arm 2
Time frame: From date of randomization to date of first documentation of progression or symptomatic deterioration, or death due to any cause, or assessed up to 10 years
Analysis of each of the dual primary endpoints will be performed using a stratified log-rank test for comparison between arms. The analyses will be stratified according to frailty score (frail vs. intermediate fit), presence of one or more high-risk abnormalities by fluorescence in situ hybridization (iFISH) (yes vs. no), and prior therapy (yes vs. no). All eligible participants will be considered in analyses of the dual primary endpoints, according to their assigned arm at randomization.
Overall survival (OS) of Arm 1 vs. Arm 3
Time frame: From date of randomization to date of death due to any cause, or assessed up to 10 years
Analysis of each of the dual primary endpoints will be performed using a stratified log-rank test for comparison between arms. The analyses will be stratified according to frailty score (frail vs. intermediate fit), presence of one or more high-risk abnormalities by iFISH (yes vs. no), and prior therapy (yes vs. no). All eligible participants will be considered in analyses of the dual primary endpoints, according to their assigned arm at randomization.
9 secondary outcomes
PFS
Time frame: From date of randomization to date of first documentation of progression or symptomatic deterioration, or death due to any cause, or assessed up to 10 years
OS
Time frame: From date of randomization to date of death due to any cause, or assessed up to 10 years
Overall response rate (ORR)
Time frame: Up to 10 years
Time to complete response (CR)
Time frame: The time from the date of registration to the date of the first documented incidence of a response of CR or better, assessed up to 10 years
Time to very good partial response (VGFR)
Time frame: The time from the date of registration to the date of the first documented incidence of a response of VGPR or better, assessed up to 10 years
Time to PR
Time frame: The time from the date of registration to the date of the first documented incidence of a response of PR or better, assessed up to 10 years
Minimal residual disease (MRD)
Time frame: At 9 months of induction therapy and 1 year of maintenance therapy
Patient report out comes (PRO) quality-of-life (QOL)
Time frame: At baseline and months 1, 3, 9, and 18 after randomization
Patient-reported toxicity (PRO-Common Terminology Criteria for Adverse Events [CTCAE])
Time frame: At baseline, at each treatment cycle up to month 18 from randomization, and at discontinuation of treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sikander Ailawadhi principal investigator
SWOG Cancer Research Network
397 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Bortezomib, Daratumumab and Hyaluronidase-fihj and Dexamethasone in people with Plasma Cell Myeloma, run by SWOG Cancer Research Network at 397 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 41 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 397 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sharon Palmer (210-614-8808, spalmer@swog.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression free survival (PFS) of Arm 1 versus (vs.) Arm 2 (time frame: From date of randomization to date of first documentation of progression or symptomatic deterioration, or death due to any cause, or assessed up to 10 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2026.