AzTrials
AzTrials

Multiple MyelomaPhase 3UPFRONTNCT00507416

Velcade,Thalidomide, and Dexamethasone Versus Velcade and Dexamethasone Versus Velcade, Melphalan, and Prednisone

A Phase 3 study testing Bortezomib, Dexamethasone and Melphalan in people with Multiple Myeloma, run by Millennium Pharmaceuticals, Inc. at 235 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

This is a randomized, open label, multicenter clinical trial to compare the efficacy and safety of Velcade (bortezomib) and dexamethasone versus Velcade, thalidomide, and dexamethasone versus Velcade, melphalan, and prednisone in patients with previously untreated multiple myeloma not considered candidates for… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Multiple Myeloma
What is being tested?
Bortezomib, Dexamethasone and Melphalan
Could I receive a placebo?
No, everyone receives an active treatment
How many people
502 participants
Where
235 sitesin 2 countries
Study dates
Jun 2007to Mar 2013
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Male or female 18 years of age or older
  • Not a candidate for high-dose chemotherapy and stem cell transplantation (HDT/SCT) due to age, presence of important comorbid condition(s) likely to have a negative impact on tolerability of HDT-SCT, or subject preference.
  • A Karnofsky Performance Status score of ≥50%
  • Symptomatic multiple myeloma or asymptomatic multiple myeloma with related organ or tissue damage.
  • Asymptomatic multiple myeloma-related organ or tissue damage can include presence of an asymptomatic lytic bone lesion or plasmacytoma, the presence of anemia (hemoglobin <10 g/dL), renal function impairment (serum creatinine > upper limit of normal [ULN]) or hypercalcemia (serum calcium >ULN).
  • Must have measurable disease requiring systemic therapy. Measurable disease is defined by at least 1 of the following criteria:
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  • Quantifiable serum M-protein value (>1 g/dL of immunoglobulin (Ig)G or IgM M-protein, >0.5g/dL of IgA M-protein, >0.5 g/dL of IgD M-protein)
  • Urine light-chain excretion ≥200 mg/24 hours
  • Voluntary written informed consent must be given before performance of any study related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the participant at any time without prejudice to future medical care.

Who cannot join

  • Diagnosis of smoldering multiple myeloma or monoclonal gammopathy of undetermined significance (MGUS). Smoldering multiple myeloma is defined as asymptomatic multiple myeloma with absence of lytic bone lesions. MGUS is defined by presence of serum monoclonal protein <3 g/dL; absence of lytic bone lesions, anemia, hypercalcemia, and renal insufficiency related to the monoclonal protein; and (if determined) proportion of plasma cells in the bone marrow of 10% or less.
  • Diagnosis of Waldenström's disease or other conditions in which immunoglobulin M (IgM) M-protein is present in the absence of a clonal plasma cell infiltration or lytic bone lesions.
  • Previously or currently treated with any systemic therapy for multiple myeloma. Prior treatment of hypercalcemia or spinal cord compression with corticosteroids or radiation therapy, respectively, does not disqualify the subject (the dose of corticosteroids should not exceed the equivalent of 160 mg of dexamethasone in 2-week period).
  • Radiation therapy within 2 weeks before randomization. Enrollment of patients who require concurrent radiotherapy (which must be localized in its field size) should be deferred until the radiotherapy is completed and 2 weeks have elapsed since the last date of therapy.
  • Major surgery within 30 days before randomization (Kyphoplasty is not considered major surgery)
  • History of allergy to any of the study medications, their analogues, or excipients in the various formulations
Show all 17Show fewer
  • ≥Grade 2 peripheral neuropathy on clinical examination within 21 days before enrollment.
  • Any of the following clinical laboratory values within 21 days prior to enrollment:
  • Absolute neutrophil count (ANC) <1000 cells/mm^3
  • Platelets <100,000 × 10^9/L, or <70 × 10^9/L if thrombocytopenia is considered by the investigator to be due to myeloma infiltration of bone marrow
  • Aspartate aminotransferase [serum glutamic oxaloacetic transaminase] (AST [SGOT]) or alanine aminotransferase [serum glutamic-pyruvic transaminase] (ALT [SGPT]) >2× the upper limit of normal (ULN)
  • Serum creatinine >2 mg/dL (>176.8 µmol/L); if the rise in creatinine is related to myeloma and there has been demonstrated a response to hydration, the subject may be enrolled.
  • Myocardial infarction within 6 months prior to enrollment or New York Hospital Association Class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or significant conduction system abnormalities in the opinion of the investigator. Prior to study entry, any abnormality on electrocardiogram at screening must be determined and documented by the investigator as not medically relevant.
  • Any condition, including laboratory abnormalities, that in the opinion of the Investigator places the patient at unacceptable risk if he/she were to participate in the study. This includes but is not limited to serious medical conditions or psychiatric illness likely to interfere with participation in this clinical study.
  • Prior malignancy except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, in situ breast cancer, in situ prostate cancer, or other cancer for which the patient has been disease-free for at least 3 years.
  • Female who is pregnant or breastfeeding. Female participants of childbearing potential must have a negative pregnancy test with a sensitivity of at least 50 mIU/mL during Screening.
  • Use of any investigational drugs within 30 days before randomization.

Trial locations and contacts

235 sites in 2 countries.

235 sites in 2 countries

United States234 sites

  • Texas Cancer Center

    Abilene, Texas, 79606-5208

  • Stratton VA Medical Center IRB

    Albany, New York, 12208

  • Christus St. Francis Cabrini Cancer Center

    Alexandria, Louisiana, 71301

  • McFarland Clinic, P.C.

    Ames, Iowa, 50010

  • Pacific Cancer Medical Centre

    Anaheim, California, 92801

  • Annapolis Oncology Center

    Annapolis, Maryland, 21401

  • Texas Oncology, P.A.

    Arlington, Texas, 76014

  • Cancer Care & Hematology Specialists of Chicagoland

    Arlington Heights, Illinois, 60005

  • Cancer Care of WNC

    Asheville, North Carolina, 28801

  • Medical Oncology Associates of Augusta

    Augusta, Georgia, 30901

  • Southwest Regional Cancer Center

    Austin, Texas, 78705

  • Texas Oncology, PA

    Austin, Texas, 78731

  • Greater Baltimore Medical Center

    Baltimore, Maryland, 21204

  • St. Agnes Health Care

    Baltimore, Maryland, 21229

  • Auerbach Hematology Oncology Associates

    Baltimore, Maryland, 21237

  • Maryland Hematology Oncology Association

    Baltimore, Maryland, 21237

  • Hematology-Oncology Clinic

    Baton Rouge, Louisiana, 70809

  • Texas Oncology, PA

    Beaumont, Texas, 77702

  • Texas Oncology, P.A.

    Bedford, Texas, 76022

  • Center for Cancer and Blood Disorders

    Bethesda, Maryland, 20817

  • Onc-Hem of Lehigh Valley, PC

    Bethlehem, Pennsylvania, 18015

  • Tower Cancer Research Foundation

    Beverly Hills, California, 90211-1850

  • Birmingham Hematology Oncology Assciates, LLC

    Birmingham, Alabama, 35205

  • St. Alexius Clinical Research Services

    Bismarck, North Dakota, 58501

  • The Center for Hematology-Oncology

    Boca Raton, Florida, 33486

  • St. Lukes Mountain States Tumor Institute

    Boise, Idaho, 83712

  • Boston Medical Center

    Boston, Massachusetts, 02118

  • Pasco Hernando Oncology

    Brooksville, Florida, 34613

  • Buffalo Institute for Medical Research, Inc.

    Buffalo, New York, 14215

  • Erie County Medical Center

    Buffalo, New York, 14215

  • Alamance Regional Medical Center

    Burlington, North Carolina, 27215

  • The University of Vermont

    Burlington, Vermont, 05401

  • Gabrail Cancer Center

    Canton, Ohio, 44718

  • Desert Oasis Cancer Center

    Casa Grande, Arizona, 85222

  • MUSC Hollings Cancer Center

    Charleston, South Carolina, 29425

  • Chattanooga Oncology Hematology Associates

    Chattanooga, Tennessee, 37404

  • Cancer Specialists of Tidewater

    Chesapeake, Virginia, 23320

  • St. Louis Cancer Center

    Chesterfield, Missouri, 63017

  • Hematology Oncology Associates of Illinois

    Chicago, Illinois, 60611

  • John H. Stroger, Jr. Hospital of Cook County

    Chicago, Illinois, 60612

  • University of Chicago

    Chicago, Illinois, 60637

  • Hematology Oncology Associates of Illinois

    Chicago, Illinois, 60657

  • Oncology Hematology Care, Inc.

    Cincinnati, Ohio, 45215

  • Oncology Partners Network

    Cincinnati, Ohio, 45247

  • University Hospitals of Cleveland

    Cleveland, Ohio, 44106

  • Oncology-Hematology Associates, P.A.

    Clinton, Maryland, 20735

  • The Family Cancer Center, PLLC

    Collierville, Tennessee, 38017

  • Maryland Oncology Hematology, PA

    Columbia, Maryland, 21044

  • Hematology Oncology Consultants Inc.

    Columbus, Ohio, 43235

  • The Cancer Center of Cookeville Regional Medical Center

    Cookeville, Tennessee, 38501

  • Northwest Oncology & Hematology Associates

    Coral Springs, Florida, 33065

  • Compassionate Cancer Care Medical Group

    Corona, California, 92882

  • Coastal Bend Cancer Center

    Corpus Christi, Texas, 73112

  • South Texas Institute of Cancer and Blood Disorders

    Corpus Christi, Texas, 78405

  • Heartland Hematology-Oncology Associates, Inc.

    Council Bluffs, Iowa, 51503

  • Texas Oncology

    Dallas, Texas, 75230-2510

  • Dallas Oncology Consultants

    Dallas, Texas, 75237

  • Texas Oncology, PA / Methodist Charlton Cancer Center

    Dallas, Texas, 75237

  • Texas Oncology PA

    Dallas, Texas, 75246

  • Commonwealth Cancer Center

    Danville, Kentucky, 40422

  • Dayton Clinical Oncology Program

    Dayton, Ohio, 45429

  • Texas Cancer Center

    Denton, Texas, 76210

  • Rocky Mountain Cancer Center

    Denver, Colorado, 80218

  • Henry Ford Health System

    Detroit, Michigan, 48202

  • St. Luke's Hospital

    Duluth, Minnesota, 55805

  • Hematology & Oncology Associates of NEPA

    Dunmore, Pennsylvania, 18512

  • Veterans Affairs New Jersey Healthcare System

    East Orange, New Jersey, 07018

  • Puget Sound Cancer Center - Edmonds

    Edmonds, Washington, 98026

  • El Paso Cancer Treatment Center

    El Paso, Texas, 79902

  • Elmhurst Memorial Hospital

    Elmhurst, Illinois, 60126

  • Drs. Forte, Schleider, Attas and Condemi, PA

    Englewood, New Jersey, 07631

  • Willamette Valley Cancer Center

    Eugene, Oregon, 97401

  • Deaconess Clinic Incorporated

    Evansville, Indiana, 47713

  • Providence Everett Medical Center

    Everett, Washington, 98201

  • Fairfax/Northern Virginia Hematology/Oncology

    Fairfax, Virginia, 22031

  • Blood and Cancer Clinic

    Fayetteville, North Carolina, 28304

  • Florida Cancer Specialists

    Fort Myers, Florida, 33901

  • Texas Cancer Center

    Fort Worth, Texas, 76104

  • Compassionate Cancer Care Medical Group, Inc.

    Fountain Valley, California, 92708

  • Robert A. Moss, MD, FACP, Inc.

    Fountain Valley, California, 92708

  • Cancer Care Associates

    Fresno, California, 93720

  • Texas Oncology, PA

    Garland, Texas, 75042

  • Gaston Hematology & Oncology

    Gastonia, North Carolina, 28054

  • The Jones Clinic

    Germantown, Tennessee, 38138

  • Glendale Memorial Hospital & Health Center

    Glendale, California, 91204

  • Goshen Medical Associates

    Goshen, New York, 10924

  • Cancer & Hematology Centers of Western Michigan

    Grand Rapids, Michigan, 49546

  • Lee C. Drinkard, MD

    Grapevine, Texas, 76051

  • Great Falls Clinic, LLP

    Great Falls, Montana, 59405

  • California Cancer Care

    Greenbrae, California, 94904

  • Cancer Center of the Carolinas

    Greenville, South Carolina, 29605

  • Oncology Hematology Associates of North Illinois Ltd.

    Gurnee, Illinois, 60031-3399

  • Kentucky Cancer Clinic

    Hazard, Kentucky, 41701

  • Las Vegas Cancer Center

    Henderson, Nevada, 89052

  • Carolina Oncology Specialist, PA

    Hickory, North Carolina, 28603

  • Emerywood Hematology/Oncology

    High Point, North Carolina, 27262

  • Beaver Medical Group

    Highland, California, 92346

  • Horizon Institute for Clinical Research

    Hollywood, Florida, 33021

  • Heritage Physician Group Oncology

    Hot Springs, Arkansas, 71913

  • Houston Cancer Institute

    Houston, Texas, 77055

  • Medicus Alliance Clinical Research Organization, LLC

    Houston, Texas, 77090

  • Huntington Medical Group

    Huntington Station, New York, 11746

  • Snake River Oncology of Eastern Idaho, PLLC.

    Idaho Falls, Idaho, 83404

  • Central Indiana Cancer Centers

    Indianapolis, Indiana, 46227

  • Investigative Clinical Research of Indiana, LLC

    Indianapolis, Indiana, 46254

  • Baptist Cancer Institute

    Jacksonville, Florida, 32207

  • University of Florida- Jacksonville

    Jacksonville, Florida, 32209

  • Capital Region Medical Center/Cancer Center

    Jefferson City, Missouri, 65109

  • Midwest Center for Hematology / Oncology

    Joliet, Illinois, 60432

  • Joliet Oncology-Hematology Associates, Ltd.

    Joliet, Illinois, 60435

  • Kalamazoo Hematology and Oncology

    Kalamazoo, Michigan, 49048

  • Heartland Hematology-Oncology Associates, Inc.

    Kansas City, Missouri, 64118

  • Kansas City Veterans Administration Medical Center

    Kansas City, Missouri, 64128

  • Dayton Oncology & Hematology

    Kettering, Ohio, 45409

  • Medical Oncology Associates

    Kingston, Pennsylvania, 18704

  • East Tennessee Oncology/Hematology

    Knoxville, Tennessee, 37920

  • University of Tennesee Medical Center

    Knoxville, Tennessee, 37920

  • Gundersen Clinic, Ltd.

    La Crosse, Wisconsin, 54601

  • Clarian Arnett Cancer Center

    Lafayette, Indiana, 47904

  • Edward A. Wagner, MD

    Laguna Beach, California, 92882

  • Cancer Care of North Florida

    Lake City, Florida, 32024

  • North Shore-Long Island Jewish Health System

    Lake Success, New York, 11042

  • Lakeland Regional Cancer Center

    Lakeland, Florida, 33805

  • Hematology Oncology Associates of Ohio & Michigan, PC

    Lambertville, Michigan, 48144

  • Regional Hematology Oncology Associates

    Langhorne, Pennsylvania, 19047

  • Breslin Cancer Center / Great Lakes Cancer Institute

    Lansing, Michigan, 48910

  • Comprehensive Cancer Centers of Nevada

    Las Vegas, Nevada, 89169

  • Cancer & Blood Disease Center

    Lecanto, Florida, 34461

  • Lake Vista Cancer Center

    Lewisville, Texas, 75067

  • Hematology Oncology Services of Arkansas

    Little Rock, Arkansas, 72205

  • St. Barnabas Medical Center

    Livingston, New Jersey, 07039

  • Longview Cancer Center

    Longview, Texas, 75601

  • Lynchburg Hematology Oncology Clinic, Inc.

    Lynchburg, Virginia, 24501

  • Central Georgia Cancer Care

    Macon, Georgia, 31201

  • Northwest Georgia Oncology Centers, P.C.

    Marietta, Georgia, 30060

  • Texas Cancer Center of Mesquite

    Mesquite, Texas, 75150

  • Texas Oncology, P.A.

    Midland, Texas, 79701

  • Metro MN CCOP

    Minneapolis, Minnesota, 55416

  • Clinical Trials and Research Associates, Inc.

    Montebello, California, 90640

  • Low Country Hematology & Oncology

    Mt. Pleasant, South Carolina, 29464

  • Medical Consultants, PC

    Muncie, Indiana, 47303

  • Hematology Oncology Consultants, Inc.

    Naperville, Illinois, 60540

  • Sarah Cannon Research Institute

    Nashville, Tennessee, 37203

  • Cancer Care Center

    New Albany, Indiana, 47150

  • Arena Oncology Associates

    New Hyde Park, New York, 11042

  • Pasco Hernando Oncology

    New Port Richey, Florida, 34652

  • Florida Cancer Institute

    New Port Richey, Florida, 34655

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10021

  • New York Presbyterian Hospital-Cornell Campus

    New York, New York, 10021

  • Christiana Care Health Services

    Newark, Delaware, 19718

  • Newark Beth Israel Hospital

    Newark, New Jersey, 07112

  • Peninsula Cancer Institute Riverside Cancer Center

    Newport News, Virginia, 23601

  • Cancer Care and Hematology Specialists of Chicagoland

    Niles, Illinois, 60714

  • Virginia Oncology Associates

    Norfolk, Virginia, 23502

  • Mid-Illinois Hem & Onc

    Normal, Illinois, 61761

  • Innovative Medical Research of South Florida Inc.

    North Miami Beach, Florida, 33179

  • Great Plains Regional Medical Center

    North Platte, Nebraska, 69101

  • Ocala Oncology Center

    Ocala, Florida, 34474

  • Cancer Centers of Florida, P.A.

    Ocoee, Florida, 34761

  • Texas Oncology - Odessa

    Odessa, Texas, 79761

  • Northern Utah Associates

    Ogden, Utah, 84403

  • Cancer Care Associates

    Oklahoma City, Oklahoma, 73112

  • Creighton Cancer Center

    Omaha, Nebraska, 68131-2137

  • Medical Oncology Care Associates

    Orange, California, 92868

  • MD Anderson Cancer Center Orlando

    Orlando, Florida, 32806

  • Kansas City Cancer Centers - Southwest

    Overland Park, Kansas, 66210

  • Ventura County Hematology Oncology Specialists

    Oxnard, California, 93030

  • Western Kentucky Hematology and Oncology Group

    Paducah, Kentucky, 42003

  • Paris Regional Cancer Center

    Paris, Texas, 75460

  • Greater Philadelphia Cancer and Hematology Specialists, PC

    Philadelphia, Pennsylvania, 19114

  • UPMC Cancer Pavillioin

    Pittsburgh, Pennsylvania, 15232

  • Hematology Oncology Associates of the Treasure Coast, PA

    Port Saint Lucie, Florida, 34952

  • Southwest Cancer Care

    Poway, California, 92064

  • Roger Williams Medical Center

    Providence, Rhode Island, 02908

  • Quincy Medical Group

    Quincy, Illinois, 62301

  • Raleigh Hematology Oncology / Associates, P.C.

    Raleigh, North Carolina, 27607

  • Desert Cancer Care, Incorporated

    Rancho Mirage, California, 92270

  • Virginia Cancer Institute

    Richmond, Virginia, 23230

  • Compassionate Cancer Care Medical Group, Inc.

    Riverside, California, 92501

  • Hubert H. Humphrey Cancer Center

    Robbinsdale, Minnesota, 55422

  • Interlakes Foundation, Inc.

    Rochester, New York, 14623

  • Sutter Cancer Center

    Sacramento, California, 95816

  • Oncology Care Associates, P.L.L.C.

    Saint Joseph, Michigan, 49085

  • St. Joseph Oncology

    Saint Joseph, Missouri, 64507

  • Oncology and Hematology Associates of Southwest Virginia, Inc.

    Salem, Virginia, 24153

  • Utah Cancer Specialists

    Salt Lake City, Utah, 84106

  • Cancer Care Network of South Texas

    San Antonio, Texas, 78217

  • Cancer Care Center of South Texas

    San Antonio, Texas, 78229

  • CTRC Institute for Drug Development

    San Antonio, Texas, 78245

  • New Mexico Cancer Care Associates

    Santa Fe, New Mexico, 87505

  • Summit Cancer Care

    Savannah, Georgia, 31405

  • Guthrie Research Institute

    Sayre, Pennsylvania, 18840

  • Scranton Hematology Oncology

    Scranton, Pennsylvania, 18510

  • Puget Sound Cancer Center, Inc

    Seattle, Washington, 98133

  • Northern Arizona Hematology & Oncology Associates - AOA

    Sedona, Arizona, 86336

  • Texas Cancer Center - Sherman

    Sherman, Texas, 75090

  • Siouxland Hematology/Oncology Assoc., LLP

    Sioux City, Iowa, 51101

  • Avera Research Institute

    Sioux Falls, South Dakota, 57105

  • Somerset Hematology Oncology Associates

    Somerville, New Jersey, 08876

  • Cancer Research & Prevention Center

    Soquel, California, 95073

  • Memorial Hospital of South Bend

    South Bend, Indiana, 46601

  • Providence Cancer Center

    Southfield, Michigan, 48075

  • Cancer Center of Central Connecticut

    Southington, Connecticut, 06489

  • Sparta Cancer Center

    Sparta, New Jersey, 07871

  • Cancer Care Northwest, US Oncology

    Spokane, Washington, 99202

  • Gulfcoast Oncology Associates

    St. Petersburg, Florida, 33705

  • Richmond University Medical Center

    Staten Island, New York, 10301

  • Stockton Hematology/Oncology

    Stockton, California, 95204

  • Santee Hematology/Oncology

    Sumter, South Carolina, 29150

  • SUNY Upstate Medical University

    Syracuse, New York, 13210

  • Northwest Medical Specialties, PLLC

    Tacoma, Washington, 98405

  • Hope Center

    Terre Haute, Indiana, 47802

  • Eastchester Center for Cancer Care

    The Bronx, New York, 10469

  • Toledo Community Hospital Oncology Program

    Toledo, Ohio, 43617

  • Arizona Oncology Associates

    Tucson, Arizona, 85704

  • Oklahoma Oncology and Hematology

    Tulsa, Oklahoma, 74136

  • Blood and Cancer Center of East Texas

    Tyler, Texas, 75701

  • Tyler Hematology/Oncology, PA

    Tyler, Texas, 75701

  • Texas Oncology, PA

    Tyler, Texas, 75702

  • New York Medical College

    Valhalla, New York, 10595

  • Texas Oncology

    Waco, Texas, 76712

  • Wenatchee Valley Medical Center

    Wenatchee, Washington, 98801

  • Alyce & Elmore Kraemer Cancer Center

    West Bend, Wisconsin, 53095

  • S. Florida Oncology/ Hematology

    West Palm Beach, Florida, 33458

  • Trivalley Oncology Hematology

    Westlake Village, California, 91361

  • Carroll County Cancer Center

    Westminster, Maryland, 21157

  • White River Junction VAMC

    White River Junction, Vermont, 05009-001

  • Cancer Center of Kansas

    Wichita, Kansas, 67214

  • Hanover Medical Specialists, P.A.

    Wilmington, North Carolina, 28401

  • Masoom Kandahari, MD, PC

    Woodbridge, Virginia, 22191

  • Osteopathic Medical Hematology & Oncology

    Woodhaven, Michigan, 48183

  • Trilogy Cancer Center

    Wooster, Ohio, 44691

  • Fallon Clinic at Worcester Medical Center

    Worcester, Massachusetts, 01608-1320

  • Yakima Valley Memorial Hospital / North Star Lodge

    Yakima, Washington, 98902

Other trials in United States

Puerto Rico1 site

  • Hospital Auxillo Mutuo, Auxilio Mutuo Cancer Center

    San Juan, 00919-1227

Other trials in Puerto Rico

About this study

Official title: Randomized Phase 3b Study of Three Treatment Regimens in Subjects With Previously Untreated Multiple Myeloma Who Are Not Considered Candidates for High-Dose Chemotherapy and Autologous Stem Cell Transplantation: VELCADE, Thalidomide, and Dexamethasone Versus VELCADE and Dexamethasone Versus VELCADE, Melphalan, and Prednisone

This is a randomized, open label, multicenter clinical trial to compare the efficacy and safety of Velcade (bortezomib) and dexamethasone versus Velcade, thalidomide, and dexamethasone versus Velcade, melphalan, and prednisone in patients with previously untreated multiple myeloma not considered candidates for high-dose chemotherapy and autologous stem cell transplantation.

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 Velcade

    Bortezomib bolus intravenous (IV) injection

  • DexamethasoneDrug

    Dexamethasone for oral administration

  • MelphalanDrug

    Melphalan for oral administration

  • PrednisoneDrug

    Prednisone for oral administration

  • ThalidomideDrug

    Thalidomide for oral administration

Study groups in NCT00507416
Study groupRoleWhat they receive
Bortezomib and Dexamethasone (VD)ExperimentalParticipants received bortezomib (Velcade) 1.3 mg/m^2 administered as a bolus intravenous (IV) injection on Days 1, 4, 8, and 11, and dexamethasone 20 mg orally on Days 1, 2, 4, 5, 8, 9, 11 and 12 for eight 21-day treatment cycles (Induction). Participants then received bortezomib 1.6 mg/^2 IV on Days 1, 8, 15 and 22 for five 35-day cycles (Maintenance).
Receives: Drug: Bortezomib; Drug: Dexamethasone
Bortezomib, Thalidomide, and Dexamethasone (VTD)ExperimentalParticipants received bortezomib (Velcade) 1.3 mg/m^2 administered as a bolus IV injection on Days 1, 4, 8, and 11, and dexamethasone 20 mg orally on Days 1, 2, 4, 5, 8, 9, 11 and 12, and thalidomide 100 mg orally on Days 1-21 for eight 21-day treatment cycles (Induction). Participants then received bortezomib 1.6 mg/^2 IV on Days 1, 8, 15 and 22 for five 35-day cycles (Maintenance) .
Receives: Drug: Bortezomib; Drug: Dexamethasone; Drug: Thalidomide
Bortezomib, Melphalan and Prednisone (VMP)ExperimentalParticipants received bortezomib (Velcade) 1.3 mg/m^2 administered as a bolus IV injection on Days 1, 4, 8, and 11, and melphalan 9 mg/m^2 orally on Days 1-4 every other cycle and prednisone 60 mg/m^2 orally on Days 1-4 every other cycle for eight 21-day treatment cycles (Induction). Participants then received bortezomib 1.6 mg/^2 IV on Days 1, 8, 15 and 22 for five 35-day cycles (Maintenance).
Receives: Drug: Bortezomib; Drug: Melphalan; Drug: Prednisone

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression Free Survival (PFS)

    PFS is defined as the time from randomization to disease progression or death, whichever occurs first. Participants who did not progress and were still alive at the cut-off date were censored at the date of last contact. Response was assessed by the Investigator using the International Myeloma Working Group (IMWG) uniform response criteria.

    Progressive disease requires 1 of the following:

    • Increase of ≥ 25% from nadir in:
    • Serum M-component (absolute increase ≥ 0.5 g/dl)
    • Urine M-component (absolute increase ≥ 200 mg/24 hours)
    • In patients without measurable serum and urine M-protein levels the difference between involved and uninvolved free light chain (FLC) levels (absolute increase > 100 mg/dl)
    • Bone marrow plasma cell percentage (absolute % ≥ 10%)
    • Development of new or increase in the size of existing bone lesions or soft tissue plasmacytomas.
    • Development of hypercalcemia (corrected serum calcium > 11.5 mg/dl) attributed solely to plasma cell proliferative disease

    Measured: From randomization until disease progression. Median follow-up time was 43 months.

Secondary outcomes (7)

  1. Percentage of Participants With an Overall Response

    Overall response defined as a best overall response of complete response (CR), very good partial response (VGPR) or partial response (PR), assessed by the Investigator using the IMWG uniform response criteria.

    CR: Negative immunofixation on the serum and urine, disappearance of any soft tissue plasmacytomas, and <5% plasma cells in bone marrow.

    VGPR: Serum and urine M-protein detectable by immunofixation but not on electrophoresis or ≥ 90% reduction in serum M-protein plus urine M-protein level <100 mg per 24 hours (h).

    PR requires 1 of the following:

    • ≥50% reduction of serum M-protein and 24-h urinary M-protein by ≥ 90% or to <200 mg/24 h, or
    • If M-protein not measurable, a ≥50% decrease in the difference between involved and uninvolved FLC levels, or
    • If FLC not measurable, a ≥ 50% reduction in plasma cells, provided baseline bone marrow plasma cell percentage was ≥30%.

    If present at baseline, a ≥50% reduction in the size of soft tissue plasmacytomas is also required.

    Measured: Response assessed every other cycle for up to 13 cycles (49 weeks).

  2. Percentage of Participants With a Complete Response

    Participants with a best overall response of complete response, defined as negative immunofixation on the serum and urine, disappearance of any soft tissue plasmacytomas, and <5% plasma cells in bone marrow. Response was assessed by the Investigator using the IMWG uniform response criteria.

    Measured: Response assessed every other cycle, for up to 13 cycles (49 weeks).

  3. Percentage of Participants With a Complete Response or a Very Good Partial Response

    Complete response is defined by negative immunofixation on the serum and urine, disappearance of any soft tissue plasmacytomas, and <5% plasma cells in bone marrow.

    Very good partial response is defined by serum and urine M-protein detectable by immunofixation but not on electrophoresis or 90% or greater reduction in serum M-protein plus urine M-protein level <100 mg per 24 hours.

    Response was assessed by the Investigator using the IMWG uniform response criteria.

    Measured: Response assessed every other cycle for up to 13 cycles (49 weeks).

  4. Duration of Response

    Duration of response is defined in participants with an overall response as the time between first documentation of response and disease progression. Responders without disease progression were censored at the last clinical assessment of response.

    Measured: From first documented response until disease progression. Median follow-up time was 43 months.

  5. Overall Survival

    Overall survival is defined as the time between randomization and death. Participants still alive at the cutoff date or lost to follow-up were censored at the date of last contact.

    Measured: From randomization until death. Median follow-up time was 43 months.

  6. Time to Alternative Therapy

    Time to alternative therapy is defined as the time between randomization and alternative therapy. Participants who did not receive alternative therapy were censored at the time of last contact.

    Measured: From randomization until alternative therapy. Median follow-up time was 43 months.

  7. Change From Baseline in EORTC QLQ-C30 - Global Health Status

    The European Organisation for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact).

    The EORTC QLQ-C30 Global Health Status/QOL Scale is scored between 0 and 100, where higher scores indicate better Global Health Status/QOL. Negative changes from baseline indicate deterioration in QOL or functioning and positive changes indicate improvement.

    Measured: Baseline and Day 1 of Cycles 3, 5, 7, 9, 11 and 13

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Jul 2007 (estimated)
  2. Study startJun 2007
  3. Primary completionMar 2013
  4. Study completionMar 2013

Resources

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
502 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00507416
Sponsor's protocol ID
C05009
Acronym
UPFRONT
Status last verified
Mar 2014
First submitted
25 Jul 2007
Last updated
1 May 2014

Publications

  • Niesvizky R, Flinn IW, Rifkin R, Gabrail N, Charu V, Clowney B, Essell J, Gaffar Y, Warr T, Neuwirth R, Zhu Y, Elliott J, Esseltine DL, Niculescu L, Reeves J. Community-Based Phase IIIB Trial of Three UPFRONT Bortezomib-Based Myeloma Regimens. J Clin Oncol. 2015 Nov 20;33(33):3921-9. doi: 10.1200/JCO.2014.58.7618. Epub 2015 Jun 8.

    PubMed 26056177

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Bortezomib, Dexamethasone and Melphalan in people with Multiple Myeloma, run by Millennium Pharmaceuticals, Inc. at 235 sites in 2 countries.

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 9 inclusion and 17 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: finished, as of the sponsor's last update on 1 May 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 235 sites in United States, Puerto Rico. 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?

Yes. Results are posted in the registry (first posted 1 May 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression Free Survival (PFS) (time frame: From randomization until disease progression. Median follow-up time was 43 months.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00507416, which also lists 1 linked publication.

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 1 May 2014.

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