Multiple MyelomaPhase 3NCT03652064
A Study Comparing Daratumumab, VELCADE (Bortezomib), Lenalidomide, and Dexamethasone (D-VRd) With VELCADE, Lenalidomide, and Dexamethasone (VRd) in Participants With Untreated Multiple Myeloma and for Whom Hematopoietic Stem Cell Transplant is Not Planned as Initial Therapy
A Phase 3 study testing Daratumumab, Bortezomib and Lenalidomide in people with Multiple Myeloma, run by Janssen Research & Development, LLC at 114 sites in 13 countries.
Trial summary
The purpose of this study to determine if the addition of daratumumab to bortezomib + lenalidomide + dexamethasone (VRd) will improve overall minimal residual disease (MRD) negativity rate compared with VRd alone. 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?
- Daratumumab, Bortezomib and Lenalidomide
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 395 participants
- Where
- 114 sitesin 13 countries
- Study dates
- 6 Nov 2018to 21 Apr 2026
- Phase
- Phase 3
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
- Diagnosis of multiple myeloma as documented per International Myeloma Working Group (IMWG) criteria Monoclonal plasma cells in the bone marrow greater than or equal to (>=)10 percentage (%) or presence of a biopsy proven plasmacytoma and documented multiple myeloma satisfying at least one of the calcium, renal, anemia, bone (CRAB) criteria or biomarkers of malignancy criteria. CRAB criteria: Hypercalcemia: serum calcium greater than (>) 0.25 millimoles per liter (mmol/L) (>1 milligram per deciliter [mg/dL]) higher than upper limit of normal (ULN) or >2.75 mmol/L (>11 mg/dL); Renal insufficiency: creatinine clearance less than (<) 40 milliliter per minute (mL/min) or serum creatinine >177 micro millimoles per liter (umol/L) (>2 mg/dL); Anemia: hemoglobin >2 g/dL below the lower limit of normal or hemoglobin <10 g/dL; Bone lesions: one or more osteolytic lesions on skeletal radiography, computed tomography (CT), or positron emission tomography (PET)-CT.
- Biomarkers of Malignancy: Clonal bone marrow plasma cell percentage >=60%; Involved: uninvolved serum free light chain (FLC) ratio >=100; >1 focal lesion on magnetic resonance imaging (MRI) studies
- Must have measurable disease, as assessed by central laboratory
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1, or 2
- A woman of childbearing potential must have 2 negative serum or urine pregnancy tests at Screening, first within 10 to 14 days prior to dosing and the second within 24 hours prior to dosing
- A woman must agree not to donate eggs (ova, oocytes) for the purposes of assisted reproduction during the study and for a period of 3 months after receiving the last dose of any component of the treatment regimen
Who cannot join
- Frailty index of >=2 according to Myeloma Geriatric Assessment score
- Prior therapy for multiple myeloma other than a short course of corticosteroids (not to exceed 40 mg of dexamethasone, or equivalent per day, total of 160 mg dexamethasone or equivalent)
- Prior or concurrent invasive malignancy (other than multiple myeloma) within 5 years of date of randomization (exceptions are adequately treated basal cell or squamous cell carcinoma of the skin, carcinoma in situ of the cervix or breast, or other non-invasive lesion that in the opinion of the investigator, with concurrence with the sponsor's medical monitor, is considered cured with minimal risk of recurrence within 3 years)
- Peripheral neuropathy or neuropathic pain Grade 2 or higher, as defined by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 5
- Focal radiation therapy within 14 days of randomization with the exception of palliative radiotherapy for symptomatic pain management. Radiotherapy within 14 days prior to randomization on measurable extramedullary plasmacytoma is not permitted even in the setting of palliation for symptomatic management
Trial locations and contacts
114 sites in 13 countries.
114 sites in 13 countries
United States19 sites
Tufts Medical Center
Boston, Massachusetts, 02111
Boston University Medical Center
Boston, Massachusetts, 02118
Roswell Park Cancer Institute
Buffalo, New York, 14263
Innovative Clinical Research Inc
Cerritos, California, 90703
Levine Cancer Institute
Charlotte, North Carolina, 28204
University of Virginia
Charlottesville, Virginia, 22908
Cleveland Clinic
Cleveland, Ohio, 44195
Good Samaritan Hospital Corvallis
Corvallis, Oregon, 97330
San Juan Oncology Associates
Farmington, New Mexico, 87401
Fort Wayne Medical Oncology and Hematology, Inc.
Fort Wayne, Indiana, 46804
Cancer And Hematology Centers of Western Michigan PC
Grand Rapids, Michigan, 49503
University of Texas, MD Anderson Cancer Center
Houston, Texas, 77030
Baptist MD Anderson
Jacksonville, Florida, 32207
Saint Lukes Hospital Saint Lukes Cancer Specialists
Kansas City, Missouri, 64111
Norton Healthcare
Louisville, Kentucky, 40207
NYU Winthrop
Mineola, New York, 11501
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, 08901
University Of Pittsburgh Medical Center UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, 15232 1301
Gibbs Cancer Center
Spartanburg, South Carolina, 29303
Japan13 sites
Fukuoka University Hospital
Fukuoka, 814-0180
Ogaki Municipal Hospital
Gifu, 503-8502
Kanazawa University Hospital
Kanazawa, 920 8641
Kobe City Medical Center General Hospital
Kobe, 650 0047
National Hospital Organization Kumamoto Medical Center
Kumamoto, 860-0008
University Hospital Kyoto Prefectural University of Medicine
Kyoto, 602-8566
National Hospital Organization Matsumoto Medical Center
Matsumoto, 399-8701
Matsuyama Red Cross Hospital
Matsuyama, 790-8524
Nagoya City University Hospital
Nagoya, 467 8602
National Hospital Organization Okayama Medical Center
Okayama, 701-1192
Japanese Red Cross Osaka Hospital
Osaka, 543 8555
National Hospital Organization Shibukawa Medical Center
Shibukawa, 377-0280
Japanese Red Cross Medical Center
Shibuya City, 150-8935
Brazil10 sites
Universidade Estadual De Campinas
Campinas, 13083-878
Liga Norte Riograndense Contra O Cancer
Natal, 59062 000
Uniao Brasileira de Educacao e Assistencia Hospital Sao Lucas da PUCRS
Porto Alegre, 90610-000
Ministerio da Saude Instituto Nacional do Cancer
Rio de Janeiro, 20230-130
Instituto de Educacao, Pesquisa e Gestao em Saude Instituto Americas (COI)
Rio de Janeiro, 22775 001
Instituto de Ensino e Pesquisa São Lucas
São Paulo, 01227-200
Real e Benemerita Associacao Portuguesa de Beneficencia
São Paulo, 01323 900
Instituto Brasileiro de Controle do Cancer - Sao Camilo Oncologia
São Paulo, 03102-002
Hospital Santa Cruz
São Paulo, 04122-000
Clinica Medica Sao Germano S/S LTDA
São Paulo, 04537-081
Poland10 sites
Szpital Specjalistyczny w Brzozowie Podkarpacki Osrodek Onkologiczny im Ks B Markiewicza
Brzozów, 36-200
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Zespol Szpitali Miejskich
Chorzów, 41-500
Uniwersyteckie Centrum Kliniczne
Gdansk, 80 214
Swietokrzyskie Centrum Onkologii SPZOZ w Kielcach
Kielce, 25 734
NSSU Szpital Uniwersytecki w Krakowie
Krakow, 30 688
Centrum Onkologii Ziemi Lubelskiej im sw Jana z Dukli
Lublin, 20090
Uniwersytecki Szpital Kliniczny w Poznaniu
Poznan, 60-569
Wojewodzki Szpital Specjalistyczny im. Janusza Korczaka
Słupsk, 76-200
Instytut Hematologii i Transfuzjologii
Warsaw, 02 776
Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut Badawczy
Warsaw, 02-781
Canada9 sites
Brampton Civic Hospital
Brampton, Ontario, L6R 3J7
Arthur J E Child Comprehensive Cancer Centre
Calgary, Alberta, T2N 5G2
Cross Cancer Institute
Edmonton, Alberta, T6G 1Z2
QEII Health Sciences Centre
Halifax, Nova Scotia, B3H 1V7
Victoria Hospital
London, Ontario, N6A 5W9
McGill University Health Centre
Montreal, Quebec, H4A 3J1
Lakeridge Health Oshawa
Oshawa, Ontario, L1G-2B9
CHU de Quebec L Hotel Dieu de Quebec
Québec, Quebec, G1J 1Z4
The Gordon & Leslie Diamond Health Care Center
Vancouver, British Columbia, V5Z 1M9
United Kingdom9 sites
Monklands District General Hospital
Airdrie, ML6 0JS
Blackpool Victoria Hospital
Blackpool, FY3 8NR
University Hospital Wales
Cardiff, CF14 4XN
Colchester Hospital University NHS
Colchester, CO4 5JL
Leicester Royal Infirmary - Haematology
Leicester, LE1 5WW
Altnagelvin Hospital
Londonderry, BT47 6SB
The Royal Oldham Hospital
Oldham, OL1 2JH
Derriford Hospital
Plymouth, PL6 8DH
New Cross Hospital
Wolverhampton, WV10 0QP
France8 sites
CHU Henri Mondor
Créteil, 94010
Centre Hospitalier Départmental La Roche sur Yon
La Roche-sur-Yon, 85925
Hopital Claude Huriez
Lille, 59037
Institut Paoli Calmettes
Marseille, 13009
CHU de Montpellier Hopital Saint Eloi
Montpellier, 34295
CHU de Bordeaux - Hospital Haut-Leveque
Pessac, 33604
Strasbourg Oncologie Libérale
Strasbourg, 67000
Institut Universitaire du cancer de Toulouse-Oncopole
Toulouse, 31059
Israel8 sites
Barzilai Medical Center
Ashkelon, 78741
Hillel Yaffe Medical Center
Hadera, 38100
Rambam Med.Center - Hematology Institute
Haifa, 3109601
Carmel Medical Center
Haifa, 3436212
Meir Hospital
Kfar Saba, 44281
Rabin Medical Center
Petah Tikva, 49100
Sheba Medical Center
Ramat Gan, 52621
Sourasky (Ichilov) Medical Center
Tel Aviv, 64239
Germany7 sites
phase 3 - Hämatoonkologischer Studienkreis am Klinikum Aschaffenburg
Aschaffenburg, 63739
Universitatsklinikum Freiburg
Freiburg im Breisgau, 79106
St. Josef-Krankenhaus Hamm-Bockum-Hövel
Hamm, 59075
Institut für Versorgungsforschung
Koblenz, 56068
Universitatsmedizin Leipzig
Leipzig, 4103
Klinikum Großhadern der Ludwig-Maximilians-Universität
München, 81377
Universitaetsklinikum Tuebingen der Eberhard-Karls-Universitaet, Abteilung fuer Innere Medizin II,
Tübingen, 72076
Turkey (Türkiye)7 sites
Gulhane Egitim ve Arastirma Hastanesi
Ankara, 06010
Dr Abdurrahman Yurtaslan Oncology Training and Research Hospital
Ankara, 06200
Hacettepe Universitesi Tip Fakultesi
Ankara, 06230
Ankara University School of Medicine Cebeci Hospital
Ankara, 06590
Istanbul University Istanbul Medical Faculty
Istanbul, 34093
Dokuz Eylul University Medical Faculty
Izmir, 35340
On Dokuz Mayis Universitesi Tip Fakultesi
Samsun, 55200
Spain6 sites
Hosp. Univ. Fundacion Alcorcon
Alcorcón, 28922
Hosp. Del Mar
Barcelona, 08003
Hosp. Univ. de Guadalajara
Guadalajara, 19002
Hosp. Univ. Pta. de Hierro Majadahonda
Majadahonda, 28222
Hosp. Quiron Madrid Pozuelo
Pozuelo de Alarcón, 28223
Hosp. Mutua Terrassa
Terrassa, 08221
Czechia5 sites
Fakultni nemocnice Brno
Brno, 625 00
Fakultni nemocnice Hradec Kralove
Hradec Králové, 500 05
Fakultni Nemocnice Ostrava
Ostrava, 708 52
Fakultni nemocnice Plzen, Hemato-onkologicke oddeleni
Pilsen, 323 00
Vseobecna fakultni nemocnice v Praze
Prague, 128 08
Netherlands3 sites
VU Medisch Centrum
Amsterdam, 1081 HV
Albert Schweitzer ziekenhuis-lokatie Dordwijk
Dordrecht, 3318 AT
Erasmus MC
Rotterdam, 3015CE
About this study
Official title: A Phase 3 Study Comparing Daratumumab, VELCADE (Bortezomib), Lenalidomide, and Dexamethasone (D-VRd) With VELCADE, Lenalidomide, and Dexamethasone (VRd) in Subjects With Untreated Multiple Myeloma and for Whom Hematopoietic Stem Cell Transplant is Not Planned as Initial Therapy
The purpose of this study to determine if the addition of daratumumab to bortezomib + lenalidomide + dexamethasone (VRd) will improve overall minimal residual disease (MRD) negativity rate compared with VRd alone.
Read the detailed description
This study will evaluate participants with newly diagnosed multiple myeloma (MM) for whom hematopoietic stem cell transplant is not planned as initial therapy. The data available from other available studies suggests that addition of daratumumab with Velcade (bortezomib), lenalidomide, and dexamethasone [VRd] is anticipated to improve the response rates and the depth of response and may lead to improved long-term outcomes in newly diagnosed participants with MM. Daratumumab targets CD38, a protein expressed on the surface of MM cells and other hematopoietic cells. Bortezomib is a proteasome inhibitor, which plays a critical role in the pathogenesis of MM. Lenalidomide has cytotoxic effects on myeloma cells and is capable of inducing apoptosis, or programmed cell death and dexamethasone induces apoptosis in MM cells. The rationale for the study is to utilize the subcutaneous (SC) formulation of daratumumab instead of the intravenous (IV) formulation, which is expected to provide similar exposure and is expected to limit additional toxicity to participants, treated with this quadruplet regimen. The study will consist of 3 phases: Screening (up to 28 days before randomization), Treatment phase (from Cycle 1 [21 days] Day 1 and continues until disease progression) and Follow up (Postintervention). Efficacy evaluations will include measurements of tumor burden/residual disease, myeloma proteins, bone marrow examinations, skeletal surveys, extramedullary plasmacytomas, and serum calcium corrected for albumin. Participants will undergo procedures like electrocardiogram (ECG), chest x-rays or full dose chest CT scans, Pulmonary function test (PFT), spirometry etc. during the course of study. Participants will also be monitored closely for adverse events (AEs), laboratory abnormalities, and clinical response. The duration of the study will be approximately 6.5 years.
- Conditions
- Multiple Myeloma
- Being tested
- Daratumumab, Bortezomib, Lenalidomide, Dexamethasone
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DaratumumabDrug
Also called JNJ-54767414, DARZALEX
Daratumumab (1800 mg) will be administered by SC injection once every week for Cycles 1 to 2, then every 3 weeks for Cycles 3-8. For Cycle 9 and beyond, participants will receive daratumumab 1800 mg SC once every 4 weeks until documented disease progression or unacceptable toxicity.
BortezomibDrug
Also called Velcade
Bortezomib 1.3 mg/m^2 will be administered by SC injection twice weekly on Days 1, 4, 8, and 11 of each 21-day cycle for Cycles 1-8.
LenalidomideDrug
Also called Revlimid
Lenalidomide will be self-administered at a dose of 25 mg orally on Day 1 to Day 14 for Cycles 1 through 8 and on Days 1 to 21 for Cycle 9 and beyond until disease progression or unacceptable toxicity whichever occurs first.
DexamethasoneDrug
Dexamethasone will be self-administered orally, 20 mg on Days 1, 2, 4, 5, 8, 9, 11, 12 of each 21-day cycle for Cycles 1-8. During Cycle 9 and beyond dexamethasone, will be self-administered orally at a total dose of 40 mg on Days 1, 8, 15, 22 of each 28-day cycle.
| Study group | Role | What they receive |
|---|---|---|
| Bortezomib + Lenalidomide + Dexamethasone (VRd) and Rd | Active comparator | Participants will receive bortezomib 1.3 milligram per square meter (mg/m^2) as subcutaneous (SC) injection twice weekly on Days 1, 4, 8, 11 for Cycles 1 through 8 (each cycle is of 21 days); lenalidomide 25 mg orally on Day 1 to Day 14 for Cycles 1 through 8 and on Days 1 to 21 for Cycle 9 (cycle of 28 days); dexamethasone 20 mg orally or intravenously on Days 1, 2, 4, 5, 8, 9, 11, 12 for Cycles 1 through 8 and 40 mg on Days 1,8, 15 and 22 during Cycle 9 and beyond (each cycle is of 28 days) followed by lenalidomide-dexamethasone (Rd) until disease progression or unacceptable toxicity. Participants aged greater than (>)75 years or body mass index (BMI) less than (<) 18.5 kilograms per meters (kg/m^2) will receive dexamethasone 20 mg oral tablets on Days 1, 4, 8, and 11 of each cycle. Receives: Drug: Bortezomib; Drug: Lenalidomide; Drug: Dexamethasone |
| Daratumumab + VRd (D-VRd) and DRd | Experimental | Participants will receive daratumumab 1800 mg as SC injection once every week for Cycles 1 to 2, then every 3 weeks for Cycles 3 through 8 and every 4 weeks for Cycle 9 and beyond; bortezomib 1.3 mg/m^2 as SC injection twice weekly on Days 1, 4, 8, 11 for Cycles 1 through 8 (each cycle is of 21 days); lenalidomide 25 mg orally on Day 1 to Day 14 for Cycles 1 through 8 and on Days 1 to 21 for Cycle 9; dexamethasone 20 mg orally or intravenously on Days 1, 2, 4, 5, 8, 9, 11, 12 for Cycles 1 through 8 and 40 mg on Days 1,8, 15 and 22 during Cycle 9 and beyond followed by daratumumab-lenalidomide-dexamethasone (DRd) until disease progression or unacceptable toxicity. Participants aged >75 years or BMI <18.5 kg/m^2 will receive Dexamethasone 20 mg oral tablets on Days 1, 4, 8, and 11 of each cycle. Receives: Drug: Daratumumab; Drug: Bortezomib; Drug: Lenalidomide; Drug: Dexamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Analysis: Overall Minimal Residual Disease (MRD) Negative Rate
Overall MRD negativity rate was defined as the percentage of participants who achieved complete response (CR) or better response and had MRD negative status (at 10^5) by bone marrow biopsy or aspirate after randomization but prior to progressive disease (PD), subsequent anti-myeloma therapy, or both. CR or better rate was defined as the percentage of participants achieving CR or stringent complete response (sCR) prior to subsequent anti-myeloma therapy in accordance with the International Myeloma Working Group (IMWG) criteria during or after the study treatment. CR was defined as negative immunofixation on the serum and urine, and disappearance of any soft tissue plasmacytomas, and less than (<) 5 percent (%) plasma cells (PCs) in bone marrow. sCR was defined as CR plus normal free light chain (FLC) ratio, and absence of clonal PCs by immunohistochemistry, immunofluorescence or 2- to 4-color flow cytometry.
Measured: From randomization (Day 1) up to 27.9 months
Final Progression-Free Survival (PFS) Analysis : Overall Minimal Residual Disease (MRD) Negative Rate
Overall MRD negativity rate was defined as the percentage of participants who achieved CR or better response and had MRD negative status (at 10^5) by bone marrow biopsy or aspirate after randomization but prior to PD, subsequent anti-myeloma therapy, or both. CR or better rate was defined as the percentage of participants achieving CR or sCR prior to subsequent anti-myeloma therapy in accordance with the IMWG criteria during or after the study treatment. CR was defined as negative immunofixation on the serum and urine, and disappearance of any soft tissue plasmacytomas, and < 5 % PCs in bone marrow. sCR was defined as CR plus normal FLC ratio, and absence of clonal PCs by immunohistochemistry, immunofluorescence or 2- to 4-color flow cytometry.
Measured: From randomization (Day 1) up to 64.8 months
Secondary outcomes (19)
Complete Response (CR) or Better Rate
Measured: From randomization (Day 1) up to 64.8 months
Progression-Free Survival (PFS)
Measured: From randomization (Day 1) up to 64.8 months
MRD Negativity Rate at 1 Year
Measured: At 1 Year
Overall Response Rate (ORR)
Measured: From randomization (Day 1) up to 64.8 months
Durable MRD Negative Rate
Measured: From randomization (Day 1) up to 64.8 months
Very Good Partial Response (VGPR) or Better Rate
Measured: From randomization (Day 1) up to 64.8 months
Duration of Response (DOR)
Measured: From randomization (Day 1) up to 64.8 months
Time to Response
Measured: From randomization (Day 1) up to 64.8 months
PFS on the Next Line of Therapy
Measured: From randomization (Day 1) up to 64.8 months
Overall Survival (OS)
Measured: From screening (-28 Days) up to 64.8 months
Overall MRD Negativity Rate in High-risk Molecular Subgroups
Measured: From randomization (Day 1) up to 64.8 months
PFS in High-risk Molecular Subgroups
Measured: From randomization (Day 1) up to 64.8 months
Maximum Observed Serum Concentration (Cmax) of Daratumumab
Measured: Predose on Day 1 and post dose on Day 4 of Cycles 1, 3 (each cycle consisted of 21 days); Predose on Day 1 of Cycles 9 and 12 (each cycle consisted of 28 days); Post treatment Week 8
Minimum Observed Serum Concentration (Cmin) of Daratumumab
Measured: Predose on Day 1 and post dose on Day 4 of Cycles 1 and 3 (each cycle consisted of 21 days); Predose on Day 1 of Cycles 9 and 12 (each cycle consisted of 28 days); Post treatment Week 8
Number of Participants With Anti-daratumumab Antibodies
Measured: Predose on Day 1 of Cycles 1, 9, and 12 (Cycle 1 consisted of 21 days, Cycles 9 and 12 consisted of 28 days); and Post-Treatment Week 8
Number of Participants With Anti-recombinant Human Hyaluronidase PH20 (Anti-rHuPH20) Antibodies
Measured: Predose on Day 1 of Cycles 1, 9, and 12 (Cycle 1 consisted of 21 days, Cycles 9 and 12 consisted of 28 days); and Post-Treatment Week 8
Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core-30 Item (EORTC QLQ-C30)
Measured: From screening (-28 Days) up to 64.8 months
Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Multiple Myeloma 20-item (EORTC QLQ-MY20)
Measured: From screening (-28 Days) up to 64.8 months
Mean Change From Baseline in EuroQol Five Dimension Five Level Questionnaire (EQ-5D-5L)
Measured: From screening (-28 Days) up to 64.8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2018
- Study start6 Nov 2018
- Primary completion7 May 2024
- Study completion21 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Multiple MyelomaStudies of the same condition, open and under way.
- More trials run by Janssen Research & Development, LLCThe 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
- 395 participants (actual)
Sponsor and investigators
- Lead sponsor
- Janssen Research & Development, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Janssen Research & Development, LLC Clinical Trial, Study director, Janssen Research & Development, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03652064
- Sponsor's protocol ID
- CR108529
- Other IDs
- 54767414MMY3019, 2018-001545-13, 2023-507312-13-00, 2023, 2018
- Status last verified
- May 2026
- First submitted
- 17 Aug 2018
- Last updated
- 2 Jun 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Usmani SZ, Facon T, Hungria V, Bahlis NJ, Venner CP, Braunstein M, Pour L, Marti JM, Basu S, Cohen YC, Matsumoto M, Suzuki K, Hulin C, Grosicki S, Legiec W, Beksac M, Maiolino A, Takamatsu H, Perrot A, Turgut M, Liu W, Wang J, Krevvata M, Stanziola J, Loi M, Van Brummelen EMJ, Lopez-Masi L, Rowe M, Carson RL, Zweegman S. Daratumumab Plus Bortezomib, Lenalidomide, and Dexamethasone in Newly Diagnosed Multiple Myeloma: Transplant-Ineligible Subgroup Analysis of CEPHEUS. J Clin Oncol. 2026 Sep 25:JCO2600401. doi: 10.1200/JCO-26-00401. Online ahead of print.
PubMed 42789828Zweegman S, Facon T, Hungria V, Bahlis NJ, Venner CP, Braunstein M, Pour L, Marti J, Basu S, Cohen YC, Matsumoto M, Suzuki K, Hulin C, Legiec WM, Beksac M, Maiolino A, Takamatsu H, Perrot A, Turgut M, Liu W, Wang J, Van Brummelen E, Krevvata M, Lopez-Masi L, Carey J, Borgsten F, Rowe M, Carson R, Usmani SZ. Daratumumab in Transplant-Ineligible or -Deferred Newly Diagnosed Multiple Myeloma: Minimal Residual Disease in CEPHEUS. Blood Adv. 2026 Jun 3:bloodadvances.2026019937. doi: 10.1182/bloodadvances.2026019937. Online ahead of print.
PubMed 42234958Usmani SZ, Facon T, Hungria V, Bahlis NJ, Venner CP, Braunstein M, Pour L, Marti JM, Basu S, Cohen YC, Matsumoto M, Suzuki K, Hulin C, Grosicki S, Legiec W, Beksac M, Maiolino A, Takamatsu H, Perrot A, Turgut M, Ahmadi T, Liu W, Wang J, Chastain K, Vermeulen J, Krevvata M, Lopez-Masi L, Carey J, Rowe M, Carson R, Zweegman S. Daratumumab plus bortezomib, lenalidomide and dexamethasone for transplant-ineligible or transplant-deferred newly diagnosed multiple myeloma: the randomized phase 3 CEPHEUS trial. Nat Med. 2025 Apr;31(4):1195-1202. doi: 10.1038/s41591-024-03485-7. Epub 2025 Feb 5.
PubMed 39910273Abdallah N, Kumar SK. Up-Front Treatment of Elderly (Age >/=75 Years) and Frail Patients With Multiple Myeloma. J Natl Compr Canc Netw. 2024 Nov;22(9):e247039. doi: 10.6004/jnccn.2024.7039.
PubMed 39536451