Study Comparing Daratumumab, Lenalidomide, and Dexamethasone With Lenalidomide and Dexamethasone in Participants With Previously Untreated Multiple Myeloma
A Phase 3 Study Comparing Daratumumab, Lenalidomide, and Dexamethasone (DRd) vs Lenalidomide and Dexamethasone (Rd) in Subjects With Previously Untreated Multiple Myeloma Who Are Ineligible for High Dose Therapy
3 other identifiers
interventional
737
12 countries
201
Brief Summary
The purpose of this study is to compare the efficacy of daratumumab in combination with lenalidomide and dexamethasone to that of lenalidomide and dexamethasone in terms of progression-free survival (PFS) in participants with newly diagnosed multiple myeloma (a blood cancer of plasma cells) who are not candidates for high dose chemotherapy (treatment of disease, usually cancer, by chemical agents) and autologous stem cell transplant (ASCT).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 multiple-myeloma
Started Feb 2015
Longer than P75 for phase_3 multiple-myeloma
201 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 11, 2014
CompletedFirst Posted
Study publicly available on registry
September 30, 2014
CompletedStudy Start
First participant enrolled
February 16, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 24, 2018
CompletedResults Posted
Study results publicly available
January 9, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
October 2, 2024
CompletedOctober 20, 2025
October 1, 2025
3.6 years
August 11, 2014
September 24, 2019
October 1, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Progression-free Survival (PFS)
PFS was defined as time from date of randomization to either progressive disease (PD) or death, whichever occurred first based on computerized algorithm as per IMWG criteria. PD was defined as an increase of 25 percent (%) from the lowest response value in one of the following: serum and urine M-component (absolute increase must be greater than or equal to \[\>=\] 0.5 gram per deciliter \[g/dL\] and \>=200 milligram \[mg\]/24 hours respectively); Only in participants without measurable serum and urine M-protein levels the difference between involved and uninvolved free light chain (FLC) levels (absolute increase must be greater than \[\>\]10 mg/dL); Definite development of new bone lesions or soft tissue plasmacytomas or definite increase in the size of existing bone lesions or soft tissue plasmacytomas; Development of hypercalcemia (corrected serum calcium \>11.5 mg/dL) that could be attributed solely to Plasma cell (PC) proliferative disorder.
From randomization (Day -3) to disease progression, death, subsequent anti-myeloma therapy, withdrawal of consent to study participation or clinical cut-off (CCO) whichever occurs first (up to 3.5 years)
Secondary Outcomes (16)
Percentage of Participants With Complete Response (CR) or Better
From randomization (Day -3) up to 6.6 years
Percentage of Participants With Very Good Partial Response (VGPR) or Better
From randomization (Day -3) up to 6.6 years
Percentage of Participants With Negative Minimal Residual Disease (MRD)
From randomization (Day -3) up to 6.6 years
Percentage of Participants With Stringent Complete Response (sCR)
From randomization (Day -3) up to 6.6 years
Overall Response Rate (ORR)
From randomization (Day -3) up to 6.6 years
- +11 more secondary outcomes
Study Arms (2)
Lenalidomide and Dexamethasone (Rd)
ACTIVE COMPARATORParticipants will receive Lenalidomide 25 mg capsule orally on Day 1 through Day 21 of each 28-day cycle, Dexamethasone 40 mg orally or intravenously once a week. Study treatment continues until disease progression, unacceptable toxicity, or end of study (maximum up to 7 years after last subject is randomized) whichever comes first.
Daratumumab + Lenalidomide + Dexamethasone (DRd)
ACTIVE COMPARATORParticipants will receive Daratumumab 16 milligram per kilogram (mg/kg) by intravenous infusion, once a week for 8 weeks, then once every other week for 16 weeks, thereafter once every 4 weeks, Lenalidomide 25 mg capsule orally on Day 1 through Day 21 of each 28-day cycle, Dexamethasone 40 mg orally or intravenously once a week. Following implementation of protocol amendment 8, participants still receiving treatment with daratumumab IV will have the option to switch to daratumumab SC on Day 1 of any cycle, at the discretion of the investigator. Daratumumab subcutaneous (SC) will be administered by SC injection at a fixed dose of 1800 mg once every 4 weeks until documented progression, unacceptable toxicity, or study completion. Study treatment continues until disease progression, unacceptable toxicity, or end of study (maximum up to 7 years after last subject is randomized) whichever comes first.
Interventions
Daratumumab will be administered at a dose of 16 milligram per kilogram (mg/kg) by intravenous (IV) infusion, once a week for 8 weeks, then once every other week for 16 weeks, thereafter once every 4 weeks until documented progression of disease, unacceptable toxicity, or end of study (maximum up to 7 years).
Lenalidomide 25 mg capsule orally on Day 1 through Day 21 of each 28-day cycle.
Dexamethasone 40 mg orally or intravenously once in a week.
Daratumumab SC will be administered by SC injection at a fixed dose of 1800 mg once every 4 weeks until documented progression, unacceptable toxicity, or study end. Following implementation of protocol amendment 8, participants still receiving treatment with daratumumab IV will have the option to switch to daratumumab SC on Day 1 of any cycle, at the discretion of the investigator.
Eligibility Criteria
You may qualify if:
- Participant must have documented multiple myeloma satisfying the CRAB (calcium elevation, renal insufficiency, anemia and bone abnormalities) criteria, monoclonal plasma cells in the bone marrow greater than or equal to (\>=) 10 percent (%) or presence of a biopsy proven plasmacytoma and measurable disease as defined by any of the following: (a) immunoglobulin (Ig) G myeloma (serum monoclonal paraprotein \[M-protein\] level \>=1.0 gram/deciliter \[g/dL\] or urine M-protein level \>=200 milligram\[mg\]/24 hours\[hrs\]; or (b) IgA, IgM, IgD, or IgE multiple myeloma (serum M-protein level \>=0.5 g/dL or urine M-protein level \>=200 mg/24 hrs); or (c) light chain multiple myeloma without measurable disease in serum or urine (serum immunoglobulin free light chain \>=10 mg/dL and abnormal serum immunoglobulin kappa lambda free light chain ratio)
- Participant must have an Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1, or 2
- Participants who are newly diagnosed and not considered for high-dose chemotherapy due to: being age \>=65 years; or participants less than (\<) 65 years with presence of important comorbid condition(s) likely to have a negative impact on tolerability of high dose chemotherapy with stem cell transplantation. Sponsor review and approval of participants below 65 years of age is required before randomization
- Women of childbearing potential must commit to either abstain continuously from sexual intercourse or to use 2 methods of reliable birth control simultaneously as deemed appropriate by the Investigator. Contraception must begin 4 weeks prior to dosing and must continue for 3 months after the last dose of daratumumab
- Man, who is sexually active with a woman of child-bearing potential must agree to use a latex or synthetic condom, even if he had a successful vasectomy, must agree to use an adequate contraception method as deemed appropriate by the Investigator, and must also agree to not donate sperm during the study and for 4 weeks after last dose of lenalidomide and 4 months after last dose of daratumumab
You may not qualify if:
- Participant has a diagnosis of primary amyloidosis, monoclonal gammopathy of undetermined significance (presence of serum M-protein \<3 g/dL; absence of lytic bone lesions, anemia, hypercalcemia, and renal insufficiency related to the M-protein), or smoldering multiple myeloma (asymptomatic multiple myeloma with absence of related organ or tissue impairment end organ damage)
- Participant has a diagnosis of Waldenström's disease, or other conditions in which IgM M protein is present in the absence of a clonal plasma cell infiltration with lytic bone lesions
- Participant has a history of malignancy (other than multiple myeloma) within 5 years before the date of randomization (exceptions are squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix, or malignancy that in the opinion of the Investigator, with concurrence with the Sponsor's medical monitor, is considered cured with minimal risk of recurrence within 5 years)
- Participant has prior or current systemic therapy or SCT for multiple myeloma, with the exception of an emergency use of a short course (equivalent of dexamethasone 40 mg/day for 4 days) of corticosteroids before treatment
- Participant has had radiation therapy within 14 days of randomization
- Participant has known chronic obstructive pulmonary disease (COPD) (defined as a forced expiratory volume in 1 second \[FEV1\] \<50% of predicted normal), persistent asthma, or a history of asthma within the last 2 years (controlled intermittent asthma or controlled mild persistent asthma is allowed)
- Participants with known or suspected COPD must have a FEV1 test during Screening
- Participant is known to be seropositive for human immunodeficiency virus (HIV) or hepatitis B (defined by a positive test for hepatitis B surface antigen \[HBsAg\] or antibodies to hepatitis B surface and core antigens \[anti-HBs and anti-HBc, respectively\]) or hepatitis C (anti-HCV antibody positive or HCV-ribonucleic acid \[RNA\] quantitation positive)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (206)
Unknown Facility
Birmingham, Alabama, United States
Unknown Facility
Mobile, Alabama, United States
Unknown Facility
Glendale, Arizona, United States
Unknown Facility
Berkeley, California, United States
Unknown Facility
Beverly Hills, California, United States
Unknown Facility
El Cajon, California, United States
Unknown Facility
Greenbrae, California, United States
Unknown Facility
Los Angeles, California, United States
Unknown Facility
Oceanside, California, United States
Unknown Facility
San Diego, California, United States
Unknown Facility
West Hills, California, United States
Unknown Facility
Whittier, California, United States
Unknown Facility
Denver, Colorado, United States
Unknown Facility
Fort Collins, Colorado, United States
Unknown Facility
Glenwood Springs, Colorado, United States
Unknown Facility
New Haven, Connecticut, United States
Unknown Facility
Norwalk, Connecticut, United States
Unknown Facility
Washington D.C., District of Columbia, United States
Unknown Facility
Boca Raton, Florida, United States
Unknown Facility
Boynton Beach, Florida, United States
Unknown Facility
Fort Lauderdale, Florida, United States
Unknown Facility
Fort Myers, Florida, United States
Unknown Facility
Hollywood, Florida, United States
Unknown Facility
Jacksonville, Florida, United States
Unknown Facility
Lake City, Florida, United States
Unknown Facility
St. Petersburg, Florida, United States
Unknown Facility
Weston, Florida, United States
Unknown Facility
Atlanta, Georgia, United States
Unknown Facility
Augusta, Georgia, United States
Unknown Facility
Macon, Georgia, United States
Unknown Facility
Marietta, Georgia, United States
Unknown Facility
Chicago, Illinois, United States
Unknown Facility
Niles, Illinois, United States
Unknown Facility
Fort Wayne, Indiana, United States
Unknown Facility
Iowa City, Iowa, United States
Unknown Facility
Louisville, Kentucky, United States
Unknown Facility
Lafayette, Louisiana, United States
Unknown Facility
Marrero, Louisiana, United States
Unknown Facility
Shreveport, Louisiana, United States
Unknown Facility
Annapolis, Maryland, United States
Unknown Facility
Baltimore, Maryland, United States
Unknown Facility
Frederick, Maryland, United States
Unknown Facility
Boston, Massachusetts, United States
Unknown Facility
Detroit, Michigan, United States
Unknown Facility
Duluth, Minnesota, United States
Unknown Facility
Rochester, Minnesota, United States
Unknown Facility
Kansas City, Missouri, United States
Unknown Facility
St Louis, Missouri, United States
Unknown Facility
Omaha, Nebraska, United States
Unknown Facility
Hooksett, New Hampshire, United States
Unknown Facility
Brick, New Jersey, United States
Unknown Facility
Hackensack, New Jersey, United States
Unknown Facility
Livingston, New Jersey, United States
Unknown Facility
Plainfield, New Jersey, United States
Unknown Facility
Summit, New Jersey, United States
Unknown Facility
Mineola, New York, United States
Unknown Facility
New York, New York, United States
Unknown Facility
Rochester, New York, United States
Unknown Facility
Asheboro, North Carolina, United States
Unknown Facility
Charlotte, North Carolina, United States
Unknown Facility
Pinehurst, North Carolina, United States
Unknown Facility
Winston-Salem, North Carolina, United States
Unknown Facility
Canton, Ohio, United States
Unknown Facility
Cleveland, Ohio, United States
Unknown Facility
Columbus, Ohio, United States
Unknown Facility
Bend, Oregon, United States
Unknown Facility
Bethlehem, Pennsylvania, United States
Unknown Facility
Pittsburgh, Pennsylvania, United States
Unknown Facility
Spartanburg, South Carolina, United States
Unknown Facility
Sioux Falls, South Dakota, United States
Unknown Facility
Chattanooga, Tennessee, United States
Unknown Facility
Nashville, Tennessee, United States
Unknown Facility
Arlington, Texas, United States
Unknown Facility
Edinburg, Texas, United States
Unknown Facility
Fort Sam Houston, Texas, United States
Unknown Facility
Fort Worth, Texas, United States
Unknown Facility
Houston, Texas, United States
Unknown Facility
Plano, Texas, United States
Unknown Facility
San Antonio, Texas, United States
Unknown Facility
Ogden, Utah, United States
Unknown Facility
Seattle, Washington, United States
Unknown Facility
Spokane, Washington, United States
Unknown Facility
Tacoma, Washington, United States
Unknown Facility
Box Hill, Australia
Unknown Facility
Fitzroy, Australia
Unknown Facility
Footscray, Australia
Unknown Facility
Kogarah, Australia
Unknown Facility
Kurralta Park, Australia
Unknown Facility
Nedlands, Australia
Unknown Facility
New South Wales, Australia
Unknown Facility
Woodville, Australia
Unknown Facility
Woolloongabba, Australia
Unknown Facility
Innsbruck, Austria
Unknown Facility
Linz, Austria
Unknown Facility
Salzburg, Austria
Unknown Facility
Vienna, Austria
Unknown Facility
Wien Wien, Austria
Unknown Facility
Bruges, Belgium
Unknown Facility
Brussels, Belgium
Unknown Facility
Haine Saint Paul La Louviere, Belgium
Unknown Facility
Leuven, Belgium
Unknown Facility
Liège, Belgium
Unknown Facility
Calgary, Alberta, Canada
Unknown Facility
Nova Scotia, Nova Scotia, Canada
Unknown Facility
Toronto, Ontario, Canada
Unknown Facility
Greenfield Park, Quebec, Canada
Unknown Facility
Montreal, Quebec, Canada
Unknown Facility
Québec, Quebec, Canada
Unknown Facility
N/a N/a, Canada
Unknown Facility
Aarhus C, Denmark
Unknown Facility
Odense, Denmark
Unknown Facility
Vejle, Denmark
Unknown Facility
Amiens N/a Picardie, France
Unknown Facility
Angers, France
Unknown Facility
Bayonne, France
Unknown Facility
Bretagne, France
Unknown Facility
Caen, France
Unknown Facility
Cergy-Pontoise, France
Unknown Facility
Chalon-sur-Saône, France
Unknown Facility
Clermont-Ferrand, France
Unknown Facility
Créteil, France
Unknown Facility
Dijon, France
Unknown Facility
Dunkirk, France
Unknown Facility
Grenoble, France
Unknown Facility
La Roche-sur-Yon, France
Unknown Facility
Le Chesnay, France
Unknown Facility
Le Mans, France
Unknown Facility
Lille, France
Unknown Facility
Limoges, France
Unknown Facility
Lyon, France
Unknown Facility
Marseille, France
Unknown Facility
Metz-Tessy, France
Unknown Facility
Montivilliers, France
Unknown Facility
Montpellier, France
Unknown Facility
Mulhouse, France
Unknown Facility
Nantes, France
Unknown Facility
Nice, France
Unknown Facility
Paris, France
Unknown Facility
Perpignan, France
Unknown Facility
Pessac, France
Unknown Facility
Périgueux, France
Unknown Facility
Poitiers, France
Unknown Facility
Reims, France
Unknown Facility
Rennes, France
Unknown Facility
Rouen, France
Unknown Facility
Saint-Brieuc, France
Unknown Facility
Saint-Priest-en-Jarez, France
Unknown Facility
Saint-Quentin, France
Unknown Facility
St-Malo, France
Unknown Facility
Strasbourg, France
Unknown Facility
Toulouse, France
Unknown Facility
Tours, France
Unknown Facility
Vandœuvre-lès-Nancy, France
Unknown Facility
Aschaffenburg, Germany
Unknown Facility
Bad Berka, Germany
Unknown Facility
Bonn, Germany
Unknown Facility
Braunschweig, Germany
Unknown Facility
Dresden, Germany
Unknown Facility
Essen, Germany
Unknown Facility
Frankfurt, Germany
Unknown Facility
Hanover, Germany
Unknown Facility
Heidelberg, Germany
Unknown Facility
Hessen, Germany
Unknown Facility
Kiel, Germany
Unknown Facility
Koblenz, Germany
Unknown Facility
Mainz, Germany
Unknown Facility
Mannheim, Germany
Unknown Facility
Rostock, Germany
Unknown Facility
Schwerin, Germany
Unknown Facility
Stuttgart, Germany
Unknown Facility
Tübingen, Germany
Unknown Facility
Ulm, Germany
Unknown Facility
Villingen-Schwenningen, Germany
Unknown Facility
Dublin, Ireland
Unknown Facility
Galway, Ireland
Unknown Facility
Hadera, Israel
Unknown Facility
Haifa, Israel
Unknown Facility
Jerusalem, Israel
Unknown Facility
Nahariya, Israel
Unknown Facility
Petah Tikva, Israel
Unknown Facility
Tel Aviv, Israel
Unknown Facility
Hilversum, Netherlands
Unknown Facility
Hoofddorp, Netherlands
Unknown Facility
Rotterdam, Netherlands
Unknown Facility
Tilburg, Netherlands
Unknown Facility
Falun, Sweden
Unknown Facility
Gothenburg, Sweden
Unknown Facility
Halmstad, Sweden
Unknown Facility
Helsingborg, Sweden
Unknown Facility
Huddinge, Sweden
Unknown Facility
Luleå, Sweden
Unknown Facility
Lund, Sweden
Unknown Facility
Örebro, Sweden
Unknown Facility
Stockholm, Sweden
Unknown Facility
Aberdeen, United Kingdom
Unknown Facility
Canterbury, United Kingdom
Unknown Facility
Dundee, United Kingdom
Unknown Facility
Leeds, United Kingdom
Unknown Facility
London, United Kingdom
Unknown Facility
Manchester, United Kingdom
Unknown Facility
Nottingham, United Kingdom
Unknown Facility
Oxford, United Kingdom
Unknown Facility
Plymouth, United Kingdom
Unknown Facility
Southampton, United Kingdom
Unknown Facility
Truro, United Kingdom
Unknown Facility
Wolverhampton, United Kingdom
Related Publications (10)
Perrot A, Facon T, Plesner T, Usmani SZ, Kumar S, Bahlis NJ, Hulin C, Orlowski RZ, Nahi H, Mollee P, Ramasamy K, Roussel M, Jaccard A, Delforge M, Karlin L, Arnulf B, Chari A, Wang G, Gupta-Werner N, Kaila S, Pei H, Matt K, Gries KS, Carson R, Borgsten F, Weisel K. Sustained Improvement in Health-Related Quality of Life in Transplant-Ineligible Newly Diagnosed Multiple Myeloma Treated With Daratumumab, Lenalidomide, and Dexamethasone: MAIA Final Analysis of Patient-Reported Outcomes. Eur J Haematol. 2025 May;114(5):883-889. doi: 10.1111/ejh.14392. Epub 2025 Feb 14.
PMID: 39952901DERIVEDMoreau P, Facon T, Usmani SZ, Bahlis N, Raje N, Plesner T, Orlowski RZ, Basu S, Nahi H, Hulin C, Quach H, Goldschmidt H, O'Dwyer M, Perrot A, Venner CP, Weisel K, Tiab M, Macro M, Frenzel L, Leleu X, Wang G, Pei H, Krevvata M, Carson R, Borgsten F, Kumar SK. Daratumumab plus lenalidomide/dexamethasone in untreated multiple myeloma: analysis of key subgroups of the MAIA study. Leukemia. 2025 Mar;39(3):710-719. doi: 10.1038/s41375-024-02506-1. Epub 2025 Jan 15.
PMID: 39815052DERIVEDAlmansour SA, Alqudah MAY, Abuhelwa Z, Al-Shamsi HO, Alhuraiji A, Semreen MH, Bustanji Y, Alzoubi KH, Modi ND, Mckinnon RA, Sorich MJ, Hopkins AM, Abuhelwa AY. Antithrombotic utilization, adverse events, and associations with treatment outcomes in multiple myeloma: pooled analysis of three clinical trials. Ther Adv Med Oncol. 2024 Sep 2;16:17588359241275387. doi: 10.1177/17588359241275387. eCollection 2024.
PMID: 39229471DERIVEDFacon T, Kumar SK, Plesner T, Orlowski RZ, Moreau P, Bahlis N, Basu S, Nahi H, Hulin C, Quach H, Goldschmidt H, Perrot A, Weisel K, Raje N, Macro M, Frenzel L, Leleu X, Wang J, Rampelbergh RV, Uhlar CM, Vermeulen J, Duran J, Borgsten F, Usmani SZ. Plain language summary of the MAIA study of daratumumab plus lenalidomide and dexamethasone for the treatment of people with newly diagnosed multiple myeloma. Future Oncol. 2023 Apr;19(13):887-895. doi: 10.2217/fon-2023-0082. Epub 2023 May 22.
PMID: 37212642DERIVEDMateos MV, Rigaudeau S, Basu S, Spicka I, Schots R, Wrobel T, Cook G, Beksac M, Gries KS, Kudva A, Tromp B, Van Rampelbergh R, Pei H, Wroblewski S, Carson R, Delioukina M, White D. Switching to daratumumab SC from IV is safe and preferred by patients with multiple myeloma. J Oncol Pharm Pract. 2023 Jul;29(5):1172-1177. doi: 10.1177/10781552221103551. Epub 2022 Sep 6.
PMID: 36067063DERIVEDFacon T, Kumar SK, Plesner T, Orlowski RZ, Moreau P, Bahlis N, Basu S, Nahi H, Hulin C, Quach H, Goldschmidt H, O'Dwyer M, Perrot A, Venner CP, Weisel K, Mace JR, Raje N, Tiab M, Macro M, Frenzel L, Leleu X, Ahmadi T, Wang J, Van Rampelbergh R, Uhlar CM, Tromp B, Delioukina M, Vermeulen J, Usmani SZ. Daratumumab, lenalidomide, and dexamethasone versus lenalidomide and dexamethasone alone in newly diagnosed multiple myeloma (MAIA): overall survival results from a randomised, open-label, phase 3 trial. Lancet Oncol. 2021 Nov;22(11):1582-1596. doi: 10.1016/S1470-2045(21)00466-6. Epub 2021 Oct 13.
PMID: 34655533DERIVEDCavo M, San-Miguel J, Usmani SZ, Weisel K, Dimopoulos MA, Avet-Loiseau H, Paiva B, Bahlis NJ, Plesner T, Hungria V, Moreau P, Mateos MV, Perrot A, Iida S, Facon T, Kumar S, van de Donk NWCJ, Sonneveld P, Spencer A, Krevvata M, Heuck C, Wang J, Ukropec J, Kobos R, Sun S, Qi M, Munshi N. Prognostic value of minimal residual disease negativity in myeloma: combined analysis of POLLUX, CASTOR, ALCYONE, and MAIA. Blood. 2022 Feb 10;139(6):835-844. doi: 10.1182/blood.2021011101.
PMID: 34289038DERIVEDSan-Miguel J, Avet-Loiseau H, Paiva B, Kumar S, Dimopoulos MA, Facon T, Mateos MV, Touzeau C, Jakubowiak A, Usmani SZ, Cook G, Cavo M, Quach H, Ukropec J, Ramaswami P, Pei H, Qi M, Sun S, Wang J, Krevvata M, DeAngelis N, Heuck C, Van Rampelbergh R, Kudva A, Kobos R, Qi M, Bahlis NJ. Sustained minimal residual disease negativity in newly diagnosed multiple myeloma and the impact of daratumumab in MAIA and ALCYONE. Blood. 2022 Jan 27;139(4):492-501. doi: 10.1182/blood.2020010439.
PMID: 34269818DERIVEDPerrot A, Facon T, Plesner T, Usmani SZ, Kumar S, Bahlis NJ, Hulin C, Orlowski RZ, Nahi H, Mollee P, Ramasamy K, Roussel M, Jaccard A, Delforge M, Karlin L, Arnulf B, Chari A, He J, Ho KF, Van Rampelbergh R, Uhlar CM, Wang J, Kobos R, Gries KS, Fastenau J, Weisel K. Health-Related Quality of Life in Transplant-Ineligible Patients With Newly Diagnosed Multiple Myeloma: Findings From the Phase III MAIA Trial. J Clin Oncol. 2021 Jan 20;39(3):227-237. doi: 10.1200/JCO.20.01370. Epub 2020 Dec 16.
PMID: 33326255DERIVEDFacon T, Kumar S, Plesner T, Orlowski RZ, Moreau P, Bahlis N, Basu S, Nahi H, Hulin C, Quach H, Goldschmidt H, O'Dwyer M, Perrot A, Venner CP, Weisel K, Mace JR, Raje N, Attal M, Tiab M, Macro M, Frenzel L, Leleu X, Ahmadi T, Chiu C, Wang J, Van Rampelbergh R, Uhlar CM, Kobos R, Qi M, Usmani SZ; MAIA Trial Investigators. Daratumumab plus Lenalidomide and Dexamethasone for Untreated Myeloma. N Engl J Med. 2019 May 30;380(22):2104-2115. doi: 10.1056/NEJMoa1817249.
PMID: 31141632DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Director
- Organization
- Janssen Research & Development, LLC
Study Officials
- STUDY DIRECTOR
Janssen Research & Development, LLC Clinical Trial
Janssen Research & Development, LLC
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 11, 2014
First Posted
September 30, 2014
Study Start
February 16, 2015
Primary Completion
September 24, 2018
Study Completion
October 2, 2024
Last Updated
October 20, 2025
Results First Posted
January 9, 2020
Record last verified: 2025-10