Study Comparing Daratumumab, Lenalidomide, and Dexamethasone With Lenalidomide and Dexamethasone in Participants With Previously Untreated Multiple Myeloma

NCT ID: NCT02252172

Last Updated: 2025-10-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 737 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-02-16
• Study Completion Date: 2024-10-02

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).

Detailed Description

This is a Phase 3, randomized (study drug assigned by chance), open-label (participants and researchers are aware about the treatment, participants are receiving), active-controlled (study in which the experimental treatment or procedure is compared to a standard treatment or procedure), parallel-group (each group of participants will be treated at the same time), and multicenter (when more than one hospital or medical school team work on a medical research study) study in participants with newly diagnosed multiple myeloma and who are not candidates for high dose chemotherapy and ASCT. All the eligible participants will be randomly assigned to receive either lenalidomide and dexamethasone (Rd) (Arm A) or daratumumab in combination with lenalidomide and dexamethasone (DRd) (Arm B). Daratumumab (16 milligram per kilogram [mg/kg]) will be administered weekly for first 8 weeks (Cycles 1 to 2) of treatment and then every other week for 16 weeks (Cycles 3 to 6), then every 4 weeks (from Cycle 7 and beyond) until progression of disease or unacceptable toxicity. Lenalidomide will be administered at a dose of 25 mg orally on Days 1 through 21 of each 28-day cycle, and dexamethasone will be administered at a dose of 40 mg once a week for both treatment arms. Participants in both treatment arms will continue lenalidomide and dexamethasone until disease progression or unacceptable toxicity. All participants randomized to Treatment Arm B (DRd) in this study initially received daratumumab IV formulation; however, 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. Participants in Arm A who have sponsor-confirmed disease progression may have the option to receive daratumumab provided by the sponsor (in any subsequent line of therapy) in the Follow-up phase. The study consists of 3 phases: Screening Phase (within 21 days prior to the first dose administration on Day 1), Treatment Phase (Day 1 up to discontinuation of all study treatment), and Follow-up Phase (from discontinuation of all study treatment up to death, lost to follow up, consent withdrawal, or study end, whichever occurs first). The maximum duration of study will be 7 years after last participant is randomized. Efficacy will primarily be evaluated by PFS. Participants' safety will be monitored throughout the study.

Conditions

Multiple Myeloma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Lenalidomide and Dexamethasone (Rd)

Participants 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.

Group Type: ACTIVE_COMPARATOR

Daratumumab IV

Intervention Type: DRUG

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

Intervention Type: DRUG

Lenalidomide 25 mg capsule orally on Day 1 through Day 21 of each 28-day cycle.

Dexamethasone

Intervention Type: DRUG

Dexamethasone 40 mg orally or intravenously once in a week.

Daratumumab + Lenalidomide + Dexamethasone (DRd)

Participants 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.

Group Type: ACTIVE_COMPARATOR

Lenalidomide

Intervention Type: DRUG

Lenalidomide 25 mg capsule orally on Day 1 through Day 21 of each 28-day cycle.

Dexamethasone

Intervention Type: DRUG

Dexamethasone 40 mg orally or intravenously once in a week.

Daratumumab SC

Intervention Type: DRUG

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.

Interventions

Daratumumab IV

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).

Intervention Type: DRUG

Lenalidomide

Lenalidomide 25 mg capsule orally on Day 1 through Day 21 of each 28-day cycle.

Intervention Type: DRUG

Dexamethasone

Dexamethasone 40 mg orally or intravenously once in a week.

Intervention Type: DRUG

Daratumumab SC

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.

Intervention Type: DRUG

Other Intervention Names

JNJ-54767414; JNJ-54767414

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Janssen Research & Development, LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Janssen Research & Development, LLC Clinical Trial

Role: STUDY_DIRECTOR

Janssen Research & Development, LLC

Locations

Birmingham, Alabama, United States

Mobile, Alabama, United States

Glendale, Arizona, United States

Berkeley, California, United States

Beverly Hills, California, United States

El Cajon, California, United States

Greenbrae, California, United States

Los Angeles, California, United States

Oceanside, California, United States

San Diego, California, United States

West Hills, California, United States

Whittier, California, United States

Denver, Colorado, United States

Fort Collins, Colorado, United States

Glenwood Springs, Colorado, United States

New Haven, Connecticut, United States

Norwalk, Connecticut, United States

Washington D.C., District of Columbia, United States

Boca Raton, Florida, United States

Boynton Beach, Florida, United States

Fort Lauderdale, Florida, United States

Fort Myers, Florida, United States

Hollywood, Florida, United States

Jacksonville, Florida, United States

Lake City, Florida, United States

St. Petersburg, Florida, United States

Weston, Florida, United States

Atlanta, Georgia, United States

Augusta, Georgia, United States

Macon, Georgia, United States

Marietta, Georgia, United States

Chicago, Illinois, United States

Niles, Illinois, United States

Fort Wayne, Indiana, United States

Iowa City, Iowa, United States

Louisville, Kentucky, United States

Lafayette, Louisiana, United States

Marrero, Louisiana, United States

Shreveport, Louisiana, United States

Annapolis, Maryland, United States

Baltimore, Maryland, United States

Frederick, Maryland, United States

Boston, Massachusetts, United States

Detroit, Michigan, United States

Duluth, Minnesota, United States

Rochester, Minnesota, United States

Kansas City, Missouri, United States

St Louis, Missouri, United States

Omaha, Nebraska, United States

Hooksett, New Hampshire, United States

Brick, New Jersey, United States

Hackensack, New Jersey, United States

Livingston, New Jersey, United States

Plainfield, New Jersey, United States

Summit, New Jersey, United States

Mineola, New York, United States

New York, New York, United States

Rochester, New York, United States

Asheboro, North Carolina, United States

Charlotte, North Carolina, United States

Pinehurst, North Carolina, United States

Winston-Salem, North Carolina, United States

Canton, Ohio, United States

Cleveland, Ohio, United States

Columbus, Ohio, United States

Bend, Oregon, United States

Bethlehem, Pennsylvania, United States

Pittsburgh, Pennsylvania, United States

Spartanburg, South Carolina, United States

Sioux Falls, South Dakota, United States

Chattanooga, Tennessee, United States

Nashville, Tennessee, United States

Arlington, Texas, United States

Edinburg, Texas, United States

Fort Sam Houston, Texas, United States

Fort Worth, Texas, United States

Houston, Texas, United States

Plano, Texas, United States

San Antonio, Texas, United States

Ogden, Utah, United States

Seattle, Washington, United States

Spokane, Washington, United States

Tacoma, Washington, United States

Box Hill, , Australia

Fitzroy, , Australia

Footscray, , Australia

Kogarah, , Australia

Kurralta Park, , Australia

Nedlands, , Australia

New South Wales, , Australia

Woodville, , Australia

Woolloongabba, , Australia

Innsbruck, , Austria

Linz, , Austria

Salzburg, , Austria

Vienna, , Austria

Wien Wien, , Austria

Bruges, , Belgium

Brussels, , Belgium

Haine Saint Paul La Louviere, , Belgium

Leuven, , Belgium

Liège, , Belgium

Calgary, Alberta, Canada

Nova Scotia, Nova Scotia, Canada

Toronto, Ontario, Canada

Greenfield Park, Quebec, Canada

Montreal, Quebec, Canada

Québec, Quebec, Canada

N/a N/a, , Canada

Aarhus C, , Denmark

Odense, , Denmark

Vejle, , Denmark

Amiens N/a Picardie, , France

Angers, , France

Bayonne, , France

Bretagne, , France

Caen, , France

Cergy-Pontoise, , France

Chalon-sur-Saône, , France

Clermont-Ferrand, , France

Créteil, , France

Dijon, , France

Dunkirk, , France

Grenoble, , France

La Roche-sur-Yon, , France

Le Chesnay, , France

Le Mans, , France

Lille, , France

Limoges, , France

Lyon, , France

Marseille, , France

Metz-Tessy, , France

Montivilliers, , France

Montpellier, , France

Mulhouse, , France

Nantes, , France

Nice, , France

Paris, , France

Perpignan, , France

Pessac, , France

Périgueux, , France

Poitiers, , France

Reims, , France

Rennes, , France

Rouen, , France

Saint-Brieuc, , France

Saint-Priest-en-Jarez, , France

Saint-Quentin, , France

St-Malo, , France

Strasbourg, , France

Toulouse, , France

Tours, , France

Vandœuvre-lès-Nancy, , France

Aschaffenburg, , Germany

Bad Berka, , Germany

Bonn, , Germany

Braunschweig, , Germany

Dresden, , Germany

Essen, , Germany

Frankfurt, , Germany

Hanover, , Germany

Heidelberg, , Germany

Hessen, , Germany

Kiel, , Germany

Koblenz, , Germany

Mainz, , Germany

Mannheim, , Germany

Rostock, , Germany

Schwerin, , Germany

Stuttgart, , Germany

Tübingen, , Germany

Ulm, , Germany

Villingen-Schwenningen, , Germany

Dublin, , Ireland

Galway, , Ireland

Hadera, , Israel

Haifa, , Israel

Jerusalem, , Israel

Nahariya, , Israel

Petah Tikva, , Israel

Tel Aviv, , Israel

Hilversum, , Netherlands

Hoofddorp, , Netherlands

Rotterdam, , Netherlands

Tilburg, , Netherlands

Falun, , Sweden

Gothenburg, , Sweden

Halmstad, , Sweden

Helsingborg, , Sweden

Huddinge, , Sweden

Luleå, , Sweden

Lund, , Sweden

Örebro, , Sweden

Stockholm, , Sweden

Aberdeen, , United Kingdom

Canterbury, , United Kingdom

Dundee, , United Kingdom

Leeds, , United Kingdom

London, , United Kingdom

Manchester, , United Kingdom

Nottingham, , United Kingdom

Oxford, , United Kingdom

Plymouth, , United Kingdom

Southampton, , United Kingdom

Truro, , United Kingdom

Wolverhampton, , United Kingdom

Countries

United States; Australia; Austria; Belgium; Canada; Denmark; France; Germany; Ireland; Israel; Netherlands; Sweden; United Kingdom

References

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Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

54767414MMY3008

Identifier Type: OTHER

Identifier Source: secondary_id

2014-002273-11

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CR104762

Identifier Type: -

Identifier Source: org_study_id