Multiple Myeloma Clinical Trial

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

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).

View Full Description

Full 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.

View Eligibility Criteria

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 gdL; absence of lytic bone lesions, anemia, hypercalcemia, and renal insufficiency related to the M-protein), or smoldering multiple myeloma (asymptomatic with organ tissue impairment end 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)

Study is for people with:

Multiple Myeloma

Phase:

Phase 3

Estimated Enrollment:

737

Study ID:

NCT02252172

Recruitment Status:

Active, not recruiting

Sponsor:

Janssen Research & Development, LLC

Check Your Eligibility

Let’s see if you might be eligible for this study.

What is your age and gender ?

Submit

There is 1 Location for this study

See Locations Near You


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 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

Saint 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

Saint 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

Somerville 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 N/a , , Australia

Innsbruck , , Austria

Linz , , Austria

Salzburg , , Austria

Wien N/a , , Austria

Wien Wien , , Austria

Brugge , , Belgium

Brussels , , Belgium

Brussel , , Belgium

Haine-saint-paul, LA Louviere , , Belgium

Leuven , , Belgium

Liege , , Belgium

Calgary Alberta, , Canada

Toronto Ontario, , Canada

Montreal Quebec, , Canada

Montréal Quebec, , Canada

Greenfield Park , , Canada

N/a N/a , , Canada

Nova Scotia , , Canada

Quebec , , Canada

Aarhus C , , Denmark

Odense , , Denmark

Vejle , , Denmark

Amiens N/a Picardie , , France

Angers , , France

Bayonne Cedex , , France

Bretagne , , France

Caen , , France

Cergy Pontoise , , France

Chalons Sur Saone , , France

Clermont-Ferrand , , France

Creteil , , France

Dijon , , France

Dunkerque Cedex 1 , , France

Grenoble Cedex 9 , , France

La Roche sur Yon Cedex 9 , , France

Le Chesnay Cedex , , France

Le Mans , , France

Lille Cedex , , France

Lille , , France

Limoges , , France

Lyon, Pierre-Benite , , France

Marseille Cedex 9 , , France

Metz-Tessy , , France

Montivilliers , , France

Montpellier , , France

Mulhouse , , France

Nantes , , France

Nice N/a , , France

Paris Cedex 12 , , France

Paris, 75 , , France

Paris , , France

PERIGUEUX cedex , , France

Perpignan , , France

Pessac , , France

Poitiers , , France

Reims , , France

Rennes , , France

Rouen Cedex , , France

Saint Brieuc Cedex 1 , , France

Saint Priest en Jarez , , France

St Malo Cedex , , France

St Quentin Cedex , , France

Strasbourg , , France

Toulouse Cedex 9 , , France

TOURS Cedex 9 , , France

Vandoeuvre Les Nancy , , France

Aschaffenburg , , Germany

Bad Berka , , Germany

Bonn , , Germany

Braunschweig , , Germany

Dresden , , Germany

Essen , , Germany

Frankfurt , , Germany

Hannover , , Germany

Heidelberg , , Germany

Hessen , , Germany

Kiel , , Germany

Koblenz , , Germany

Mainz , , Germany

Mannheim , , Germany

Rostock , , Germany

Schwerin , , Germany

Stuttgart , , Germany

Tuebingen , , 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

Göteborg , , Sweden

Halmstad , , Sweden

Helsingborg , , Sweden

Huddinge , , Sweden

Lulea , , Sweden

Lund , , Sweden

Stockholm , , Sweden

Örebro , , 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, Devon , , United Kingdom

Southampton , , United Kingdom

Truro , , United Kingdom

Wolverhampton , , United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Multiple Myeloma

Phase:

Phase 3

Estimated Enrollment:

737

Study ID:

NCT02252172

Recruitment Status:

Active, not recruiting

Sponsor:


Janssen Research & Development, LLC

How clear is this clinincal trial information?

×

Introducing, the Journey Bar

Use this bar to access information about the steps in your cancer journey.