Study Comparing Daratumumab, Lenalidomide, Bortezomib, and Dexamethasone (D-RVd) Versus Lenalidomide, Bortezomib, and Dexamethasone (RVd) in Subjects With Newly Diagnosed Multiple Myeloma

PHASE2CompletedINTERVENTIONAL
Enrollment

224

Participants

Timeline

Start Date

August 29, 2016

Primary Completion Date

January 25, 2019

Study Completion Date

April 8, 2022

Conditions
Multiple Myeloma
Interventions
DRUG

Lenalidomide

Cycles 1 through 6: lenalidomide 25 (milligram) mg orally on Days 1 through 14 and each cycle is of 21-days followed by maintenance treatment with lenalidomide 10 mg on days 1-21 throughout each 28-day cycle on Cycles 7 through 9. Beginning at Cycle 10, the lenalidomide dose will be increased to 15 mg unless there is a tolerability concern.

DRUG

Bortezomib

Bortezomib 1.3 mg/m\^2 subcutaneously on Days 1, 4, 8, and 11 during Cycles 1-6.

DRUG

Dexamethasone

Dexamethasone 40 mg orally every week (20 mg on Days 1, 2, 8, 9, 15, and 16).

DRUG

Daratumumab

Daratumumab intravenously at a dose of 16 milligram per kilogram (mg/kg) weekly during induction treatment (Days 1, 8, and 15 of Cycles 1 through 4), and every 3 weeks during consolidation treatment (Day 1 of Cycles 5 and 6), followed by maintenance treatment with daratumumab every 4 or 8 weeks.

Trial Locations (36)

Unknown

Birmingham

Duarte

La Jolla

Los Angeles

San Francisco

Aurora

Washington D.C.

Orlando

Tampa

Atlanta

Chicago

Westwood

New Orleans

Baltimore

Boston

Worcester

Detroit

St Louis

Omaha

Buffalo

New York

Chapel Hill

Charlotte

Durham

Winston-Salem

Columbus

Portland

Abington

Philadelphia

Nashville

Dallas

Houston

Salt Lake City

Seattle

Spokane

Milwaukee

All Listed Sponsors
lead

Janssen Research & Development, LLC

INDUSTRY

NCT02874742 - Study Comparing Daratumumab, Lenalidomide, Bortezomib, and Dexamethasone (D-RVd) Versus Lenalidomide, Bortezomib, and Dexamethasone (RVd) in Subjects With Newly Diagnosed Multiple Myeloma | Biotech Hunter | Biotech Hunter