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

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Janssen Research & Development, LLC
Study ID
NCT02874742
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Lenalidomide — DRUG
    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.
  • Bortezomib — DRUG
    Bortezomib 1.3 mg/m\^2 subcutaneously on Days 1, 4, 8, and 11 during Cycles 1-6.
  • Dexamethasone — DRUG
    Dexamethasone 40 mg orally every week (20 mg on Days 1, 2, 8, 9, 15, and 16).
  • Daratumumab — DRUG
    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.

Study Details

The purpose of this study is to determine if the addition of daratumumab to lenalidomide-bortezomib-dexamethasone (RVd) will increase the proportion of participants achieving stringent complete response (sCR), as defined by the International Myeloma Working Group (IMWG) criteria, by the time of completion of post autologous stem cell transplantation (ASCT) consolidation treatment, compared with RVd alone.

Key Dates

Start date
Aug 29, 2016
Status verified
Jan 2025
Primary completion
Jan 25, 2019
Completion
Apr 8, 2022

Study Design

Enrollment
224 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Daratumumab+Lenalidomide+Bortezomib+Dexamethasone (D-RVd)
    Participants will receive lenalidomide, bortezomib, dexamethasone and daratumumab.
  • Experimental: Lenalidomide+Bortezomib+Dexamethasone (RVd)
    Participants will receive lenalidomide, bortezomib and dexamethasone.

Primary Outcome Measure

Percentage of Participants With Stringent Complete Response (sCR) [ Time Frame: From randomization to post-ASCT consolidation (after Cycle 6) before maintenance treatment (up to 10 months) ]

Locations (36)

FacilityCityStateZIPSite coordinators
-BirminghamAlabama--
-DuarteCalifornia--
-La JollaCalifornia--
-Los AngelesCalifornia--
-San FranciscoCalifornia--
-AuroraColorado--
-Washington D.C.District of Columbia--
-OrlandoFlorida--
-TampaFlorida--
-AtlantaGeorgia--
-ChicagoIllinois--
-WestwoodKansas--
-New OrleansLouisiana--
-BaltimoreMaryland--
-BostonMassachusetts--
-WorcesterMassachusetts--
-DetroitMichigan--
-St LouisMissouri--
-OmahaNebraska--
-BuffaloNew York--
-New YorkNew York--
-Chapel HillNorth Carolina--
-CharlotteNorth Carolina--
-DurhamNorth Carolina--
-Winston-SalemNorth Carolina--
-ColumbusOhio--
-PortlandOregon--
-AbingtonPennsylvania--
-PhiladelphiaPennsylvania--
-NashvilleTennessee--
-DallasTexas--
-HoustonTexas--
-Salt Lake CityUtah--
-SeattleWashington--
-SpokaneWashington--
-MilwaukeeWisconsin--

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By condition
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By specialty
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