Addition of Daratumumab to Combination of Bortezomib and Dexamethasone in Participants With Relapsed or Refractory Multiple Myeloma

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Janssen Research & Development, LLC
Study ID
NCT02136134
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Daratumumab — DRUG
    Daratumumab will be administered as an IV infusion or 16 mg/kg weekly for the first 3 cycles, on Day 1 of Cycles 4-9, and then every 4 weeks thereafter. As per protocol amendment-6 participants receiving treatment with daratumumab IV will have the option to switch to daratumumab SC 1800 mg on Day 1 of any cycle, at the discretion of the investigator.
  • VELCADE (Bortezomib) — DRUG
    VELCADE will be administered at a dose of 1.3 mg/m2 subcutaneously (SC) on Days 1, 4, 8 and 11 of each 21-day cycle. Eight VELCADE treatment cycles are to be administered.
  • Dexamethasone — DRUG
    Dexamethasone will be administered orally at 20 mg on Days 1, 2, 4, 5, 8, 9, 11 and 12 of the first 8 VELCADE treatment cycles.

Study Details

The purpose of this study is to assess the effects of administration of daratumumab when combined with VELCADE (bortezomib) and dexamethasone compared with bortezomib and dexamethasone alone, for participants with relapsed or refractory multiple myeloma.

Key Dates

Start date
Aug 15, 2014
Status verified
Aug 2025
Primary completion
Jan 11, 2016
Completion
Jan 10, 2024

Study Design

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

Arms

  • Experimental: Daratumumab+VELCADE+dexamethasone
    Daratumumab, VELCADE and dexamethasone
  • Active Comparator: VELCADE+dexamethasone
    VELCADE and dexamethasone.

Primary Outcome Measure

Progression-free Survival (PFS) [ Time Frame: From the date of randomization to either progressive disease or death, whichever occurred first (approximately 1 year 4 months) ]

Locations (17)

FacilityCityStateZIPSite coordinators
-BirminghamAlabama--
-Los AngelesCalifornia--
-StamfordConnecticut--
-JacksonvilleFlorida--
-AtlantaGeorgia--
-NilesIllinois--
-TopekaKansas--
-WestwoodKansas--
-MarreroLouisiana--
-BostonMassachusetts--
-LansingMichigan--
-New YorkNew York--
-Chapel HillNorth Carolina--
-PortlandOregon--
-PhiladelphiaPennsylvania--
-ProvidenceRhode Island--
-SeattleWashington--

Find similar trials in Birmingham, AL

By condition
Multiple myeloma
By specialty
OncologyBlood cancer

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