A Study to Evaluate Daratumumab in Transplant Eligible Participants With Previously Untreated Multiple Myeloma

Sponsor
Intergroupe Francophone du Myelome
Study ID
NCT02541383
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Bortezomib (VELCADE), Thalidomide, and Dexamethasone (VTD) — DRUG
    Part 1: 4 Cycles of Bortezomib,Thalidomide and Dexamethasone induction therapy, followed by Autologous Stem Cell Transplantation, followed by 2 cycles of Bortezomib, Thalidomide and Dexamethasone consolidation
  • Bortezomib, Thalidomide, Dexamethasone (VTD) + daratumumab — DRUG
    Part 1: 4 Cycles of Bortezomib, Thalidomide and Dexamethasone plus daratumumab 16mg/kg induction therapy, followed by Autologous Stem Cell Transplantation, followed by 2 cycles of Bortezomib, Thalidomide and Dexamethasone plus daratumumab 16 mg/kg consolidation
  • Daratumumab — DRUG
    Daratumumab 16mg/kg every 8 weeks for 2 years

Study Details

The purpose of this study is to evaluate if the addition of daratumumab to Bortezomib, Thalidomide and Dexamethasone will increase the stringent complete response rate after consolidation therapy and increase the progression free survival after daratumumab maintenance therapy in transplant eligible participants with previously untreated Multiple Myeloma.

Key Dates

Start date
Sep 30, 2015
Status verified
Mar 2025
Primary completion
Aug 27, 2020
Completion
Sep 1, 2023

Study Design

Enrollment
1,085 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Other: Arm A Part 1
    Bortezomib (VELCADE), Thalidomide, and Dexamethasone (VTD)
  • Experimental: Arm B Part 1
    Bortezomib (VELCADE), Thalidomide, and Dexamethasone (VTD) plus daratumumab
  • No Intervention: Arm A Part 2
    Observation
  • Experimental: Arm B Part 2
    daratumumab

Primary Outcome Measure

Post-Consolidation Stringent Complete Response (sCR) Rate [ Time Frame: At day 100 post Autologous Stem Cell Transplant (ASCT), up to 114 days post ASCT ]

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