Addition of Daratumumab to Combination of Bortezomib and Dexamethasone in Participants With Relapsed or Refractory Multiple Myeloma
Addition of Daratumumab to Combination of Bortezomib and Dexamethasone in Participants With Relapsed or Refractory Multiple Myeloma
ClinicalTrials.gov ID: NCT02136134
Sponsor: Janssen Research & Development, LLC
Information provided by: Janssen Research & Development, LLC (Responsible Party)
Last Update Posted: 2024-02-01
Brief Summary:
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.
Detailed Description:
This is an open-label (physicians and participants know the identity of the assigned treatment), randomized (the study medication is assigned by chance), multicenter, active-controlled study comparing daratumumab, VELCADE, and dexamethasone (DVd) with VELCADE and dexamethasone (Vd) in participants with relapsed or refractory multiple myeloma. Approximately 480 participants will be randomly assigned in a 1:1 ratio to receive either DVd or Vd. Randomization will be stratified by International Staging System (ISS), number of prior treatment programs (1 vs. 2 or 3 vs. >3), and prior VELCADE treatment ("no" vs. "yes"). Within each stratum, participants will be randomized to one of the treatment groups.The study will consist of a Screening Phase, a Treatment Phase, and a Follow-up Phase. Participants will be treated until disease progression, unacceptable toxicity, or other reasons to discontinue the study.
Official Title:
Phase 3 Study Comparing Daratumumab, Bortezomib and Dexamethasone (DVd) vs Bortezomib and Dexamethasone (Vd) in Subjects With Relapsed or Refractory Multiple Myeloma
Intervention / Treatment:
- Drug: Daratumumab
- Drug: VELCADE (Bortezomib)
- Drug: Dexamethasone
| Category | Value |
|---|---|
| Study Start (Actual) | 2014-08-15 |
| Primary Completion (Actual) | 2016-01-11 |
| Study Completion (Estimated) | 2024-06-30 |
| Enrollment (Actual) | 498 |
| Study Type | Interventional |
| Phase | Phase 3 |
| Other Study ID Numbers |
CR103995
2014-000255-85 (EudraCT Number) 54767414MMY3004 (Other Identifier) (OTHER: Janssen Research & Development, LLC) |