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Clinical trial

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

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Last updated:15th Aug 2014
Identifier: NCT02136134

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.


Study Type: Interventional
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: No masking
Primary Purpose: Treatment
Official Title: Phase 3 Study Comparing Daratumumab, Bortezomib and Dexamethasone (DVd) vs Bortezomib and Dexamethasone (Vd) in Subjects With Relapsed or Refractory Multiple Myeloma
Enrollment: 500
Actual Study Start Date: August 15, 2014
Estimated Study Completion Date: November 11, 2021
Primary Completion Date: January 11, 2016 (Final data collection date for primary outcome measure)

Arms:
- Experimental:
Daratumumab+VELCADE+dexamethasone
- Active Comparator: VELCADE+dexamethasone

Category Value
Date last updated at source 2017-06-01
Study type(s) Interventional
Expected enrolment 500
Study start date 2014-08-15
Estimated primary completion date 2016-01-11

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