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Clinical trial

A Study Comparing Daratumumab, Lenalidomide, and Dexamethasone With Lenalidomide and Dexamethasone in Relapsed or Refractory Multiple Myeloma

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Last updated:23rd May 2014
Identifier: NCT02076009

The purpose of this study is to compare the effectiveness of daratumumab when combined with lenalidomide and dexamethasone (DRd) to that of lenalidomide and dexamethasone (Rd), in terms of progression-free survival in participants with relapsed or refractory multiple myeloma.


Study Type: Interventional
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase 3 Study Comparing Daratumumab, Lenalidomide, and Dexamethasone (DRd) vs Lenalidomide and Dexamethasone (Rd) in Subjects With Relapsed or Refractory Multiple Myeloma
Enrollment: 571
Study Start Date: May 2014
Estimated Study Completion Date: September 2020
Estimated Primary Completion Date: May 2017 (Final data collection date for primary outcome measure)

Arms:
- Experimental:
Daratumumab + lenalidomide + dexamethasone
- Active Comparator: Lenalidomide + dexamethasone

Category Value
Date last updated at source 2017-06-01
Study type(s) Interventional
Expected enrolment 569
Study start date 2014-05-23
Estimated primary completion date 2016-03-07

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