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

Active:	No
Cancer Type:	Multiple Myeloma	NCT ID:	NCT02136134
Trial Phases:	Phase III	Protocol IDs:	CR103995 (primary) 54767414MMY3004 2014-000255-85
Eligibility:	18 Years and older, Male and Female	Study Type:	Treatment
Study Sponsor:	Janssen Research & Development, LLC
NCI Full Details:	http://clinicaltrials.gov/show/NCT02136134

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.

Objectives

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.

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