Addition of Daratumumab to Combination of Bortezomib and Dexamethasone in Participants With Relapsed or Refractory Multiple Myeloma
18 Years and older, Male and Female
CR103995 (primary)
54767414MMY3004
2014-000255-85
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.
Eligibility
- Must have had documented multiple myeloma
- Must have received at least 1 prior line of therapy for multiple myeloma
- Must have had documented evidence of progressive disease as defined based on Investigator's determination of response of International Myeloma Working Group (IMWG) criteria on or after their last regimen
- Must have an Eastern Cooperative Oncology Group Performance Status score of 0, 1, or 2
- Must have achieved a response (partial response [PR] or better based on investigator's determination of response by the IMWG criteria) to at least 1 prior regimen in the past
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