Addition of Daratumumab to Combination of Bortezomib and Dexamethasone in Participants With Relap… (NCT02136134) | Clinical Trial Compass
CompletedPhase 3
Addition of Daratumumab to Combination of Bortezomib and Dexamethasone in Participants With Relapsed or Refractory Multiple Myeloma
United States498 participantsStarted 2014-08-15
Plain-language 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.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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
Exclusion Criteria:
* Has received daratumumab or other anti-CD38 therapies previously
* Is refractory to VELCADE or another PI, like ixazomib and carfilzomib (had progression of disease while receiving VELCADE therapy or within 60 days of ending VELCADE therapy or another PI therapy, like ixazomib and carfilzomib
* Is intolerant to VELCADE (ie, discontinued due to any adverse event while on VELCADE treatment)
* Has received anti-myeloma treatment within 2 weeks or 5 pharmacokinetic half-lives of the treatment, whichever is longer, before the date of randomization. The only exception is emergency use of a short course of corticosteroids (equivalent of dexamethasone 40 milligram per day \[mg/day\] for a maximum of 4 days) before treatment. A list of anti-myeloma treatments with the corresponding pharmacokinetic half-lives is provided in the Site Investigational Product Pro…
What they're measuring
1
Progression-free Survival (PFS)
Timeframe: From the date of randomization to either progressive disease or death, whichever occurred first (approximately 1 year 4 months)