Phase 3 Study Comparing Daratumumab, Bortezomib and Dexamethasone (DVd) vs Bortezomib and Dexamethasone (Vd) in Subjects With Relapsed or Refractory Multiple Myeloma

Phase 3

Recruiting

Conditions: Multiple Myeloma
10018865

Registration Number: NL-OMON50435

Lead Sponsor: Janssen-Cilag

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 24

Inclusion Criteria

- Must have had documented multiple myeloma
- Must have received at least 1 prior line of therapy for multiple myeloma
- Must have documented evidence of progressive disease based on
investigator*s determination of response by the International Myeloma Working
Group 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 or better) to at least 1
prior regimen

Exclusion Criteria

- Has received daratumumab or other anti-CD38 therapies previously
- Is refractory to VELCADE or another Proteasome Inhibitor (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
- Has a history of malignancy (other than multiple myeloma) within 3 years
before the date of randomization
- Has any concurrent medical condition or disease (eg, active systemic
infection) that is likely to interfere with study procedures

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Percentage of participants with progression-free survival (PFS)</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Time to disease progression (TTP)<br /><br>Percentage of Participants With Overall Response<br /><br>Duration of response<br /><br>Time to Response<br /><br>Percentage of participants with a very good partial response (VGPR) or better<br /><br>Percentage of participants with Minimal Residual Disease (MRD)<br /><br>Percentage of participants with overall survival (OS)</p><br>