Status:
RECRUITING
A Study to Evaluate Mezigdomide, Bortezomib and Dexamethasone (MEZIVd) Versus Pomalidomide, Bortezomib and Dexamethasone (PVd) in Participants With Relapsed or Refractory Multiple Myeloma (RRMM)
Lead Sponsor:
Celgene
Conditions:
Relapsed or Refractory Multiple Myeloma
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The purpose of this study is to compare the efficacy and safety of mezigdomide (CC-92480), bortezomib and dexamethasone (MeziVd) versus pomalidomide, bortezomib and dexamethasone (PVd) in participants...
Eligibility Criteria
Inclusion
- \- Participant has documented diagnosis of MM and measurable disease, defined as any of the following:.
- i) M-protein ≥ 0.5 grams per deciliter (g/dL) by serum protein electrophoresis (sPEP) or.
- ii) M-protein ≥ 200 milligrams (mg) per 24-hour urine collection by urine protein electrophoresis (uPEP).
- iii) For participants without measurable disease in sPEP or uPEP: serum free light chain (sFLC) levels \> 100 mg/L (10 mg/dL) involved light chain and an abnormal kappa/lambda FLC ratio.
- Participants received 1 to 3 prior lines of antimyeloma therapy.
- Participants achieved minimal response \[MR\] or better to at least 1 prior antimyeloma therapy.
Exclusion
- \- Participant has had progression during treatment or within 60 days of the last dose of a proteasome inhibitor, except as noted below:.
- i) Subjects who progressed while being treated with, or within 60 days of last dose of bortezomib maintenance given once every 2 weeks (or less frequently) are not excluded.
- ii) Participants who progressed while being treated with ixazomib monotherapy maintenance ≥ 6 months prior to the time of starting study treatment are not excluded.
- For participants with prior treatment of a bortezomib containing regimen, the best response achieved was not a minimal response (MR) or better, or participant discontinued bortezomib due to toxicity.
- Participant has had prior treatment with mezigdomide or pomalidomide.
- Other protocol-defined Inclusion/Exclusion criteria apply.
Key Trial Info
Start Date :
September 20 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 30 2033
Estimated Enrollment :
810 Patients enrolled
Trial Details
Trial ID
NCT05519085
Start Date
September 20 2022
End Date
November 30 2033
Last Update
March 11 2026
Active Locations (266)
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1
Cancer and Blood Specialty Clinic
Los Alamitos, California, United States, 90720
2
Sharp Memorial Hospital
San Diego, California, United States, 92123
3
Local Institution - 0273
West Hollywood, California, United States, 90069
4
Local Institution - 0381
Aurora, Colorado, United States, 80045