Relapsed or Refractory Multiple Myeloma (RRMM)
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Participant has documented diagnosis of multiple myeloma and measurable disease, defined as any of the following: a. M-protein >= 0.5 grams per deciliter (g/dL) by serum protein electrophoresis (sPEP) or b. M-protein >=200 milligrams (mg) per 24-hour urine collection by urine protein electrophoresis (uPEP) c. 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. 2. Participants received 1 to 3 prior lines of antimyeloma therapy. 3. Subject must have received prior treatment with a lenalidomide-containing regimen. 4. Participants achieved minimal response [MR] or better to at least 1 prior antimyeloma therapy.
Exclusion criteria
Exclusion criteria: 1. Participant has had progression during treatment or within 60 days of the last dose of a proteasome inhibitor, except as noted below: a. Subjects who progressed while being treated with, or within 60 days of last dose of bortezomib maintenance given once every 2 weeks or less are not excluded. 2. 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. 3. Participant has had prior treatment with mezigdomide or pomalidomide.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-Free Survival (PFS) | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall Survival (OS),Overall Response (OR),Complete Response (CR) or better,Very Good Partial Response (VGPR) or better,Time to Response (TTR),Duration of Response (DOR),Time to Progression (TTP),Time to Next Treatment (TTNT),Progression-free Survival 2 (PFS-2),Minimal Residual Disease (MRD) negativity,Safety,Health Related Quality of Life (HRQoL) Evaluation | — |
Countries
Argentina, Australia, Austria, Belgium, Brazil, Canada, China, Czech Republic, Finland, France, Germany, Greece, Ireland, Israel, Italy, Japan, Poland, Portugal, Republic of Korea, Romania, Spain, United Kingdom,, United States
Contacts
Bristol-Myers Squibb