A Multicenter Study of Belantamab Mafodotin and Mezigdomide in Patients With Relapsed Multiple Myeloma
A Multicenter Phase 2 Study of Belantamab Mafodotin and Mezigdomide in Combination With a Phase Ib Safety Run in Patients With Relapsed Multiple Myeloma Following BCMA-targeting CAR-T Cells or Bispecific Antibodies
Sponsor: Centre Hospitalier Universitaire de Saint Etienne
No open prediction endpoints
Endpoints are classified and published by ProgramSignal analysts.
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Primary Endpoints (CT.gov)
Progression Free Survival
Time frame: Year 5
Secondary Endpoints
Overall response rate (ORR)
Percentage of patients achieving very good partial response (VGPR) or better, complete response (CR), and partial response (PR).
Time to response (TTR)
Eligibility Criteria
Inclusion Criteria: 1. Subjects who are ≥ 18 years of age 2. Participant has a histologically or cytologically confirmed diagnosis of MM as defined by IMWG criteria 3. Participant has Eastern Cooperative Oncology Group (ECOG) performance status of score of 0, 1, or 2 4. Participant is considered transplant ineligible or for participants with a history of autologous stem cell transplant (ASCT), ASCT was \>100 days before initiating study treatment 5. Participant has measurable disease with at least one of the following criteria: * Serum M protein \>0.5 g/dL (\>5 g/L), or * Urine M protein \>200 mg/24h, or * Serum free light chain (FLC) assay: Involved FLC level \>5 mg/dL (\>50 mg/L) and an abnormal serum FLC ratio (\<0.26 or \>1.65) 6. Participant is quadruple-class exposed or refractory (anti-CD38 antibody (e.g., daratumumab, isatuximab) alone or in combination, immunomodulatory agent (e.g., lenalidomide, pomalidomide), a proteasome inhibitor (e.g., bortezomib, ixazomib, car…
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