Elotuzumab, CC-92480, and Dexamethasone for the Treatment of Relapsed or Refractory Myeloma After CD38- and BCMA-Targeted Therapies
Phase 1b Study to Assess Safety and Efficacy of Elotuzumab, CC-92480, and Dexamethasone in Relapsed/Refractory Myeloma After CD38- and BCMA-Targeted Therapies
Sponsor: Abdullah Khan
No open prediction endpoints
Endpoints are classified and published by ProgramSignal analysts.
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Primary Endpoints (CT.gov)
The recommended phase 2 dose of mezigdomide (CC-92480) in combination with elotuzumab and dexamethasone
Time frame: Up to 28 days (Cycle 1)
Incidence of adverse events
Time frame: Up to 2 years
Secondary Endpoints
Time to progression (TTP)
Time to response (TTR)
Duration of response (DOR)
Eligibility Criteria
Inclusion Criteria: * Patients 18 years of age or older with evidence of relapsed or refractory disease as defined by International Myeloma Working Group (IMWG) criteria and measurable disease as defined by any of the following: * Serum M-protein \>= 1.0 g/dl * Urine monoclonal protein \>= 200 mg/24h * Involved free light chain (FLC) level \>= 10mg/dl (\>= 100mg/l) and an abnormal serum free light chain ratio (\< 0.26, or \> 1.65) * Patients must have had at least 2 prior lines of therapy including lenalidomide, proteasome inhibitor (PI), anti-CD38 directed antibody, and BCMA-targeted therapy * Prior elotuzumab is permitted but patients with progressive disease (PD) as best reponse on elotuzumab are excluded; at least 6 months must have lapsed from prior elotuzumab exposure * Patients must have hemoglobin \>= 7g/dL * Absolute neutrophil count (ANC) \>= 1000/uL * Platelets \>= 70,000/uL * If plasma cell percentage on bone marrow biopsy aspirate or core is \> 30%, platelet …
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