Mezigdomide Plus Ixazomib and Dexamethasone for Relapsed and Refractory Multiple Myeloma
Phase I/II Trial of Mezigdomide Plus Ixazomib and Dexamethasone for Relapsed and Refractory Multiple Myeloma
Sponsor: Kathleen Dorritie + Bristol-Myers Squibb
No open prediction endpoints
Endpoints are classified and published by ProgramSignal analysts.
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Primary Endpoints (CT.gov)
Phase l: Recommended Phase II Dose (RP2D)
Time frame: Up to 17 months
Phase ll: Overall Response Rate (ORR)
Time frame: Up to 36 months
Secondary Endpoints
Incidence and severity of Adverse Events
Depth of Response
Duration of Response (DOR)
Eligibility Criteria
Inclusion Criteria: * ECOG performance status \< 2 * Patients must have a confirmed diagnosis of multiple myeloma and have received 1-3 prior lines of therapy and must be: * Exposed to a proteasome inhibitor, IMiD, and anti-CD38 antibody prior to enrollment. Patients must have measurable evidence of multiple myeloma defined as one of the following: * Serum M protein ≥ 0.5 g/dL * Abnormal free light chain ratio, provided involved light chain is \>10mg/dL * Urine M protein ≥ 200 mg/24 hours * Hematologic laboratory parameters of: * Absolute neutrophil count (ANC) \> 1,000/mm3 * Hemoglobin \> 8g/dL * Platelet count \> 75,000/μL if plasma cells account for \< 50% bone marrow * Nucleated cells and \> 50,000/μL if plasma cells account for \> 50% of bone marrow nucleated cells * Non-hematologic laboratory parameters of: * Total Bilirubin of \< 2 times the upper limit of normal * ALT and AST \< 3 times the upper limit of normal * Corrected serum calcium \>13 mg/dL * Est…
Read full criteria on CT.gov →✦ Analyst Commentary
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