Mezigdomide and Elranatamab for Relapsed and/or Refractory Multiple Myeloma
Phase I/II Study of Mezigdomide and Elranatamab for Relapsed/Refractory Multiple Myeloma Patients
Sponsor: YOUNGIL KOH
No open prediction endpoints
Endpoints are classified and published by ProgramSignal analysts.
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Primary Endpoints (CT.gov)
Overall response rate (ORR)
Time frame: From C1D1 to confirmed PD, lost to follow-up, or death (whichever occurs first), assessed up to 24 months
Secondary Endpoints
Progression-free survival (PFS)
Overall survival (OS)
Complete Response Rate (CR) or better
Eligibility Criteria
Inclusion Criteria: * Subjects must satisfy the following criteria to be enrolled in the study: * Subject is ≥ 19 years of age at the time of signing the informed consent form (ICF). ② Subject must understand and voluntarily sign an ICF prior to any study-related assessments/procedures being conducted. * Subject is willing and able to adhere to the study visit schedule and other protocol requirements. ④ Subject has documented diagnosis of MM and measurable disease, defined as any of the following: A. M-protein ≥ 0.5 g/dL by serum protein electrophoresis (sPEP) or B. M-protein ≥ 200 mg/24-hour urine collection by urine protein electrophoresis (uPEP) or C. For subjects 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. \*Patients with measurable disease and extramedullary disease will be allowed to participate if there is a measurable extramedull…
Read full criteria on CT.gov →✦ Analyst Commentary
Expert commentary on why this trial matters and what to watch for.
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