Mezigdomide, Carfilzomib, and Dexamethasone for the Treatment of Relapsed or Refractory Multiple Myeloma in Patients With Extramedullary Disease
Phase II Clinical Trial of Mezigdomide/Carfilzomib/Dexamethasone (MeziKD) in Patients With Relapsed or Refractory Multiple Myeloma (MM) With Extramedullary Disease (EMD)
Sponsor: Roswell Park Cancer Institute
No open prediction endpoints
Endpoints are classified and published by ProgramSignal analysts.
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Primary Endpoints (CT.gov)
Overall Response Rate
Time frame: At the end of cycle 6 (each cycle is 28 days).
Clinical benefit rate
Time frame: At the end of cycle 6 (each cycle is 28 days)
Secondary Endpoints
Incidence of Adverse Events (AEs)
Duration of response
Progression Free survival
Eligibility Criteria
Inclusion Criteria: * Age ≥ 18 years of age * Have an Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2 * RRMM patients with one or more prior lines of therapy with at least one ES or PS lesion that is accessible to a biopsy. Accessibility will be assessed by the MM tumor board * Measurable disease meeting at least one of the following: * Serum M-protein ≥1 g/dL * Urine M-protein ≥200 mg/24 h * Serum FLC assay: involved FLC level ≥10 mg/dL provided serum FLC ratio is abnormal * Up to 10 patients without measurable disease can be enrolled but screening imaging and/or bone marrow biopsy have to confirm RRMM. Follow-up response assessment will be performed with imaging using RECIST 1.1 and Deauville Criteria and bone marrow biopsies * Absolute neutrophil count: ≥ 1 x 10\^9/L * Platelets: ≥ 75 x 10\^9/L * Total bilirubin: ≤ 1.5 x upper limit of normal (ULN) * Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \[SGOT\])/alanine aminotransfe…
Read full criteria on CT.gov →✦ Analyst Commentary
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