Elranatamab in Relapsed/Refractory Multiple Myeloma
Phase II MRD-Adapted Study of Elranatamab in Relapsed/Refractory
Sponsor: University of California, San Diego
No open prediction endpoints
Endpoints are classified and published by ProgramSignal analysts.
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Primary Endpoints (CT.gov)
MRD negativity rate as best response
Time frame: 1 year of starting treatment
Secondary Endpoints
Sustained MRD negativity rate at 10^-5
Overall response rate
Complete response rate
Eligibility Criteria
Inclusion Criteria: 1. Provision of signed and dated informed consent form 2. Stated willingness to comply with all study procedures and availability for the duration of the study 3. Prior diagnosis of relapsed/refractory MM and have received 1 to 3 prior lines of therapy as defined by the IMWG criteria (Rajkumar et al., 2014) including anti-CD38 monoclonal antibody, proteosome inhibitor (PI), and immunomodulatory drug (IMiD), and BCMA-directed chimeric antigen receptor T-cell (CAR T-cell) therapy 1. Refractory is defined as having disease progression while on therapy or within 60 days of last dose in any line, regardless of response. 2. If participant has not received BCMA-directed CAR T-cell therapy, must be ineligible for CAR T-cell therapy or deferred such treatment by participant 4. Aged greater or equal to 18 years 5. Measurable disease as defined by any of the following: 1. Serum M-protein level ≥ 0.5 g/dL by serum protein electrophoresis (SPEP), or 2. Urine M-pro…
Read full criteria on CT.gov →✦ Analyst Commentary
Expert commentary on why this trial matters and what to watch for.
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