Outpatient and Intermittent Dosing of Elranatamab in Relapsed/Refractory Multiple Myeloma

No open prediction endpoints

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Key Facts

Primary Endpoints (CT.gov)

Secondary Endpoints

Eligibility Criteria

Inclusion Criteria: 1. Relapsed and/or refractory MM defined as: 1. Documented evidence of progressive disease (PD) after achieving at least minimal response (MR) for ≥ 1 cycle during a previous MM treatment (i.e., relapsed MM). 2. Disease progression during or within 60 days from the end of the most recent MM treatment (i.e., refractory MM). 2. Measurable disease based on IMWG criteria, defined as at least one of the following, documented within 28 days before enrollment: 1. Serum M-protein ≥ 0.5 g/dl. 2. Urine M-protein excretion ≥ 200 mg/24 h. 3. Serum-free light chains (FLC) assay: Involved FLC level ≥ 10 mg/dl (≥ 100 mg/l) AND an abnormal serum-free light chain ratio (\< 0.26 or \> 1.65) only for patients without measurable serum or urine M protein. 3. Receipt of at least three prior classes of drugs either in separate regimens or as combinations. The three classes are defined as: An immunomodulatory drug (lenalidomide or pomalidomide), a proteasome inhib…

✦ Analyst Commentary

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