A Study of Elranatamab Management With Outpatient and Intermittent Dosing in Relapsed/Refractory Multiple Myeloma
A phase II study of single agent elranatamab in patients with relapsed and/or refractory multiple myeloma (MM) who have previously received at least three classes of therapeutic agents and are refractory to the last line of treatment. The primary objective of this study is to improve the tolerability and safety of elranatamab in patients with relapsed and/or refractory multiple myeloma by evaluating an outpatient and intermittent dosing strategy.
• Relapsed and/or refractory MM defined as:
‣ 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).
⁃ Disease progression during or within 60 days from the end of the most recent MM treatment (i.e., refractory MM).
• Measurable disease based on IMWG criteria, defined as at least one of the following, documented within 28 days before enrollment:
‣ Serum M-protein ≥ 0.5 g/dl.
⁃ Urine M-protein excretion ≥ 200 mg/24 h.
⁃ 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.
• 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 inhibitor (bortezomib, ixazomib, carfilzomib), and an anti-CD38 drug (daratumumab or isatuximab).
• At least 18 years of age.
• Eastern Cooperative Oncology Group (ECOG) performance status score of ≤2.