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.
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).
Serum M-protein ≥ 0.5 g/dl.
Urine M-protein excretion ≥ 200 mg/24 h.
Active plasma cell leukemia (either 20% of peripheral white blood cells or > 2.0 × 109/L circulating plasma cells by standard differential).
Amyloidosis.
POEMS syndrome (Polyneuropathy, Organomegaly, Endocrinopathy, Monoclonal plasma cell disorder, Skin Changes).
Monoclonal gammopathy of unknown significance or smoldering multiple myeloma.