Study of Elranatamab Given Outpatient for Adults with Relapsed or Refractory Multiple Myeloma Evaluating Safety and Cytokine Release Syndrome

What This Trial Is About

Researchers are evaluating the safety and effects of elranatamab administered in the outpatient setting for adults with relapsed or refractory multiple myeloma who have previously received at least one therapy and have been exposed to both lenalidomide and an anti-CD38 antibody. This Phase II, open-label, single-arm study focuses primarily on measuring the incidence of cytokine release syndrome CRS during the first treatment cycle after giving a single prophylactic dose of tocilizumab, an agent aimed at reducing CRS risk. Participants will receive a one-time intravenous dose of tocilizumab before starting elranatamab, which is given subcutaneously in step-up doses during the first 28-day cycle and then at regular intervals for up to 12 cycles. The initial cycle involves doses on Days 1, 4, 8, 15, and 22, followed by every other week dosing in cycles two and three, then once per cycle from cycle four to twelve. The study includes two sequential groups a safety lead-in cohort of six participants followed by an expansion cohort of forty participants. During the study, participants will have regular assessments for CRS and other side effects, including infections and neurotoxicity, monitored throughout treatment and up to 30 days after the last dose, covering approximately 13 months. Researchers will also evaluate response rates, duration of response, progression-free survival, and overall survival. Participants will undergo laboratory tests and clinical evaluations throughout the treatment cycles and survival follow-up, with the total study duration lasting up to around two years.

A Study of Elranatamab Outpatient Administration in Patients With Relapsed/Refractory Multiple Myeloma