Outpatient Treatment Study of Elranatamab with Tocilizumab for Adults with Relapsed or Refractory Multiple Myeloma

What this Trial Is About

Researchers are evaluating elranatamab in adults with relapsed or refractory multiple myeloma RRMM who have previously received at least one therapy and are exposed to lenalidomide and an anti-CD38 treatment. This Phase II, open-label, nonrandomized, single-arm study aims primarily to assess the occurrence of cytokine release syndrome CRS during the first treatment cycle after a single preventive dose of tocilizumab. The study includes two sequential groups of participants to evaluate safety and expansion of treatment. Participants will receive a single intravenous dose of tocilizumab before the first step-up dose of elranatamab. Elranatamab is administered subcutaneously in a step-up dosing schedule during the first 28-day cycle, followed by maintenance dosing every other week for cycles 2 and 3, then once per cycle for cycles 4 to 12. The study includes a safety lead-in cohort of 6 participants and an expansion cohort of 40 participants. Each treatment cycle lasts 28 days. Throughout the study, participants will be closely monitored with assessments including incidence and severity of CRS, infections, neurotoxicity, response rates, progression-free and overall survival, among others. Monitoring occurs during treatment cycles and up to 30 days after the last elranatamab dose, with follow-up extending up to approximately two years. Participants will undergo laboratory tests, imaging, and clinical evaluations as part of the study to assess safety and treatment effects.

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