Phase 1 Study of Cevostamab and Elranatamab Combination Therapy for Adults With Relapsed or Refractory Multiple Myeloma

What this Trial Is About

This research aims to evaluate the safety and tolerability of combining two drugs, cevostamab and elranatamab, in participants with relapsed or refractory multiple myeloma. The study also seeks to determine the recommended Phase II dose regimen for this combination treatment. The trial includes a safety lead-in stage followed by an expansion stage to further assess these treatments. Participants will receive cevostamab intravenously and elranatamab subcutaneously with step-up dosing during a pre-phase. After this, participants will continue to receive elranatamab as a subcutaneous injection until disease progression or unacceptable side effects occur. Cevostamab will be given as an intravenous infusion until disease progression, unacceptable toxicity, or up to one year of treatment, whichever comes first. Different dosing groups include combination therapy and elranatamab monotherapy. Throughout the study, participants will undergo monitoring for adverse events and treatment responses for up to approximately 36 months. Assessments include measuring drug levels in the blood, immune responses to the drugs, and clinical responses based on established myeloma criteria. Safety and tolerability are closely tracked, and the studys primary outcomes focus on adverse events and determining dosing recommendations. Participants may have regular visits for evaluations during the treatment and follow-up periods.

A Study Evaluating the Safety, Pharmacokinetics, and Activity of the Combination of Cevostamab and Elranatamab in Participants With Relapsed or Refractory Multiple Myeloma (R/R MM)