Phase 1B Study to Evaluate Safety and Early Effects of Oral Cemsidomide Combined with Subcutaneous Elranatamab in Adults with Relapsed or Refractory Multiple Myeloma

What this Trial Is About

Researchers are studying the safety and tolerability of cemsidomide combined with elranatamab in people with relapsed or refractory multiple myeloma. This Phase 1B, open-label study explores different dose levels of cemsidomide alongside elranatamab, aiming to find a safe dose and gather early information on anti-myeloma activity. The study is led by C4 Therapeutics, Inc. and focuses on treatment for patients who have received prior therapies for multiple myeloma. Participants will take cemsidomide orally for 14 days followed by 14 days off in 28-day cycles. Elranatamab is given as a subcutaneous injection twice monthly. Additionally, dexamethasone is administered weekly until a confirmed response or for up to 4 cycles. The study includes a dose escalation phase to find a safe dose and a dose expansion phase to further assess safety and preliminary effectiveness. During the trial, participants will be monitored for safety and tolerability, especially in the first 28 days and through 30 days after stopping treatment. Researchers will also evaluate anti-myeloma activity over about 2 years and study how the body processes both cemsidomide and elranatamab for up to 2 years. Immunogenicity of elranatamab will be assessed, and participants will have various visits and assessments throughout the study period, which runs until June 2029.

A Study to Learn About the Effects of Cemsidomide in Combination With Elranatamab in Relapsed/Refractory Multiple Myeloma Subjects