Phase III Study Evaluating Mezigdomide and Elranatamab Combination Treatment for Adults with Relapsed or Refractory Multiple Myeloma

What this Trial Is About

Researchers are studying how well a combination of two medicines, mezigdomide and elranatamab, works in treating patients with relapsed or refractory multiple myeloma. This phase III, open-label, single-arm, multicenter trial aims to evaluate the safety, tolerability, and effectiveness of this combination treatment. The study is led by Youngil Koh and focuses on patients who have received prior therapies but whose disease has progressed. The study has two parts. Part 1 will include about 12 participants to find the recommended phase 2 dose and assess safety and preliminary effectiveness. Part 2 will enroll approximately 63 participants to determine the overall response rate at 24 months. Participants will receive elranatamab by subcutaneous injection with a step-up dosing schedule, oral mezigdomide capsules daily for 21 days per 28-day cycle, and dexamethasone as premedication. Dosing schedules adjust based on response levels and disease progression. Participants will undergo regular assessments including response evaluations using International Myeloma Working Group criteria over 24 months. Researchers will monitor disease progression, survival, safety, and minimal residual disease status. The study includes frequent visits during treatment cycles with monitoring of laboratory tests, imaging, and clinical status. The study duration covers treatment and follow-up to capture long-term outcomes and side effects.

Mezigdomide and Elranatamab for Relapsed and/or Refractory Multiple Myeloma