Clayfield

Researchers are evaluating the study medicine elranatamab alone and in combination with daratumumab for people with relapsed or refractory multiple myeloma who have received prior treatments including lenalidomide and a proteasome inhibitor. The study aims to compare elranatamab to a combination therapy of daratumumab, pomalidomide, and dexamethasone, while also assessing the safety and activity of elranatamab with daratumumab. This is an open-label, phase 3 randomized trial involving multiple centers. The study includes three parts. Part 1 evaluates the safety and activity of different doses of elranatamab combined with daratumumab. In Part 2, participants are randomly assigned to receive either elranatamab alone, elranatamab with daratumumab, or the combination of daratumumab, pomalidomide, and dexamethasone. Part 3 investigates the effect of increased infection protection measures in participants treated with elranatamab alone or with daratumumab. All drugs are given by either subcutaneous injection or orally depending on the medication. Participants will receive study treatment until their disease worsens, unacceptable side effects occur, or they decide to stop. Researchers will monitor safety by tracking dose limiting toxicities during the first 42 days after starting elranatamab and treatment-emergent adverse events during the first 84 days. Progression-free survival will be assessed up to 51 months after randomization. Throughout the study, participants will undergo regular assessments to evaluate treatment safety and effectiveness.