Phase 2 Study of Elranatamab as Maintenance Therapy After Cilta-cel in Adults with High-Risk Relapsed Myeloma

What this Trial Is About

This research aims to evaluate the effect of Elranatamab therapy as a maintenance treatment after receiving ciltacabtagene-autoleucel cilta-cel in patients with clinical high-risk relapsed myeloma. High-risk myeloma includes patients with a history of myeloma that has spread outside the bones or those with high-risk mutations in myeloma cells. These patients typically benefit less from cilta-cel, so the study focuses on improving how long they live without their disease worsening, known as progression-free survival PFS. Participants who have received cilta-cel without signs of disease progression and have clinical high-risk myeloma will receive Elranatamab maintenance therapy. This treatment will start 3 to 6 months after the cilta-cel infusion and continue for 12 months at the FDA-approved full dose. During this time, patients will be closely monitored to assess the treatments effects. Throughout the study, participants will have regular visits to track their response to Elranatamab and monitor side effects. Researchers will measure progression-free survival for up to 24 months and evaluate other outcomes such as complete response and minimal residual disease MRD negativity over 12 months. Participants must be able to follow the visit schedule and protocol requirements for successful monitoring and data collection.

Elranatamab Post Cilta-cel in Patients With Clinical High Risk Relapsed Myeloma