Phase 2 Study of Low-Dose Radiation to Boost Elranatamab Treatment in Relapsed or Refractory Multiple Myeloma with Extramedullary or Paramedullary Disease

What this Trial Is About

Researchers are investigating whether low doses of radiation therapy can help the drug elranatamab improve its ability to kill cancer cells in patients with relapsed or refractory multiple myeloma who also have extramedullary or paramedullary disease. This phase 2 study aims to evaluate the overall response rate at 3 months and to understand safety, time to next treatment, progression-free survival, overall survival, quality of life, and local control of irradiated lesions. Participants will receive elranatamab given intravenously along with radiotherapy aimed at priming the immune system to enhance the drugs effect on cancer cells. The study focuses on treating lesions that have not been previously radiated and can be targeted with radiation. This trial is sponsored by M.D. Anderson Cancer Center and involves monitoring response differences between patients with extramedullary versus paramedullary disease and between high-risk and standard-risk groups. During the study, participants will be closely monitored for safety and adverse events for about one year. Researchers will collect data on treatment effects, quality of life, and disease progression. Assessments will include imaging to confirm disease location, blood tests to monitor blood counts and organ function, and performance status evaluations. The total duration of participation depends on individual treatment and follow-up needs throughout the study.

A Phase 2 Study of Radiotherapy-induced Immune Priming to Enhance Elranatamab (Elra) in Relapsed Refractory Multiple Myeloma (RRMM) With Extramedullary Disease (EMD) and Paramedullary Disease (PMD) "PRIME-EMD-PMD"