Phase III Open-Label Study of Elranatamab to Treat Patients With Relapsed or Resistant AL Amyloidosis

What this Trial Is About

Researchers are evaluating the safety, tolerability, and effectiveness of elranatamab in patients with relapsed or refractory light chain AL amyloidosis. This Phase III, open-label study aims to find the recommended dose and assess response rates in patients who have previously received treatment but experienced disease progression. The study is sponsored by Brigham and Womens Hospital and includes participants aged 18 and older with specific disease and health criteria. The study includes two phases. Phase I will enroll 4 to 20 participants to determine the safe dose by monitoring dose-limiting toxicities. Participants will receive elranatamab subcutaneously with doses varying in cycles over 28-day periods. Phase II will enroll an additional 29 participants who will receive the recommended Phase II dose identified in Phase I. Treatment lasts for six cycles of 28 days each, with dosing schedules adjusted based on treatment response. Participants will be closely monitored through hospital stays during initial dosing, blood tests, bone marrow biopsies, and other assessments to measure disease response and safety. Researchers will track response rates, duration of response, survival, and adverse events including specific syndromes related to immune response. The study may continue up to several years to observe long-term outcomes and safety. Participants must agree to contraception and follow study procedures for the duration of the trial.

Elranatamab in Patients With Relapsed or Refractory AL Amyloidosis