Actively Recruiting
Phase 12 Study of Linvoseltamab for Adults with Relapsed or Refractory Multiple Myeloma to Find Safe and Effective Dosage
Led by Regeneron Pharmaceuticals · Updated on 2026-04-20
387
Participants Needed
40
Research Sites
11 weeks
Total Duration
AI-Summary
What this Trial Is About
Researchers are studying linvoseltamab, an anti-BCMA x anti-CD3 bispecific antibody, in adults with relapsed or refractory multiple myeloma. The main goals are to evaluate the safety and find the best dose of linvoseltamab, while also exploring its effects on the body and any signs it can treat cancer. This Phase 12 study also examines side effects and how linvoseltamab is present in the blood over time. The study has two parts in Phase 1 dose escalation with intravenous IV linvoseltamab and subcutaneous SC administration. Participants receive either low or high doses of IV linvoseltamab, with some receiving anti-interleukin-6 receptor therapy before high-dose IV treatment. In Phase 2, there are multiple cohorts receiving linvoseltamab monotherapy following these dosing strategies. Participants will be monitored for dose-limiting toxicities, treatment-emergent adverse events, and cytokine release syndrome up to five years. The study measures linvoseltamab levels in serum, anti-drug antibodies, response rates, progression-free and overall survival, and patient quality of life. Various questionnaires and criteria are used throughout the follow-up period, which can last up to five years.
CONDITIONS
Brief Title
Phase 1/2 Study of Linvoseltamab in Adult Patients With Relapsed or Refractory Multiple Myeloma
Research Team
C
Clinical Trial Administrator
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here
