First Human Study of REGN7945 Combined With Linvoseltamab for Adults With Relapsed or Refractory Multiple Myeloma Phase 12 Trial to Evaluate Safety, Tolerability, and Anti-Tumor Effects

What this Trial Is About

Researchers are evaluating an experimental drug called REGN7945 combined with another experimental drug, linvoseltamab, in adults with relapsed or refractory multiple myeloma. This is the first time REGN7945 is tested in humans, while linvoseltamab has been studied alone in similar patients. The study aims to assess the safety, tolerability, and effectiveness of REGN7945 with linvoseltamab compared to linvoseltamab alone. It also investigates side effects, the level of drug in the blood, immune response to the drugs, and impacts on pain, symptoms, function, and quality of life. Participants receive either REGN7945 plus linvoseltamab or linvoseltamab alone, administered according to the study protocol. The study includes Phase 1 and Phase 2 periods to evaluate initial safety and anti-tumor activity. Treatment and follow-up may continue for up to 5 years, allowing detailed monitoring of drug effects and participant outcomes. The trial uses a parallel design to compare the two treatment groups without random assignment. During the study, participants undergo regular assessments including blood tests to measure drug levels and immune responses, evaluations of disease status using international criteria, and questionnaires to assess quality of life and symptom changes. Researchers monitor side effects and overall response to treatment over time. The primary outcomes focus on treatment safety and tumor response within the first 12 weeks, while secondary outcomes include long-term safety, drug concentrations, immune reactions, symptom changes, and survival outcomes. Participation may last several years to fully capture these effects.

A Study to Assess the Safety and Anti-Tumor Activity of REGN7945 in Combination With Linvoseltamab in Adult Participants With Relapsed/Refractory Multiple Myeloma