Phase 3 Study Comparing Linvoseltamab Added to Daratumumab, Lenalidomide, and Dexamethasone Versus Standard Treatment in Adults With Newly Diagnosed Multiple Myeloma Who Cannot Have a Stem Cell Transplant

What this Trial Is About

Researchers are studying an experimental drug called linvoseltamab in adults with newly diagnosed multiple myeloma who are not eligible for autologous stem cell transplantation. The study aims to compare the effects and safety of linvoseltamab combined with standard treatment against the standard treatment alone. This is a Phase 3 randomized, open-label trial sponsored by the European Myeloma Network B.V. Participants will receive either the combination of daratumumab, lenalidomide, dexamethasone, and linvoseltamab or continued treatment with daratumumab, lenalidomide, and dexamethasone alone. Treatments will be given according to the study protocol, and participants will be randomly assigned to one of these two groups. The study will continue for up to 11 years to assess long-term effects. During the study, participants will undergo various assessments including measurements of minimal residual disease MRD, progression-free survival, overall survival, and response rates. Quality of life will also be evaluated using standardized questionnaires. Safety will be closely monitored by tracking adverse events and laboratory tests. Participants will be followed up for up to 11 years, with regular visits to assess disease status and treatment impact.

A Study to Learn How Safe and How Well Linvoseltamab Works Compared to Standard Treatment in Adult Patients With Multiple Myeloma Who Are Not Eligible for Transplant