Phase 3 Study Comparing Belantamab Mafodotin Plus Lenalidomide and Dexamethasone BRd to Daratumumab Plus Lenalidomide and Dexamethasone DRd in Newly Diagnosed Multiple Myeloma Patients Not Eligible for Stem Cell Transplant

What this Trial Is About

Researchers are evaluating treatments for newly diagnosed multiple myeloma in patients who cannot undergo autologous stem cell transplantation. This Phase 3 study compares two drug combinations belantamab mafodotin with lenalidomide and dexamethasone BRd versus daratumumab with lenalidomide and dexamethasone DRd. The goal is to see if BRd extends progression-free survival and improves minimal residual disease negative status compared to DRd. Participants receive either BRd or DRd treatment, continuing until disease progression, death, unacceptable side effects, withdrawal, or study end. Both treatment arms involve the administration of lenalidomide and dexamethasone alongside either belantamab mafodotin or daratumumab. Treatment duration may last up to approximately seven years. During the study, participants will undergo regular assessments including monitoring disease progression, response to treatment, and side effects. Measurements include progression-free survival, overall survival, and the number achieving minimal residual disease negative status. Quality of life questionnaires and blood tests will also be conducted. Safety monitoring includes eye exams and tracking adverse events throughout the study duration.

A Study of Belantamab Mafodotin Administered in Combination With Lenalidomide and Dexamethasone (BRd) Versus Daratumumab, Lenalidomide, and Dexamethasone (DRd) in Participants With Newly Diagnosed Multiple Myeloma (NDMM) Who Are Ineligible for Autologous Stem Cell Transplantation (TI-NDMM)