Comparing Elranatamab Plus Daratumumab and Lenalidomide to Standard Treatment in Adults with Newly Diagnosed Multiple Myeloma Not Eligible for Transplant

What this Trial Is About

Researchers are evaluating the combination of elranatamab, daratumumab, and lenalidomide compared with the combination of daratumumab, bortezomib, lenalidomide, and dexamethasone in adults with newly diagnosed multiple myeloma who are not candidates for transplant. This phase 3 study aims to determine whether the new combination offers better clinical benefits by assessing safety, tolerability, minimal residual disease negative complete response rates, and progression-free survival. The study has two parts. Part 1 focuses on characterizing the safety and tolerability of elranatamab combined with daratumumab and lenalidomide or with lenalidomide alone, and determining the best dose. Part 2 compares the effectiveness of elranatamab plus daratumumab and lenalidomide against the standard combination of daratumumab, bortezomib, lenalidomide, and dexamethasone in participants with newly diagnosed multiple myeloma. Participants receive study drugs according to their assigned group, and dosing and combinations vary by part and arm. Participants will undergo regular assessments including monitoring of disease status, progression, and response using criteria such as minimal residual disease and progression-free survival. Safety will be monitored through adverse event reporting and laboratory tests. Quality of life will also be evaluated using questionnaires. The study may last up to several years, with follow-up extending up to 97 months to assess long-term outcomes and survival.

A Study to Learn About the Effects of the Combination of Elranatamab, Daratumumab and Lenalidomide Compared With Daratumumab, Bortezomib, Lenalidomide, and Dexamethasone in Patients With Newly Diagnosed Multiple Myeloma Who Are Not Candidates for Transplant