FAQ: Using Minimal Residual Disease (MRD) in Multiple Myeloma Clinical Trials
An overview of the FDA’s draft guidance on MRD as a clinical trial end point, with expert insight on what it means for drug development in multiple myeloma.
Minimal residual disease (MRD) has emerged as a valuable tool in evaluating the efficacy of multiple myeloma drugs, reflecting the field’s shift toward deeper, more sensitive measures of treatment response. As therapies have become increasingly effective, traditional end points such as overall response rate and complete response are no longer sufficient to distinguish meaningful clinical benefit in feasible trial designs. The FDA’s draft guidance on the use of MRD and complete response (CR) as end points provides a regulatory framework for leveraging MRD to support accelerated approval.1