Guideline on the use of minimal residual disease as a clinical endpoint in multiple myeloma studies
Table of contents
The guideline aims to address the use of undetectable minimal residual disease (MRD) as an intermediate efficacy endpoint in controlled randomised clinical studies in patients with multiple myeloma (MM), adequately designed to demonstrate efficacy by relevant hard endpoints. MRD as an endpoint in this context would allow earlier approval of new drugs pending final confirmatory data.
Note that this guideline is currently on hold, pending discussions of emerging analyses in the context of a moving scientific field.
Keywords: Minimal residual disease (MRD), Myeloma