Reflection paper on the use of measurable residual disease as a clinical endpoint in multiple myeloma studies - Scientific guideline
Table of contents
The reflection paper 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.
Keywords: Minimal residual disease (MRD), Myeloma