Draft guideline on the use of minimal residual disease as a clinical endpoint in multiple myeloma studies

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Download document Draft guideline on the use of minimal residual disease as a clinical endpoint in multiple myeloma studies
Reference number EMA/CHMP/459559/2018
Status draft: consultation open
First published 2018-08-06
Last updated 2018-08-06
Consultation start date 2018-08-06
Consultation end date 2018-10-31
Email address for submissions ONCWP@ema.europa.eu

Summary

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.