Abstract
•Summary from the second annual BMT CTN Myeloma Intergroup minimal residual disease (MRD)/immune profiling (IP) workshop.•MRD is currently considered a prognostic biomarker from a regulatory perspective.•Additional prospective studies are required to develop MRD as a surrogate endpoint.•Standardization of immunophenotyping/IP studies is needed.
The second annual Blood and Marrow Transplant Clinical Trials Network (BMT CTN) Myeloma Intergroup Workshop on Minimal Residual Disease and Immune Profiling was convened on December 7, 2017, at the American Society of Hematology (ASH) meeting. During this workshop, investigators from around the world presented their latest research involving assessment of minimal residual disease (MRD) and immune profiling (IP) in myeloma. This document summarizes the workshop presentations as well as relevant ASH abstracts and focuses on the regulatory issues involved in the integration of MRD and IP assessment in clinical trial design and practice.