Department of Internal Medicine, Division of Oncology and Hematology, University of Nebraska Medical Center, Omaha, Nebraska.
Department of Internal Medicine, Division of Hematology/Oncology, University of Michigan, Ann Arbor, Michigan.
Biol Blood Marrow Transplant. 2019 Mar;25(3):e89-e97. doi: 10.1016/j.bbmt.2018.11.001. Epub 2018 Nov 5.
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.
第二届血液和骨髓移植临床研究网络（BMT CTN）多发性骨髓瘤协作组微小残留病和免疫分析研讨会于 2017 年 12 月 7 日在美国血液学会（ASH）会议上召开。在本次研讨会上，来自世界各地的研究人员展示了他们在多发性骨髓瘤微小残留病（MRD）评估和免疫分析（IP）方面的最新研究成果。本文总结了研讨会的演讲内容以及相关 ASH 摘要，并重点关注了在临床试验设计和实践中整合 MRD 和 IP 评估所涉及的监管问题。
