Minimal Residual Disease–Based End Point for Accelerated Assessment of Clinical Trials in Multiple Myeloma: A Pooled Analysis of Individual Patient Data From Multiple Randomized Trials
Shi Q, et al.
J Clin Oncol
February 2025
Authors and Affiliates
Qian Shi, PhD1 ; Bruno Paiva, PhD2 ; Levi D. Pederson, MS1 ; Natalie Dimier, PhD3; Ela Talpes, PhD4; Thomas J. Prior, PhD5 ;
Alberto Orfao, MD, PhD6 ; Philippe Moreau, MD, PhD7 ; Pieter Sonneveld, MD, PhD8 ; Shaji K. Kumar, MD9 ; Jesse G. Dixon, MS1;
Reshma Patel, PhD10; Blake J. Bartlett, PhD5; Jordan Schecter, MD5; Phillip McCarthy, MD11 ; Dirk Hose, MD12 ; Anja Seckinger, MD12 ;
D’Agostino Mattia, MD13 ; Hartmut Goldschmidt, MD14 ; Stefania Oliva, MD15 ; Roger G. Owen, MD16; Kenneth C. Anderson, MD17 ;
Jes´us San-Miguel, MD, PhD18 ; Brian G.M. Durie, MD19; and Nikhil Munshi, MD17 ; on behalf of the International Independent Team for Endpoint
Approval of Myeloma Minimal Residual Disease (i2TEAMM) Group
1Department of Quantitative Health Sciences, Mayo Clinic, Rochester,
MN
2Department of Hematology and Immunology, University of Navara,
Pamplona, Spain
3Roche Products Limited, St Albans, United Kingdom
4Amgen Inc, San Francisco, CA
5Johnson & Johnson Inc, New Brunswick, NJ
6Department of Medicine, University of Salamanca, Salamanca, Spain
7Hematology Department, University Hospital Hotel-dieu, Nantes,
France
8Department of Hematology, Erasmus MC Cancer Institute, Rotterdam,
the Netherlands
9Division of Hematology, Mayo Clinic, Rochester, MN
10Johnson & Johnson Inc, High Wycombe, United Kingdom
11Roswell Park Cancer Institute, Buffalo, NY
12Department of Hematology and Immunology, Myeloma Center
Brussels & Labor f¨ur Myelomforschung, Vrije Universiteit Brussel (VUB),
Jette, Belgium
13Division of Hematology, Department of Molecular Biotechnology and
Health Sciences, AOU Citt `a della Salute e della Scienza di Torino,
University of Torino, Torino, Italy
14University Hospital Heidelberg, GMMG—Study Group at the University
Hospital Heidelberg, Heidelberg, Germany
15Myeloma Unit, Division of Hematology, University of Torino, Turin,
Italy
16St James Institute, Leeds, United Kingdom
17Harvard Medical School, Dana-Farber Cancer Institute, Boston, MA
18Professor of Hematology, Senior Consultant & Strategic Advisor,
Clinica Universidad de Navarra, Pamplona, Spain
19Cedars Sinai Outpatient Cancer Center, Los Angeles, CA