TY - JOUR
T1 - International harmonization in performing and reporting minimal residual disease assessment in multiple myeloma trials
AU - Costa, Luciano J.
AU - Derman, Benjamin A.
AU - Bal, Susan
AU - Sidana, Surbhi
AU - Chhabra, Saurabh
AU - Silbermann, Rebecca
AU - Ye, Jing C.
AU - Cook, Gordon
AU - Cornell, Robert F.
AU - Holstein, Sarah A.
AU - Shi, Qian
AU - Omel, James
AU - Callander, Natalie S.
AU - Chng, Wee Joo
AU - Hungria, Vania
AU - Maiolino, Angelo
AU - Stadtmauer, Edward
AU - Giralt, Sergio
AU - Pasquini, Marcelo
AU - Jakubowiak, Andrzej J.
AU - Morgan, Gareth J.
AU - Krishnan, Amrita
AU - Jackson, Graham H.
AU - Mohty, Mohamad
AU - Mateos, Maria Victoria
AU - Dimopoulos, Meletious A.
AU - Facon, Thierry
AU - Spencer, Andrew
AU - Miguel, Jesus San
AU - Hari, Parameswaran
AU - Usmani, Saad Z.
AU - Manier, Salomon
AU - McCarthy, Phillip
AU - Kumar, Shaji
AU - Gay, Francesca
AU - Paiva, Bruno
N1 - Publisher Copyright:
© 2020, The Author(s), under exclusive licence to Springer Nature Limited.
PY - 2021/1
Y1 - 2021/1
N2 - Minimal residual disease (MRD) assessment is incorporated in an increasing number of multiple myeloma (MM) clinical trials as a correlative analysis, an endpoint or even as a determinant of subsequent therapy. There is substantial heterogeneity across clinical trials in how MRD is assessed and reported, creating challenges for data interpretation and for the design of subsequent studies. We convened an international panel of MM investigators to harmonize how MRD should be assessed and reported in MM clinical trials. The panel provides consensus on which MM trials should include MRD, the recommended time points for MRD assessment, and expected analytical validation for MRD assays. We subsequently outlined parameters for reporting MRD results implementing the intention-to-treat principle. The panel provides guidance regarding the incorporation of newer peripheral blood-based and imaging-based approaches to detection of residual disease. Recommendations are summarized in 13 consensus statements that should be followed by sponsors, investigators, editors, and reviewers engaged in designing, performing, and interpreting MM trials.
AB - Minimal residual disease (MRD) assessment is incorporated in an increasing number of multiple myeloma (MM) clinical trials as a correlative analysis, an endpoint or even as a determinant of subsequent therapy. There is substantial heterogeneity across clinical trials in how MRD is assessed and reported, creating challenges for data interpretation and for the design of subsequent studies. We convened an international panel of MM investigators to harmonize how MRD should be assessed and reported in MM clinical trials. The panel provides consensus on which MM trials should include MRD, the recommended time points for MRD assessment, and expected analytical validation for MRD assays. We subsequently outlined parameters for reporting MRD results implementing the intention-to-treat principle. The panel provides guidance regarding the incorporation of newer peripheral blood-based and imaging-based approaches to detection of residual disease. Recommendations are summarized in 13 consensus statements that should be followed by sponsors, investigators, editors, and reviewers engaged in designing, performing, and interpreting MM trials.
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U2 - 10.1038/s41375-020-01012-4
DO - 10.1038/s41375-020-01012-4
M3 - Review article
C2 - 32778736
AN - SCOPUS:85089253567
SN - 0887-6924
VL - 35
SP - 18
EP - 30
JO - Leukemia
JF - Leukemia
IS - 1
ER -