Περίληψη:
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. © 2020, The Author(s), under exclusive licence to Springer Nature Limited.
Συγγραφείς:
Costa, L.J.
Derman, B.A.
Bal, S.
Sidana, S.
Chhabra, S.
Silbermann, R.
Ye, J.C.
Cook, G.
Cornell, R.F.
Holstein, S.A.
Shi, Q.
Omel, J.
Callander, N.S.
Chng, W.J.
Hungria, V.
Maiolino, A.
Stadtmauer, E.
Giralt, S.
Pasquini, M.
Jakubowiak, A.J.
Morgan, G.J.
Krishnan, A.
Jackson, G.H.
Mohty, M.
Mateos, M.V.
Dimopoulos, M.A.
Facon, T.
Spencer, A.
Miguel, J.S.
Hari, P.
Usmani, S.Z.
Manier, S.
McCarthy, P.
Kumar, S.
Gay, F.
Paiva, B.
Λέξεις-κλειδιά:
analytic method; bioassay; bone marrow; clinical outcome; clinical trial (topic); consensus; diagnostic test; disease assessment; human; intention to treat analysis; limit of detection; minimal residual disease; multiple myeloma; peripheral circulation; priority journal; Review; diagnostic imaging; disease management; global health; health survey; metabolism; minimal residual disease; molecular diagnosis; multiple myeloma; pathology; procedures; reproducibility; smoldering multiple myeloma; time factor; tumor embolism, Clinical Trials as Topic; Diagnostic Imaging; Disease Management; Drug Collateral Sensitivity; Global Health; Humans; Molecular Diagnostic Techniques; Multiple Myeloma; Neoplasm, Residual; Neoplastic Cells, Circulating; Outcome Assessment, Health Care; Population Surveillance; Reproducibility of Results; Smoldering Multiple Myeloma; Time Factors
