Real-World Evidence on Prognostic Value of MRD in Multiple Myeloma Using Flow Cytometry.
lenalidomide maintenance
minimal residual disease (MRD)
multiparameter flow cytometry
multiple myeloma
overall survival (OS)
progression‐free survival (PFS)
real‐world
Journal
European journal of haematology
ISSN: 1600-0609
Titre abrégé: Eur J Haematol
Pays: England
ID NLM: 8703985
Informations de publication
Date de publication:
10 Oct 2024
10 Oct 2024
Historique:
revised:
21
09
2024
received:
08
08
2024
accepted:
23
09
2024
medline:
11
10
2024
pubmed:
11
10
2024
entrez:
11
10
2024
Statut:
aheadofprint
Résumé
Minimal residual disease (MRD) is one of the most important prognostic factors in multiple myeloma (MM) and a valid surrogate for progression-free survival (PFS) and overall survival (OS). Recently, MRD negativity was approved as an early clinical endpoint for accelerated drug approval in MM. Nevertheless, there is limited evidence of MRD utility in real-world setting. In this retrospective multicenter study, we report outcomes of 331 newly diagnosed MM patients with MRD evaluation at Day+100 after autologous stem cell transplantation using flow cytometry with a median limit of detection of 0.001%. MRD negativity was reached in 47% of patients and was associated with significantly prolonged median PFS (49.2 months vs. 18.4 months; hazard ratios (HR) = 0.37; p < 0.001) and OS (not reached vs. 74.9 months; HR = 0.50; p = 0.007). Achieving MRD negativity was associated with PFS improvements regardless of age, International Staging System (ISS) stage, lactate dedydrogenase (LDH) level, or cytogenetic risk. Importantly, MRD positive patients benefited from lenalidomide maintenance versus no maintenance (18-months PFS: 81% vs. 46%; HR = 0.24; p = 0.002) while in MRD negative patients such benefit was not observed (p = 0.747). The outcomes of our real-world study recapitulate results from clinical trials including meta-analyses and support the idea that MRD positive patients profit more from lenalidomide maintenance than MRD negative ones.
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Subventions
Organisme : European Union project LERCO
ID : CZ.10.03.01/00/22_003/0000003
Organisme : SALVAGE project
ID : CZ.02.01.01/00/22_008/0004644
Organisme : Czech Health Research Council
ID : NU23-03-00374
Organisme : Czech Health Research Council
ID : NW24-03-00347
Organisme : Institutional support
ID : MH CZ-DRO-FNOs/2022
Organisme : Institutional support
ID : MH CZ-DRO-FNOs/2023
Organisme : Institutional support
ID : MH CZ-DRO-FNOs/2024
Organisme : Ministry of Health of the Czech Republic
ID : FNBr 65 269 705
Organisme : Ministry of Education, Youth and Sports of the Czech Republic through the e-INFRA CZ
ID : ID:90254
Informations de copyright
© 2024 The Author(s). European Journal of Haematology published by John Wiley & Sons Ltd.
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