Journal Article

DKFZ-2023-02577

http://join2-wiki.gsi.de/foswiki/pub/Main/Artwork/join2_logo100x88.png Predictors of early morbidity and mortality in newly diagnosed multiple myeloma: data from five randomized, controlled, phase III trials in 3700 patients.

Mai, E. K. ; Hielscher, T.DKFZ* ; Bertsch, U. ; Salwender, H. J. ; Zweegman, S. ; Raab, M. S. ; Munder, M. ; Pantani, L. ; Mancuso, K. ; Brossart, P. ; Beksac, M. ; Blau, I. W. ; Dürig, J. ; Besemer, B. ; Fenk, R. ; Reimer, P. ; van der Holt, B. ; Hänel, M. ; von Metzler, I. ; Graeven, U. ; Müller-Tidow, C. ; Boccadoro, M. ; Scheid, C. ; Dimopoulos, M. A. ; Hillengass, J. ; Weisel, K. C. ; Cavo, M. ; Sonneveld, P. ; Goldschmidt, H.

2024
Springer Nature London

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Please use a persistent id in citations: doi:10.1038/s41375-023-02105-6

Abstract: Early morbidity and mortality affect patient outcomes in multiple myeloma. Thus, we dissected the incidence and causes of morbidity/mortality during induction therapy (IT) for newly diagnosed multiple myeloma (NDMM), and developed/validated a predictive risk score. We evaluated 3700 transplant-eligible NDMM patients treated in 2005-2020 with novel agent-based triplet/quadruplet IT. Primary endpoints were severe infections, death, or a combination of both. Patients were divided in a training (n = 1333) and three validation cohorts (n = 2367). During IT, 11.8%, 1.8%, and 12.5% of patients in the training cohort experienced severe infections, death, or both, respectively. Four major, baseline risk factors for severe infection/death were identified: low platelet count (<150/nL), ISS III, higher WHO performance status (>1), and age (>60 years). A risk score (1 risk factor=1 point) stratified patients in low (39.5%; 0 points), intermediate (41.9%; 1 point), and high (18.6%; ≥2 points) risk. The risk for severe infection/death increased from 7.7% vs. 11.5% vs. 23.3% in the low- vs. intermediate- vs. high-risk groups (p < 0.001). The risk score was independently validated in three trials incorporating quadruplet IT with an anti-CD38 antibody. Our analyses established a robust and easy-to-use score to identify NDMM patients at risk of severe infection/death, covering the latest quadruplet induction therapies. Trial registrations: HOVON-65/GMMG-HD4: EudraCT No. 2004-000944-26. GMMG-MM5: EudraCT No. 2010-019173-16. GMMG-HD6: NCT02495922. EMN02/HOVON-95: NCT01208766. GMMG-HD7: NCT03617731.

Note: 2024 Mar;38(3):640-647

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Contributing Institute(s):

1. C060 Biostatistik (C060)

Research Program(s):

1. 313 - Krebsrisikofaktoren und Prävention (POF4-313) (POF4-313)

Appears in the scientific report 2023

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Database coverage:
; BIOSIS Previews ; Biological Abstracts ; Clarivate Analytics Master Journal List ; Current Contents - Life Sciences ; DEAL Springer ; Ebsco Academic Search ; Essential Science Indicators ; IF >= 10 ; JCR ; SCOPUS ; Science Citation Index Expanded ; Web of Science Core Collection

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