Home > Publications database > Predictors of early morbidity and mortality in newly diagnosed multiple myeloma: data from five randomized, controlled, phase III trials in 3700 patients. > print

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005     20240306155143.0
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100 1 _ |a Mai, Elias K
|0 0000-0002-6226-1252
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245 _ _ |a Predictors of early morbidity and mortality in newly diagnosed multiple myeloma: data from five randomized, controlled, phase III trials in 3700 patients.
260 _ _ |a London
|c 2024
|b Springer Nature
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500 _ _ |a 2024 Mar;38(3):640-647
520 _ _ |a 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.
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700 1 _ |a Hielscher, Thomas
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700 1 _ |a Bertsch, Uta
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700 1 _ |a Salwender, Hans J
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700 1 _ |a Zweegman, Sonja
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700 1 _ |a Raab, Marc S
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700 1 _ |a Munder, Markus
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700 1 _ |a Pantani, Lucia
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700 1 _ |a Mancuso, Katia
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700 1 _ |a Brossart, Peter
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700 1 _ |a Beksac, Meral
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700 1 _ |a Blau, Igor W
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700 1 _ |a Dürig, Jan
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700 1 _ |a Besemer, Britta
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700 1 _ |a Fenk, Roland
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700 1 _ |a Reimer, Peter
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700 1 _ |a van der Holt, Bronno
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700 1 _ |a Hänel, Mathias
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700 1 _ |a von Metzler, Ivana
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700 1 _ |a Graeven, Ullrich
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700 1 _ |a Müller-Tidow, Carsten
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700 1 _ |a Boccadoro, Mario
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700 1 _ |a Scheid, Christof
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700 1 _ |a Dimopoulos, Meletios A
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700 1 _ |a Hillengass, Jens
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700 1 _ |a Weisel, Katja C
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700 1 _ |a Cavo, Michele
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700 1 _ |a Sonneveld, Pieter
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700 1 _ |a Goldschmidt, Hartmut
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