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Efficacy and safety of daratumumab in intermediate/high-risk smoldering multiple myeloma: final analysis of CENTAURUS

Early intervention in smoldering multiple myeloma (SMM) may delay progression to MM. Here, we present the final analysis of the phase 2 CENTAURUS study. In total, 123 patients with intermediate/high-risk SMM were randomized to IV daratumumab 16 mg/kg after a long-intense (n = 41), intermediate (n =...

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Hauptverfasser: Landgren, Ola (VerfasserIn) , Chari, Ajai (VerfasserIn) , Cohen, Yael C. (VerfasserIn) , Spencer, Andrew (VerfasserIn) , Voorhees, Peter M. (VerfasserIn) , Sandhu, Irwindeep (VerfasserIn) , Jenner, Matthew W. (VerfasserIn) , Smith, Dean (VerfasserIn) , Cavo, Michele (VerfasserIn) , van de Donk, Niels W. C. J. (VerfasserIn) , Beksac, Meral (VerfasserIn) , Moreau, Philippe (VerfasserIn) , Goldschmidt, Hartmut (VerfasserIn) , Vieyra, Diego (VerfasserIn) , Sha, Linlin (VerfasserIn) , Li, Liang (VerfasserIn) , Rousseau, Els (VerfasserIn) , Dennis, Robyn (VerfasserIn) , Carson, Robin (VerfasserIn) , Hofmeister, Craig C. (VerfasserIn)
Dokumenttyp: Article (Journal)
Sprache:Englisch
Veröffentlicht: April 10, 2025
In: Blood
Year: 2025, Jahrgang: 145, Heft: 15, Pages: 1658-1669
ISSN:1528-0020
DOI:10.1182/blood.2024025897
Online-Zugang:Verlag, lizenzpflichtig, Volltext: https://doi.org/10.1182/blood.2024025897
Verlag, lizenzpflichtig, Volltext: https://ashpublications.org/blood/article-abstract/145/15/1658/534407/Efficacy-and-safety-of-daratumumab-in-intermediate?redirectedFrom=fulltext
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Verfasserangaben:Ola Landgren, Ajai Chari, Yael C. Cohen, Andrew Spencer, Peter M. Voorhees, Irwindeep Sandhu, Matthew W. Jenner, Dean Smith, Michele Cavo, Niels W.C.J. van de Donk, Meral Beksac, Philippe Moreau, Hartmut Goldschmidt, Diego Vieyra, Linlin Sha, Liang Li, Els Rousseau, Robyn Dennis, Robin Carson, Craig C. Hofmeister
Beschreibung
Zusammenfassung:Early intervention in smoldering multiple myeloma (SMM) may delay progression to MM. Here, we present the final analysis of the phase 2 CENTAURUS study. In total, 123 patients with intermediate/high-risk SMM were randomized to IV daratumumab 16 mg/kg after a long-intense (n = 41), intermediate (n = 41), or short-intense (n = 41) dosing schedule. At a combined median follow-up of 85.2 months, in the long-intense, intermediate, and short-intense arms complete response or better rates were 4.9%, 9.8%, and 0%; overall response rates were 58.5%, 53.7%, and 37.5%; progressive disease/death rates were 0.096, 0.102, and 0.109 (P < .0001 for all arms); and median progression-free survival was not reached, 84.4, and 74.1 months, respectively. Median overall survival was not reached in any arm. Thirty-six patients in the long-intense or intermediate arms continued daratumumab in an optional extension phase after completing 20 cycles of per-protocol treatment. The median duration of study treatment was 44.0 (range, 1.0-91.6), 35.2 (range, 1.9-90.6), and 1.6 (range, 0.1-1.9) months in the long-intense, intermediate, and short-intense arms, respectively. No new safety signals were observed. With extended follow-up (median, ∼7 years), these data highlight the tolerability of daratumumab and support ongoing trials investigating daratumumab as an early intervention for SMM. This trial was registered at www.ClinicalTrials.gov as #NCT02316106.
Beschreibung:Gesehen am 11.11.2025
Beschreibung:Online Resource
ISSN:1528-0020
DOI:10.1182/blood.2024025897

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