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Isatuximab, Lenalidomide, Bortezomib, and Dexamethasone induction therapy for transplant-eligible newly diagnosed multiple myeloma: final part 1 analysis of the GMMG-HD7 trial

Previously, addition of isatuximab (Isa) to standard-of-care lenalidomide-bortezomib-dexamethasone (RVd) in transplant-eligible patients with newly diagnosed multiple myeloma in the GMMG-HD7 trial (ClinicalTrials.gov identifier: NCT03617731) resulted in a significant increase of minimal residual dis...

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Autori principali: Mai, Elias K. (Autore) , Bertsch, Uta (Autore) , Pozek, Ema (Autore) , Fenk, Roland (Autore) , Besemer, Britta (Autore) , Hanoun, Christine (Autore) , Schroers, Roland (Autore) , Von Metzler, Ivana (Autore) , Hänel, Mathias (Autore) , Mann, Christoph (Autore) , Leypoldt, Lisa B. (Autore) , Heilmeier, Bernhard (Autore) , Huhn, Stefanie (Autore) , Vogel, Sabine K. (Autore) , Hundemer, Michael (Autore) , Scheid, Christof (Autore) , Blau, Igor-Wolfgang (Autore) , Luntz, Steffen P. (Autore) , Weinhold, Niels (Autore) , Tichy, Diana (Autore) , Holderried, Tobias A.W. (Autore) , Trautmann-Grill, Karolin (Autore) , Gezer, Deniz (Autore) , Klaiber-Hakimi, Maika (Autore) , Müller, Martin (Autore) , Shumilov, Evgenii (Autore) , Knauf, Wolfgang (Autore) , Michel, Christian S. (Autore) , Geer, Thomas (Autore) , Riesenberg, Hendrik (Autore) , Lutz, Christoph (Autore) , Raab, Marc-Steffen (Autore) , Benner, Axel (Autore) , Hoffmann, Martin (Autore) , Weisel, Katja C. (Autore) , Salwender, Hans J. (Autore) , Goldschmidt, Hartmut (Autore)
Altri autori: Egerer, Gerlinde (Altro)
Natura: Article (Journal)
Lingua:inglese
Pubblicazione: December 9, 2024
In: Journal of clinical oncology
Year: 2025, Volume: 43, Fascicolo: 11, Pages: 1279-1288
ISSN:1527-7755
DOI:10.1200/JCO-24-02266
Accesso online:Verlag, kostenfrei, Volltext: https://doi.org/10.1200/JCO-24-02266
Verlag, kostenfrei, Volltext: https://ascopubs.org/doi/10.1200/JCO-24-02266
Testo
Note sull'autore:Elias K. Mai, MD ; Uta Bertsch, MD ; Ema Pozek, MSc ; Roland Fenk ; Britta Besemer ; Christine Hanoun ; Roland Schroers ; Ivana von Metzler ; Mathias Hänel ; Christoph Mann, MD ; Lisa B. Leypoldt, MD ; Bernhard Heilmeier, MD ; Stefanie Huhn, Dr sc hum ; Sabine K. Vogel, PhD ; Michael Hundemer, MD ; Christof Scheid, MD ; Igor W. Blau, MD ; Steffen Luntz, MD ; Niels Weinhold, PhD ; Diana Tichy, PhD ; Tobias A.W. Holderried, MD ; Karolin Trautmann-Grill, MD; Deniz Gezer, MD ; Maika Klaiber-Hakimi, MD ; Martin Müller, MD ; Evgenii Shumilov, MD ; Wolfgang Knauf, MD ; Christian S. Michel, MD ; Thomas Geer, MD ; Hendrik Riesenberg, MD ; Christoph Lutz, MD ; Marc S. Raab, MD ; Axel Benner, Dipl Stat ; Martin Hoffmann, MD ; Katja C. Weisel, MD ; Hans J. Salwender, MD ; and Hartmut Goldschmidt, MD, Gerlinde Egerer [und viele weitere] for the German-Speaking Myeloma Multicenter Group (GMMG) HD7 Investigators
Descrizione
Riassunto:Previously, addition of isatuximab (Isa) to standard-of-care lenalidomide-bortezomib-dexamethasone (RVd) in transplant-eligible patients with newly diagnosed multiple myeloma in the GMMG-HD7 trial (ClinicalTrials.gov identifier: NCT03617731) resulted in a significant increase of minimal residual disease negativity (MRD-) rates after induction therapy. A total of 662 patients were randomly assigned to receive induction therapy with Isa-RVd (n = 331) or RVd (n = 329), followed by single or tandem autologous stem-cell transplant and second random assignment to maintenance with lenalidomide alone or Isa-lenalidomide. We report updated results for part 1 from first random assignment to post-transplant. As of January 31, 2024, MRD- rates continued to deepen after transplant (66% Isa-RVd v 48% RVd). Isa-RVd induction therapy significantly prolonged progression-free survival (PFS) compared with RVd regardless of maintenance therapy (hazard ratio, 0.70 [95% CI, 0.52 to 0.95]; P = .0184). Weighted risk set estimator analysis accounting for second random assignment followed by maintenance with only lenalidomide confirmed a statistically significant benefit for Isa-RVd followed by lenalidomide maintenance versus RVd followed by lenalidomide maintenance (stratified weighted log-rank test P= .016). In conclusion, after 18-week induction therapy followed by transplant without consolidation therapy, adding Isa to RVd resulted in a significant PFS benefit, regardless of maintenance strategy.
Descrizione del documento:German-Speaking Myeloma Multicenter Group (GMMG) HD7: Miriam Ahlhorn, Gerlinde Egerer [und viele weitere]
Gesehen am 02.06.2026
Descrizione fisica:Online Resource
ISSN:1527-7755
DOI:10.1200/JCO-24-02266

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