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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| Autores principales: | , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , |
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| Otros Autores: | |
| Formato: | Article (Journal) |
| Lenguaje: | inglés |
| Publicado: |
December 9, 2024
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| In: |
Journal of clinical oncology
Year: 2025, Volumen: 43, Número: 11, Pages: 1279-1288 |
| ISSN: | 1527-7755 |
| DOI: | 10.1200/JCO-24-02266 |
| Acceso en línea: | Verlag, kostenfrei, Volltext: https://doi.org/10.1200/JCO-24-02266 Verlag, kostenfrei, Volltext: https://ascopubs.org/doi/10.1200/JCO-24-02266 
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| Notas de Autor: | 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 |
| Sumario: | 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. |
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| Notas: | German-Speaking Myeloma Multicenter Group (GMMG) HD7: Miriam Ahlhorn, Gerlinde Egerer [und viele weitere] Gesehen am 02.06.2026 |
| Descripción Física: | Online Resource |
| ISSN: | 1527-7755 |
| DOI: | 10.1200/JCO-24-02266 |