Journal Article

DKFZ-2024-02612

http://join2-wiki.gsi.de/foswiki/pub/Main/Artwork/join2_logo100x88.png Isatuximab, Lenalidomide, Bortezomib, and Dexamethasone Induction Therapy for Transplant-Eligible Newly Diagnosed Multiple Myeloma: Final Part 1 Analysis of the GMMG-HD7 Trial.

Mai, E. K. ; Bertsch, U. ; Pozek, E.DKFZ* ; Fenk, R. ; Besemer, B. ; Hanoun, C. ; Schroers, R. ; von Metzler, I. ; Hänel, M. ; Mann, C. ; Leypoldt, L. B. ; Heilmeier, B. ; Huhn, S. ; Vogel, S. K. ; Hundemer, M. ; Scheid, C. ; Blau, I. W. ; Luntz, S. ; Weinhold, N. ; Tichy, D. ; Holderried, T. A. W. ; Trautmann-Grill, K. ; Gezer, D. ; Klaiber-Hakimi, M. ; Müller, M. ; Shumilov, E. ; Knauf, W. ; Michel, C. S. ; Geer, T. ; Riesenberg, H. ; Lutz, C. ; Raab, M. S. ; Benner, A.DKFZ* ; Hoffmann, M. ; Weisel, K. C. ; Salwender, H. J. ; Goldschmidt, H. ; Group, G. M. M. (Collaboration Author) ; Group, G. M. M. (Collaboration Author) ; Ahlborn, M. (Contributor) ; Behringer, J. (Contributor) ; Bernhard, H. (Contributor) ; Besemer, B. (Contributor) ; Bittenbring, J. (Contributor) ; Blau, I. W. (Contributor) ; Bolling, C. (Contributor) ; Boquoi, A. (Contributor) ; Debatin, D. (Contributor) ; Egerer, G. (Contributor) ; Fenk, R. (Contributor) ; Ferstl, B. (Contributor) ; Fronhoffs, S. (Contributor) ; Gaska, T. (Contributor) ; Geer, T. (Contributor) ; Gezer, D. (Contributor) ; Goldschmidt, H. (Contributor) ; Görner, M. (Contributor) ; Graeven, U. (Contributor) ; Hänel, M. (Contributor) ; Heilmeier, B. (Contributor) ; Heinsch, M. (Contributor) ; Hoffmann, M. (Contributor) ; Holderried, T. A. W. (Contributor) ; Hopfer, O. (Contributor) ; Janjetovic, S. (Contributor) ; Klaiber-Hakimi, M. (Contributor) ; Klausmann, M. (Contributor) ; Klein, S. (Contributor) ; Knauf, W. (Contributor) ; Ko, Y.-D. (Contributor) ; Kraemer, D. M. (Contributor) ; Kropff, M. (Contributor) ; La Rosée, P. (Contributor) ; Mahlberg, R. (Contributor) ; Mann, C. (Contributor) ; Martens, U. (Contributor) ; von Metzler, I. (Contributor) ; Michel, C. (Contributor) ; Müller, M. (Contributor) ; Pönisch, W. (Contributor) ; Reimer, P. (Contributor) ; Riechel, C. (Contributor) ; Ringhoffer, M. (Contributor) ; Rummel, M. (Contributor) ; Runde, V. (Contributor) ; Salwender, H. J. (Contributor) ; Schaich, M. (Contributor) ; Scheid, C. (Contributor) ; Schmidt-Hieber, M. (Contributor) ; Schöndube, D. (Contributor) ; Schroers, R. (Contributor) ; Schütte, H.-J. (Contributor) ; Shumilov, E. (Contributor) ; Staib, P. (Contributor) ; Strumberg, D. (Contributor) ; Tischler, H.-J. (Contributor) ; Trautmann-Grill, K. (Contributor) ; Verbeek, W. (Contributor) ; Weide, R. (Contributor) ; Weidmann, E. (Contributor) ; Weisel, K. (Contributor) ; de Wit, M. (Contributor) ; Bernhardt, C. (Contributor) ; Fietz, T. (Contributor) ; Grassinger, J. (Contributor) ; Köchling, G. (Contributor) ; Neise, M. (Contributor) ; Schmitt, S. (Contributor) ; Steiniger, H. (Contributor) ; Tschechne, B. (Contributor) ; Whitlock, B. (Contributor) ; Zaiß, M. (Contributor) ; Ziske, C. (Contributor)

2025
American Society of Clinical Oncology Alexandria, Va.

This record in other databases:  

Please use a persistent id in citations: doi:10.1200/JCO-24-02266

Abstract: 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.

Note: 2025 Apr 10;43(11):1279-1288

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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 2024

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Database coverage:
; Clarivate Analytics Master Journal List ; Current Contents - Clinical Medicine ; Current Contents - Life Sciences ; Essential Science Indicators ; IF >= 40 ; JCR ; Nationallizenz ; PubMed Central ; SCOPUS ; Science Citation Index Expanded ; Web of Science Core Collection

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