Isatuximab, Lenalidomide, Bortezomib, and Dexamethasone Induction Therapy for Transplant-Eligible Newly Diagnosed Multiple Myeloma: Final Part 1 Analysis of the GMMG-HD7 Trial

Publikation: Beitrag in FachzeitschriftForschungsartikelBeigetragenBegutachtung

Beitragende

  • German-Speaking Myeloma Multicenter Group (GMMG) HD7 Investigators - (Autor:in)
  • Medizinische Klinik und Poliklinik I
  • Universitätsklinikum Heidelberg
  • Nationales Zentrum für Tumorerkrankungen (NCT) Heidelberg
  • Deutsches Krebsforschungszentrum (DKFZ)
  • Universitätsklinikum Düsseldorf
  • Universitätsklinikum Tübingen
  • Universitätsklinikum Essen
  • LWL-Universitätsklinikum Bochum
  • Universitätsklinikum Frankfurt
  • Klinikum Chemnitz gGmbH
  • Universitätsklinikum Gießen und Marburg GmbH
  • Universitätsklinikum Hamburg-Eppendorf (UKE)
  • Krankenhaus Barmherzige Brüder Regensburg
  • Universitätsklinikum Köln
  • Charité – Universitätsmedizin Berlin
  • Universitätsklinikum Bonn
  • Rheinisch-Westfälische Technische Hochschule Aachen
  • Marien Hospital Düsseldorf
  • KRH Klinikum Siloah
  • Universitätsklinikum Münster
  • Center for Hematology and Oncology Bethanien, Frankfurt am Main, Germany.
  • Universitätsmedizin Mainz
  • Diakonie-Klinikum Schwäbisch Hall gGmbH
  • Hematology/Oncology Center, Bielefeld, Germany.
  • Hematology/Oncology Center, Koblenz, Germany.
  • Klinikum Ludwigshafen
  • Asklepios Tumorzentrum Hamburg

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.

Details

OriginalspracheEnglisch
AufsatznummerJCO2402266
FachzeitschriftJournal of Clinical Oncology
PublikationsstatusElektronische Veröffentlichung vor Drucklegung - 9 Dez. 2024
Peer-Review-StatusJa

Externe IDs

unpaywall 10.1200/jco-24-02266

Schlagworte