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

Research output: Contribution to journalResearch articleContributedpeer-review

Contributors

  • German-Speaking Myeloma Multicenter Group (GMMG) HD7 Investigators - (Author)
  • Department of Internal Medicine I
  • University Hospital Heidelberg
  • National Center for Tumor Diseases (NCT) Heidelberg
  • German Cancer Research Center (DKFZ)
  • University Hospital Duesseldorf
  • University Hospital Tübingen
  • University Hospital Essen
  • LWL University Hospital Bochum
  • University Hospital Frankfurt
  • Klinikum Chemnitz gGmbH
  • University Hospital Gießen and Marburg
  • University Hospital Hamburg Eppendorf
  • Hospital of the Brothers of Mercy Regensburg
  • Uniklinik Köln
  • Charité – Universitätsmedizin Berlin
  • University of Bonn Medical Center
  • RWTH Aachen University
  • Marien Hospital Düsseldorf
  • KRH Hospital Siloah
  • University Hospital Münster
  • Agaplesion Bethanien Hospital
  • University Medical Center Mainz
  • Diakoneo Clinic Schwäbisch-Hall
  • Medical Center Bethel
  • Practice for hematology and oncology
  • Klinikum Ludwigshafen
  • Asklepios Cancer Center 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

Original languageEnglish
Article numberJCO2402266
JournalJournal of Clinical Oncology
Publication statusE-pub ahead of print - 9 Dec 2024
Peer-reviewedYes

External IDs

unpaywall 10.1200/jco-24-02266

Keywords