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 Fachzeitschrift › Forschungsartikel › Beigetragen › Begutachtung
Beitragende
- 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
Originalsprache | Englisch |
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Aufsatznummer | JCO2402266 |
Fachzeitschrift | Journal of Clinical Oncology |
Publikationsstatus | Elektronische Veröffentlichung vor Drucklegung - 9 Dez. 2024 |
Peer-Review-Status | Ja |
Externe IDs
unpaywall | 10.1200/jco-24-02266 |
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