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

Autor: Mai EK; Heidelberg Myeloma Center, Department of Internal Medicine V, Heidelberg University Hospital and Medical Faculty Heidelberg, Heidelberg University, Heidelberg, Germany., Bertsch U; Heidelberg Myeloma Center, Department of Internal Medicine V, Heidelberg University Hospital and Medical Faculty Heidelberg, Heidelberg University, Heidelberg, Germany.; National Center for Tumor Diseases (NCT) Heidelberg, Heidelberg, Germany., Pozek E; Division of Biostatistics, German Cancer Research Center (DKFZ) Heidelberg, Heidelberg, Germany., Fenk R; Department of Hematology, Oncology and Clinical Immunology, University Hospital Düsseldorf, Düsseldorf, Germany., Besemer B; Department of Internal Medicine II, University Hospital Tübingen, Tübingen, Germany., Hanoun C; Department for Hematology and Stem Cell Transplantation, University Hospital Essen, Essen, Germany., Schroers R; Medical Clinic II-Hematology and Oncology, Ruhr-University Bochum, Bochum, Germany., von Metzler I; Department of Medicine II-Hematology and Oncology, Goethe-University Frankfurt, University Hospital, Frankfurt am Main, Germany., Hänel M; Department of Internal Medicine III, Klinikum Chemnitz, Chemnitz, Germany., Mann C; Department for Hematology, Oncology and Immunology, University Hospital Gießen and Marburg, Marburg, Germany., Leypoldt LB; Department of Oncology, Hematology and BMT, University Medical Center Hamburg-Eppendorf, Hamburg, Germany., Heilmeier B; Clinic for Oncology and Hematology, Hospital Barmherzige Brueder Regensburg, Regensburg, Germany., Huhn S; Heidelberg Myeloma Center, Department of Internal Medicine V, Heidelberg University Hospital and Medical Faculty Heidelberg, Heidelberg University, Heidelberg, Germany., Vogel SK; Heidelberg Myeloma Center, Department of Internal Medicine V, Heidelberg University Hospital and Medical Faculty Heidelberg, Heidelberg University, Heidelberg, Germany., Hundemer M; Heidelberg Myeloma Center, Department of Internal Medicine V, Heidelberg University Hospital and Medical Faculty Heidelberg, Heidelberg University, Heidelberg, Germany., Scheid C; Department of Internal Medicine I, University Hospital Cologne, Cologne, Germany., Blau IW; Medical Clinic, Charité University Medicine Berlin, Berlin, Germany., Luntz S; Coordination Centre for Clinical Trials (KKS) Heidelberg, Heidelberg, Germany., Weinhold N; Heidelberg Myeloma Center, Department of Internal Medicine V, Heidelberg University Hospital and Medical Faculty Heidelberg, Heidelberg University, Heidelberg, Germany., Tichy D; Division of Biostatistics, German Cancer Research Center (DKFZ) Heidelberg, Heidelberg, Germany., Holderried TAW; Department of Hematology, Oncology, Stem Cell Transplantation, Immune and Cell Therapy, Clinical Immunology and Rheumatology, University Hospital Bonn, Bonn, Germany., Trautmann-Grill K; Department of Internal Medicine I, University Hospital Dresden, TU Dresden, Germany., Gezer D; Department of Hematology, Oncology, Hemostaseology, and Stem Cell Transplantation, Faculty of Medicine, RWTH Aachen University, Aachen, Germany., Klaiber-Hakimi M; Clinic for Hematology, Oncology and Palliative Care, Marien Hospital Düsseldorf, Düsseldorf, Germany., Müller M; Clinic for Hematology, Oncology and Immunology, Klinikum Siloah Hannover, Hannover, Germany., Shumilov E; Department of Medicine A, Hematology, Oncology and Pneumology, University Hospital Münster, Münster, Germany., Knauf W; Center for Hematology and Oncology Bethanien, Frankfurt am Main, Germany., Michel CS; Department of Internal Medicine III, University Hospital Mainz, Mainz, Germany., Geer T; Department of Internal Medicine III, Diakoneo Clinic Schwäbisch-Hall, Schwäbisch-Hall, Germany., Riesenberg H; Hematology/Oncology Center, Bielefeld, Germany., Lutz C; Hematology/Oncology Center, Koblenz, Germany., Raab MS; Heidelberg Myeloma Center, Department of Internal Medicine V, Heidelberg University Hospital and Medical Faculty Heidelberg, Heidelberg University, Heidelberg, Germany., Benner A; Division of Biostatistics, German Cancer Research Center (DKFZ) Heidelberg, Heidelberg, Germany., Hoffmann M; Medical Clinic A, Clinic Ludwigshafen, Ludwigshafen, Germany., Weisel KC; Department of Oncology, Hematology and BMT, University Medical Center Hamburg-Eppendorf, Hamburg, Germany., Salwender HJ; Asklepios Tumorzentrum Hamburg, AK Altona and AK St Georg, Hamburg, Germany., Goldschmidt H; Heidelberg Myeloma Center, Department of Internal Medicine V, Heidelberg University Hospital and Medical Faculty Heidelberg, Heidelberg University, Heidelberg, Germany.; National Center for Tumor Diseases (NCT) Heidelberg, Heidelberg, Germany.
Jazyk: angličtina
Zdroj: Journal of clinical oncology : official journal of the American Society of Clinical Oncology [J Clin Oncol] 2024 Dec 09, pp. JCO2402266. Date of Electronic Publication: 2024 Dec 09.
DOI: 10.1200/JCO-24-02266
Abstrakt: 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.
Databáze: MEDLINE