System Maintenance Notice

Please note that maintenance work is scheduled between 4 AM and 5 AM - CET. During this time, you may experience reduced performance. Thanks for your patience.

Publications

Journal Article Randomized Controlled Trial Ppublish

PubMed: 42637879 DOI: 10.1038/s41375-026-03097-9

Daratumumab, lenalidomide, and dexamethasone in transplant-ineligible newly diagnosed multiple myeloma: MAIA final survival analysis.

Leukemia 40(11):2530-2539

Authors: Thierry Facon, Shaji K Kumar, Robert Z Orlowski, Nizar Bahlis, Philippe Moreau, Hartmut Goldschmidt, Supratik Basu, Cyrille Hulin, Sonja Zweegman, Katja Weisel, Aurore Perrot, Caroline Jacquet, Noopur Raje, Salomon Manier, Ajai Chari, Markus Hansson, Mohamad Mohty, Michel Delforge, Torben Plesner, Gordon Cook, Xavier Leleu, Hang Quach, Christopher P Venner, Mourad Tiab, Margaret Macro, Laurent Frenzel, George Wang, Huiling Pei, Kasey Bolyard, Robin Carson, Fredrik Borgsten, Saad Z Usmani

Affiliations

  • University of Lille, CHU de Lille, Service des Maladies du Sang, Lille, France.
  • Department of Hematology, Mayo Clinic Rochester, Rochester, MN, USA.
  • Department of Lymphoma & Myeloma, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.
  • Arnie Charbonneau Cancer Research Institute, University of Calgary, Calgary, AB, Canada.
  • Hematology Department, University Hospital Hôtel-Dieu, Nantes, France.
  • Internal Medicine V, Hematology, Oncology and Rheumatology, GMMG Study Group, Heidelberg University Hospital and National Center for Tumor Diseases, Heidelberg, Germany.
  • Royal Wolverhampton NHS Trust and University of Wolverhampton, CRN West Midlands, NIHR, Wolverhampton, UK.
  • Department of Hematology, Hôpital Haut Lévêque, University Hospital, Pessac, France.
  • Department of Hematology, Amsterdam University Medical Center, Vrije Universiteit Amsterdam, Cancer Center Amsterdam, Amsterdam, The Netherlands.
  • Department of Oncology, Hematology and Bone Marrow Transplantation with Section of Pneumology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.
  • Université de Toulouse, Centre Hospitalo-Universitaire, IUCT-Oncopole, Service d'Hématologie, Toulouse, France.
  • Hematology Department, University Hospital, Nancy, France.
  • Center for Multiple Myeloma, Massachusetts General Hospital Cancer Center, Boston, MA, USA.
  • University of Lille, CHU de Lille, Hôpital Huriez, Service d'Hématologie, Lille, France.
  • Department of Medicine, Hematology and Medical Oncology, Icahn School of Medicine at Mount Sinai, New York, NY, USA.
  • Department of Hematology, SkÃ¥ne University Hospital, Lund and Sahlgrenska University Hospital, Göteborg, Sweden.
  • Department of Clinical Hematology and Cellular Therapy, Saint-Antoine Hospital, Sorbonne University, Paris, France.
  • University Hospital Leuven, Leuven, Belgium.
  • Vejle Hospital and University of Southern Denmark, Vejle, Denmark.
  • NIHR Leeds BRC & CRUK Clinical Trials Unit, University of Leeds, Leeds, UK.
  • CHU de Poitiers, Hôpital la Milétrie, Poitiers, France.
  • University of Melbourne, St Vincent's Hospital, Melbourne, VIC, Australia.
  • Department of Medical Oncology, Cross Cancer Institute, University of Alberta, Edmonton, AB, Canada.
  • BC Cancer - Vancouver Centre, University of British Columbia, Vancouver, BC, Canada.
  • CHD Vendée, La Roche sur Yon, France.
  • CHU de Caen, Caen, France.
  • Hôpital Necker-Enfants Malades, Paris, France.
  • Johnson & Johnson, Spring House, PA, USA.
  • Johnson & Johnson, Titusville, NJ, USA.
  • Johnson & Johnson, Raritan, NJ, USA.
  • Memorial Sloan Kettering Cancer Center, New York, NY, USA.

Abstract

In previous analyses of MAIA, daratumumab plus lenalidomide/dexamethasone (D-Rd) significantly improved progression-free survival and overall survival (OS) versus lenalidomide/dexamethasone (Rd) in transplant-ineligible newly diagnosed multiple myeloma (NDMM). We report results on long-term OS and subsequent antimyeloma therapies from the MAIA final analysis. A protocol amendment (July 20, 2021) led to a long-term extension of MAIA, during which patients were followed for OS. A total of 737 patients were randomized to D-Rd (n = 368) or Rd (n = 369). At a median follow-up of 89.3 months (range, 0.0-102.2; interquartile range, 85.3-93.0), median OS was 90.3 months (95% confidence interval [CI], 80.8-not estimable [NE]) with D-Rd versus 64.1 months (56.0-70.8) with Rd (hazard ratio [HR], 0.67; 95% CI, 0.55-0.82); estimated 7-year OS rates were 53.1% (95% CI, 47.8-58.2) and 39.3% (34.1-44.5), respectively. Median time to subsequent antimyeloma treatment was not reached (95% CI, 84.1-NE) for D-Rd versus 42.4 months (33.5-50.6) for Rd (HR, 0.51; 95% CI, 0.41-0.63; P < 0.0001). Death due to adverse events occurred in 84 patients (D-Rd, n = 44/364 [12%]; Rd, n = 40/365 [11%]). With >7 years of follow-up, D-Rd demonstrated a new benchmark for median OS (7.5 years) in transplant-ineligible NDMM, further supporting frontline D-Rd use to maximize survival.

MeSH

Dexamethasone, Leukemia, Survival Analysis, Multiple Myeloma, Lenalidomide, Transplants, Therapeutics