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Peer-reviewedCC BY 4.0Leukemia

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

20 more authors
31 affiliations
  1. 1University of Lille, CHU de Lille, Service des Maladies du Sang, Lille, France
  2. 2Department of Hematology, Mayo Clinic Rochester, Rochester, MN USA
  3. 3Department of Lymphoma & Myeloma, The University of Texas MD Anderson Cancer Center, Houston, TX USA
  4. 4Arnie Charbonneau Cancer Research Institute, University of Calgary, Calgary, AB Canada
  5. 5Hematology Department, University Hospital Hôtel-Dieu, Nantes, France
  6. 6Internal Medicine V, Hematology, Oncology and Rheumatology, GMMG Study Group, Heidelberg University Hospital and National Center for Tumor Diseases, Heidelberg, Germany
  7. 7Royal Wolverhampton NHS Trust and University of Wolverhampton, CRN West Midlands, NIHR, Wolverhampton, UK
  8. 8Department of Hematology, Hôpital Haut Lévêque, University Hospital, Pessac, France
  9. 9Department of Hematology, Amsterdam University Medical Center, Vrije Universiteit Amsterdam, Cancer Center Amsterdam, Amsterdam, The Netherlands
  10. 10Department of Oncology, Hematology and Bone Marrow Transplantation with Section of Pneumology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany
  11. 11Université de Toulouse, Centre Hospitalo-Universitaire, IUCT-Oncopole, Service d’Hématologie, Toulouse, France
  12. 12Hematology Department, University Hospital, Nancy, France
  13. 13Center for Multiple Myeloma, Massachusetts General Hospital Cancer Center, Boston, MA USA
  14. 14University of Lille, CHU de Lille, Hôpital Huriez, Service d’Hématologie, Lille, France
  15. 15Department of Medicine, Hematology and Medical Oncology, Icahn School of Medicine at Mount Sinai, New York, NY USA
  16. 16Department of Hematology, Skåne University Hospital, Lund and Sahlgrenska University Hospital, Göteborg, Sweden
  17. 17Department of Clinical Hematology and Cellular Therapy, Saint-Antoine Hospital, Sorbonne University, Paris, France
  18. 18University Hospital Leuven, Leuven, Belgium
  19. 19Vejle Hospital and University of Southern Denmark, Vejle, Denmark
  20. 20NIHR Leeds BRC & CRUK Clinical Trials Unit, University of Leeds, Leeds, UK
  21. 21CHU de Poitiers, Hôpital la Milétrie, Poitiers, France
  22. 22University of Melbourne, St Vincent’s Hospital, Melbourne, VIC Australia
  23. 23Department of Medical Oncology, Cross Cancer Institute, University of Alberta, Edmonton, AB Canada
  24. 24BC Cancer – Vancouver Centre, University of British Columbia, Vancouver, BC Canada
  25. 25CHD Vendée, La Roche sur Yon, France
  26. 26CHU de Caen, Caen, France
  27. 27Hôpital Necker-Enfants Malades, Paris, France
  28. 28Johnson & Johnson, Spring House, PA USA
  29. 29Johnson & Johnson, Titusville, NJ USA
  30. 30Johnson & Johnson, Raritan, NJ USA
  31. 31Memorial 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.

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BibTeX
@article{facon2026daratumumab,
  title = {{Daratumumab, lenalidomide, and dexamethasone in transplant-ineligible newly diagnosed multiple myeloma: MAIA final survival analysis}},
  author = {Thierry Facon and Shaji K. Kumar and Robert Z. Orlowski and Nizar Bahlis and Philippe Moreau and Hartmut Goldschmidt and Supratik Basu and Cyrille Hulin and Sonja Zweegman and Katja Weisel and Aurore Perrot and Caroline Jacquet and Noopur Raje and Salomon Manier and Ajai Chari and Markus Hansson and Mohamad Mohty and Michel Delforge and Torben Plesner and Gordon Cook and Xavier Leleu and Hang Quach and Christopher P. Venner and Mourad Tiab and Margaret Macro and Laurent Frenzel and George Wang and Huiling Pei and Kasey Bolyard and Robin Carson and Fredrik Borgsten and Saad Z. Usmani},
  journal = {Leukemia},
  year = {2026},
  month = aug,
  doi = {10.1038/s41375-026-03097-9},
  url = {https://doi.org/10.1038/s41375-026-03097-9},
  note = {CC BY 4.0},
}
RIS
TY  - JOUR
TI  - Daratumumab, lenalidomide, and dexamethasone in transplant-ineligible newly diagnosed multiple myeloma: MAIA final survival analysis
AU  - Thierry Facon
AU  - Shaji K. Kumar
AU  - Robert Z. Orlowski
AU  - Nizar Bahlis
AU  - Philippe Moreau
AU  - Hartmut Goldschmidt
AU  - Supratik Basu
AU  - Cyrille Hulin
AU  - Sonja Zweegman
AU  - Katja Weisel
AU  - Aurore Perrot
AU  - Caroline Jacquet
AU  - Noopur Raje
AU  - Salomon Manier
AU  - Ajai Chari
AU  - Markus Hansson
AU  - Mohamad Mohty
AU  - Michel Delforge
AU  - Torben Plesner
AU  - Gordon Cook
AU  - Xavier Leleu
AU  - Hang Quach
AU  - Christopher P. Venner
AU  - Mourad Tiab
AU  - Margaret Macro
AU  - Laurent Frenzel
AU  - George Wang
AU  - Huiling Pei
AU  - Kasey Bolyard
AU  - Robin Carson
AU  - Fredrik Borgsten
AU  - Saad Z. Usmani
PY  - 2026
DA  - 2026/08/24
JO  - Leukemia
DO  - 10.1038/s41375-026-03097-9
UR  - https://doi.org/10.1038/s41375-026-03097-9
AB  - 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.
SN  - 0887-6924
SN  - 1476-5551
ER  -