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Daratumumab plus lenalidomide and dexamethasone for untreated myeloma
Facon, Thierry Kumar, Shaji Plesner, Torben Orlowski, Robert Z. Moreau, Philippe Bahlis, Nizar Basu, Supratik Nahi, Hareth Hulin, Cyrille Quach, Hang
Facon, Thierry
Kumar, Shaji
Plesner, Torben
Orlowski, Robert Z.
Moreau, Philippe
Bahlis, Nizar
Basu, Supratik
Nahi, Hareth
Hulin, Cyrille
Quach, Hang
Authors
Facon, Thierry
Kumar, Shaji
Plesner, Torben
Orlowski, Robert Z.
Moreau, Philippe
Bahlis, Nizar
Basu, Supratik
Nahi, Hareth
Hulin, Cyrille
Quach, Hang
Goldschmidt, Hartmut
O'Dwyer, Michael
Perrot, Aurore
Venner, Christopher P.
Weisel, Katja
Mace, Joseph R.
Raje, Noopur
Attal, Michel
Tiab, Mourad
Macro, Margaret
Frenzel, Laurent
Leleu, Xavier
Ahmadi, Tahamtan
Chiu, Christopher
Wang, Jianping
Rampelbergh, Rian Van
Uhlar, Clarissa M.
Kobos, Rachel
Qi, Ming
Usmani, Saad Z.
Kumar, Shaji
Plesner, Torben
Orlowski, Robert Z.
Moreau, Philippe
Bahlis, Nizar
Basu, Supratik
Nahi, Hareth
Hulin, Cyrille
Quach, Hang
Goldschmidt, Hartmut
O'Dwyer, Michael
Perrot, Aurore
Venner, Christopher P.
Weisel, Katja
Mace, Joseph R.
Raje, Noopur
Attal, Michel
Tiab, Mourad
Macro, Margaret
Frenzel, Laurent
Leleu, Xavier
Ahmadi, Tahamtan
Chiu, Christopher
Wang, Jianping
Rampelbergh, Rian Van
Uhlar, Clarissa M.
Kobos, Rachel
Qi, Ming
Usmani, Saad Z.
Editors
Other contributors
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Epub Date
Issue Date
2019-05-30
Submitted date
Subjects
Alternative
Abstract
Copyright © 2019 Massachusetts Medical Society. Lenalidomide plus dexamethasone is a standard treatment for patients with newly diagnosed multiple myeloma who are ineligible for autologous stem-cell transplantation. We sought to determine whether the addition of daratumumab would significantly reduce the risk of disease progression or death in this population. METHODS We randomly assigned 737 patients with newly diagnosed multiple myeloma who were ineligible for autologous stem-cell transplantation to receive daratumumab plus lenalidomide and dexamethasone (daratumumab group) or lenalidomide and dexamethasone alone (control group). Treatment was to continue until the occurrence of disease progression or unacceptable side effects. The primary end point was progression-free survival. RESULTS At a median follow-up of 28.0 months, disease progression or death had occurred in 240 patients (97 of 368 patients [26.4%] in the daratumumab group and 143 of 369 patients [38.8%] in the control group). The estimated percentage of patients who were alive without disease progression at 30 months was 70.6% (95% confidence interval [CI], 65.0 to 75.4) in the daratumumab group and 55.6% (95% CI, 49.5 to 61.3) in the control group (hazard ratio for disease progression or death, 0.56; 95% CI, 0.43 to 0.73; P<0.001). The percentage of patients with a complete response or better was 47.6% in the daratumumab group and 24.9% in the control group (P<0.001). A total of 24.2% of the patients in the daratumumab group, as compared with 7.3% of the patients in the control group, had results below the threshold for minimal residual disease (1 tumor cell per 105 white cells) (P<0.001). The most common adverse events of grade 3 or 4 were neutropenia (50.0% in the daratumumab group vs. 35.3% in the control group), anemia (11.8% vs. 19.7%), lymphopenia (15.1% vs. 10.7%), and pneumonia (13.7% vs. 7.9%).
Citation
Facon, T., Kumar, S., Plesner, T., Orlowski, R. Z. et al. (2019) Daratumumab plus lenalidomide and dexamethasone for untreated myeloma, New England Journal of Medicine, 380, pp. 2104-2115 DOI: 10.1056/NEJMoa1817249
Publisher
Journal
Research Unit
PubMed ID
31141632 (pubmed)
PubMed Central ID
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Type
Journal article
Language
en
Description
This is an accepted manuscript of an article published by Massachusetts Medical Society in New England Journal of Medicine on 30/05/2019, available online: https://doi.org/10.1056/NEJMoa1817249
The accepted version of the publication may differ from the final published version.
Series/Report no.
ISSN
0028-4793
EISSN
1533-4406