Daratumumab plus Lenalidomide and Dexamethasone for Untreated Myeloma
| Autor: | Joseph R. Mace, Mourad Tiab, Philippe Moreau, Torben Plesner, Margaret Macro, Aurore Perrot, Katja Weisel, Noopur Raje, Michael O'Dwyer, Maia Trial Investigators, Shaji Kumar, Tahamtan Ahmadi, Clarissa M. Uhlar, Michel Attal, Ming Qi, Hang Quach, Thierry Facon, Hartmut Goldschmidt, Cyrille Hulin, Jianping Wang, Laurent Frenzel, Hareth Nahi, Robert Z. Orlowski, Rachel Kobos, Nizar J. Bahlis, Christopher P. Venner, Rian Van Rampelbergh, Christopher Chiu, Xavier Leleu, Supratik Basu, Saad Z. Usmani |
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| Rok vydání: | 2019 |
| Předmět: |
Dexamethasone/administration & dosage
Male Oncology medicine.medical_specialty Neutropenia Multiple Myeloma/drug therapy 030204 cardiovascular system & hematology Antibodies Monoclonal/administration & dosage Antibodies Dexamethasone 03 medical and health sciences 0302 clinical medicine Neutropenia/chemically induced Internal medicine Monoclonal Antineoplastic Combined Chemotherapy Protocols 80 and over medicine Lenalidomide/administration & dosage Humans 030212 general & internal medicine Lenalidomide Multiple myeloma Aged Aged 80 and over Isatuximab Bortezomib business.industry Antineoplastic Combined Chemotherapy Protocols/adverse effects Standard treatment Antibodies Monoclonal Female Middle Aged Multiple Myeloma Progression-Free Survival Daratumumab General Medicine medicine.disease Transplantation business medicine.drug |
| Zdroj: | Facon, T, Kumar, S, Plesner, T, Orlowski, R Z, Moreau, P, Bahlis, N, Basu, S, Nahi, H, Hulin, C, Quach, H, Goldschmidt, H, O’Dwyer, M, Perrot, A, Venner, C P, Weisel, K, Mace, J R, Raje, N, Attal, M, Tiab, M, Macro, M, Frenzel, L, Leleu, X, Ahmadi, T, Chiu, C, Wang, J, Rampelbergh, R V, Uhlar, C M, Kobos, R, Qi, M, Usmani, S Z, MAIA Trial Investigators & Abildgaard, N 2019, ' Daratumumab plus lenalidomide and dexamethasone for untreated Myeloma ', New England Journal of Medicine, vol. 380, no. 22, pp. 2104-2115 . https://doi.org/10.1056/NEJMoa1817249 |
| ISSN: | 1533-4406 0028-4793 |
| Popis: | BACKGROUND: 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; PCONCLUSIONS: Among patients with newly diagnosed multiple myeloma who were ineligible for autologous stem-cell transplantation, the risk of disease progression or death was significantly lower among those who received daratumumab plus lenalidomide and dexamethasone than among those who received lenalidomide and dexamethasone alone. A higher incidence of neutropenia and pneumonia was observed in the daratumumab group. (Funded by Janssen Research and Development; MAIA ClinicalTrials.gov number, NCT02252172.). |
| Databáze: | OpenAIRE |
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