Full metadata record
DC Field | Value | Language |
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dc.creator | Bahlis, N.J. (Nizar J.) | - |
dc.creator | Dimopoulos, M.A. (Meletios A.) | - |
dc.creator | White, D.J. (Darrell J.) | - |
dc.creator | Benboubker, L. (Lotfi) | - |
dc.creator | Cook, G. (Gordon) | - |
dc.creator | Leiba, M. (Merav) | - |
dc.creator | Ho, P.J. (P. Joy) | - |
dc.creator | Kim, K. (Kihyun) | - |
dc.creator | Takezako, N. (Naoki) | - |
dc.creator | Moreau, P. (Philippe) | - |
dc.creator | Kaufman, J.L. (Jonathan L.) | - |
dc.creator | Krevvata, M. (Maria) | - |
dc.creator | Chiu, C. (Christopher) | - |
dc.creator | Qin, X. (Xiang) | - |
dc.creator | Okonkwo, L. (Linda) | - |
dc.creator | Trivedi, S. (Sonali) | - |
dc.creator | Ukropec, J. (Jon) | - |
dc.creator | Qi, M. (Ming) | - |
dc.creator | San-Miguel, J.F. (Jesús F.) | - |
dc.date.accessioned | 2023-03-24T11:06:47Z | - |
dc.date.available | 2023-03-24T11:06:47Z | - |
dc.date.issued | 2020 | - |
dc.identifier.citation | Bahlis, N.J. (Nizar J.); Dimopoulos, M.A. (Meletios A.); White, D.J. (Darrell J.); et al. "Daratumumab plus lenalidomide and dexamethasone in relapsed/ refractory multiple myeloma: extended follow-up of POLLUX, a randomized, open-label, phase 3 study". Leukemia. 34, 2020, 1875 - 1884 | es |
dc.identifier.issn | 0887-6924 | - |
dc.identifier.uri | https://hdl.handle.net/10171/65789 | - |
dc.description.abstract | In POLLUX, daratumumab (D) plus lenalidomide/dexamethasone (Rd) reduced the risk of disease progression or death by 63% and increased the overall response rate (ORR) versus Rd in relapsed/refractory multiple myeloma (RRMM). Updated efficacy and safety after >3 years of follow-up are presented. Patients (N = 569) with ≥1 prior line received Rd (lenalidomide, 25 mg, on Days 1–21 of each 28-day cycle; dexamethasone, 40 mg, weekly) ± daratumumab at the approved dosing schedule. Minimal residual disease (MRD) was assessed by next-generation sequencing. After 44.3 months median follow-up, D-Rd prolonged progression-free survival (PFS) in the intent-to-treat population (median 44.5 vs 17.5 months; HR, 0.44; 95% CI, 0.35–0.55; P < 0.0001) and in patient subgroups. D-Rd demonstrated higher ORR (92.9 vs 76.4%; P < 0.0001) and deeper responses, including complete response or better (56.6 vs 23.2%; P < 0.0001) and MRD negativity (10–5; 30.4 vs 5.3%; P < 0.0001). Median time to next therapy was prolonged with D-Rd (50.6 vs 23.1 months; HR, 0.39; 95% CI, 0.31–0.50; P < 0.0001). Median PFS on subsequent line of therapy (PFS2) was not reached with D-Rd versus 31.7 months with Rd (HR, 0.53; 95% CI, 0.42–0.68; P < 0.0001). No new safety concerns were reported. These data support using D-Rd in patients with RRMM after first relapse. | - |
dc.description.sponsorship | This study was sponsored by Janssen Research & Development, LLC. The authors thank the patients who participated in this study and their families, as well as the study co-investigators, research nurses, and coordinators at each of the clinical sites. Medical writing and editorial support were provided by Kristin Runkle, PhD, of MedErgy and were funded by Janssen Global Services, LLC. The data sharing policy of Janssen Pharmaceutical Companies of Johnson & Johnson is available at https://www.janssen.com/clinical-trials/transpa rency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at http://yoda.yale.edu. | es_ES |
dc.language.iso | eng | es_ES |
dc.rights | info:eu-repo/semantics/openAccess | es_ES |
dc.title | Daratumumab plus lenalidomide and dexamethasone in relapsed/ refractory multiple myeloma: extended follow-up of POLLUX, a randomized, open-label, phase 3 study | es_ES |
dc.type | info:eu-repo/semantics/article | es_ES |
dc.description.note | This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The images or other third party material in this article are included in the article’s Creative Commons license, unless indicated otherwise in a credit line to the material. If material is not included in the article’s Creative Commons license and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this license, visit http://creativecommons. org/licenses/by/4.0/. | es_ES |
dc.identifier.doi | 10.1038/s41375-020-0711-6 | - |
dadun.citation.endingPage | 1884 | es_ES |
dadun.citation.publicationName | Leukemia | es_ES |
dadun.citation.startingPage | 1875 | es_ES |
dadun.citation.volume | 34 | es_ES |
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