Belantamab Mafodotin, Pomalidomide, and Dexamethasone in Multiple Myeloma

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dc.authorscopusidMeral Beksaç / 56924887200
dc.authorwosidMeral Beksaç / JJK-2013-2023
dc.contributor.authorDimopoulos, Meletios Athanasios
dc.contributor.authorBeksaç, Meral
dc.contributor.authorPour, Ludek
dc.date.accessioned2025-04-18T08:07:14Z
dc.date.available2025-04-18T08:07:14Z
dc.date.issued2024
dc.departmentİstinye Üniversitesi, Tıp Fakültesi, Temel Tıp Bilimleri Bölümü
dc.description.abstractBACKGROUND Triplet or quadruplet therapies incorporating proteasome inhibitors, immunomodulators, and anti-CD38 antibodies have led to prolonged survival among patients with newly diagnosed multiple myeloma; however, most patients have a relapse. Frontline lenalidomide therapy has increased the number of patients with lenalidomide-refractory disease at the time of the first relapse. METHODS In this phase 3, randomized, open-label trial, we evaluated belantamab mafodotin, pomalidomide, and dexamethasone (BPd), as compared with pomalidomide, bortezomib, and dexamethasone (PVd), in lenalidomide-exposed patients who had relapsed or refractory myeloma after at least one line of therapy. The primary end point was progression-free survival. Disease response and safety were also assessed. RESULTS A total of 302 patients underwent randomization; 155 were assigned to the BPd group, and 147 to the PVd group. At a median follow-up of 21.8 months (range, <0.1 to 39.2), the 12-month estimated progression-free survival with BPd was 71% (95% confidence interval [CI], 63 to 78), as compared with 51% (95% CI, 42 to 60) with PVd (hazard ratio for disease progression or death, 0.52; 95% CI, 0.37 to 0.73; P<0.001). Data on overall survival were immature. The percentage of patients with a response to treatment (partial response or better) was 77% (95% CI, 70 to 84) in the BPd group and 72% (95% CI, 64 to 79) in the PVd group; 40% (95% CI, 32 to 48) and 16% (95% CI, 11 to 23), respectively, had a complete response or better. Grade 3 or higher adverse events occurred in 94% of the patients in the BPd group and 76% of those in the PVd group. Ocular events occurred in 89% of the patients who received BPd (grade 3 or 4 in 43%) and 30% of those who received PVd (grade 3 or 4 in 2%); ocular events in the BPd group were managed with belantamab mafodotin dose modification. Ocular events led to treatment discontinuation in 9% of the patients in the BPd group and in no patients in the PVd group. CONCLUSIONS Among lenalidomide-exposed patients with relapsed or refractory myeloma, BPd conferred a significantly greater benefit than PVd with respect to progression-free survival, as well as deeper, more durable responses. Ocular events were common but were controllable by belantamab mafodotin dose modification. Copyright © 2024 Massachusetts Medical Society.
dc.identifier.citationDimopoulos, M. A., Beksac, M., Pour, L., Delimpasi, S., Vorobyev, V., Quach, H., ... & Trudel, S. (2024). Belantamab Mafodotin, Pomalidomide, and Dexamethasone in Multiple Myeloma. New England Journal of Medicine.
dc.identifier.doi10.1056/NEJMoa2403407
dc.identifier.endpage421
dc.identifier.issn00284793
dc.identifier.issue5
dc.identifier.pmid38828951
dc.identifier.scopus2-s2.0-85197401300
dc.identifier.scopusqualityQ1
dc.identifier.startpage408
dc.identifier.urihttp://dx.doi.org/10.1056/NEJMoa2403407
dc.identifier.urihttps://hdl.handle.net/20.500.12713/6522
dc.identifier.volume391
dc.indekslendigikaynakScopus
dc.institutionauthorBeksaç, Meral
dc.institutionauthoridMeral Beksaç / 0000-0003-1797-8657
dc.language.isoen
dc.publisherMassachussetts Medical Society
dc.relation.ispartofNew England Journal of Medicine
dc.relation.publicationcategoryMakale - Uluslararası Hakemli Dergi - Kurum Öğretim Elemanı
dc.rightsinfo:eu-repo/semantics/closedAccess
dc.titleBelantamab Mafodotin, Pomalidomide, and Dexamethasone in Multiple Myeloma
dc.typeArticle

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