Isatuximab, Bortezomib, Lenalidomide, and Dexamethasone for Multiple Myeloma

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dc.authorscopusidMeral Beksaç / 56924887200
dc.authorwosidMeral Beksaç / D-6411-2013
dc.contributor.authorFacon, Thierry
dc.contributor.authorDimopoulos, Meletios Athanasios
dc.contributor.authorLeleu, Xavier P.
dc.contributor.authorBeksaç, Meral
dc.contributor.authorPour, Ludek
dc.contributor.authorHájek, Roman
dc.contributor.authorLiu, Zhuogang
dc.contributor.authorMinarik, Jiri
dc.contributor.authorMoreau, Philippe
dc.contributor.authorRomejko Jarosinska, Joanna
dc.contributor.authorSpicka, Ivan
dc.contributor.authorVorobyev, Vladimir I.
dc.contributor.authorBesemer, Britta
dc.contributor.authorIshida, Tadao
dc.contributor.authorJanowski, Wojciech
dc.contributor.authorKalayoğlu Beşisik, Sevgi
dc.contributor.authorParmar, Gurdeep
dc.contributor.authorRobak, Pawel
dc.contributor.authorZamagni, Elena
dc.contributor.authorGoldschmidt, Hartmut
dc.contributor.authorMartin, Thomas G.
dc.contributor.authorManier, Salomon
dc.contributor.authorMohty, Mohamad
dc.contributor.authorOprea, Corina
dc.contributor.authorBrégeault, Marie France
dc.contributor.authorMacé, Sandrine
dc.contributor.authorBerthou, Christelle
dc.contributor.authorBregman, David
dc.contributor.authorKlippel, Zandra
dc.contributor.authorOrlowski, Robert Z.
dc.date.accessioned2025-04-18T10:27:59Z
dc.date.available2025-04-18T10:27:59Z
dc.date.issued2024
dc.departmentİstinye Üniversitesi, Tıp Fakültesi, Dahili Tıp Bilimleri Bölümü
dc.description.abstractBackground Bortezomib, lenalidomide, and dexamethasone (VRd) is a preferred first-line treatment option for patients with newly diagnosed multiple myeloma. Whether the addition of the anti-CD38 monoclonal antibody isatuximab to the VRd regimen would reduce the risk of disease progression or death among patients ineligible to undergo transplantation is unclear. Methods In an international, open-label, phase 3 trial, we randomly assigned, in a 3:2 ratio, patients 18 to 80 years of age with newly diagnosed multiple myeloma who were ineligible to undergo transplantation to receive either isatuximab plus VRd or VRd alone. The primary efficacy end point was progression-free survival. Key secondary end points included a complete response or better and minimal residual disease (MRD)-negative status in patients with a complete response. Results A total of 446 patients underwent randomization. At a median follow-up of 59.7 months, the estimated progression-free survival at 60 months was 63.2% in the isatuximab-VRd group, as compared with 45.2% in the VRd group (hazard ratio for disease progression or death, 0.60; 98.5% confidence interval, 0.41 to 0.88; P<0.001). The percentage of patients with a complete response or better was significantly higher in the isatuximab-VRd group than in the VRd group (74.7% vs. 64.1%, P=0.01), as was the percentage of patients with MRD-negative status and a complete response (55.5% vs. 40.9%, P=0.003). No new safety signals were observed with the isatuximab-VRd regimen. The incidence of serious adverse events during treatment and the incidence of adverse events leading to discontinuation were similar in the two groups. Conclusions Isatuximab-VRd was more effective than VRd as initial therapy in patients 18 to 80 years of age with newly diagnosed multiple myeloma who were ineligible to undergo transplantation. © 2024 Massachusetts Medical Society.
dc.identifier.citationFacon, T., Dimopoulos, M. A., Leleu, X. P., Beksac, M., Pour, L., Hájek, R., ... & Orlowski, R. Z. (2024). Isatuximab, bortezomib, lenalidomide, and dexamethasone for multiple myeloma. New England Journal of Medicine, 391(17), 1597-1609.
dc.identifier.doi10.1056/NEJMoa2400712
dc.identifier.endpage1609
dc.identifier.issn00284793
dc.identifier.issue17
dc.identifier.pmid38832972
dc.identifier.scopusqualityQ1
dc.identifier.startpage1597
dc.identifier.urihttp://dx.doi.org/10.1056/NEJMoa2400712
dc.identifier.urihttps://hdl.handle.net/20.500.12713/7079
dc.identifier.volume391
dc.identifier.wosWOS:001426754300001
dc.identifier.wosqualityQ1
dc.indekslendigikaynakScopus
dc.indekslendigikaynakWeb of Science
dc.indekslendigikaynakPubMed
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.subjectHematology/Oncology
dc.subjectLeukemia/Lymphoma
dc.subjectTreatments in Oncology
dc.titleIsatuximab, Bortezomib, Lenalidomide, and Dexamethasone for Multiple Myeloma
dc.typeArticle

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