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dc.contributor.authorFacon, Thierry-
dc.contributor.authorMoreau, Philippe-
dc.contributor.authorMartin, Thomas G-
dc.contributor.authorSpicka, Ivan-
dc.contributor.authorOriol, Albert-
dc.contributor.authorKoh, Youngil-
dc.contributor.authorLim, Andrew Boon Ming-
dc.contributor.authorMikala, Gabor-
dc.contributor.authorRosiñol, Laura-
dc.contributor.authorYağci, Münci-
dc.contributor.authorCavo, Michele-
dc.contributor.authorYong, Kwee-
dc.contributor.authorRisse, Marie-Laure-
dc.contributor.authorAsset, Gaëlle-
dc.contributor.authorSchwab, Sandrine-
dc.contributor.authorMartinez, Gracia-
dc.identifier.citationHematological Oncology 2022; 40(5)en
dc.description.abstractIn this subgroup analysis of the randomized, Phase 3 IKEMA study (NCT03275285), we evaluated efficacy and safety of the anti-CD38 monoclonal antibody isatuximab (Isa) in combination with carfilzomib-dexamethasone (Isa-Kd) versus Kd in older (≥70 years of age, n = 86) and younger (<70 years, n = 216) patients with relapsed multiple myeloma (MM). Patients received Isa 10 mg/kg intravenously weekly for 4 weeks, then every 2 weeks in the Isa-Kd arm, and approved schedule of carfilzomib (twice weekly) and dexamethasone in both study arms. Primary endpoint was progression-free survival (PFS); key secondary efficacy endpoints included rates of overall response (ORR), very good partial response or better (≥VGPR), minimal residual disease negativity (MRD-), and complete response (CR). Addition of Isa to Kd resulted in improved PFS in elderly patients (hazard ratio, 0.36 [95% CI, 0.18-0.75]) consistent with the significant PFS improvement observed in the overall IKEMA population. Treatment with Isa-Kd improved depth of response versus Kd, with higher rates of ≥VGPR (73.1% vs. 55.9%), MRD- (23.1% vs. 11.8%), and CR (38.5% vs. 23.5%). Although the incidence of grade ≥3 treatment-emergent adverse events (TEAEs) was higher in Isa-Kd, the incidence of serious TEAEs was similar between arms. Fewer elderly patients definitively discontinued treatment due to TEAEs in Isa-Kd than Kd: 11.8% versus 23.5%. In conclusion, Isa-Kd provides a consistent benefit versus Kd in elderly patients, with a manageable safety profile, and represents a new treatment option for patients with relapsed MM, independent of age.en
dc.subjectmonoclonal antibodyen
dc.subjectmultiple myelomaen
dc.titleIsatuximab plus carfilzomib and dexamethasone versus carfilzomib and dexamethasone in elderly patients with relapsed multiple myeloma: IKEMA subgroup analysis.en
dc.typeJournal Articleen
dc.identifier.journaltitleHematological oncologyen
dc.identifier.affiliationRepatriation Medical Center, Heidelberg, Victoria, Australia..en
dc.identifier.affiliationDepartment of Haematology, Lille University Hospital, Lille, France..en
dc.identifier.affiliationUniversity of Nantes, Nantes, France..en
dc.identifier.affiliationUniversity of California San Francisco, San Francisco, California, USA..en
dc.identifier.affiliationDepartments of Medicine and Hematology, First Faculty of Medicine, Charles University and General Hospital, Prague, Czech Republic..en
dc.identifier.affiliationHematology Department, Institut Català d'Oncologia and Josep Carreras Institute, Hospital Germans Trias i Pujol, Barcelona, Spain..en
dc.identifier.affiliationSeoul National University Hospital, Seoul, South Korea..en
dc.identifier.affiliationDepartment of Hematology and Stem Cell Transplantation, National Institute for Hematology and Infectious Diseases, South Pest Central Hospital, Budapest, Hungary..en
dc.identifier.affiliationHospital Clinic, IDIBAPS, Barcelona, Spain..en
dc.identifier.affiliationGazi University, Ankara, Turkey..en
dc.identifier.affiliationIRCCS Azienda Ospedaliero-Universitaria di Bologna, "Seràgnoli" Institute of Hematology, Bologna University School of Medicine, Bologna, Italy..en
dc.identifier.affiliationDepartment of Haematology, University College Hospital, London, UK..en
dc.identifier.affiliationSanofi R&D, Vitry-Sur-Seine, France..en
dc.identifier.affiliationSanofi R&D, Chilly-Mazarin, France..en
dc.identifier.affiliationHospital das Clínicas de São Paulo, São Paolo, Brazil..en
dc.identifier.affiliationAustin Healthen
dc.identifier.pubmedid35653225-, Andrew Boon Ming
item.fulltextNo Fulltext-
item.openairetypeJournal Article-
item.languageiso639-1en- Haematology-
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