{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,19]],"date-time":"2026-08-19T20:16:21Z","timestamp":1787170581316,"version":"build-2736575974"},"reference-count":38,"publisher":"MDPI AG","issue":"4","license":[{"start":{"date-parts":[[2025,4,19]],"date-time":"2025-04-19T00:00:00Z","timestamp":1745020800000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":["www.mdpi.com"],"crossmark-restriction":true},"short-container-title":["Pharmaceuticals"],"abstract":"<jats:p>Background: In the randomized, phase-3 IKEMA trial, the triplet isatuximab, carfilzomib, and dexamethasone (IsaKd) demonstrated superior clinical benefit compared to those of carfilzomib and dexamethasone alone in patients with relapsed\/refractory multiple myeloma after 1\u20133 prior treatments. Methods: Our real-world, AENEID study aimed to evaluate the efficacy and safety of IsaKd in patients who relapsed after frontline lenalidomide treatment, poorly represented in the IKEMA trial. Specifically, in the present multicenter analysis, we enrolled eighty-two patients who received, between April 2022 and September 2024 and outside of clinical trials, at least one cycle of IsaKd as a second-line treatment at the first relapse after induction therapy, autologous stem cell transplantation (ASCT), and lenalidomide maintenance. Results: After a median follow-up time of 12.9 months (range, 1\u201377), the overall response rate, at least a very good partial response rate, and median progression-free survival time were 79.3%, 56.1%, and 24.4 months, respectively. This slightly lower performance compared to that in the IKEMA study may be attributed to the well-known poor prognostic impact of lenalidomide refractoriness (len-R), developed by all our patients during maintenance therapy, and to a higher proportion of patients with extramedullary disease present in our series, which was identified as the only factor significantly affecting the PFS in multivariable analysis. The median overall survival was not reached, as in the pivotal trial, while the 1-year survival probability was 85.1%. Regarding the safety profile, our findings were consistent with those of the IKEMA trial, with no new safety signals reported. Conclusions: These real-world data support the use of IsaKd as a valuable option for len-R MM patients relapsing after the first-line therapy, including ASCT and lenalidomide maintenance.<\/jats:p>","DOI":"10.3390\/ph18040595","type":"journal-article","created":{"date-parts":[[2025,4,20]],"date-time":"2025-04-20T20:31:36Z","timestamp":1745181096000},"page":"595","update-policy":"https:\/\/doi.org\/10.3390\/mdpi_crossmark_policy","source":"Crossref","is-referenced-by-count":3,"title":["Efficacy and Safety of Isatuximab, Carfilzomib, and Dexamethasone (IsaKd) in Multiple Myeloma Patients at the First Relapse After Autologous Stem Cell Transplantation and Lenalidomide Maintenance: Results from the Multicenter, Real-Life AENEID Study"],"prefix":"10.3390","volume":"18","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-5447-1068","authenticated-orcid":false,"given":"Nicola","family":"Sgherza","sequence":"first","affiliation":[{"name":"Hematology and Stem Cell Transplantation Unit, AOUC Policlinico, 70124 Bari, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Olga","family":"Battisti","sequence":"additional","affiliation":[{"name":"Hematology and Stem Cell Transplantation Unit, AOUC Policlinico, 70124 Bari, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Paola","family":"Curci","sequence":"additional","affiliation":[{"name":"Hematology and Stem Cell Transplantation Unit, AOUC Policlinico, 70124 Bari, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-0862-3598","authenticated-orcid":false,"given":"Concetta","family":"Conticello","sequence":"additional","affiliation":[{"name":"Division of Hematology and Stem Cell Transplantation, Policlinico \u201cG. Rodolico-San Marco\u201d, 95123 Catania, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-9634-4147","authenticated-orcid":false,"given":"Salvatore","family":"Palmieri","sequence":"additional","affiliation":[{"name":"Hematology Unit, Ospedale Cardarelli, 80131 Napoli, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-0997-4157","authenticated-orcid":false,"given":"Daniele","family":"Derudas","sequence":"additional","affiliation":[{"name":"Department of Hematology, Businco Hospital, 09121 Cagliari, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Candida","family":"Germano","sequence":"additional","affiliation":[{"name":"Hematology Unit, \u201cDimiccoli\u201d Hospital, 70051 Barletta, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Enrica","family":"Martino","sequence":"additional","affiliation":[{"name":"Department of Onco-Hematology, Hematology Unit, Azienda Ospedaliera Annunziata, 87100 Cosenza, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-4813-8618","authenticated-orcid":false,"given":"Giuseppe","family":"Mele","sequence":"additional","affiliation":[{"name":"Hematology Unit, \u201cPerrino\u201d Hospital, 72100 Brindisi, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-5641-231X","authenticated-orcid":false,"given":"Roberta","family":"Della Pepa","sequence":"additional","affiliation":[{"name":"Hematology\u2014Department of Clinical Medicine and Surgery, University Hospital \u201cFederico II\u201d, 80131 Napoli, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-4187-8912","authenticated-orcid":false,"given":"Francesca","family":"Fazio","sequence":"additional","affiliation":[{"name":"Department of Translational and Precision Medicine Hematology, Sapienza University, 00185 Roma, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Anna","family":"Mele","sequence":"additional","affiliation":[{"name":"Hematology Unit, \u201cCardinale Panico\u201d Hospital, 70039 Tricase, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Bernardo","family":"Rossini","sequence":"additional","affiliation":[{"name":"Hematology and Cell Therapy Unit, IRCCS Istituto Tumori \u201cGiovanni Paolo II\u201d Bari, 70124 Bari, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Giulia","family":"Palazzo","sequence":"additional","affiliation":[{"name":"Haematology Unit, Ospedale G. Moscati, 74010 Taranto, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Daniela","family":"Roccotelli","sequence":"additional","affiliation":[{"name":"Department of Hematology and Bone Marrow Transplant, IRCSS \u201cCasa Sollievo Della Sofferenza\u201d, 71013 Foggia, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Simona","family":"Rasola","sequence":"additional","affiliation":[{"name":"Department of Precision and Regenerative Medicine and Ionian Area, \u201cAldo Moro\u201d University School of Medicine, 70121 Bari, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-0688-4882","authenticated-orcid":false,"given":"Maria","family":"Petrucci","sequence":"additional","affiliation":[{"name":"Department of Translational and Precision Medicine Hematology, Sapienza University, 00185 Roma, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Domenico","family":"Pastore","sequence":"additional","affiliation":[{"name":"Hematology Unit, \u201cPerrino\u201d Hospital, 72100 Brindisi, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Giuseppe","family":"Tarantini","sequence":"additional","affiliation":[{"name":"Hematology Unit, \u201cDimiccoli\u201d Hospital, 70051 Barletta, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-2563-4125","authenticated-orcid":false,"given":"Fabrizio","family":"Pane","sequence":"additional","affiliation":[{"name":"Hematology\u2014Department of Clinical Medicine and Surgery, University Hospital \u201cFederico II\u201d, 80131 Napoli, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Massimo","family":"Gentile","sequence":"additional","affiliation":[{"name":"Department of Onco-Hematology, Hematology Unit, Azienda Ospedaliera Annunziata, 87100 Cosenza, Italy"},{"name":"Department of Pharmacy, Health and Nutritional Science, University of Calabria, 87036 Rende, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Francesco","family":"Di Raimondo","sequence":"additional","affiliation":[{"name":"Division of Hematology and Stem Cell Transplantation, Policlinico \u201cG. 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