{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,3,18]],"date-time":"2026-03-18T01:43:20Z","timestamp":1773798200049,"version":"3.50.1"},"reference-count":18,"publisher":"Wiley","issue":"5","license":[{"start":{"date-parts":[[2022,8,18]],"date-time":"2022-08-18T00:00:00Z","timestamp":1660780800000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"DOI":"10.13039\/100004339","name":"Sanofi","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100004339","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["European J of Haematology"],"published-print":{"date-parts":[[2022,11]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Introduction<\/jats:title><jats:p>The presence of high\u2010risk chromosomal abnormalities [t(4;14), del(17p), and t(14;16)] has been linked with inferior outcomes in patients with multiple myeloma (MM). A prespecified interim analysis of the Phase 3 IKEMA study (NCT03275285) demonstrated that isatuximab (Isa)\u2009+\u2009carfilzomib (K) and dexamethasone (d; Isa\u2010Kd) significantly improved progression\u2010free survival (PFS) versus Kd in patients with relapsed MM. This prespecified subgroup analysis of IKEMA examined efficacy and safety in patients with high\u2010risk cytogenetics.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>High\u2010risk cytogenetics was assessed by central laboratory and patients were classified as high risk if abnormalities were present in \u22651 of the following: del(17p): 50% cutoff; t(4;14), and\/or t(14;16): 30% cutoff.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>Of the randomized patients, 23.5% (Isa\u2010Kd) and 25.2% (Kd) had \u22651 high\u2010risk chromosomal abnormality. A PFS benefit was seen in favor of Isa\u2010Kd for patients with standard\u2010risk (HR 0.440; 95% CI 0.266\u20130.728) and high\u2010risk cytogenetics (HR 0.724; 95% CI 0.361\u20131.451). Grade\u2009\u22653 treatment\u2010emergent adverse events (TEAEs) were more common with Isa\u2010Kd (85.7%) versus Kd (63.3%) in patients with high\u2010risk cytogenetics; however, the incidence of serious TEAEs (64.3% vs. 66.7%) was similar.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p>Isa\u2010Kd is a new treatment option for the difficult\u2010to\u2010treat subgroup of patients with relapsed MM and high\u2010risk cytogenetics.<\/jats:p><\/jats:sec>","DOI":"10.1111\/ejh.13835","type":"journal-article","created":{"date-parts":[[2022,7,24]],"date-time":"2022-07-24T12:44:05Z","timestamp":1658666645000},"page":"504-512","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":19,"title":["Isatuximab plus carfilzomib and dexamethasone in relapsed multiple myeloma patients with high\u2010risk cytogenetics: <scp>IKEMA<\/scp> subgroup analysis"],"prefix":"10.1111","volume":"109","author":[{"given":"Ivan","family":"Spicka","sequence":"first","affiliation":[{"name":"1st Department of Medicine\u2014Department of Hematology, First Faculty of Medicine Charles University and General Hospital  Prague Czech Republic"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-1780-8746","authenticated-orcid":false,"given":"Philippe","family":"Moreau","sequence":"additional","affiliation":[{"name":"University of Nantes  Nantes France"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Thomas G.","family":"Martin","sequence":"additional","affiliation":[{"name":"University of California San Francisco  San Francisco California USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Thierry","family":"Facon","sequence":"additional","affiliation":[{"name":"Department of Haematology Lille University Hospital  Lille 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Australia"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Gabor","family":"Mikala","sequence":"additional","affiliation":[{"name":"Department of Hematology and Stem Cell Transplantation National Institute for Hematology and Infectious Diseases, South Pest Central Hospital  Budapest Hungary"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Laura","family":"Rosi\u00f1ol","sequence":"additional","affiliation":[{"name":"Hospital Clinic, IDIBAPS  Barcelona Spain"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"M\u00fcnci","family":"Ya\u011fci","sequence":"additional","affiliation":[{"name":"Gazi University  Ankara Turkey"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Michele","family":"Cavo","sequence":"additional","affiliation":[{"name":"IRCCS Azienda Ospedaliero\u2010Universitaria di Bologna, Istituto di Ematologia \u201cSer\u00e0gnoli\u201d  Bologna Italy"},{"name":"Dipartimento di Medicina Specialistica, Diagnostica e 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