{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,10]],"date-time":"2026-09-10T00:17:39Z","timestamp":1788999459020,"version":"build-2803163510"},"reference-count":20,"publisher":"Wiley","issue":"4","license":[{"start":{"date-parts":[[2024,1,23]],"date-time":"2024-01-23T00:00:00Z","timestamp":1705968000000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Br J Haematol"],"published-print":{"date-parts":[[2024,4]]},"abstract":"<jats:title>Summary<\/jats:title><jats:p>Ide\u2010cel received approval for relapsed\u2013refractory multiple myeloma based on the results of the KarMMa\u20101 trial. However, patients with significant comorbidities, aggressive disease and prior B\u2010cell maturation antigen\u2010directed therapy (BCMA\u2010DT) were excluded. This retrospective study evaluated real\u2010world outcomes of patients who did not meet the KarMMa\u20101 eligibility criteria and were treated with standard of care (SOC) ide\u2010cel. A total of 69 patients from three US centres who did not meet the KarMMa\u20101 criteria underwent ide\u2010cel infusion. The main reasons for trial ineligibility included baseline grade 3\u20134 cytopenia (39%), prior BCMA\u2010DT (26%), renal impairment (19%) and Eastern Cooperative Oncology Group performance status \u22652 (14.5%). Cytokine\u2010release syndrome occurred in 81% vs. 84%, and immune effector cell\u2010associated neurotoxicity syndrome occurred in 28% vs. 18% of SOC versus KarMMa\u20101 patients, respectively. Early infection (\u22648\u2009weeks post\u2010infusion) and severe infection rates were 42% vs. 49% and 30% vs. 22% for the SOC versus KarMMa\u20101 cohorts, respectively. Grade 3\u20134 cytopenias for SOC versus KarMMa\u20101 cohorts were: neutropenia (87% vs. 89%), anaemia (51% vs. 60%) and thrombocytopenia (65% vs. 52%). Overall\u00a0response rate was higher for the SOC cohort (93% vs. 73%), as was the complete response or better rate (48% vs. 33%). However, median progression\u2010free survival and overall survival were comparable between the two groups. Our findings support broadening the inclusion criteria of future trials evaluating ide\u2010cel.<\/jats:p>","DOI":"10.1111\/bjh.19302","type":"journal-article","created":{"date-parts":[[2024,1,24]],"date-time":"2024-01-24T05:34:17Z","timestamp":1706074457000},"page":"1293-1299","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":29,"title":["Efficacy and safety of idecabtagene vicleucel in patients with relapsed\u2013refractory multiple myeloma not meeting the <scp>KarMMa<\/scp>\u20101 trial eligibility criteria: A real\u2010world multicentre study"],"prefix":"10.1111","volume":"204","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-3587-7975","authenticated-orcid":false,"given":"Danai","family":"Dima","sequence":"first","affiliation":[{"name":"US Myeloma Innovations Research Collaborative (USMIRC)  Kansas City Kansas USA"},{"name":"Department of Hematology\u2010Oncology, Cleveland Clinic Taussig Cancer Center  Cleveland Ohio 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