{"entity":{"id":"karmma-3","kind":"trial","name":"KarMMa-3","aka":[],"tldr":"Ide-cel tripled progression-free time versus standard regimens in heavily pretreated myeloma, but did not clearly extend life after most control patients crossed over.","summary":"KarMMa-3, trial NCT03651128 sponsored by Bristol Myers Squibb and 2seventy and published in the New England Journal of Medicine in 2023, showed that idecabtagene vicleucel tripled progression-free time versus standard regimens in triple-class-exposed myeloma after two to four prior lines, but did not clearly extend life after most control patients crossed over. It randomised 386 patients, met its primary progression-free survival endpoint with a much higher response rate, while unadjusted overall survival was no different and crossover-adjusted analyses favoured ide-cel, leading to approval after two lines in April 2024. OnCo links it to multiple myeloma, idecabtagene vicleucel, Nikhil C. Munshi and the KarMMa-3 paper. Whether ide-cel's smaller effect than cilta-cel in CARTITUDE-4 reflects the product or the population is the open question.","status":"positive","asOf":"2026-09-07","links":[{"label":"ClinicalTrials.gov NCT03651128","url":"https://clinicaltrials.gov/study/NCT03651128"}],"tags":[],"related":[],"cancers":["multiple-myeloma","myeloma-relapsed-refractory"],"sections":[],"technologies":["car-t"],"targets":[],"drugs":["idecabtagene-vicleucel"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":["nikhil-munshi"],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03651128","phase":"3","setting":"Triple-class-exposed myeloma after 2-4 prior lines: ide-cel vs standard regimens","sponsor":"BMS / 2seventy","result":"PFS 13.3 vs 4.4 months, HR 0.49.","started":"2019-04-16","startedType":"actual","yearReported":2023,"enrolled":386,"enrolledBasis":"registry","outcomes":[{"endpoint":"Progression-free survival (median)","primary":true,"unit":"months","arms":[{"name":"Ide-cel","n":254,"value":13.3},{"name":"Standard regimens","n":132,"value":4.4}],"hr":0.49,"ci":[0.38,0.65],"p":"<0.001","source":"https://www.nejm.org/doi/full/10.1056/NEJMoa2213614"}]},"route":"/trials/karmma-3/","neighbours":{"cancer":[{"id":"multiple-myeloma","kind":"cancer","name":"Multiple myeloma","route":"/cancers/multiple-myeloma/"},{"id":"myeloma-relapsed-refractory","kind":"cancer","name":"Relapsed or refractory multiple myeloma","route":"/cancers/myeloma-relapsed-refractory/"}],"technology":[{"id":"car-t","kind":"technology","name":"CAR-T cell therapy","route":"/technologies/car-t/"}],"drug":[{"id":"idecabtagene-vicleucel","kind":"drug","name":"Idecabtagene vicleucel","route":"/drugs/idecabtagene-vicleucel/"}],"person":[{"id":"nikhil-munshi","kind":"person","name":"Nikhil C. Munshi","route":"/people/nikhil-munshi/"}],"idea":[{"id":"idea-fund-public-car-t-manufacturing","kind":"idea","name":"Hospital-based CAR-T manufacturing at cost through a public network","route":"/ideas/idea-fund-public-car-t-manufacturing/"},{"id":"idea-reg-point-of-care-cart-network","kind":"idea","name":"Hospital-made CAR-T under one shared regulatory master file","route":"/ideas/idea-reg-point-of-care-cart-network/"}],"paper":[{"id":"paper-karmma-3-ide-cel-nejm-2023","kind":"paper","name":"KarMMa-3: ide-cel CAR-T versus standard regimens in triple-class-exposed relapsed myeloma","route":"/key-papers/paper-karmma-3-ide-cel-nejm-2023/"}]}}