{"entity":{"id":"imroz","kind":"trial","name":"IMROZ","aka":[],"tldr":"In IMROZ, isatuximab added to VRd cut progression by 40% in older patients not having a transplant.","summary":"IMROZ, trial NCT03319667 sponsored by Sanofi and published in the New England Journal of Medicine in 2024, showed that adding isatuximab to bortezomib, lenalidomide and dexamethasone cut the risk of progression by forty percent in newly diagnosed transplant-ineligible myeloma patients aged eighty or under. It randomised 446 patients, met its primary progression-free survival endpoint at 60 months with a higher rate of MRD-negative complete response, and led to approval in September 2024. OnCo links it to multiple myeloma, isatuximab, bortezomib, lenalidomide, Thierry Facon, the quadruplet pairing and the CEPHEUS paper. With daratumumab and isatuximab quadruplets both approved in this setting, whether the two CD38 antibodies differ is the open question.","status":"positive","asOf":"2026-09-07","links":[{"label":"ClinicalTrials.gov NCT03319667","url":"https://clinicaltrials.gov/study/NCT03319667"}],"tags":[],"related":[],"cancers":["multiple-myeloma","myeloma-transplant-ineligible"],"sections":[],"technologies":["monoclonal-antibody"],"targets":[],"drugs":["isatuximab","bortezomib","lenalidomide"],"companies":["sanofi"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":["thierry-facon"],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03319667","phase":"3","setting":"Newly diagnosed transplant-ineligible myeloma (age ≤80): Isa-VRd vs VRd","sponsor":"Sanofi","result":"PFS HR 0.60.","started":"2017-12-07","startedType":"actual","yearReported":2024,"enrolled":475,"enrolledBasis":"registry","outcomes":[{"endpoint":"Progression-free survival at 60 months","primary":true,"unit":"%","arms":[{"name":"Isa-VRd","n":265,"value":63.2},{"name":"VRd","n":181,"value":45.2}],"hr":0.6,"ci":[0.41,0.88],"p":"0.0005","source":"https://www.nejm.org/doi/full/10.1056/NEJMoa2400712"}]},"route":"/trials/imroz/","neighbours":{"cancer":[{"id":"multiple-myeloma","kind":"cancer","name":"Multiple myeloma","route":"/cancers/multiple-myeloma/"},{"id":"myeloma-transplant-ineligible","kind":"cancer","name":"Newly diagnosed multiple myeloma, transplant-ineligible","route":"/cancers/myeloma-transplant-ineligible/"}],"technology":[{"id":"monoclonal-antibody","kind":"technology","name":"Monoclonal antibodies","route":"/technologies/monoclonal-antibody/"}],"drug":[{"id":"bortezomib","kind":"drug","name":"Bortezomib","route":"/drugs/bortezomib/"},{"id":"isatuximab","kind":"drug","name":"Isatuximab","route":"/drugs/isatuximab/"},{"id":"lenalidomide","kind":"drug","name":"Lenalidomide","route":"/drugs/lenalidomide/"}],"company":[{"id":"sanofi","kind":"company","name":"Sanofi","route":"/companies/sanofi/"}],"person":[{"id":"thierry-facon","kind":"person","name":"Thierry Facon","route":"/people/thierry-facon/"}],"pairing":[{"id":"cd38-plus-triplet","kind":"pairing","name":"CD38 antibody added to PI-IMiD-dex (quadruplet induction)","route":"/pairings/cd38-plus-triplet/"}],"paper":[{"id":"paper-cepheus-dara-vrd-natmed-2025","kind":"paper","name":"CEPHEUS: daratumumab quadruplet for newly diagnosed myeloma patients not having a transplant, with MRD-negativity as the main endpoint","route":"/key-papers/paper-cepheus-dara-vrd-natmed-2025/"}]}}