{"entity":{"id":"cassiopeia","kind":"trial","name":"CASSIOPEIA","aka":[],"tldr":"CASSIOPEIA showed that adding the CD38 antibody daratumumab to a three-drug induction before stem cell transplant put more people with myeloma into deep remission and kept the disease away for longer.","summary":"CASSIOPEIA, run by the French and Dutch myeloma groups with Janssen, randomised 1085 transplant-eligible patients with newly diagnosed multiple myeloma to VTd (bortezomib, thalidomide, dexamethasone) induction and post-transplant consolidation with or without daratumumab (part 1), then re-randomised responders to daratumumab maintenance or observation (part 2). The part 1 primary endpoint was the stringent complete response rate after consolidation.\n\nDaratumumab-VTd increased stringent complete responses and minimal residual disease negativity and lengthened progression-free survival, leading to European and United States approval of the quadruplet in 2019 and 2020, the first daratumumab approval in the transplant setting. Part 2 showed that daratumumab maintenance lengthened progression-free survival mainly in patients who had not received it during induction.","status":"positive","asOf":"2026-09-17","links":[{"label":"ClinicalTrials.gov NCT02541383","url":"https://clinicaltrials.gov/study/NCT02541383"}],"tags":["subtype-trials"],"related":[],"cancers":["myeloma-transplant-eligible","multiple-myeloma"],"sections":[],"technologies":["monoclonal-antibody"],"targets":[],"drugs":["daratumumab","bortezomib","thalidomide","dexamethasone"],"companies":["johnson-johnson","ifm"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":["philippe-moreau"],"bottlenecks":[],"keyPapers":["paper-cassiopeia-lancet-2019"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT02541383","phase":"3","setting":"Transplant-eligible newly diagnosed multiple myeloma: bortezomib, thalidomide and dexamethasone (VTd) induction and consolidation with or without daratumumab, then daratumumab maintenance or observation","sponsor":"Intergroupe Francophone du Myelome","result":"Daratumumab added to VTd increased stringent complete responses and lengthened progression-free survival; approved for transplant-eligible myeloma in 2019 (EU) and 2020 (US).","started":"2015-09","startedType":"actual","yearReported":2019,"enrolled":1085,"enrolledBasis":"registry","outcomes":[{"endpoint":"Stringent complete response at day 100 after transplantation (part 1)","primary":true,"unit":"%","arms":[{"name":"Daratumumab + VTd","n":543,"value":29},{"name":"VTd","n":542,"value":20}],"p":"0.0010","source":"https://doi.org/10.1016/S0140-6736(19)31240-1"},{"endpoint":"Minimal residual disease negativity (10^-5, flow cytometry)","unit":"%","arms":[{"name":"Daratumumab + VTd","n":543,"value":64},{"name":"VTd","n":542,"value":44}],"p":"<0.0001","source":"https://doi.org/10.1016/S0140-6736(19)31240-1"},{"endpoint":"Progression-free survival from first randomisation","unit":"months","arms":[{"name":"Daratumumab + VTd","note":"Not reached"},{"name":"VTd","note":"Not reached"}],"hr":0.47,"ci":[0.33,0.67],"p":"<0.0001","source":"https://doi.org/10.1016/S0140-6736(19)31240-1"}]},"route":"/trials/cassiopeia/","neighbours":{"cancer":[{"id":"multiple-myeloma","kind":"cancer","name":"Multiple myeloma","route":"/cancers/multiple-myeloma/"},{"id":"myeloma-transplant-eligible","kind":"cancer","name":"Newly diagnosed multiple myeloma, transplant-eligible","route":"/cancers/myeloma-transplant-eligible/"}],"technology":[{"id":"monoclonal-antibody","kind":"technology","name":"Monoclonal antibodies","route":"/technologies/monoclonal-antibody/"}],"drug":[{"id":"bortezomib","kind":"drug","name":"Bortezomib","route":"/drugs/bortezomib/"},{"id":"daratumumab","kind":"drug","name":"Daratumumab","route":"/drugs/daratumumab/"},{"id":"dexamethasone","kind":"drug","name":"Dexamethasone","route":"/drugs/dexamethasone/"},{"id":"thalidomide","kind":"drug","name":"Thalidomide","route":"/drugs/thalidomide/"}],"company":[{"id":"ifm","kind":"company","name":"Intergroupe Francophone du Myélome (IFM)","route":"/companies/ifm/"},{"id":"johnson-johnson","kind":"company","name":"Johnson & Johnson","route":"/companies/johnson-johnson/"}],"person":[{"id":"philippe-moreau","kind":"person","name":"Philippe Moreau","route":"/people/philippe-moreau/"}],"paper":[{"id":"paper-cassiopeia-lancet-2019","kind":"paper","name":"CASSIOPEIA: daratumumab added to bortezomib, thalidomide and dexamethasone before and after transplant in newly diagnosed myeloma","route":"/key-papers/paper-cassiopeia-lancet-2019/"}]}}