{"entity":{"id":"nct04649060","kind":"trial","name":"Study of Melflufen (Melphalan Flufenamide) in Combination With Daratumumab in Relapsed-Refractory Multiple Myeloma","aka":[],"tldr":"A phase 3 trial of Melphalan flufenamide, Dexamethasone and Daratumumab in Multiple myeloma, run by Oncopeptides AB, recorded as terminated on the registry.","summary":"Study of Melflufen (Melphalan Flufenamide) in Combination With Daratumumab in Relapsed-Refractory Multiple Myeloma is a phase 3 interventional study registered as NCT04649060 by Oncopeptides AB, with 54 participants recorded, started 2020-12-21 and due to reach its primary completion in 2022-02-07. Interventions recorded: Melflufen, Dexamethasone, Daratumumab. Conditions recorded: Relapsed Multiple Myeloma, Relapsed-Refractory Multiple Myeloma.\n\nLinked to the drug Melphalan flufenamide because the registry names it among its interventions and Multiple myeloma among its conditions. Registry record only: no result has been read by an editor.","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT04649060","url":"https://clinicaltrials.gov/study/NCT04649060"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["multiple-myeloma","myeloma-relapsed-refractory"],"sections":[],"technologies":[],"targets":[],"drugs":["melflufen","dexamethasone","daratumumab"],"companies":["oncopeptides"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04649060","phase":"3","setting":"A Randomized, Controlled, Open-Label Phase 3 Study of Melflufen in Combination With Daratumumab Compared With Daratumumab in Patients With Relapsed or Relapsed-Refractory Multiple Myeloma","sponsor":"Oncopeptides AB","started":"2020-12-21","startedType":"actual","yearReported":2023,"enrolled":54,"enrolledBasis":"registry","outcomes":[{"endpoint":"Progression Free Survival (PFS)","primary":true,"unit":"months","arms":[{"name":"Arm A (Melflufen+Dexamethasone+Daratumumab)","n":27,"note":"The median PFS was not reached in Arm A. There were insufficient numbers of participants with events.; Figures from the ClinicalTrials.gov results section (first posted 2023-06-08), not from a publication"},{"name":"Arm B (Daratumumab)","n":27,"value":4.86,"note":"95% CI 3.38 to NA"}],"hr":0.184,"ci":[0.052,0.65],"p":"0.0032","source":"https://clinicaltrials.gov/study/NCT04649060?tab=results"},{"endpoint":"Overall Survival (OS)","unit":"months","arms":[{"name":"Arm A (Melflufen+Dexamethasone+Daratumumab)","n":27,"value":11.04,"note":"95% CI NA to NA; Figures from the ClinicalTrials.gov results section (first posted 2023-06-08), not from a publication"},{"name":"Arm B (Daratumumab)","n":27,"note":"The median OS was not reached in Arm B and the 95% CI was not available due to insufficient numbers of participants with events."}],"hr":0.47,"ci":[0.086,2.569],"p":"0.3721","source":"https://clinicaltrials.gov/study/NCT04649060?tab=results"},{"endpoint":"Overall Response Rate (ORR)","unit":"%","arms":[{"name":"Arm A (Melflufen+Dexamethasone+Daratumumab)","n":27,"value":59.3,"note":"95% CI 38.8 to 77.6; Figures from the ClinicalTrials.gov results section (first posted 2023-06-08), not from a publication"},{"name":"Arm B (Daratumumab)","n":27,"value":29.6,"note":"95% CI 13.8 to 50.2"}],"p":"0.03","source":"https://clinicaltrials.gov/study/NCT04649060?tab=results"}]},"route":"/trials/nct04649060/","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/"}],"drug":[{"id":"daratumumab","kind":"drug","name":"Daratumumab","route":"/drugs/daratumumab/"},{"id":"dexamethasone","kind":"drug","name":"Dexamethasone","route":"/drugs/dexamethasone/"},{"id":"melflufen","kind":"drug","name":"Melphalan flufenamide","route":"/drugs/melflufen/"}],"company":[{"id":"oncopeptides","kind":"company","name":"Oncopeptides","route":"/companies/oncopeptides/"}]}}