{"entity":{"id":"nct02963493","kind":"trial","name":"A Study of Melphalan Flufenamide (Melflufen) Plus Dexamethasone in Patients With Relapsed or Refractory Multiple Myeloma","aka":[],"tldr":"A phase 2 trial of Melphalan flufenamide and Dexamethasone in Multiple myeloma, run by Oncopeptides AB, completed.","summary":"A Study of Melphalan Flufenamide (Melflufen) Plus Dexamethasone in Patients With Relapsed or Refractory Multiple Myeloma is a phase 2 interventional study registered as NCT02963493 by Oncopeptides AB, with 157 participants recorded, started 2016-12-28 and reaching its primary completion in 2020-10-22. Interventions recorded: Melphalan flufenamide (Melflufen), Dexamethasone. Conditions recorded: 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.","status":"completed","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT02963493","url":"https://clinicaltrials.gov/study/NCT02963493"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["multiple-myeloma","myeloma-relapsed-refractory"],"sections":[],"technologies":[],"targets":[],"drugs":["melflufen","dexamethasone"],"companies":["oncopeptides"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT02963493","phase":"2","setting":"A Single Arm, Open-Label, Phase 2 Study of Melflufen in Combination With Dexamethasone in Patients With Relapsed Refractory Multiple Myeloma Who Are Refractory to Pomalidomide and/or an Anti-CD38 Monoclonal Antibody","sponsor":"Oncopeptides AB","started":"2016-12-28","startedType":"actual","yearReported":2022,"enrolled":157,"enrolledBasis":"registry","outcomes":[{"endpoint":"Overall Response Rate (ORR)","primary":true,"unit":"participants","arms":[{"name":"Melphalan Flufenamide (Melflufen) + Dexamethasone: Full Analysis Set","n":157,"value":53,"note":"Figures from the ClinicalTrials.gov results section (first posted 2022-02-01), not from a publication"},{"name":"Melphalan Flufenamide (Melflufen) + Dexamethasone: Patients With Extramedullary Disease","n":55,"value":14},{"name":"Melphalan Flufenamide (Melflufen) + Dexamethasone: Patients With Triple Class Refractory Disease","n":119,"value":35}],"source":"https://clinicaltrials.gov/study/NCT02963493?tab=results"},{"endpoint":"Overall Survival","unit":"months","arms":[{"name":"Melphalan Flufenamide (Melflufen) + Dexamethasone: Full Analysis Set","n":157,"value":11.79,"note":"95% CI 9.53 to 14.55; Figures from the ClinicalTrials.gov results section (first posted 2022-02-01), not from a publication"},{"name":"Melphalan Flufenamide (Melflufen) + Dexamethasone: Patients With Extramedullary Disease","n":55,"value":6.44,"note":"95% CI 5.06 to 9.66"},{"name":"Melphalan Flufenamide (Melflufen) + Dexamethasone: Patients With Triple Class Refractory Disease","n":119,"value":10.12,"note":"95% CI 7.20 to 12.29"}],"source":"https://clinicaltrials.gov/study/NCT02963493?tab=results"},{"endpoint":"Progression Free Survival (PFS)","unit":"months","arms":[{"name":"Melphalan Flufenamide (Melflufen) + Dexamethasone: Full Analysis Set","n":157,"value":4.27,"note":"95% CI 3.42 to 4.90; Figures from the ClinicalTrials.gov results section (first posted 2022-02-01), not from a publication"},{"name":"Melphalan Flufenamide (Melflufen) + Dexamethasone: Patients With Extramedullary Disease","n":55,"value":2.89,"note":"95% CI 1.97 to 3.94"},{"name":"Melphalan Flufenamide (Melflufen) + Dexamethasone: Patients With Triple Class Refractory Disease","n":119,"value":3.94,"note":"95% CI 3.09 to 4.67"}],"source":"https://clinicaltrials.gov/study/NCT02963493?tab=results"}]},"route":"/trials/nct02963493/","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":"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/"}]}}