{"entity":{"id":"nct01102426","kind":"trial","name":"Aplidin - Dexamethasone in Relapsed/Refractory Myeloma","aka":["ADMYRE"],"tldr":"A phase 3 trial of Plitidepsin and Dexamethasone in Multiple myeloma, run by PharmaMar, completed.","summary":"Aplidin - Dexamethasone in Relapsed/Refractory Myeloma is a phase 3 interventional study registered as NCT01102426 by PharmaMar, with 255 participants recorded, started 2010-06 and reaching its primary completion in 2017-11. Interventions recorded: Plitidepsin, Dexamethasone. Conditions recorded: Relapsed/Refractory Multiple Myeloma.\n\nLinked to the drug Plitidepsin 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 NCT01102426","url":"https://clinicaltrials.gov/study/NCT01102426"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["multiple-myeloma","myeloma-relapsed-refractory"],"sections":[],"technologies":[],"targets":[],"drugs":["plitidepsin","dexamethasone"],"companies":["pharmamar"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT01102426","phase":"3","setting":"Randomized, Multicenter, Open-label, Phase III Study of Plitidepsin in Combination With Dexamethasone vs. Dexamethasone Alone in Patients With Relapsed/Refractory Multiple Myeloma","sponsor":"PharmaMar","started":"2010-06","yearReported":2020,"enrolled":255,"enrolledBasis":"registry","outcomes":[{"endpoint":"Progression Free Survival (PFS) as Per Intention-to-treat (ITT)","primary":true,"unit":"months","arms":[{"name":"Plitidepsin+Dexamethasone","n":171,"value":2.6,"note":"95% CI 1.9 to 3.0; Figures from the ClinicalTrials.gov results section (first posted 2020-10-22), not from a publication"},{"name":"Dexamethasone","n":84,"value":1.7,"note":"95% CI 1.1 to 2.0"}],"hr":0.65,"ci":[0.447,0.885],"p":"0.0054","source":"https://clinicaltrials.gov/study/NCT01102426?tab=results"},{"endpoint":"Percentage of Participants With Progression Free Survival (PFS) as Per Intention-to-treat (ITT) at 6 Months","primary":true,"unit":"%","arms":[{"name":"Plitidepsin+Dexamethasone","n":171,"value":20,"note":"95% CI 13.1 to 26.9; Figures from the ClinicalTrials.gov results section (first posted 2020-10-22), not from a publication"},{"name":"Dexamethasone","n":84,"value":10,"note":"95% CI 2.0 to 18.0"}],"p":"0.0618","source":"https://clinicaltrials.gov/study/NCT01102426?tab=results"},{"endpoint":"Overall Survival","unit":"months","arms":[{"name":"Plitidepsin+Dexamethasone","n":171,"value":11.6,"note":"95% CI 9.2 to 16.1; Figures from the ClinicalTrials.gov results section (first posted 2020-10-22), not from a publication"},{"name":"Dexamethasone","n":84,"value":8.9,"note":"95% CI 6.0 to 15.4"}],"hr":0.797,"ci":[0.596,1.067],"p":"0.1261","source":"https://clinicaltrials.gov/study/NCT01102426?tab=results"},{"endpoint":"Overall Response Rate (Independent Review Committee)","unit":"%","arms":[{"name":"Plitidepsin+Dexamethasone","n":171,"value":22.8,"note":"95% CI 16.8 to 29.8; Figures from the ClinicalTrials.gov results section (first posted 2020-10-22), not from a publication"},{"name":"Dexamethasone","n":84,"value":3.6,"note":"95% CI 0.7 to 10.1"}],"p":"<0.0001","source":"https://clinicaltrials.gov/study/NCT01102426?tab=results"}]},"route":"/trials/nct01102426/","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":"plitidepsin","kind":"drug","name":"Plitidepsin","route":"/drugs/plitidepsin/"}],"company":[{"id":"pharmamar","kind":"company","name":"PharmaMar","route":"/companies/pharmamar/"}]}}