{"entity":{"id":"nct00434161","kind":"trial","name":"A Study of Palifermin for the Reduction of Oral Mucositis in Subjects With Multiple Myeloma","aka":[],"tldr":"A phase 3 trial of Palifermin in Multiple myeloma, run by Swedish Orphan Biovitrum, completed.","summary":"A Study of Palifermin for the Reduction of Oral Mucositis in Subjects With Multiple Myeloma is a phase 3 interventional study registered as NCT00434161 by Swedish Orphan Biovitrum, with 281 participants recorded, started 2006-12 and reaching its primary completion in 2009-03. Interventions recorded: Palifermin before only, Placebo, Palifermin before and after. Conditions recorded: Multiple Myeloma.\n\nLinked to the drug Palifermin 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 NCT00434161","url":"https://clinicaltrials.gov/study/NCT00434161"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["multiple-myeloma"],"sections":[],"technologies":[],"targets":[],"drugs":["palifermin"],"companies":["sobi"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT00434161","phase":"3","setting":"A Double-Blind, Randomized, Placebo-controlled Study of Two Different Schedules of Palifermin for Reduction in Severity of Oral Mucositis in Subjects With Multiple Myeloma Receiving Melphalan Followed by Autologous Blood Stem Cell Transplantation","sponsor":"Swedish Orphan Biovitrum","started":"2006-12","yearReported":2015,"enrolled":281,"enrolledBasis":"registry","outcomes":[{"endpoint":"Incidence of Cataract Development or Progression at Month 12., Yes","primary":true,"unit":"participants","arms":[{"name":"Placebo","n":22,"value":4,"note":"Figures from the ClinicalTrials.gov results section (first posted 2015-03-10), not from a publication"},{"name":"Palifermin","n":79,"value":25}],"source":"https://clinicaltrials.gov/study/NCT00434161?tab=results"},{"endpoint":"Overall Survival","unit":"months","arms":[{"name":"Palifermin (Palifermin Before Only and, Before and After)","n":220,"value":50.6,"note":"IQR 35.9 to NA; Figures from the ClinicalTrials.gov results section (first posted 2015-03-10), not from a publication"},{"name":"Placebo","n":57,"note":"Median and quartile 3 values are not available because a small number of participants died."}],"hr":0.64,"ci":[0.33,1.26],"p":"0.192","source":"https://clinicaltrials.gov/study/NCT00434161?tab=results"},{"endpoint":"Progression Free Survival","unit":"months","arms":[{"name":"Palifermin (Palifermin Before Only and, Before and After)","n":220,"value":15.1,"note":"IQR 8.4 to 24.0; Figures from the ClinicalTrials.gov results section (first posted 2015-03-10), not from a publication"},{"name":"Placebo","n":57,"value":18.3,"note":"IQR 11.9 to 27.5"}],"hr":0.8,"ci":[0.55,1.16],"p":"0.236","source":"https://clinicaltrials.gov/study/NCT00434161?tab=results"}]},"route":"/trials/nct00434161/","neighbours":{"cancer":[{"id":"multiple-myeloma","kind":"cancer","name":"Multiple myeloma","route":"/cancers/multiple-myeloma/"}],"drug":[{"id":"palifermin","kind":"drug","name":"Palifermin","route":"/drugs/palifermin/"}],"company":[{"id":"sobi","kind":"company","name":"Sobi (Swedish Orphan Biovitrum)","route":"/companies/sobi/"}]}}