drugset / Trial / NCT00434161

A Study of Palifermin for the Reduction of Oral Mucositis in Subjects With Multiple Myeloma

NCT00434161

Phase 3 Completed 281 enrolled Swedish Orphan Biovitrum
RandomizedParallel-groupQuadruple-blindSupportive care

Summary

The purpose of this study was to evaluate the efficacy and effect of palifermin on the incidence of oral mucositis in subjects with multiple myeloma receiving Melphalan followed by autologous peripheral blood stem cell transplantation. Amendment 01 (April 07) introduced three cataract assessments to be carried out at Screening, Month 6 and Month 12 in response to FDA and EMEA follow up measures.

Timeline

Start
2006-12
Primary completion
2009-03
Completion
2012-05

Drugs

EvaluationDrugModalityDoseRoute
Comparator Palifermin Protein / enzyme biologic 60 ug/kg Intravenous

Indications