drugset / Trial / NCT00352703

PROMPT - Palifermin in Reduction of Oral Mucositis in PBSC Transplantation

NCT00352703

Phase 4 Completed 145 enrolled Swedish Orphan Biovitrum
Non-randomizedSingle-groupOpen-labelPrevention

Summary

This is an open-label, single-arm, multicentre study conducted in Spain to estimate the effectiveness of palifermin administered at a dose of 60 mg/kg/day IV for 3 consecutive days before the start of the conditioning regimen and for 3 consecutive days after autologous PBSCT for treating oral mucositis in patients with NHL and MM who have received high-dose conditioning chemotherapy.

Timeline

Start
2006-04
Primary completion
2007-04
Completion
2007-05

Drugs

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