PROMPT - Palifermin in Reduction of Oral Mucositis in PBSC Transplantation
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.
Drug: Kepivance (Palifermin)
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
|Official Title:||An Open-label, Single-arm Study of Palifermin for Reduction of Mucositis in Subjects With Non-Hodgkin's Lymphoma or Multiple Myeloma Undergoing High-Dose Chemotherapy and Autologous Peripheral Blood Stem Cell (PBSC) Transplantation|
- The primary efficacy endpoints are the incidence (%) and duration of severe oral mucositis (WHO grades 3 or 4). [ Time Frame: Up to 40 days ] [ Designated as safety issue: No ]The study consisted of a screening period of up to 42 days to determine subject eligibility, followed by a treatment period of a maximum of 40 days.
|Study Start Date:||April 2006|
|Study Completion Date:||May 2007|
|Primary Completion Date:||April 2007 (Final data collection date for primary outcome measure)|
Experimental: Kepivance (palifermin) 60 μg/kg/day IV
60 μg/kg/day IV for 3 consecutive days before the conditioning regimen and 3 consecutive days after the peripheral blood stem cell transplantation.
|Drug: Kepivance (Palifermin)|