PROMPT - Palifermin in Reduction of Oral Mucositis in PBSC Transplantation
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|ClinicalTrials.gov Identifier: NCT00352703|
Recruitment Status : Completed
First Posted : July 17, 2006
Last Update Posted : November 3, 2014
|Condition or disease||Intervention/treatment||Phase|
|Non-Hodgkin's Lymphoma Multiple Myeloma||Drug: Kepivance (Palifermin)||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||145 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||April 2006|
|Actual Primary Completion Date :||April 2007|
|Actual Study Completion Date :||May 2007|
U.S. FDA Resources
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)|
- The primary efficacy endpoints are the incidence (%) and duration of severe oral mucositis (WHO grades 3 or 4). [ Time Frame: Up to 40 days ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00352703
|Study Director:||MD||Biovitrum AB|