PROMPT - Palifermin in Reduction of Oral Mucositis in PBSC Transplantation
This study has been completed.
Sponsor:
Swedish Orphan Biovitrum
Information provided by:
Swedish Orphan Biovitrum
ClinicalTrials.gov Identifier:
NCT00352703
First received: July 13, 2006
Last updated: August 30, 2010
Last verified: August 2010
Tracking Information | |||||
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First Received Date ICMJE | July 13, 2006 | ||||
Last Updated Date | August 30, 2010 | ||||
Start Date ICMJE | April 2006 | ||||
Primary Completion Date | April 2007 (final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
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. |
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Original Primary Outcome Measures ICMJE |
The primary efficacy endpoints are the incidence (%) and duration of severe oral mucositis (WHO grades 3 or 4). | ||||
Change History | Complete list of historical versions of study NCT00352703 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures ICMJE | |||||
Original Secondary Outcome Measures ICMJE | |||||
Current Other Outcome Measures ICMJE | |||||
Original Other Outcome Measures ICMJE | |||||
Descriptive Information | |||||
Brief Title ICMJE | PROMPT - Palifermin in Reduction of Oral Mucositis in PBSC Transplantation | ||||
Official Title ICMJE | 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 | ||||
Brief 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. |
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Detailed Description | |||||
Study Type ICMJE | Interventional | ||||
Study Phase | Phase 4 | ||||
Study Design ICMJE | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Prevention |
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Condition ICMJE |
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Intervention ICMJE | Drug: Kepivance (Palifermin) | ||||
Study Arm (s) | 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.
Intervention: Drug: Kepivance (Palifermin) |
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Publications * | |||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Completed | ||||
Enrollment ICMJE | 145 | ||||
Completion Date | May 2007 | ||||
Primary Completion Date | April 2007 (final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
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Gender | Both | ||||
Ages | 18 Years and older | ||||
Accepts Healthy Volunteers | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Location Countries ICMJE | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT00352703 | ||||
Other Study ID Numbers ICMJE | 20050100 | ||||
Has Data Monitoring Committee | No | ||||
Responsible Party | Clinical Development, Biovitrum AB (publ) | ||||
Study Sponsor ICMJE | Swedish Orphan Biovitrum | ||||
Collaborators ICMJE | |||||
Investigators ICMJE |
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Information Provided By | Swedish Orphan Biovitrum | ||||
Verification Date | August 2010 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |