Trials / Completed
CompletedNCT00352703
PROMPT - Palifermin in Reduction of Oral Mucositis in PBSC Transplantation
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
- Status
- Completed
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 145 (actual)
- Sponsor
- Swedish Orphan Biovitrum · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Kepivance (Palifermin) |
Timeline
- Start date
- 2006-04-01
- Primary completion
- 2007-04-01
- Completion
- 2007-05-01
- First posted
- 2006-07-17
- Last updated
- 2014-11-03
Source: ClinicalTrials.gov record NCT00352703. Inclusion in this directory is not an endorsement.