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| Sponsor: | Biovitrum |
|---|---|
| Information provided by: | Biovitrum |
| ClinicalTrials.gov Identifier: | NCT00352703 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Non-Hodgkin's Lymphoma Multiple Myeloma |
Drug: Kepivance (Palifermin) |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Prevention, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study |
| 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 |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Contacts and Locations
More Information
| Responsible Party: | Biovitrum AB (publ) ( Clinical Development ) |
| Study ID Numbers: | 20050100 |
| Study First Received: | July 13, 2006 |
| Last Updated: | February 27, 2009 |
| ClinicalTrials.gov Identifier: | NCT00352703 History of Changes |
| Health Authority: | Spain: Spanish Agency of Medicine and Health Products |
|
Oral mucositis Non-Hodgkin's lymphoma (NHL) conditioning chemotherapy |
autologous PBSCT multiple myeloma (MM) Melphalan |
|
Mouth Diseases Neoplasms by Histologic Type Immunoproliferative Disorders Mucositis Stomatitis Immune System Diseases Gastrointestinal Diseases Hematologic Diseases Blood Protein Disorders Vascular Diseases Paraproteinemias Hemostatic Disorders |
Multiple Myeloma Lymphatic Diseases Neoplasms Digestive System Diseases Hemorrhagic Disorders Cardiovascular Diseases Stomatognathic Diseases Gastroenteritis Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Lymphoma Neoplasms, Plasma Cell |