drugset / Trial / NCT00434161
A Study of Palifermin for the Reduction of Oral Mucositis in Subjects With Multiple Myeloma
RandomizedParallel-groupQuadruple-blindSupportive care
Summary
The purpose of this study was to evaluate the efficacy and effect of palifermin on the incidence of oral mucositis in subjects with multiple myeloma receiving Melphalan followed by autologous peripheral blood stem cell transplantation. Amendment 01 (April 07) introduced three cataract assessments to be carried out at Screening, Month 6 and Month 12 in response to FDA and EMEA follow up measures.
Timeline
- Start
- 2006-12
- Primary completion
- 2009-03
- Completion
- 2012-05
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Palifermin | Protein / enzyme biologic | 60 ug/kg | Intravenous |