drugset / Trial / NCT00482846
Melphalan and Palifermin in Treating Patients Undergoing An Autologous Peripheral Stem Cell Transplant for Stage II or III Multiple Myeloma
Phase 1
Completed
38 enrolled
Barbara Ann Karmanos Cancer Institute
National Cancer Institute (NCI) · collab
NaSingle-groupOpen-labelSupportive care
Summary
RATIONALE: Drugs used in chemotherapy, such as melphalan, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Keratinocyte growth factors, such as palifermin, may help prevent symptoms of mucositis, or mouth sores, in patients receiving melphalan before a peripheral stem cell transplant for multiple myeloma. PURPOSE: This phase I trial is studying the side effects and best dose of melphalan when given together with palifermin in treating patients undergoing an autologous peripheral stem cell transplant for stage II or stage III multiple myeloma.
Timeline
- Start
- 2007-06
- Primary completion
- 2011-10
- Completion
- 2012-09
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Melphalan | Small molecule | 140 mg/m2 | Intravenous |
| Subject | Melphalan | Small molecule | 160 mg/m2 | Intravenous |
| Subject | Melphalan | Small molecule | 180 mg/m2 | Intravenous |
| Subject | Melphalan | Small molecule | 200 mg/m2 | Intravenous |
| Subject | Melphalan | Small molecule | 220 mg/m2 | Intravenous |
| Subject | Melphalan | Small molecule | 240 mg/m2 | Intravenous |
| Subject | Melphalan | Small molecule | 260 mg/m2 | Intravenous |
| Subject | Melphalan | Small molecule | 280 mg/m2 | Intravenous |
| Subject | Palifermin | Protein / enzyme biologic | 60 ug/kg | Intravenous |