drugset / Trial / NCT00325416
Study of Melphalan and Topotecan (MT) Followed by Autologous Stem Cell Rescue in Patients With Multiple Myeloma.
Phase 1/2
Completed
177 enrolled
H. Lee Moffitt Cancer Center and Research Institute
GlaxoSmithKline · collabNational Cancer Institute (NCI) · collab
Non-randomizedParallel-groupOpen-labelTreatment
Summary
The purpose of this research study is to determine the safest dose of topotecan when given in a high dose before a stem cell transplant; topotecan will be given with melphalan.
Timeline
- Start
- 2001-11-19
- Primary completion
- 2013-07-15
- Completion
- 2018-01-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Melphalan | Small molecule | 50 mg/m2 | Intravenous |
| Subject | Topotecan | Small molecule | 20 mg/m2 | — |
| Subject | Topotecan | Small molecule | 30 mg/m2 | — |
| Subject | Topotecan | Small molecule | 54 mg/m2 | — |
| Subject | Topotecan | Small molecule | 72 mg/m2 | — |
| Subject | Topotecan | Small molecule | 96 mg/m2 | — |
| Subject | Topotecan | Small molecule | 127.8 mg/m2 | — |
| Subject | Topotecan | Small molecule | 170.1 mg/m2 | — |