drugset / Trial / NCT00752518
A Japan Phase I/II Study of Bortezomib in Relapsed or Refractory Multiple Myeloma Patients
Non-randomizedFactorialOpen-labelTreatment
Summary
The purpose of this study is to assess the safety/tolerability and determine the Japanese recommended dose (RD) of bortezomib administered as a once-daily intravenous bolus twice weekly for 2 consecutive weeks(Days 1, 4, 8, and 11) followed by a 10-day rest period (Days 12 to 21) in Japanese patients with relapsed or refractory multiple myeloma.
Timeline
- Start
- 2004-05
- Primary completion
- —
- Completion
- 2006-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Bortezomib | Small molecule | 0.7 mg/m2 | Intravenous |
| Subject | Bortezomib | Small molecule | 1 mg/m2 | Intravenous |
| Subject | Bortezomib | Small molecule | 1.3 mg/m2 | Intravenous |