drugset / Trial / NCT00536575
Sorafenib and Bortezomib Treatment for Relapsed or Refractory Multiple Myeloma Patients
NaSingle-groupOpen-labelTreatment
Summary
This is a single-arm Phase I/II study of sorafenib and bortezomib with dose optimization in initial patients. The initial patients on the dose-finding portion of this study will be enrolled through a single institution. Following establishment of the Phase II dose the study will open enrollment throughout the Sarah Cannon Research Institute (SCRI) Oncology Research Consortium. The purpose of this study is to develop the combination of bortezomib (which is proven to be clinically active in patients with multiple myeloma) with sorafenib (a potent inhibitor of angiogenesis). This regimen will be developed in a schedule that is convenient for patients, and that is as minimally toxic to patients as possible.
Timeline
- Start
- 2007-11
- Primary completion
- 2010-02
- Completion
- 2010-08
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Bortezomib | Small molecule | 1.3 mg/m2 | Intravenous |
| Subject | Bortezomib | Small molecule | 1.6 mg/m2 | Intravenous |
| Subject | Sorafenib | Small molecule | 200 mg | Oral |
| Subject | Sorafenib | Small molecule | 400 mg | Oral |