drugset / Trial / NCT01332617
Phase II Study of Simvastatin for Relapsed/Refractory Myeloma
NaSingle-groupOpen-labelTreatment
Summary
The purpose of this study test the hypothesis that the combination of simvastatin and zoledronic acid (for reversal of drug resistance), with bortezomib, high-dose methylprednisolone and bendamustine on a day 1,8 schedule (to reduce toxicity) will be an effective and well-tolerated treatment for relapsed and refractory multiple myeloma
Timeline
- Start
- 2011-04
- Primary completion
- 2018-02
- Completion
- 2019-02
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Bendamustine | Small molecule | 100 mg/m2 | Intravenous |
| Subject | Bortezomib | Small molecule | 1.3 mg/m2 | Intravenous |
| Subject | Methylprednisolone | Other / unclassified | 1 g | Intravenous |
| Subject | Simvastatin | Small molecule | 80 mg | Oral |
| Subject | Zoledronic acid | Other / unclassified | 4 mg | Intravenous |