drugset / Trial / NCT01394354
Vorinostat in Combination With Bortezomib, Doxorubicin and Dexamethasone (VBDD) in Patients With Refractory or Relapsed Multiple Myeloma (MM)
Phase 1/2
Completed
34 enrolled
University Hospital Freiburg
Janssen-Cilag Ltd. · collabMerck Sharp & Dohme LLC · collab
NaSingle-groupOpen-labelTreatment
Summary
Primary objective of the study is the determination of the maximum tolerated dose (MTD) of Vorinostat (V), given in combination with fixed doses of Doxorubicin (D), Bortezomib (B) and Dexamethasone (D). Secondary objectives are: Assessment of safety and tolerability of VBDD; efficacy data of VBDD.
Timeline
- Start
- 2011-08
- Primary completion
- 2015-12
- Completion
- 2015-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Vorinostat | Small molecule | 100 mg | Oral |
| Subject | Vorinostat | Small molecule | 200 mg | Oral |
| Subject | Vorinostat | Small molecule | 300 mg | Oral |
| Background | Bortezomib | Small molecule | 1.3 mg/m2 | Intravenous |
| Background | Dexamethasone | Small molecule | 20 mg | Oral |
| Background | Doxorubicin | Other / unclassified | 18 mg/m2 | Intravenous |