drugset / Trial / NCT00469209
Velcade, Trisenox, Vitamin C and Melphalan for Myeloma Patients
RandomizedParallel-groupOpen-labelTreatment
Summary
Primary Objectives: 1. To evaluate the toxicity and safety of a combination of bortezomib with arsenic trioxide, ascorbic acid and high-dose melphalan in patients with multiple myeloma 2. To evaluate the efficacy of a combination of bortezomib with arsenic trioxide, ascorbic acid and high-dose melphalan in patients with multiple myeloma 3. To determine the effects of bortezomib on melphalan pharmacokinetics
Timeline
- Start
- 2006-06
- Primary completion
- 2008-12
- Completion
- 2008-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Bortezomib | Small molecule | 1 mg/m2 | Intravenous |
| Comparator | Bortezomib | Small molecule | 1.5 mg/m2 | Intravenous |
| Comparator | Melphalan | Small molecule | 100 mg/m2 | Intravenous |
| Comparator | Vitamin C | Other / unclassified | 1000 mg | Intravenous |
| Comparator | arsenic trioxide | Small molecule | 0.25 mg/kg | Intravenous |