At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Phase I/II Study of the Combination of Bortezomib With Arsenic Trioxide, Ascorbic Acid and High-Dose Melphalan for Patients With Multiple Myeloma
In Brief
A Phase 2 clinical trial evaluating Trisenox (Arsenic Trioxide), Velcade (Bortezomib), and 2 other interventions for Myeloma. Completed, enrolled 60 participants across 1 site.
Detailed 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
Study Details
Timeline
Interventions
0.25 mg/kg by vein over 2 hours, once a day for 7 days (Days -9 to -3).
Arm 1 (Level 1): 1.0 mg/m\^2 intravenous (IV) push on Days -9, -6, and -3. An IV push takes a short period of time (less than 1 minute). Arm 2 (Level 2): 1.5 mg/m\^2 intravenous (IV) push on Days -9, -6, and -3. An IV push takes a short period of time (less than 1 minute).
100 mg/m2 by vein days -4,-3, over 30 minutes
1000 mg once a day through the vein for 7 days.