Velcade, Trisenox, Vitamin C and Melphalan for Myeloma Patients
Myeloma
About this trial
This is an interventional treatment trial for Myeloma focused on measuring Multiple Myeloma, Melphalan, Trisenox, Arsenic Trioxide, Ascorbic Acid, Vitamin C, Velcade, Bortezomib
Eligibility Criteria
Inclusion Criteria:
- a) Primary Refractory Disease (defined as failure to achieve even a partial response to induction therapy) b) Consolidation of a partial remission (defined as a decrease but continued presence of monoclonal protein on serum and urine immunofixation electrophoresis, and/or the presence of plasmacytosis on bone marrow aspirate and biopsy) c) Relapsing after prior therapy (disease relapsing after achieving a partial or complete response to prior conventional or high-dose therapy).
- Age up to 75 years.
- Zubrod performance status of <2.
- Left ventricular ejection fraction >40%. No uncontrolled arrhythmias or symptomatic cardiac disease.
- Forced expiratory volume (FEV1), forced volume vital capacity (FVC) and Diffusing Capacity of the Lung for Carbon Monoxide (DLCO) >40%. No symptomatic pulmonary disease.
- Serum bilirubin <2 times upper limit of normal, alanine aminotransferase/SGPT <4 times upper limit of normal. No evidence of chronic active hepatitis or cirrhosis. No effusion or ascites >1L prior to drainage.
- HIV-negative.
- Negative Beta human chorionic gonadotrophin (hCG) test in a woman with child bearing potential, defined as not post-menopausal for 12 months or no previous surgical sterilization
- Patient or guardian able to sign informed consent
- Corrected QT interval less than 470 msec.
Exclusion Criteria:
- Corrected QT interval greater than 470 msec.
- Patients in complete remission (defined as the absence of monoclonal protein on serum and urine immunofixation electrophoresis, and the absence of plasmacytosis in bone marrow aspirate and biopsy).
- Patients with non-secretory myeloma.
Sites / Locations
- UT MD Anderson Cancer Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Active Comparator
Active Comparator
Active Comparator
No Bortezomib
Bortezomib 1.0 mg/m^2
Bortezomib 1.5 mg/m^2
Arm 1: Melphalan 100 mg/m^2 intravenous (IV) days -4,-3 + Arsenic Trioxide 0.25 mg/kg IV for 7 days + Vitamin C IV daily
Arm 2: Bortezomib (Level 1) 1.0 mg/m^2 IV push on Days -9, -6, and -3, Melphalan 100 mg/m^2 IV days -4,-3 + Arsenic Trioxide 0.25 mg/kg IV for 7 days + Vitamin C IV daily
Arm 3: Bortezomib (Level 2) 1.5 mg/m^2 IV push on Days -9, -6, and -3, Melphalan + Arsenic Trioxide 0.25 mg/kg IV for 7 days + Vitamin C IV daily