Velcade, Trisenox, Vitamin C and Melphalan for Myeloma Patients

• Status: Completed
• Trial end date: 2008-12-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: M.D. Anderson Cancer Center
• Collaborator: Cephalon
• Treatments: Arsenic Trioxide; Ascorbic Acid; Bortezomib; Melphalan; Vitamins

Criteria

Inclusion Criteria:

1. 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).

2. Age up to 75 years.

3. Zubrod performance status of <2.

4. Left ventricular ejection fraction >40%. No uncontrolled arrhythmias or symptomatic cardiac disease.

5. Forced expiratory volume (FEV1), forced volume vital capacity (FVC) and Diffusing Capacity of the Lung for Carbon Monoxide (DLCO) >40%. No symptomatic pulmonary disease.

6. 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.

7. HIV-negative.

8. 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

9. Patient or guardian able to sign informed consent

10. Corrected QT interval less than 470 msec.

Exclusion Criteria:

1. Corrected QT interval greater than 470 msec.

2. 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).

3. Patients with non-secretory myeloma.