Status:
COMPLETED
Velcade, Trisenox, Vitamin C and Melphalan for Myeloma Patients
Lead Sponsor:
M.D. Anderson Cancer Center
Collaborating Sponsors:
Cephalon
Conditions:
Myeloma
Eligibility:
All Genders
Up to 75 years
Phase:
PHASE1
PHASE2
Brief 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...
Detailed Description
Melphalan is designed to damage the DNA of cells, which may cause cancer cells to die. High-dose melphalan is considered the standard of care for multiple myeloma. Bortezomib is designed to block a pr...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2008
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00469209
Start Date
June 1 2006
End Date
December 1 2008
Last Update
September 24 2020
Active Locations (1)
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1
UT MD Anderson Cancer Center
Houston, Texas, United States, 77030