Status:
COMPLETED
Arsenic Trioxide With Ascorbic Acid and Melphalan for Myeloma Patients
Lead Sponsor:
M.D. Anderson Cancer Center
Collaborating Sponsors:
CTI BioPharma
Conditions:
Multiple Myeloma
Stem Cell Transplantation
Eligibility:
All Genders
Up to 70 years
Phase:
PHASE1
PHASE2
Brief Summary
1. To evaluate the toxicity and safety of a combination of arsenic trioxide with ascorbic acid and high-dose Melphalan in patients with multiple myeloma 2. To evaluate the efficacy of a combination of...
Detailed Description
Treatment: High-dose melphalan followed by a transplant of autologous stem cells is thought to be one of the most effective ways to treat multiple myeloma. However, the number one cause of treatment ...
Eligibility Criteria
Inclusion
- Patients with Multiple Myeloma in any of the following disease categories: a) Primary Refractory Disease 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) All patients relapsing after prior therapy .
- Age up to 70 years.
- Zubrod Performance Status (PS) of \<2.
- Left ventricular ejection fraction \>40%. No uncontrolled arrhythmias or symptomatic cardiac disease.
- Forced vital capacity (FVC); Forced expiratory volume in 1 second (FEV1), forced vital capacity (FVC) and Carbon Monoxide Diffusing Capacity (DL CO) \>40%. No symptomatic pulmonary disease.
- Serum bilirubin \<2 times upper limit of normal, 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.
- Patient is not pregnant.
- Patient or guardian able to sign informed consent.
- Corrected QT interval less than 500 msec.
Exclusion
- Corrected QT interval greater than 500 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 :
March 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2007
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT00661544
Start Date
March 1 2004
End Date
June 1 2007
Last Update
March 4 2013
Active Locations (1)
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1
U.T.M.D. Anderson Cancer Center
Houston, Texas, United States, 77030