Arsenic Trioxide With Ascorbic Acid and Melphalan for Myeloma Patients

Completed · Phase 1/Phase 2

Conditions studied: Multiple Myeloma, Stem Cell Transplantation

In brief

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 arsenic trioxide with ascorbic acid and high-dose Melphalan in patients with multiple myeloma 3. To determine the effects of arsenic trioxide on melphalan pharmacokinetics

Key facts

Study ID

NCT00661544

Run by

M.D. Anderson Cancer Center

People needed

48

Starts

2004-03-01

Expected to finish

2007-06-01

Last updated by the study team

2013-03-04

Who can join

Age: any, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• U.T.M.D. Anderson Cancer Center — Houston, Texas, United States

Full record on ClinicalTrials.gov

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