RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells. PURPOSE: Phase II trial to study the effectiveness of combining arsenic trioxide and dexamethasone in treating patients who have recurrent or refractory stage II or stage III multiple myeloma.
OBJECTIVES: * Determine the response rate of patients with recurrent or refractory stage II or III multiple myeloma treated with arsenic trioxide and dexamethasone. * Determine the rates of overall and relapse-free survival in patients treated with this regimen. * Determine the safety profile of this treatment regimen in these patients. OUTLINE: Patients receive arsenic trioxide IV daily for 5 days during the first week only and then 2 days a week thereafter. Patients also receive IV or oral dexamethasone on days 1-4 every 4 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity. Disease assessments are conducted every 4 weeks. Patients achieving complete response (CR) receive 2 additional courses of therapy after initial determination of CR. Final assessments are conducted 4 weeks after the last study treatment and then annually thereafter. PROJECTED ACCRUAL: A total of 55 patients will be accrued for this study.
Study Type
INTERVENTIONAL
Purpose
TREATMENT
Masking
NONE
Arizona Clinical Research Center
Tucson, Arizona, United States
Highlands Oncology Group - Springdale
Springdale, Arkansas, United States
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Orange, California, United States
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