Multiple Myeloma and Plasma Cell Neoplasm Clinical Trial
Official title:
CTI 1060: A Phase II Clinical Trial of Arsenic Trioxide and Dexamethasone as Therapy for Relapsed or Refractory Multiple Myeloma
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.
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