Arsenic Trioxide and Dexamethasone in Treating Patients With Recurrent or Refractory Stage II or Stage III Multiple Myeloma
Recruitment status was: Active, not recruiting
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.
|Multiple Myeloma and Plasma Cell Neoplasm||Drug: arsenic trioxide Drug: dexamethasone||Phase 2|
|Study Design:||Masking: Open Label
Primary Purpose: Treatment
|Official Title:||CTI 1060: A Phase II Clinical Trial of Arsenic Trioxide and Dexamethasone as Therapy for Relapsed or Refractory Multiple Myeloma|
|Study Start Date:||February 2001|
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00017069
|United States, Arizona|
|Arizona Clinical Research Center|
|Tucson, Arizona, United States, 85712|
|United States, Arkansas|
|Highlands Oncology Group - Springdale|
|Springdale, Arkansas, United States, 72764|
|United States, California|
|St. Joseph Hospital Regional Cancer Center - Orange|
|Orange, California, United States, 92868-3849|
|Stockton Hematology Oncology Medical Group|
|Stockton, California, United States, 95204|
|United States, Colorado|
|Rocky Mountain Cancer Centers - Midtown|
|Denver, Colorado, United States, 80218|
|United States, Florida|
|Pasco Pinellas Cancer Center - Tarpon Springs|
|Tarpon Springs, Florida, United States, 34689|
|United States, Georgia|
|Winship Cancer Institute of Emory University|
|Atlanta, Georgia, United States, 30322|
|United States, Idaho|
|Mountain States Tumor Institute - Boise|
|Meridian, Idaho, United States, 83642|
|United States, New York|
|Memorial Sloan-Kettering Cancer Center|
|New York, New York, United States, 10021|
|United States, Texas|
|Texas Cancer Care|
|Fort Worth, Texas, United States, 76104|
|Study Chair:||Scott C. Stromatt, MD||CTI BioPharma|