CTI 1060: A Phase II Clinical Trial of Arsenic Trioxide and Dexamethasone as Therapy for Relapsed or Refractory Multiple Myeloma
- 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
- 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
PROJECTED ACCRUAL: A total of 55 patients will be accrued for this study.
Masking: Open Label, Primary Purpose: Treatment
Scott C. Stromatt, MD
United States: Federal Government
|Memorial Sloan-Kettering Cancer Center||New York, New York 10021|
|Winship Cancer Institute of Emory University||Atlanta, Georgia 30322|
|Mountain States Tumor Institute - Boise||Boise, Idaho 83712|
|St. Joseph Hospital Regional Cancer Center - Orange||Orange, California 92868-3849|
|Arizona Clinical Research Center||Tucson, Arizona 85712|
|Texas Cancer Care||Fort Worth, Texas 76104|
|Highlands Oncology Group - Springdale||Springdale, Arkansas 72764|
|Stockton Hematology Oncology Medical Group||Stockton, California 95204|
|Rocky Mountain Cancer Centers - Midtown||Denver, Colorado 80218|
|Pasco Pinellas Cancer Center - Tarpon Springs||Tarpon Springs, Florida 34689|