CTI 1060: A Phase II Clinical Trial of Arsenic Trioxide and Dexamethasone as Therapy for Relapsed or Refractory 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.
Interventional
Masking: Open Label, Primary Purpose: Treatment
Scott C. Stromatt, MD
Study Chair
Cell Therapeutics
United States: Federal Government
CDR0000068646
NCT00017069
February 2001
Name | Location |
---|---|
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 |