Arsenic Trioxide and Dexamethasone in Treating Patients With Recurrent or Refractory Stage II or Stage III Multiple Myeloma
- Conditions
- Multiple Myeloma and Plasma Cell Neoplasm
- Registration Number
- NCT00017069
- Lead Sponsor
- CTI BioPharma
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- Not specified
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (10)
Mountain States Tumor Institute - Boise
🇺🇸Meridian, Idaho, United States
Texas Cancer Care
🇺🇸Fort Worth, Texas, United States
Rocky Mountain Cancer Centers - Midtown
🇺🇸Denver, Colorado, United States
Arizona Clinical Research Center
🇺🇸Tucson, Arizona, United States
St. Joseph Hospital Regional Cancer Center - Orange
🇺🇸Orange, California, United States
Stockton Hematology Oncology Medical Group
🇺🇸Stockton, California, United States
Highlands Oncology Group - Springdale
🇺🇸Springdale, Arkansas, United States
Pasco Pinellas Cancer Center - Tarpon Springs
🇺🇸Tarpon Springs, Florida, United States
Winship Cancer Institute of Emory University
🇺🇸Atlanta, Georgia, United States
Memorial Sloan-Kettering Cancer Center
🇺🇸New York, New York, United States