Isotretinoin Plus Dexamethasone in Treating Patients With Multiple Myeloma
- Conditions
- Multiple Myeloma and Plasma Cell Neoplasm
- Registration Number
- NCT00021359
- Lead Sponsor
- Fox Chase Cancer Center
- Brief Summary
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining chemotherapy with dexamethasone may be an effective treatment for multiple myeloma.
PURPOSE: Phase II trial to study the effectiveness of combining isotretinoin and dexamethasone in treating patients who have multiple myeloma.
- Detailed Description
OBJECTIVES: I. Determine the response rate and duration of response of patients with multiple myeloma treated with dexamethasone and isotretinoin. II. Determine the toxicity of this regimen in these patients. III. Correlate the changes in serum interleukin (IL)-6, IL-6R, and C-reactive and IL-6R expression on plasma cells in the bone marrow with response in patients treated with this regimen.
OUTLINE: Patients receive oral dexamethasone on days 1-4, 9-12, and 17-20 and oral isotretinoin daily. Treatment repeats every 5 weeks for at least 2 courses in the absence of disease progression, insufficient response, or unacceptable toxicity. Patients achieving adequate response continue treatment for 2 courses after achieving a plateau of monoclonal protein, for a minimum of 6 courses total.
PROJECTED ACCRUAL: A total of 18-36 patients will be accrued for this study within 3 years.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 17
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (18)
Hunterdon Regional Cancer Center
🇺🇸Flemington, New Jersey, United States
Fox Chase Cancer Center
🇺🇸Philadelphia, Pennsylvania, United States
Fox Chase Cancer Center at Virtua Memorial Hospital Burlington County
🇺🇸Mount Holly, New Jersey, United States
St. Francis Medical Center
🇺🇸Trenton, New Jersey, United States
South Jersey Regional Cancer Center
🇺🇸Millville, New Jersey, United States
Pinnacle Health Hospitals
🇺🇸Harrisburg, Pennsylvania, United States
Paoli Memorial Hospital
🇺🇸Paoli, Pennsylvania, United States
Riverview Medical Center - Booker Cancer Center
🇺🇸Red Bank, New Jersey, United States
Southern Chester County Medical Center
🇺🇸West Grove, Pennsylvania, United States
Reading Hospital and Medical Center
🇺🇸Reading, Pennsylvania, United States
Community Medical Center
🇺🇸Toms River, New Jersey, United States
Bon Secours-Holy Family Health System
🇺🇸Altoona, Pennsylvania, United States
Pottstown Memorial Regional Cancer Center
🇺🇸Pottstown, Pennsylvania, United States
North Penn Hospital
🇺🇸Lansdale, Pennsylvania, United States
Saint Mary Regional Center
🇺🇸Langhorne, Pennsylvania, United States
Conemaugh Memorial Hospital
🇺🇸Johnstown, Pennsylvania, United States
Kimball Medical Center
🇺🇸Lakewood, New Jersey, United States
Delaware County Memorial Hospital
🇺🇸Drexel Hill, Pennsylvania, United States