Bortezomib, Cyclophosphamide, Dexamethasone, and Thalidomide in Treating Patients With Newly Diagnosed, Previously Untreated Multiple Myeloma
- Conditions
- Multiple Myeloma and Plasma Cell Neoplasm
- Registration Number
- NCT00438841
- Lead Sponsor
- Fred Hutchinson Cancer Center
- Brief Summary
RATIONALE: Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as cyclophosphamide and dexamethasone, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Thalidomide may stop the growth of cancer cells by blocking blood flow to the cancer. Giving bortezomib together with cyclophosphamide, dexamethasone, and thalidomide may kill more cancer cells.
PURPOSE: This phase II trial is studying how well giving bortezomib together with cyclophosphamide, dexamethasone, and thalidomide works in treating patients with newly diagnosed, previously untreated multiple myeloma.
- Detailed Description
OBJECTIVES:
Primary
* Determine the response rate in patients with newly diagnosed, previously untreated multiple myeloma treated with bortezomib, cyclophosphamide, dexamethasone, and thalidomide.
Secondary
* Determine the safety and tolerability of this regimen in these patients.
OUTLINE: This is an open-label, multicenter study.
Patients receive bortezomib IV on days 1, 4, 8, and 11; cyclophosphamide IV on days 1 and 8 of courses 1-3; oral thalidomide once daily on days 1-21 beginning in course 4; and dexamethasone IV or orally once daily on days 1, 2, 4, 5, 8, 9, 11, and 12. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed every 3 months.
PROJECTED ACCRUAL: A total of 43 patients will be accrued for this study.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 43
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Response rate
- Secondary Outcome Measures
Name Time Method Safety and tolerability
Trial Locations
- Locations (10)
Oregon Health and Science University Cancer Institute
🇺🇸Portland, Oregon, United States
Desert Regional Medical Center Comprehensive Cancer Center
🇺🇸Palm Springs, California, United States
Samuel Oschin Comprehensive Cancer Institute at Cedars-Sinai Medical Center
🇺🇸Los Angeles, California, United States
Eugene M. and Christine E. Lynn Cancer Institute at Boca Raton Community Hospital - Main Campus
🇺🇸Boca Raton, Florida, United States
St. Vincent's Comprehensive Cancer Center - Manhattan
🇺🇸New York, New York, United States
Alta Bates Summit Comprehensive Cancer Center
🇺🇸Berkeley, California, United States
Sutter Cancer Center
🇺🇸Sacramento, California, United States
Fred Hutchinson Cancer Research Center
🇺🇸Seattle, Washington, United States
Lone Star Oncology - Austin
🇺🇸Austin, Texas, United States
Seattle Cancer Care Alliance
🇺🇸Seattle, Washington, United States