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.
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.
Study Type
INTERVENTIONAL
Purpose
TREATMENT
Masking
NONE
Enrollment
43
Alta Bates Summit Comprehensive Cancer Center
Berkeley, California, United States
Samuel Oschin Comprehensive Cancer Institute at Cedars-Sinai Medical Center
Los Angeles, California, United States
Desert Regional Medical Center Comprehensive Cancer Center
Palm Springs, California, United States
Sutter Cancer Center
Sacramento, 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
Oregon Health and Science University Cancer Institute
Portland, Oregon, United States
Lone Star Oncology - Austin
Austin, Texas, United States
Seattle Cancer Care Alliance
Seattle, Washington, United States
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States
Response rate
Safety and tolerability
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.