Multiple Myeloma and Plasma Cell Neoplasm Clinical Trial
Official title:
A Phase II Trial With VELCADE® (PS-341), Cytoxan (Cyclophosphamide), Dexamethasone and Thalomid® (VEL-CTD) in Previously Untreated Multiple Myeloma Patients
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.
;
Masking: Open Label, Primary Purpose: Treatment
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