A Phase II Trial of Cyclophosphamide, Bortezomib and Dexamethasone (CYBOR-D) in Patients With Newly Diagnosed Active Multiple Myeloma
* To evaluate the response rate (complete response [CR], near CR [nCR], and very good
partial response) in patients with newly diagnosed multiple myeloma treated with bortezomib
in combination with cyclophosphamide and dexamethasone .
- Determine the overall response rate (partial response, PR, or better) in these patients
after 4, 8, and 12 courses of this regimen.
- Determine the duration of progression-free and overall survival of patients treated
with this regimen.
- To evaluate the toxicity of this regimen in these patients.
- To evaluate the ability to successfully collect peripheral blood stem cells from these
patients after 4 months of this regimen.
- To evaluate the CR or nCR rate in these patients after 8 and 12 courses of this
OUTLINE: This is a multicenter study.
Patients receive oral cyclophosphamide on days 1, 8, 15, and 22; bortezomib IV on days 1, 4,
8 , and 11 OR days 1, 8, 15 and 22; and dexamethasone on days 1-4, 9-12, and 17-20 in
courses 1 and 2 and days 1, 18, 15, and 22 in all subsequent courses. Courses repeats every
28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Number of Participants Who Achieved a Confirmed Responses Defined as a Complete Response (CR), Near CR or Very Good Partial Response (VGPR) After the First 4 Months of Treatment
Response that was confirmed on 2 consecutive evaluations during the first 4 months of treatment. Complete Response(CR): Complete disappearance of M-protein from serum and urine on immunofixation, normalization of Free Light Chain (FLC) ratio and <5% plasma cells in bone marrow. near Complete Response (nCR): Patients who meet all criteria for CR except a positive immunofixation will be classified as nCR. Very Good Partial Response(VGPR): >=90% reduction in serum M-component; Urine M-Component <100mg per 24hours; <=5% plasma cells in bone marrow.
After 4 months of treatment
A. Keith Stewart, M.B., Ch.B.
United States: Federal Government
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