The purpose of the study is to evaluate the clinical effectiveness and side effects of the vorinostat, bortezomib, lenalidomide, and dexamethasone investigational combination.
The purpose of the study is to evaluate the clinical effectiveness and side effects of the vorinostat, bortezomib, lenalidomide, and dexamethasone investigational combination. All of these drugs - vorinostat, bortezomib, lenalidomide and dexamethasone, are approved by the FDA (U.S. Food and Drug Administration). They have not been approved in this combination for use in your type of cancer or any other type of cancer. Vorinostat is approved for treatment of patients with a different type of cancer (Cutaneous T-Cell Lymphoma). Bortezomib is currently approved for the treatment of multiple myeloma. Lenalidomide is currently approved for the treatment of certain types of myelodysplastic syndrome (another form of cancer affecting the blood) and for use with dexamethasone for patients with multiple myeloma who have received at least one prior therapy. Dexamethasone is commonly used, either alone, or in combination with other drugs, to treat multiple myeloma.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
1.3mg/m² given IV or subcutaneously
25 mg given PO
20 mg given PO
Emory University Winship Cancer Institute
Atlanta, Georgia, United States
To determine the maximum tolerated dose (MTD) and recommended phase II doses (RP2D) of vorinostat in combination with lenalidomide, bortezomib, and dexamethasone.
Time frame: Every 3 weeks
Efficacy by standard myeloma measurements (SPEP, UPEP [urine protein electrophoresis], bone marrow)
Time frame: Every 3 weeks
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100, 200, or 300 mg given PO