Vorinostat (SAHA) and Lenalidomide After Autologous Transplant for Patients With Multiple Myeloma
- To assess the dose-limiting toxicities and safety of vorinostat and lenalidomide after
autologous peripheral blood stem cell transplantation in patients with multiple
- To evaluate the overall response rate to the combination of Vorinostat (SAHA) and
- To evaluate the effect of this treatment regimen on natural killer cell activity and
regulatory T cells in the post-transplant period.
- To determine preliminary clinical activity of this treatment regimen by assessing
overall survival and progression-free survival of these patients.
- To obtain pilot data regarding an association between this treatment regimen and
patient quality of life and circulating inflammatory cytokines.
OUTLINE: This is a dose-escalation study of vorinostat.
Patients receive oral vorinostat alone once daily on days 1-21 in course 1. For the second
and subsequent courses, patients receive oral vorinostat in combination with oral
lenalidomide once daily on days 1-21. Courses repeat every 28 days in the absence of disease
progression or unacceptable toxicity.
Patients undergo blood sample collection periodically for correlative laboratory studies.
Studies include functional immune assays (T-cell and natural killer cell activity and
regulatory T-cell recovery) by fluorescence activated cell sorting (FACS) or ELISPOT;
analysis of inflammatory markers (cytokines and catecholamines); and analysis of global H3
and H4 acetylation by immunohistochemistry.
Quality of life is assessed periodically using the Brief Pain Inventory (Short Form), The
Center for Epidemiologic Studies Depression Scale (CES-D-10), a 9-item Brief Fatigue
Inventory, and the FACT-G questionnaires.
After completion of study treatment, patients are followed for at least 30 days.
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Craig C. Hofmeister, MD
Ohio State University Comprehensive Cancer Center
United States: Institutional Review Board
|Ohio State University||Columbus, Ohio 43210|