Vorinostat and Lenalidomide After Autologous Stem Cell Transplant in Treating Patients With Multiple Myeloma
RATIONALE: Vorinostat may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Lenalidomide may stop the growth of multiple myeloma by blocking blood flow to the cancer. Giving vorinostat together with lenalidomide may kill more cancer cells.
PURPOSE: This phase I trial is studying the side effects and best dose of vorinostat when given together with lenalidomide after autologous stem cell transplant in treating patients with multiple myeloma.
|Multiple Myeloma Plasma Cell Neoplasm||Drug: lenalidomide Drug: vorinostat||Phase 1|
|Study Design:||Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Treatment
|Official Title:||Vorinostat (SAHA) and Lenalidomide After Autologous Transplant for Patients With Multiple Myeloma|
- Safety [ Time Frame: up to 3 years ]
- Duration of response [ Time Frame: up to 3 years ]
- Time to progression [ Time Frame: up to 3 years ]
- Progression-free survival [ Time Frame: up to 3 years ]
- Time to response [ Time Frame: up to 3 years ]
- Duration of overall response [ Time Frame: up to 3 years ]
- Overall survival [ Time Frame: up to 3 years ]
- Response rate [ Time Frame: up to 3 years ]
|Actual Study Start Date:||September 26, 2008|
|Estimated Study Completion Date:||December 31, 2018|
|Estimated Primary Completion Date:||December 31, 2017 (Final data collection date for primary outcome measure)|
Experimental: Lenalidomide + Vorinostat
Maintenance post autologous transplant
combined with Vorinostat (SAHA) days 1-21 of a 28-day cycle until progression or clinically significant toxicity.
Other Names:Drug: vorinostat
Vorinostat (SAHA) will be administered orally beginning at dose level 1 starting day +90 ±6 days after HSCT for days 1 and 15-21 of a 28-day cycle combined with lenalidomide days 1-21 of a 28-day cycle until progression or clinically significant toxicity.
- To assess the dose-limiting toxicities and safety of vorinostat and lenalidomide after autologous peripheral blood stem cell transplantation in patients with multiple myeloma.
- To evaluate the overall response rate to the combination of Vorinostat (SAHA) and lenalidomide.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00729118
|United States, Ohio|
|Ohio State University|
|Columbus, Ohio, United States, 43210|
|Principal Investigator:||Craig C. Hofmeister, MD||Ohio State University Comprehensive Cancer Center|