Bortezomib and Vorinostat in Treating Patients With Multiple Myeloma Who Have Undergone Autologous Stem Cell Transplant
DS Stage I Plasma Cell Myeloma
DS Stage II Plasma Cell Myeloma
DS Stage III Plasma Cell Myeloma
|Study Design:||Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Bortezomib and Vorinostat as Maintenance Therapy After Autologous Stem Cell Transplant for Multiple Myeloma|
- Toxicity as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v3.0 [ Time Frame: The first three months of therapy ] [ Designated as safety issue: Yes ]The first three months of therapy will be used as the time period in which toxicity will be evaluated and stopping rules for unacceptable toxicity will be implemented. Patients who received only one autologous transplant and patients who received two autologous transplants will be analyzed separately for toxicity. The withdrawal rate will be examined after every 10th enrolled patient becomes evaluable in each group. Sufficient evidence will be taken to be a lower limit to the corresponding one-side 80% confidence interval that exceeds 15%
- Time to disease progression [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]Patients will be followed for initial response to therapy and for progression of disease. Response criteria will be scored according to International Myeloma Working Group uniform response criteria.
|Study Start Date:||February 2009|
|Primary Completion Date:||August 2012 (Final data collection date for primary outcome measure)|
Experimental: Treatment (enzyme inhibitor therapy)
Patients receive bortezomib IV on days 2 and 5 and vorinostat PO QD on days 1-14. Treatment repeats every 28 days for 12 courses in the absence of disease progression or unacceptable toxicity.
Other Names:Drug: Vorinostat
I. Evaluate the toxicity of the use of vorinostat and bortezomib as maintenance therapy after autologous transplant.
I. Evaluate the median time to disease progression.
II. Evaluate survival.
OUTLINE: Patients receive bortezomib intravenously (IV) on days 2 and 5 and vorinostat orally (PO) once daily (QD) on days 1-14. Treatment repeats every 28 days for 12 courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up periodically.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00839956
|United States, Washington|
|Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium|
|Seattle, Washington, United States, 98109|
|Principal Investigator:||Leona Holmberg||Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium|