Bortezomib and Vorinostat in Treating Patients With Multiple Myeloma Who Have Undergone Autologous Stem Cell Transplant
|ClinicalTrials.gov Identifier: NCT00839956|
Recruitment Status : Completed
First Posted : February 10, 2009
Results First Posted : March 29, 2017
Last Update Posted : May 9, 2017
|Condition or disease||Intervention/treatment||Phase|
|DS Stage I Plasma Cell Myeloma DS Stage II Plasma Cell Myeloma DS Stage III Plasma Cell Myeloma||Drug: Bortezomib Drug: Vorinostat||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||31 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Bortezomib and Vorinostat as Maintenance Therapy After Autologous Stem Cell Transplant for Multiple Myeloma|
|Study Start Date :||February 2009|
|Actual Primary Completion Date :||August 2012|
|Actual Study Completion Date :||March 31, 2017|
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.
- 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 ]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. Rules for stopping the study will be based on the rate of withdrawal due to significant toxicity (grade IV, non-hematological, non-metabolic, nonperipheral neuropathy).
- Time to Disease Progression in Patients Who Progressed [ Time Frame: Up to 5 years ]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.
- Survival for All Patients [ Time Frame: Up to 5 years ]
- Median Follow-up Survival for All Patients [ Time Frame: Up to 5 years ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|