A Phase II Study of Belinostat in Combination With Bortezomib in Patients With Relapsed, Refractory Multiple Myeloma
This open-label study will assess anti-tumor activity and safety of belinostat in combination with bortezomib (Velcade®) in multiple myeloma patients refractory to or relapsed from at least one prior bortezomib-containing regimen. Subjects will be administered both PXD101 and bortezomib on the same days: i.e. days 1, 4, 8, and 11 of a 3-week cycle, for up to 8 cycles.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Study of Belinostat in Combination With Bortezomib in Patients With Relapsed, Refractory Multiple Myeloma|
- Objective response rate of belinostat administered in combination with bortezomib in multiple myeloma subjects who are refractory to or have relapsed from at least one prior bortezomib-containing regimen.
- Safety of belinostat plus bortezomib.
- Duration of response, time to response (TTR), and time to progression (TTP).
- Effect on biomarkers of bone metabolism. Effect on disease-related bone pain.
|Study Start Date:||March 2007|
|Study Completion Date:||June 2007|
|Primary Completion Date:||June 2007 (Final data collection date for primary outcome measure)|
Please refer to this study by its ClinicalTrials.gov identifier: NCT00431340
|United States, California|
|West Hollywood, California, United States, 90069|
|United States, Maryland|
|Center for cancer and blood disorders|
|Bethesda, Maryland, United States, 20817|
|United States, Texas|
|Baylor University Medical Center|
|Dallas, Texas, United States, 75246|
|Principal Investigator:||James Berenson, MD||James R. Berenson, MD, Inc.|