Clinical Trial: A Phase II Study of Belinostat in Combination With Bortezomib in Patients With Relapsed, Refractory Multiple Myeloma
Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional
Official Title: A Phase II Study of Belinostat in Combination With Bortezomib in Patients With Relapsed, Refractory Multiple Myeloma
Brief Summary: 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.
Detailed Summary:
Sponsor: Onxeo
Current Primary Outcome:
- 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.
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Duration of response, time to response (TTR), and time to progression (TTP).
- Effect on biomarkers of bone metabolism. Effect on disease-related bone pain.
Original Secondary Outcome: Same as current
Information By: Onxeo
Dates:
Date Received: February 2, 2007
Date Started: March 2007
Date Completion:
Last Updated: July 7, 2015
Last Verified: July 2015
