drugset / Trial / NCT00773838

Study of Vorinostat (MK0683), an Histone Deacetylase (HDAC) Inhibitor in Combination With Bortezomib in Patients With Relapsed or Refractory Multiple Myeloma (MK-0683-095)

NCT00773838

Phase 2 Completed 143 enrolled Merck Sharp & Dohme LLC
Non-randomizedSingle-groupOpen-labelTreatment

Summary

The purpose of this study is to evaluate the clinical activity of vorinostat in combination with bortezomib in participants with relapsed or refractory multiple myeloma after at least 2 prior treatment regimens. The primary objective is to define the objective response rate (RR) associated with the administration of vorinostat in combination with bortezomib to patients with relapsed and refractory multiple myeloma after at least 2 prior treatment regimens. The primary hypothesis of the study is the administration of vorinostat in combination with bortezomib will result in a clinically meaningful rate of objective response.

Timeline

Start
2008-12-01
Primary completion
2011-05-16
Completion
2012-04-09

Drugs

EvaluationDrugModalityDoseRoute
Subject Bortezomib Small molecule 1.3 mg/m2 Intravenous
Subject Vorinostat Small molecule 400 mg Oral
Background Dexamethasone Small molecule 20 mg Oral