Safety and efficacy of the combination of bortezomib with the deacetylase inhibitor romidepsin in patients with relapsed or refractary multiple myeloma: Preliminary results of a phase I trial

Abstract

Abstract INTRODUCTION. There is substantial pre-clinical data demonstrating single agent and synergistic activity of the proteasome inhibitor (PI) bortezomib and deacetylase inhibitors (DACi) in multiple myeloma (MM). This is the first clinical trial combining these two classes of drugs. METHODS. This is an ongoing open label single-centre single-arm phase I/II dose escalation trial of bortezomib, dexamethasone and romidepsin (depsipeptide) in patients with relapsed or refractory MM. All patients received bortezomib (1.3 mg/m2; d1,4,8,11) with dexamethasone (20mg d1,2,4,5,8,9,11,12). The dose escalation of romidepsin commenced at a dose of 8 mg/m2 IV d1, 8, 15 e..