Overview

Vorinostat, Bortezomib and Dexamethasone in Multiple Myeloma (MUKFour)

Status:
Completed
Trial end date:
2018-08-29
Target enrollment:
Participant gender:
Summary
Bortezomib is an established treatment in multiple myeloma; it is common practice in the UK to administer bortezomib with dexamethasone. This practice is based on data that supports improved response rates with this combination. Recent trial data indicates that the addition of vorinostat to bortezomib treatment overcomes treatment resistance to bortezomib. As such this current trial is designed to investigate the efficacy, safety and tolerability of combination treatment with vorinostat, bortezomib and dexamethasone in patients with relapsed and relapsed refractory myeloma. A comparison of this Phase II trial with the pivotal Phase III trial conducted by MSD (using the labelled bortezomib indication without dexamethasone) will address the impact of dexamethasone in regards to tolerability and additional efficacy in myeloma patients.
Phase:
Phase 2
Details
Lead Sponsor:
University of Leeds
Collaborators:
Merck Sharp & Dohme Corp.
Myeloma UK
Treatments:
BB 1101
Bortezomib
Dexamethasone
Dexamethasone 21-phosphate
Dexamethasone acetate
Vorinostat