Vorinostat, Bortezomib and Dexamethasone in Multiple Myeloma (MUKFour)

Sponsor
University of Leeds
Study ID
NCT01720875
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

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.

Key Dates

Start date
Aug 9, 2013
Status verified
Aug 2021
Primary completion
Aug 31, 2015
Completion
Aug 29, 2018

Study Design

Enrollment
16 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Vorinostat Velcade Dexamethasone (VVD)
    Up to 8 cycles of VVD followed by vorinostat maintenance until disease progression. Cycles 1-8 (21-day cycle) * Velcade: 1.3mg/m2 (subcutaneous) on days 1, 4, 8 and 11 * Dexamethasone: 20 mg (PO) on days 1, 2, 4, 5, 8, 9, 11 and 12 * Vorinostat: 400mg (PO) on days 1-4, 8-11, 15-18 Maintenance (28-day cycle) * Vorinostat: 400mg PO on 1-4 and 15-18

Primary Outcome Measure

Overall response rate to vorinostat, bortezomib and dexamethasone. [ Time Frame: up to 24 weeks ]

Related Studies