Trials / Completed
CompletedNCT01720875
Vorinostat, Bortezomib and Dexamethasone in Multiple Myeloma (MUKFour)
A Phase II Trial of Combination Treatment With Vorinostat, Bortezomib and Dexamethasone in Patients With Relapsed and Relapsed Refractory Multiple Myeloma
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 16 (actual)
- Sponsor
- University of Leeds · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Vorinostat Velcade Dexamethasone |
Timeline
- Start date
- 2013-08-09
- Primary completion
- 2015-08-01
- Completion
- 2018-08-29
- First posted
- 2012-11-02
- Last updated
- 2021-08-16
Locations
2 sites across 1 country: United Kingdom
Source: ClinicalTrials.gov record NCT01720875. Inclusion in this directory is not an endorsement.