MUK Eight
Research type
Research Study
Full title
A randomised phase II trial of Cyclophosphamide and Dexamethasone in combination with Ixazomib, in relapsed or refractory multiple myeloma (RRMM) patients who have relapsed after treatment with thalidomide, lenolidomide and bortezomib.
IRAS ID
167060
Contact name
Debbie Sherratt
Contact email
Sponsor organisation
University of Leeds
Eudract number
2014-004511-36
Duration of Study in the UK
3 years, 0 months, 1 days
Research summary
Current treatment for relapsed refractory multiple myeloma is the use of cyclophosphamide and dexamethasone, often given with a third drug (e.g. thalidomide, lenalidomide or bortezimib). The combination of conventional and novel agents have provided benefits in both overall survival and progression free survival however many patients develop resistance and relapse. Thus there is a need for novel agents for these patients.
The development of ixazomib, a proteasome 20S inhibitor, provides the opportunity to increase anti-tumour activity against a wider range of tumour types. Early phase I trials and clinical experience with ixazomib suggest it has anti-tumour activity in heavily pre-treated multiple myeloma patients with durable responses/disease control. Additionally its emerging safety profile indicates ixazomib is generally well tolerated.
Cyclophosphamide and dexamethasone are both predominantly used in the treatment of multiple myeloma and for patients with RRMM who have relapsed after bortezomib and lenalidomide. Therefore evaluation of ixazomib in combination with cyclophosphamide and dexamethasone is the most valuable and practical option for patients.
Although no phase I trials have been completed with ixazomib in combination with cyclophosphamide and dexamethasone safety data from previous combinations with proteasome inhibitors phase I studies are available.
This trial is therefore designed to compare the activity of ixazomib with cyclophosphamide and dexamethasone (ICD) to that of the cyclophosphamide and dexamethasone in patients with refractory or relapsed multiple myeloma.REC name
North West - Liverpool Central Research Ethics Committee
REC reference
15/NW/0416
Date of REC Opinion
5 Jun 2015
REC opinion
Further Information Favourable Opinion