MUK Seven
Research type
Research Study
Full title
Pomalidomide in relapsed and refractory multiple myeloma (RRMM)
IRAS ID
138598
Contact name
Martin Kaiser
Contact email
Sponsor organisation
University of Leeds
Eudract number
2013-002101-62
ISRCTN Number
ISRCTN24593488
Clinicaltrials.gov Identifier
Duration of Study in the UK
5 years, 0 months, 1 days
Research summary
Multiple myeloma is the second most common haematologic malignancy in the European Union, responsible for an estimated 21,000 deaths in the EU in 2008. For patients that relapse or are refractory to current standard treatment (combination of proteasome inhibitors/lenalidomide, dexamethasone and an alkylating agent) there are few options available and therefore the prognosis within this group is often poor with response to treatment decreasing with successive relapses until resistant disease develops. Pomalidomide in combination with dexamethasone is frequently used and has demonstrated to be effective. Current standard treatment at first relapse in the UK is the use of bortezomib in combination with dexamethasone and cyclophosphamide. Another common treatment is lenalidomide given with dexamethasone and cyclophosphamide. The addition of cyclophosphamide has demonstrated to improve treatment outcomes whilst being tolerated well. A recent clinical study has shown the addition of cyclophosphamide to the combination of pomalidomide and dexamethasone has shown to be safe and tolerable and beneficial in terms of treatment outcomes. The primary aim of this study is to investigate whether the addition of cyclophosphamide to pomalidomide and dexamethasone leads to an improved progression free survival. A secondary aim is to identify markers from clinical material that will predict response to pomalidomide in a group of relapsed and refractory multiple myeloma (RRMM) patients to provide important information for use in discussions with NICE on how best to improve the value and use of pomalidomide in the UK in the RRMM setting. The present proposed study will recruit 250 RRMM patients who will be allocated to receive the combination of cyclophosphamide, pomalidomide, dexamethasone (CPD) or the standard comparator pomalidomide and dexamethasone. Treatment will be continued, for both treatment groups until disease progression or unacceptable toxicity. Biological samples will be collected at baseline and at day 1 of 1st cycle, day 14 of the 1st and 4th cycle and at progression. Participants will be recruited from NHS Hospitals throughout the UK, which are approved research sites within the Myeloma UK Early Phase Clinical Network.
REC name
London - Surrey Borders Research Ethics Committee
REC reference
14/LO/2163
Date of REC Opinion
29 Dec 2014
REC opinion
Favourable Opinion