MUKSeven

• Research type

  Research Study

• Full title

  Pomalidomide in relapsed and refractory multiple myeloma

• IRAS ID

  191851

• Contact name

  Louise Flanagan

• Contact email

  l.m.flanagan@leeds.ac.uk

• Sponsor organisation

  Leeds Teaching Hospitals NHS Trust

• Eudract number

  2015-004508-49

• ISRCTN Number

  ISRCTN24593488

• Clinicaltrials.gov Identifier

  NCT02406222

• Duration of Study in the UK

  5 years, 0 months, 1 days

• Research summary

  Multiple myeloma is the second most common haematologic cancer in the EU, causing about 21,000 deaths in the EU in 2008. For patients whose myeloma have returned after treatmentor for patients that have not responded to current standard treatment there are few options available and therefore the prognosis is often poor. Pomalidomide in combination with dexamethasone is frequently used and has been shown to be effective. Current standard treatment at first relapse 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 shown to improve results whilst being tolerated well.
  The primary aim of this study is to compare cyclophosphamide, pomalidomide and dexamethasone with pomalidomide and dexamethasone alone on the length of time after treatment that the myeloma does not get worse.
  A secondary aim is to look at response to pomalidomide to provide important information for use in discussions with NICE on how best to improve the use of pomalidomide in the UK. This will be done by collecting blood and bone marrow samples from participants to investigate how the body responds to treatment and identify any markers on the cells that will help to predict which patients will respond to pomalidomide treatment.
  The proposed study will recruit 250 patients who will be allocated to receive the combination of cyclophosphamide, pomalidomide, dexamethasone or the standard pomalidomide and dexamethasone. Treatment will be continued, for both treatment groups until disease progression or until treatment cannot be continued due to side effects. Biological samples will be collected at baseline and at day 1 of 1st cycle, day 14 of the 1st and 4th cycle and at disease progression.

• REC name

  East of England - Cambridge East Research Ethics Committee

• REC reference

  15/EE/0421

• Date of REC Opinion

  14 Dec 2015

• REC opinion

  Further Information Favourable Opinion