CC-4047-MM-015- Pomalidomide for relapsed and refractory MM patients

• Research type

  Research Study

• Full title

  A non-interventional post authorisation registry of patients treated with pomalidomide for relapsed and refractory multiple myeloma who have received at least two prior treatment regimens, including both lenalidomide and bortezomib, and have demonstrated disease progression on the last therapy.

• IRAS ID

  156084

• Contact name

  Graham Jackson

• Contact email

  graham.jackson@newcastle.ac.uk

• Sponsor organisation

  Celgene Europe Limited

• Clinicaltrials.gov Identifier

  EU/1/13/850/001-004, Product reference

• Research summary

  Multiple myeloma is an incurable cancer of plasma cells (a type of immune cell that produces antibodies) in the bone marrow. Imnovid has been approved for the treatment of multiple myeloma in the United Kingdom.
  The purpose of this study is to collect additional safety data for the safety profile of pomalidomide in a non-interventional post-authorisation
  setting in previously treated multiple myeloma patients, to enhance real world safety knowledge, beyond the clinical trial safety data previously collected.
  It is not the purpose of this study to test a new experimental product.

• REC name

  North West - Greater Manchester East Research Ethics Committee

• REC reference

  14/NW/1314

• Date of REC Opinion

  17 Sep 2014

• REC opinion

  Unfavourable Opinion