Revlimid (lenalidomide) NIS Post Authorization Safety Study (PASS)

• Research type

  Research Study

• Full title

  A prospective non-interventional post- authorization safety study (PASS), designed as a disease registry of patients with transfusion dependent IPSS low or intermediate-1-risk myelodysplastic syndromes (MDS)and isolated del(5q)

• IRAS ID

  167788

• Contact name

  Manoj Raghavan

• Contact email

  manoj.raghavan@uhb.nhs.uk

• Sponsor organisation

  Celgene International Sarl

• Duration of Study in the UK

  4 years, 6 months, 31 days

• Research summary

  It is currently unclear from previous clinical studies, whether the amount of progression to Acute Myeloid Leukaemia (AML) is related to natural history of the disease or the administration of lenalidomide and subsequent progression to Acute Myeloid Leukaemia (AML.
  This study will determine whether the progression of Acute Myeloid Leukaemia in patients with the Myelodysplastic Syndromes (MDS) isolated 5q minus genotype treated with lenalidomide, is similar to progression data previously reported. The study will also detect any difference in progression according to baseline risk factors.

• REC name

  South Central - Oxford C Research Ethics Committee

• REC reference

  15/SC/0303

• Date of REC Opinion

  11 Jun 2015

• REC opinion

  Further Information Favourable Opinion