1. SUB-TYPE OF MDS: Del 5q
  2. SEVERITY OF MDS: Low or Intermediate
  3. NAME OF DRUG: Lenalidomide
  4. Aims and benefits: This trial will investigate how lenalidomide, Revlimid®, affects the disease progression of patients with transfusion dependent MDS. This is a registry, non-interventional study.

  1. Main aims: (Outcome measures)
    Ascertain how well the drug lenalidomide slows down the disease progression to AML (for those with transfusion dependent Low to Intermediate 1 risk MDS del 5 q.Overall Survival for patients with transfusion-dependent low to intermediate 1 risk MDS and isolated del (5q) and who have been treated with Lenalidomide

    Time Frame: Up to 3 years

  2. Secondary aims:
    Type, frequency, severity of adverse events and relationship of adverse events to Lenalidomide (any event such as unfavorable and unintended sign, symptom, or disease temporarily associated with the use of a medicinal product - whether or not considered related to the medicinal product)Provide insight into treatment regimens and therapy sequence in clinical practice as they relate to clinical outcomes (response, overall survival, progression-free survival) in patients
  3. Main basic inclusion criteria:
    • Transfusion-dependence or a history of tranfusion-dependence (defined as = 1 Red Blood Cell (RBC) units every 8 weeks during a minimum observation period of 16 weeks)
    • Have commenced first treatment with lenalidomide in Europe after 13th June 2013
    • Have been diagnosed with transfusion-dependent, IPSS Low or Int-1 MDS and isolated del5q on 15th June 2007 or after.
  4. Main basic exclusion criteria:
    • currently participating in an interventional therapeutic clinical trial for MDS - except for erythrocyte stimulating agents (ESAs) and granulocyte colony-stimulating growth factors (GCSF)
    • or receive any type of investigational agent in combination with lenalidomide for MDS
  5. Trial sites/locations and name of physician in charge of trial:
    Maidstone Hospital - Maidstone, Kent, United Kingdom, ME16 9QQ
    Aberdeen Royal Infirmary - Foresterhill Road - Aberdeen, United Kingdom, AB25 2ZN
    Monklands hospital Aidrie, United Kingdom, ML6 0JS
    Bath United Hospital - Coombe Park Bath, United Kingdom, BA1 3NG
    Queen Elizabeth Hospital Birmingham, United Kingdom, B15 2TH
    Royal Bournemouth Hospital Bournemouth, United Kingdom, BH7 7DW
    Basildon and Thurrock Hospitals Essex, United Kingdom, SS16 5NL
    Lincoln county Hospital Lincoln, United Kingdom, LN2 5QY
    Aintree Hospital - Longmoor Lane Liverpool, United Kingdom, L9 7AL
    Hammersmith Hospital London, United Kingdom, W12 0HS
    University Hospital South Manc Manchester, United Kingdom, M23 9LT
    Royal Oldham Hospital Oldham, United Kingdom, OL1 2JH
    Radcliffe Hospitals and University - Headley Way, Headington Oxford, United Kingdom, OX3 9DU
    Wexham Park Hospital Slough, United Kingdom, SL2 4HL
    Southampton General Hospital Southhampton, United Kingdom, S016 6YD
    Great Western Hospital Swindon, United Kingdom, SN3 6BB
  6. Other countries: Belgium, Denmark, France, Germany, Greece, Italy, Norway, Spain, Sweden
    Medical Affairs Disease Lead for Celgene, Bruno Costa, MSc; PhD
  7. More information: https://clinicaltrials.gov/ct2/show/NCT02279654

Please read information and always discuss trial information with your own physician.

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