A post-authorisation, non-interventional, retrospective, drug-utilisation study to describe the pattern of use of lenalidomide in patients with myelodysplastic syndromes (MDS) (CC-5013-MDS-012)

Study type

• Study type:
  Non-interventional study
• Scope of the study:
  Drug utilisation

Study drug and medical condition

• Name of medicine:
  REVLIMID
• Study drug International non-proprietary name (INN) or common name:
  LENALIDOMIDE
• Anatomical Therapeutic Chemical (ATC) code:
  (L04AX04) lenalidomide

  lenalidomide
• Medical condition to be studied:
  Myelodysplastic syndrome

Population studied

• Short description of the study population:
  Those MDS patients who have received at least one dose of lenalidomide and who started their treatment after lenalidomide has obtained EU Regulatory approval for the MDS indication and in countries that subsequently had a positive reimbursement decision with the exception of eligible patients from the company-sponsored Connect® Myeloid Disease Registry (US Cohort Registry) who will be included regardless of start date of treatment.
• Age groups:
  Adults (18 to < 46 years)

  Adults (46 to < 65 years)

  Adults (65 to < 75 years)

  Adults (75 to < 85 years)

  Adults (85 years and over)
• Estimated number of subjects:
  460

Study design details

• Main study objective:
  To describe the pattern of use of lenalidomide in clinical routine practice of MDS in EU countries in which Revlimid® (lenalidomide) is marketed for the treatment of patients with transfusion-dependent anaemia due to low- or intermediate-1-risk myelodysplastic syndromes associated with an isolated deletion 5q cytogenetic abnormality when other therapeutic options are insufficient or inadequate.
• Outcomes:
  To describe the pattern of use of lenalidomide in the clinical routine practice of MDS patients in the countries concerned. ; To further describe the safety of lenalidomide both within the EU approved indication on-label cohort and outside of the EU approved indication (i.e., in patients with any type of MDS other than transfusion-dependent International Prognostic Scoring System IPSS low- or intermediate-1 int-1-risk MDS with isolated del(5q)) off-label cohort.
• Data analysis plan:
  MDS patients who are outside of the labeled EU indication will be further characterized as to the following: · IPSS Status (Int-2 or High). ; · Presence of additional cytogenetic abnormalities (yes/no) and characterization of type of additional cytogenetic abnormalities based upon the Revised International Prognostic Scoring System (IPSS-R) classification. ; · Lack of documentation of transfusion-dependent status or documentation of transfusion burden insufficient to meet accepted criteria for transfusion-dependence.