Database study of lenalidomide (Revlimid®) in Germany: Monitoring off-label use

Study type

• Study topic:
  Disease /health condition

  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Drug utilisation
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Cross-sectional

Study drug and medical condition

• Medicinal product name:
  REVLIMID
• Study drug International non-proprietary name (INN) or common name:
  LENALIDOMIDE
• Medical condition to be studied:
  Plasma cell myeloma

Population studied

• Short description of the study population:
  Adult patients with multiple myeloma with off-label use of lenalidomide in Germany.
• 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)
• Special population of interest:
  Other
• Special population of interest, other:
  Multiple myeloma patients
• Estimated number of subjects:
  500

Study design details

• Main study objective:
  The objectives are to determine frequency and proportion of off-label use of lenalidomide by indication in 2008 and to investigate probable off label indications for lenalidomide. The initial dose of lenalidomide, dose changes and the number of lenalidomide dispensations per patient for on-label and off-label users were characterised. Incidence rates of lenalidomide use in 2008 were calculated.
• Outcomes:
  frequency of off-label use
• Data analysis plan:
  Descriptive analyses were conducted for all users of lenalidomide with respect to demographic characteristics, i.e. sex, age and federal state of residence, death and frequency of dispensations. Incidence rates of lenalidomide use by sex, age and federal state of residence were determined. Prevalence and incidence rates of lenalidomid use were calculated with 95% confidence intervals. Demographics and comorbidities are determined for patient with off-label use.