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 (CC-4047-MM-015 (ARTIMiDs))

Study type

• Study type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness

  Drug utilisation

Study drug and medical condition

• Anatomical Therapeutic Chemical (ATC) code:
  (L04AX06) pomalidomide

  pomalidomide
• Medical condition to be studied:
  Plasma cell myeloma

Population studied

• 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:
  750

Study design details

• Main study objective:
  To characterize the safety profile of pomalidomide in a non interventional post-authorisation setting in previously treated MM patients to enhance real world safety knowledge beyond the clinical trial safety observed
• Outcomes:
  To characterize and determine the incidence of important identified and potential risks as outlined in the risk management plan (RMP) among previously treated MM patients who are currently being treated with pomalidomide in a post-marketing setting. -To describe and assess the effectiveness, implementation and compliance of the Celgene PPP for patients recruited in this registry.-To describe the type of myeloma treatment administered immediately prior to receiving pomalidomide.
• Data analysis plan:
  Data from all patients who receive at least one dose of treatment will be analyzed.For demographic and baseline characteristics data, descriptive statistics (mean, standarddeviation, median, minimum, and maximum) will be provided for continuous variables,categorical variables will be summarized using frequency tabulations.Kaplan-Meier and/or competing risk procedures will be used to characterize time to onset for adverse events of special interest, when appropriate. For SPM analyses, product limit estimators will be calculated with and without consideration of competing risks.Univariate and (when feasible) multivariate Cox proportional hazards models will be employed to identify demographic and clinical factors predictive of key identified and potential risks.