A prospective non-interventional post-authorization safety study (PASS) of lenalidomide in previously untreated adult multiple myeloma patients who are not eligible for transplant (“transplant noneligible” [TNE]) (“Revlimid® TNE NDMM PASS”) (CC-5013-MM-034)

Study type

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

  Drug utilisation

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• 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:
  888

Study design details

• Main study objective:
  To compare the incidence of cardiovascular events between TNE NDMM patients treated with a first-line lenalidomide-containing regimen and those treated with a first-line nonlenalidomide-containing regimen.
• Outcomes:
  To identify, quantify, and characterize risk factors for cardiovascular events in this population of TNE NDMM patients. Document renal function throughout therapy and to ascertain the incidence of renal dysfunctionDocument the incidence and severity of infections, including but not limited to pneumoniaDescribe the incidence of SPM (including hematologic and nonhematologic invasive malignancies and non-melanoma skin cancers) Characterize the safety profile of first-line regimens among TNE NDMM patients
• Data analysis plan:
  Continuous demographic and baseline variables will be summarized using descriptive statistics while categorical variables will be summarized using frequency tabulations. Dose and duration information for lenalidomide and other first-line MM therapies other medications included in the treatment regimen other supportive care medications, concomitant medications for thromboprophylaxis, and concomitant medications used for lenalidomide, cardiovascular/cerebrovascular disease/diabetes will be summarized. Pertinent risk factor information for cardiovascular events will be tabulated and presented separately for patients treated with a lenalidomide-containing regimen and patients treated with other first-line regimens. Patients treated with other first-line regimens will be subgrouped by main therapy for descriptive purposes Individual patient listings will be provided. All concomitant treatment usage documented during the study period will be summarized in frequency tabulations