Risk Prediction, Prognosis and Management of Cardiac Events among Patients with Multiple Myeloma (20160220)

Study type

• Study type:
  Non-interventional study
• Scope of the study:
  Disease epidemiology

Non-interventional study

• Non-interventional study design:
  Other
• Non-interventional study design, other:
  Retrospective cohort study

Study drug and medical condition

• Name of medicine:
  KYPROLIS
• Medical condition to be studied:
  Plasma cell myeloma

Population studied

• Age groups:
  • Adult and elderly population (≥18 years)

    • Adults (18 to < 65 years)

      • Adults (18 to < 46 years)
      • Adults (46 to < 65 years)
    • Elderly (≥ 65 years)

      • Adults (65 to < 75 years)
      • Adults (75 to < 85 years)
      • Adults (85 years and over)
• Estimated number of subjects:
  540

Study design details

• Main study objective:
  The aim of this observational study is to describe cardiac events in carfilzomib-treated Multiple Myeloma (MM) patients using a real world data source in the Optum administrative database in the United States.
• Outcomes:
  Cardiac events in MM patients treated with carfilzomib, Subsequent treatment and prognosis of cardiac events
• Data analysis plan:
  Among the MM patients treated with carfilzomib, the occurrence of chart-confirmed cardiac events will be summarized overall by subtype and key comorbidity strata within the MM patient population. The frequency and percent of claims-identified events as well as those of chart-adjudicated events will be reported for each cardiac event. To describe predictors for preselected cardiac events in MM patients receiving carfilzomib, cross tabulations of confirmed cardiac events from medical chart review by treatment patterns, patient attributes, and potential cardiovascular risk factors will be presented. After assessment of univariate analyses, regression modeling will be used to evaluate the adjusted association between the potential risk factors and cardiac events.Indicators of cardiac prognosis and treatment will be described overall by line of therapy, treatment regimen, and refractory disease state. Indicators of prognosis will include claims based measures and chart-based measures