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

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

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