An observational study of Cardiovascular complications of Carfilzomib treatment in clinical practice (Cardiovascular complications of carfilzomib)

Study type

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

  Drug utilisation

  Other
• If ‘other’, further details on the scope of the study:
  Cardiovascular indices

Non-interventional study

• Non-interventional study design:
  Other
• Non-interventional study design, other:
  Intensive monitoring schemes, prescription event monitoring

Study drug and medical condition

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

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:
  46

Study design details

• Main study objective:
  • to describe cardiovascular complications associated with the use of carfilzomib and investigate the role of the UPS inhibition, in patients treated with carfilzomib and dexametahsone, on atheromatosis and vascular inflammation and function
• Outcomes:
  Changes in hemodynamic markers (peripheral and aortic office blood pressure and 24 hour ambulatory BP monitoring parameters) and in peripheral vascular function (endothelial function, arterial stiffness, arterial wave reflections) before, during and after study drug administration, • Changes in subclinical atherosclerosis markers (carotid intima-media thickness and vascular wall and plaque echogenicity) • changes in markers of cardiac function (ejection fraction, systolic and diastolic strain and strain rate) • changes in circulating cardiac and vascular inflammatory biomarkers before and after study drug administration
• Data analysis plan:
  Data will be presented as mean ± standard deviation (SD). Continuous variables will be tested for normal distribution with the Kolmogorov-Smirnov test. Repeated measures ANOVA will be performed in order to assess significant variations of parameters of interest over time. Linear mixed models analysis will be performed in order to adjust for possible confounders over time. All tests will be two-tailed and statistical significance will be considered for P values less than 0.05. All statistical analyses will be performed using SPSS version 21 for windows (Chicago, ILL, USA).