An Observational Study to Estimate Incidence Rates of Heart Failure Among US Racial and Ethnic Minority Patients With Multiple Myeloma Treated or Not Treated With Carfilzomib

Study type

• Study topic:
  Human medicinal product

  Disease /health condition
• Study type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

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

Population studied

• Short description of the study population:
  Patients who satisfied the following key criteria were eligible:; 1. Multiple myeloma diagnosis, as determined utilizing an algorithm based upon presence of a combination of ICD-9-CM and ICD-10-CM diagnosis codes, Current; Procedural Terminology codes for diagnosis tests or National Drug Codes and Healthcare Common Procedure Coding System codes for treatments ; 2. Age ≥ 18 years.; 3. Receipt of carfilzomib or other multiple myeloma treatments in at least 1 LOT ; 4. Continuously enrolled in medical and pharmacy insurance coverage for 12 months before the treatment index.; ; Exclusion Criteria; Patients with missing or unknown race/ethnicity variable or evidence of renal transplant or dialysis were excluded.
• 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)
• Special population of interest:
  Other
• Special population of interest, other:
  Multiple myeloma patients
• Estimated number of subjects:
  3689

Study design details

• Main study objective:
  1. Estimate the incidence rates of cardiac failure in US racial and ethnic populations of patients with multiple myeloma treated with carfilzomib2. Estimate the incidence rates of cardiac failure in US racial and ethnic populations of patients with multiple myeloma not treated with carfilzomib
• Outcomes:
  The primary outcome is the incidence rate of heart failure in the US white, black, Asian, and Hispanic multiple myeloma patients treated with carfilzomib-containing or carfilzomib-free drug regimens.
• Data analysis plan:
  The incidence rate of heart failure will be estimated for US racial and ethnic minority multiple myeloma patients treated with carfilzomib-containing or carfilzomib-free regimens. As exploratory analysis, risk for heart failure will be compared between myeloma patients treated with carfilzomib-containing vs. carfilzomib-free regimens among whites and blacks in the US.