Topological Analysis of the baseline characteristics of relapsed and/or refractory multiple myeloma (R/R MM) patients treated with carfilzomib in clinical trials to identify cohorts that represent levels of risk of select cardiovascular adverse events (CV AEs) in that patient population (20190506)

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:
  Other
• Non-interventional study design, other:
  Retrospective analysis of randomized controlled trial data using machine learning

Study drug and medical condition

• Study drug International non-proprietary name (INN) or common name:
  CARFILZOMIB
• Medical condition to be studied:
  Cardiac failure

  Hypertension

  Arrhythmia

  Pulmonary hypertension

Population studied

• Short description of the study population:
  The study population consists of both (Kyprolis treatment) arms of the ARROW study (Moreau 2018) and the Kyprolis treatment arms of the ASPIRE (Stewart 2015), ENDEAVOR (Dimopoulos 2016) and FOCUS studies (Hajek 2017).; Inclusion Criteria; The subjects in this study are the individuals who participated in the ARROW, ASPIRE, ENDEAVOR and FOCUS studies and were treated with carfilzomib.
• 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)
• Special population of interest:
  Other
• Special population of interest, other:
  Patients with Cardiac failure, Hypertension, Arrhythmia, Pulmonary hypertension
• Estimated number of subjects:
  1485

Study design details

• Main study objective:
  Develop and characterize risk profiles for select cardiovascular adverse events in patients with relapsed and/or refractory (R/R) multiple myeloma (MM) treated with carfilzomib across four clinical trials through an analysis of baseline characteristics.
• Outcomes:
  Rate of CVAEs in cohorts of patients identified as having high, intermediate or low risks for the select CVAEs
• Data analysis plan:
  The analysis uses three techniques in sequence:Topological data analysis to produce network representations of data,Network clustering known as cold-spot detection to identify coherent sets of non-AE subjects, andMulti-class single-decision-tree learning to discover groups of subjects and conditions on variables that explain them.The sequence may be repeated more than once.

Documents

Study results

20190506_Abstract Observational Research Study Report Published Report