A retrospective analysis of pre-existing and acquired major adverse cardiovascular events (MACE) in a real world cohort of multiple myeloma (MM) patients treated with proteasome inhibitors

Study type

• Study topic:
  Human medicinal product

  Disease /health condition
• Study type:
  Non-interventional study
• Scope of the study:
  Disease epidemiology
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Cohort

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

Study drug and medical condition

• Name of medicine:
  KYPROLIS

  VELCADE
• Medical condition to be studied:
  Plasma cell myeloma

Population studied

• Short description of the study population:
  Patients with multiple myeloma (MM) treated with proteasome inhibitors.; Patients eligible for this study will have received treatment for MM at one of the following institutions: Brigham & Women’s Hospital, Dana Farber Cancer Institute, or Massachusetts General Hospital, Boston. Patient cohorts will include:; a) 400 consecutive patients treated with bortezomib with MM who have received ≥ 1prior treatments, and; a) 250 consecutive patients with relapsed and/or refractory MM treated with carfilzomib, who have received ≥ 1prior treatments prior to initiating carfilzomib. ; Inclusion Criteria; 1. Patients with a diagnosis of MM who have received ≥ 1prior treatments prior to treatment with carfilzomib or bortezomib; 2. Treatment for at least 1 cycle with bortezomib (21 day cycle) or carfilzomib (28 day cycle); 3. Age ≥ 18 years; Exclusion Criteria; 1. Use of bortezomib or carfilzomib as first line treatment for MM (i.e. no prior treatment).
• 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:
  Multiple myeloma patients
• Estimated number of subjects:
  650

Study design details

• Main study objective:
  The aim of this observational study is to describe the differences in the incidence of CV outcomes for bortezomib- and carfilzomib- treated patients.
• Outcomes:
  • Incidence of MACE and extended MACE in bortezomib and carfilzomib- treated patients with MM• Pre-treatment cardiovascular risk profile and overall comorbidities in bortezomib and carfilzomib-treated patients with MM, Risk factors for MACE and extended MACE in MM patients: overall, bortezomib-treated, and carfilzomib- treated
• Data analysis plan:
  For the primary endpoint, the incidence of MACE and extended MACE will be calculated separately for bortezomib- and carfilzomib- treated patients. Incidence of MACE and extended MACE will be calculated by counting incident events in the carfilzomib-treated cohort or bortezomib-treated cohort. For the secondary objective, pre-treatment cardiovascular risk profile and overall comorbidities in bortezomib- and carfilzomib-treated patients will be compared using the Fisher Exact Test for categorical data and the Student t-test for continuous data. For the exploratory objective, risk factors for MACE and extended MACE in MM patients will be analyzed overall and for bortezomib-treated and carfilzomib- treated cohorts, separately. A generalized logistic regression model will be used to identify predictors of MACE and extended MACE.

Documents

Study results

20160154 ORS20May2020_Redacted