The patients included in this study were from the PROTECT study, a prospective, observational multi‐institutional study,
7 (link) conducted at the Vanderbilt University Medical Center and the University of Pennsylvania Abramson Cancer Center between September 2015 and March 2018 to evaluate the risk factors and outcomes in patients with MM treated with carfilzomib‐ or bortezomib‐based therapy. This study was approved by the Institutional Review Board of Vanderbilt University Medical Center and the University of Pennsylvania Abramson Cancer Center, and all human participants gave written informed consent.
7 (link) The details and the main findings of the PROTECT study have been published previously.
7 (link) Briefly, patients were included if they had relapsed MM, defined according to the International Myeloma Working Group criteria,
9 (link) and were initiating treatment with physician choice of carfilzomib‐ or bortezomib‐based therapy. Patients with symptomatic cardiac arrhythmia or New York Heart Association Class 3 or 4 heart failure (HF) within 3 months prior to enrollment or those with light chain amyloidosis were excluded.
7 (link) Enrolled patients underwent comprehensive baseline cardiovascular evaluations, including traditional cardiovascular risk factors (such as hypertension, hyperlipidemia, and diabetes), cardiac biomarkers (brain natriuretic peptide (BNP), or N‐terminal proBNP (NT‐proBNP), transthoracic echocardiography, and cardiologist evaluation). CVAE was diagnosed and adjudicated by a cardiologist with a specialty in Cardio‐Oncology. International Myeloma Working Group criteria were used to explain the advancement of MM.
9 (link) All CVAE were graded according to the Common Terminology Criteria for Adverse Events (version 4.03). The main findings of the PROTECT study were that the rate of CVAE was higher in relapsed MM patients treated with carfilzomib (51%) than bortezomib (17%), that most CVAE occurred within 3 months of the initiation of carfilzomib therapy, and that natriuretic peptides above normal (BNP > 100 pg/mL or NT‐proBNP >125 pg/mL) were highly predictive of CVAE.
7 (link)
7 (link) conducted at the Vanderbilt University Medical Center and the University of Pennsylvania Abramson Cancer Center between September 2015 and March 2018 to evaluate the risk factors and outcomes in patients with MM treated with carfilzomib‐ or bortezomib‐based therapy. This study was approved by the Institutional Review Board of Vanderbilt University Medical Center and the University of Pennsylvania Abramson Cancer Center, and all human participants gave written informed consent.
7 (link) The details and the main findings of the PROTECT study have been published previously.
7 (link) Briefly, patients were included if they had relapsed MM, defined according to the International Myeloma Working Group criteria,
9 (link) and were initiating treatment with physician choice of carfilzomib‐ or bortezomib‐based therapy. Patients with symptomatic cardiac arrhythmia or New York Heart Association Class 3 or 4 heart failure (HF) within 3 months prior to enrollment or those with light chain amyloidosis were excluded.
7 (link) Enrolled patients underwent comprehensive baseline cardiovascular evaluations, including traditional cardiovascular risk factors (such as hypertension, hyperlipidemia, and diabetes), cardiac biomarkers (brain natriuretic peptide (BNP), or N‐terminal proBNP (NT‐proBNP), transthoracic echocardiography, and cardiologist evaluation). CVAE was diagnosed and adjudicated by a cardiologist with a specialty in Cardio‐Oncology. International Myeloma Working Group criteria were used to explain the advancement of MM.
9 (link) All CVAE were graded according to the Common Terminology Criteria for Adverse Events (version 4.03). The main findings of the PROTECT study were that the rate of CVAE was higher in relapsed MM patients treated with carfilzomib (51%) than bortezomib (17%), that most CVAE occurred within 3 months of the initiation of carfilzomib therapy, and that natriuretic peptides above normal (BNP > 100 pg/mL or NT‐proBNP >125 pg/mL) were highly predictive of CVAE.
7 (link)
