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

Study identification

• EU PAS number:
  EUPAS19053
• Study ID:
  33299
• Official title and acronym:
  An observational study of Cardiovascular complications of Carfilzomib treatment in clinical practice (Cardiovascular complications of carfilzomib)
• DARWIN EU® study:
  No
• Study countries:
  Greece
• Study description:
  This is an, observational, non interventional, study in patients with relapsed or refractory myeloma treated with carfilzomib (CFZ), according to the approved indications. Patients will be evaluated prospectively for different parameters of vascular function, blood pressure and cardiac function in conjunction with studies of proteasome inhibition and function. The aim of this study is to provide insights into the effects of carfilzomib on vascular function and the mechanisms of UPS inhibition on cardiovascular complications of proteasome inhibitors.Primary objective is 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. Secondary objective is to outline the clinical significance of carfilzomib toxicity in hemodynamic parameters and cardiovascular function and vascular structure. Primary end points are • 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 Secondary endpoints are • 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 Patients with relapsed or refractory myeloma treated with carfilzomib as per approved indications will be enrolled in the study
• Study status:
  Ongoing

Research institutions and networks

Institutions

National and Kapodistrian University of Athens

Department of Clinical Therapeutics

Study timelines

Date when funding contract was signed

Planned: 01/06/2017

Actual: 01/06/2017

Study start date

Planned: 03/07/2017

Actual: 03/07/2017

Data analysis start date

Planned: 03/07/2019

Date of final study report

Planned: 01/06/2020

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

AMGEN

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable