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 identification

• PURI:
  https://redirect.ema.europa.eu/resource/35617
• EU PAS number:
  EUPAS16302
• Study ID:
  35617
• Official title and acronym:
  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
• DARWIN EU® study:
  No
• Study countries:
  United States
• Study description:
  The primary objectives are observational and descriptive. The purpose of the study is to estimate the incidence of CV outcomes for bortezomib- and carfilzomib- treated patients. For the exploratory objective, Kaplan Meier curves will compare time to CV event rate between the two groups- bortezomib- and carfilzomib- treated patients.
• Study status:
  Finalised

Research institutions and networks

Institutions

Amgen

United States

Brigham & Women's Hospital Boston USA, Dana Farber Institute Boston USA, Massachusetts General Hospital Boston USA

Study timelines

Date when funding contract was signed

Planned: 31/05/2016

Actual: 11/07/2016

Study start date

Planned: 30/11/2016

Actual: 30/11/2016

Data analysis start date

Planned: 30/06/2019

Actual: 05/06/2019

Date of final study report

Planned: 01/06/2020

Actual: 02/06/2020

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Amgen

Study protocol

Initial protocol

01.20.01 Protocol Ver 1.0 2016-08-26 English

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  EU RMP category 3 (required)