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
First published:
21/02/2024
Institution
Brigham & Women's Hospital Boston USA, Dana Farber Institute Boston USA, Massachusetts General Hospital Boston USA

Contact details

Global Development Leader Amgen Inc.

Primary lead investigator
Study timelines

Date when funding contract was signed

Planned:
Actual:

Study start date

Planned:
Actual:

Data analysis start date

Planned:
Actual:

Date of final study report

Planned:
Actual:
Sources of funding
Pharmaceutical company and other private sector 

More details on funding

Amgen
Study protocol
Initial protocol
English (414.07 KB - PDF)View document
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)