Study identification

EU PAS number

EUPAS30748

Study ID

38535

Official title and acronym

An Observational Study to Estimate Incidence Rates of Heart Failure Among US Racial and Ethnic Minority Patients With Multiple Myeloma Treated or Not Treated With Carfilzomib

DARWIN EU® study

No

Study countries

United States

Study description

On 14 June 2018, Amgen submitted to the FDA a labeling supplement which proposed an update to the Kyprolis US Prescribing Information indicating that the risk of developing cardiac failure is higher among Asian patients. This increased risk was identified following analysis of data from Amgen sponsored clinical trials and postmarketing reports. On 14 December 2018, the FDA issued a complete response letter, which highlighted the lack of evidence to support that there is an increased risk of cardiac failure in US Asian patients. In addition, based on the submission of this supplement, the Agency stated the concern of the potential differential risk of cardiac failure among racial and ethnic minorities. To address these issues, Amgen agreed to conduct a postmarketing requirement in the form of an observational study to estimate incidence rates of heart failure among US racial and ethnic minority patients with multiple myeloma treated or not treated with carfilzomib.

Study status

Finalised
Research institutions and networks

Institutions

Amgen
United States
First published:
21/02/2024
Institution

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
Regulatory

Was the study required by a regulatory body?

Yes

Is the study required by a Risk Management Plan (RMP)?

EU RMP category 3 (required)