Study identification

PURI

https://redirect.ema.europa.eu/resource/46780

EU PAS number

EUPAS18108

Study ID

46780

Official title and acronym

Postmarketing Surveillance Study for Kyprolis® (carfilzomib) in Korea (20160117)

DARWIN EU® study

No

Study countries

Korea, Republic of

Study description

To assess safety and effectiveness of Kyprolis® in post-marketing real-life setting

Study status

Ongoing
Research institutions and networks

Institutions

Amgen
United States
First published:
21/02/2024
Institution
Multiple centres: 40 centres are involved in the study

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 interim report, if expected

Planned:

Date of final study report

Planned:
Sources of funding
Pharmaceutical company and other private sector 

More details on funding

Amgen
Study protocol
Initial protocol
English (717.33 KB - PDF)View document
Regulatory

Was the study required by a regulatory body?

Yes

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

Non-EU RMP only