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

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

Multiple centres: 40 centres are involved in the study

Study timelines

Date when funding contract was signed

Planned: 29/03/2016

Actual: 29/03/2016

Study start date

Planned: 01/01/2018

Actual: 26/12/2017

Data analysis start date

Planned: 21/02/2023

Actual: 21/02/2023

Date of interim report, if expected

Planned: 30/03/2022

Date of final study report

Planned: 30/06/2023

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 2016-03-29 English (002)

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  Non-EU RMP only