Retrospective Analysis of Second Primary Malignancies (SPM) Data From ASPIRE and ENDEAVOR Studies (20220146)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/104100
• EU PAS number:
  EUPAS103648
• Study ID:
  104100
• Official title and acronym:
  Retrospective Analysis of Second Primary Malignancies (SPM) Data From ASPIRE and ENDEAVOR Studies (20220146)
• DARWIN EU® study:
  No
• Study countries:
  United States
• Study status:
  Ongoing

Research institutions and networks

Institutions

Amgen

United States

Study timelines

Date when funding contract was signed

Planned: 01/12/2022

Actual: 01/12/2022

Study start date

Planned: 01/03/2023

Actual: 01/03/2023

Data analysis start date

Planned: 20/03/2023

Actual: 20/03/2023

Date of final study report

Planned: 30/10/2023

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Amgen

Study protocol

Initial protocol

Protocol-Published Original carfilzomib 20220146

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable