Topological Analysis of the baseline characteristics of relapsed and/or refractory multiple myeloma (R/R MM) patients treated with carfilzomib in clinical trials to identify cohorts that represent levels of risk of select cardiovascular adverse events (CV AEs) in that patient population (20190506)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/43766
• EU PAS number:
  EUPAS35042
• Study ID:
  43766
• Official title and acronym:
  Topological Analysis of the baseline characteristics of relapsed and/or refractory multiple myeloma (R/R MM) patients treated with carfilzomib in clinical trials to identify cohorts that represent levels of risk of select cardiovascular adverse events (CV AEs) in that patient population (20190506)
• DARWIN EU® study:
  No
• Study countries:
  United States
• Study description:
  Develop and characterize risk profiles for select cardiovascular adverse events in patients with relapsed and/or refractory (R/R) multiple myeloma (MM) treated with carfilzomib across four clinical trials through an analysis of baseline characteristics
• Study status:
  Finalised

Research institutions and networks

Institutions

Amgen

United States

Study timelines

Date when funding contract was signed

Planned: 23/04/2020

Actual: 23/04/2020

Study start date

Planned: 24/01/2020

Actual: 24/01/2020

Data analysis start date

Planned: 06/07/2020

Actual: 29/09/2020

Date of final study report

Planned: 31/01/2021

Actual: 29/09/2021

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Amgen

Study protocol

Initial protocol

EUPAS35042-43764

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable