Real-world Evidence of the Use of Carfilzomib Among Multiple Myeloma Patients in Europe Who Have Received at Least One Prior Therapy (Use of Carfilzomib In Multiple Myeloma Patients)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/40100
• EU PAS number:
  EUPAS30534
• Study ID:
  40100
• Official title and acronym:
  Real-world Evidence of the Use of Carfilzomib Among Multiple Myeloma Patients in Europe Who Have Received at Least One Prior Therapy (Use of Carfilzomib In Multiple Myeloma Patients)
• DARWIN EU® study:
  No
• Study countries:
  Austria

  Belgium

  Bulgaria

  France

  Greece

  Israel

  Italy

  Netherlands

  Norway

  Romania
• Study description:
  With the recent addition of carfilzomib as a treatment option for multiple myeloma, no data is available yet on how the drug is being used outside of the clinical trial setting. This study will therefore provide essential data to demonstrate the real world utilization of carfilzomib in routine clinical practice, including dosage, administration schedule, regimen, duration of treatment and reason for discontinuation in Europe.
• Study status:
  Finalised

Research institutions and networks

Institutions

Amgen

United States

Multiple centres: 117 centres are involved in the study

Study timelines

Date when funding contract was signed

Planned: 25/08/2016

Actual: 25/08/2016

Study start date

Planned: 14/03/2017

Actual: 14/03/2017

Data analysis start date

Planned: 18/03/2020

Actual: 17/03/2020

Date of interim report, if expected

Planned: 01/03/2018

Date of final study report

Planned: 17/03/2021

Actual: 15/03/2021

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Amgen

Study protocol

Initial protocol

20150262_01.02.06 Public Redacted Protocol Ver 1.0 English

Regulatory

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

Other study registration identification numbers and links

20150262