Disease progression and resource utilization in treated relapse/refractory multiple myeloma in Spain (PREMIERE)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/21438
• EU PAS number:
  EUPAS10691
• Study ID:
  21438
• Official title and acronym:
  Disease progression and resource utilization in treated relapse/refractory multiple myeloma in Spain (PREMIERE)
• DARWIN EU® study:
  No
• Study countries:
  Spain
• Study description:
  This is a retrospective chart review study to explore progression-free survival (PFS), overall survival (OS), health resource utilisation (HRU) and their associated costs in a sample of patients treated for a first episode of RRMM in a real-world setting in Spain. While data on treatments and resources will be collected from patients’ clinical notes, costs will be extracted from a local cost databases. Such information will be used to populate a cost-effectiveness model for Spain using real world data.
• Study status:
  Finalised

Research institutions and networks

Institutions

OXON Epidemiology

Spain

United Kingdom

Multiple centres: 27 centres are involved in the study

Study timelines

Date when funding contract was signed

Actual: 30/10/2014

Study start date

Planned: 07/09/2015

Actual: 11/09/2015

Data analysis start date

Planned: 01/09/2015

Actual: 14/12/2015

Date of interim report, if expected

Actual: 30/12/2015

Date of final study report

Planned: 31/10/2016

Actual: 23/12/2016

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

BMS, Bristol Myers Squibb

Regulatory

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