Status: Finalised First registered on: 18/08/2015
Last updated on: 27/10/2017
1. Study identification
EU PAS Register NumberEUPAS10691
Official titleDisease progression and resource utilization in treated relapse/refractory multiple myeloma in Spain
Study title acronymPREMIERE
Study typeObservational study
Brief description of the studyThis 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.
Was this study requested by a regulator?No
Is the study required by a Risk Management Plan (RMP)? Not applicable
Regulatory procedure number (RMP Category 1 and 2 studies only)
Other study registration identification numbers and URLs as applicable
2. Research centres and Investigator details
Coordinating study entity
Centre to which the investigator belongsOXON
Department/Research group
Organisation/affiliationOxon Epidemiology Ltd.
Website/Homepagewww.oxonepi.com
Details of (Primary) lead investigator
Title Dr
Last name Qizilbash MBChB MRCP(UK) BSc MSc DPhil(Oxon.)
First name Nawab
Is this study being carried out with the collaboration of a research network?
No
Other centres where this study is being conducted
Multiple centres

In total how many centres are involved in this Study?27
Countries in which this study is being conducted
National study

Spain
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed30/10/2014
Start date of data collection07/09/201511/09/2015
Start date of data analysis01/09/201514/12/2015
Date of interim report, if expected30/12/2015
Date of final study report31/10/201623/12/2016
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companiesBMS, Bristol Myers Squibb100
Charities
Government body
Research councils
EU funding scheme
5. Contact details for enquiries
Scientific Enquiries
Title Dr
Last name Qizilbash MBChB MRCP(UK) BSc MSc DPhil(Oxon.)
First name Nawab
Address line 1The Euston Office
Address line 21 Euston Square 
Address line 340 Melton Street 
CityLondon 
PostcodeNW1 2FD 
CountryUnited Kingdom
Phone number (incl. country code)442035744617 
Alternative phone number34-629846059 
Fax number (incl. country code)442033977497 
Public Enquiries
Title Dr 
Last name Qizilbash MBChB MRCP(UK) BSc MSc DPhil(Oxon.) 
First name Nawab 
Address line 1The Euston Office 
Address line 21 Euston Square 
Address line 340 Melton Street 
CityLondon 
PostcodeNW1 2FD 
CountryUnited Kingdom 
Phone number (incl. country code)442035744617 
Alternative phone number34-629846059 
Fax number (incl. country code)442033977497 
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