Status: Ongoing First registered on: 04/07/2023
Last updated on: 28/08/2023
1. Study identification
EU PAS Register NumberEUPAS105033
Official titleDARWIN EU® CC - Multiple myeloma: patient characterisation, treatments and survival in the period 2012-2022
Study title acronym
Study typeObservational study
Brief description of the studyThe overall objective of this study is to characterise patients with multiple myeloma diagnosed in the period 2012-2022. The specific objectives of this study are: 1. To describe demographic and clinical characteristics of patients with multiple myeloma at the time of diagnosis. 2. To describe multiple myeloma treatments (including combinations and regimen types, e.g. induction, maintenance, etc.). 3. To describe multiple myeloma treatment sequences. 4. To estimate the overall survival of incident multiple myeloma cases during the study period (2012-2022).
Was this study requested by a regulator?Yes: EMA
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 nameDARWIN EU® CC
Centre locationRotterdam
Details of (Primary) lead investigator
Title Dr
Last name Duarte-Salles
First name Talita
Is this study being carried out with the collaboration of a research network?
Yes
Other centres where this study is being conducted
Multiple centres

In total how many centres are involved in this Study?7
Institut Municipal Assistencia Sanitaria Information System (IMASIS), Spain
Estonian Biobank, Estonia
Auria Clinical Informatics (ACI)-Varha, Finland
Clinical Data Warehouse of Bordeaux University Hospital (CDWBordeaux), France
Countries in which this study is being conducted
International study

Estonia
Finland
France
Germany
Netherlands
Spain
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed07/03/202307/03/2023
Start date of data collection01/01/201201/01/2012
Start date of data analysis
Date of interim report, if expected
Date of final study report01/11/2023
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companies
Charities
Government bodyEMA100
Research councils
EU funding scheme
5. Contact details for enquiries
Scientific Enquiries
Title Dr
Last name Duarte-Salles
First name Talita
Address line 1Dr Molewaterplein 40
Address line 2 
Address line 3 
CityRotterdam 
Postcode 
CountryNetherlands
Phone number (incl. country code)31107043050 
Alternative phone number 
Fax number (incl. country code) 
Email address study@darwin-eu.org
Public Enquiries
Title Mrs 
Last name Schuemie 
First name Ilse 
Address line 1Dr Molewaterplein 40 
Address line 2 
Address line 3 
CityRotterdam 
Postcode 
CountryNetherlands 
Phone number (incl. country code)31107043050 
Alternative phone number 
Fax number (incl. country code) 
Email address study@darwin-eu.org 
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