Study identification

PURI

https://redirect.ema.europa.eu/resource/106363

EU PAS number

EUPAS105033

Study ID

106363

Official title and acronym

DARWIN EU® Multiple myeloma: patient characterisation, treatments and survival in the period 2012-2022

DARWIN EU® study

Yes

Study countries

Estonia
Finland
France
Germany
Netherlands
Spain

Study description

The 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).

Study status

Ongoing
Research institution and networks

Institutions

IQVIA
United Kingdom
First published:
22/04/2024
Institution
Non-Pharmaceutical companyENCePP partner
University of Tartu
Estonia
First published:
01/02/2024
Institution
Educational Institution
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

Networks

Contact details

Talita Duarte-Salles

Primary lead investigator
Study timelines

Date when funding contract was signed

Planned:
Actual:

Data collection

Planned:
Actual:

Date of final study report

Planned:
Sources of funding
EMA
Study protocol
Initial protocol

D2.2.3_Darwin_EU_Study_Protocol_P2 C1-001_v3.0_Final

English (684.53 KB - PDF)View document
Updated protocol

DARWIN EU Final Study Protocol P2 C1-001 Multiple myeloma

English (1.46 MB - PDF)View document
Regulatory

Was the study required by a regulatory body?

Yes

Is the study required by a Risk Management Plan (RMP)?

Not applicable