Status: Ongoing First registered on: 20/06/2017
Last updated on: 17/01/2020
1. Study identification
EU PAS Register NumberEUPAS19582
Official titleAn Observational Cohort Study on Multiple Myeloma Patients in Finland
Study title acronym-
Study typeObservational study
Brief description of the studyMultiple myeloma (MM) is a progressive clonal haematologic malignancy of plasma cells. In Finland, approximately 400 new MM cases are diagnosed each year, primarily amongst the elderly. The average survival time following diagnosis is 5-6 years, but prognosis varies greatly and the recent introduction of novel therapies has improved overall survival. However, in Finland, it is not completely known how MM patients are treated in real-life clinical settings. Also, the prevalence of various risk factors, and the effect of a patient’s risk status on treatment, e.g. on type, duration, and outcomes such as overall survival and time to next treatment, have not been sufficiently reported. To evaluate the effectiveness of new MM treatments in real-life clinical practice it may not be possible to find suitable comparators shortly after a new treatment has entered the market. To better understand treatment and outcomes of MM in Finland, Takeda Finland will conduct a descriptive retrospective study using nationwide data from the Finnish Hematology Register (FHR). The “whole study cohort” will include patients diagnosed for MM and aged 18 years or older at diagnosis during the period 1 Jan 2010 – 31 Dec 2015. The “actual study cohort” will include patients treated for MM during the period 1 Jan 2010 – 31 Dec 2014, who have at least one year of potential follow-up time following start of treatment (to 31 Dec 2015). Characteristics of all MM patients recorded in the FHR will be described on an overall level. This study aims to provide a representative description of MM patient characteristics and treatment and outcomes in Finland. The results can then be used as a historical reference for evaluating the changing MM treatment landscape. This study also aims to identify subgroups of patients who may not be able to receive or must discontinue/modify certain conventional therapies due to their unsuitable nature, and to evaluate the outcomes under current and past treatment options.
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 belongsEPID Research
Department/Research group
Organisation/affiliationEPID Research Oy
Website/Homepagewww.epidresearch.com
Details of (Primary) lead investigator
Title Dr
Last name Korhonen
First name Pasi
Is this study being carried out with the collaboration of a research network?
No
Other centres where this study is being conducted
Not applicable (single centre)

Countries in which this study is being conducted
National study

Finland
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed03/12/201603/12/2016
Start date of data collection03/09/201812/09/2017
Start date of data analysis02/10/201721/09/2018
Date of interim report, if expected
Date of final study report28/02/2019
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companiesTakeda100
Charities
Government body
Research councils
EU funding scheme
5. Contact details for enquiries
Scientific Enquiries
Title Dr
Last name Korhonen
First name Pasi
Address line 1EPID Research Oy
Address line 2Metsänneidonkuja 12 
Address line 3 
CityEspoo 
Postcode02130 
CountryFinland
Phone number (incl. country code)358-50-3652990 
Alternative phone number 
Fax number (incl. country code) 
Email address pasi.korhonen@epidresearch.com
Public Enquiries
Title Dr 
Last name Korhonen 
First name Pasi 
Address line 1EPID Research Oy 
Address line 2Metsänneidonkuja 12 
Address line 3 
CityEspoo 
Postcode02130 
CountryFinland 
Phone number (incl. country code)358-50-3652990 
Alternative phone number 
Fax number (incl. country code) 
Email address pasi.korhonen@epidresearch.com 
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