An Observational Cohort Study on Multiple Myeloma Patients in Finland

Study identification

• EU PAS number:
  EUPAS19582
• Study ID:
  47393
• Official title and acronym:
  An Observational Cohort Study on Multiple Myeloma Patients in Finland
• DARWIN EU® study:
  No
• Study countries:
  Finland
• Study description:
  Multiple 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 at age 18 years or older during 1 Jan 2010 – 31 Dec 2015. The “actual study cohort” will include a subset of the above patients who are treated for MM during 1 Jan 2010 – 31 Dec 2016, and who have at least one year of potential follow-up time following start of treatment (to 31 Dec 2017). 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, 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 The results can then be used as a historical reference for evaluating the changing MM treatment landscape.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.
• Study status:
  Finalised

Research institutions and networks

Institutions

IQVIA

United Kingdom

Study timelines

Date when funding contract was signed

Planned:03/12/2016

Actual:03/12/2016

Study start date

Planned:03/09/2018

Actual:12/09/2017

Data analysis start date

Planned:02/10/2017

Actual:21/09/2018

Date of final study report

Planned:28/02/2019

Actual:29/05/2020

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Takeda

Regulatory

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