An Observational Cohort Study on Multiple Myeloma Patients in Finland

Study type

• Study topic:
  Disease /health condition
• Study type:
  Non-interventional study
• Scope of the study:
  Drug utilisation
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Cohort

  Other
• Non-interventional study design, other:
  Retrospective observational study

Study drug and medical condition

• Medical condition to be studied:
  Plasma cell myeloma

Population studied

• Short description of the study population:
  The study will include:; 1) Patients diagnosed with MM during the period 01 January 2010 – 31 December 2015 and aged 18 years or older at diagnosis (i.e. the whole study cohort).; 2) Patients diagnosed with MM during the period 01 January 2010 – 31 December 2015 and treated for MM during the period 01 January 2010 – 31 December 2016 and aged 18 years or older at diagnosis. This actual study cohort will include only patients for whom at least one treatment initiation date can be identified and; who have a minimum of one year of potential follow-up time (to 31 December 2017).; ; Inclusion criteria; • MM diagnosis recorded in the FHR; • Age 18 years or older at the time of MM diagnosis; ; Exclusion criteria; • Multiple haematological diagnoses in the FHR for which the treatments cannot be differentiated
• Age groups:
  Adults (18 to < 46 years)

  Adults (46 to < 65 years)

  Adults (65 to < 75 years)

  Adults (75 to < 85 years)

  Adults (85 years and over)
• Special population of interest:
  Other
• Special population of interest, other:
  Multiple Myeloma patients
• Estimated number of subjects:
  1600

Study design details

• Main study objective:
  The main objectives of the study are to describe the demographics, disease characteristics, and treatment patterns of Finnish MM patients, to identify patient, disease, and treatment-related factors associated with study outcomes, and to identify subpopulations of Finnish MM patients.
• Outcomes:
  The primary outcomes are patient demographics, disease characteristics, and treatment patterns e.g. types of treatments and treatment lines. The secondary outcomes are patient, disease, and treatment-related factors associated with treatment selection, overall survival, treatment duration, and time to next treatment.
• Data analysis plan:
  Patient demographics and disease characteristics will be described for the whole study cohort by mean, standard deviation, median, 25th and 75th percentiles, minimum and maximum (continuous variables) and by proportion and frequency per category (categorical variables). Study outcomes will be described with the Kaplan-Meier estimator in the actual study cohort and in identified subpopulations, and stratified by demographics, disease characteristics, and types and lines of treatment. Factors associated with study outcomes will be identified using a multivariate Cox regression model, with additional demographic variables, disease characteristics and treatment patterns added as variables of interest. Factors associated with treatment selection will be identified using a multivariate logistic model. Sensitivity analyses will be performed to test robustness of the models based on representativeness of the actual study cohort, treatment line definitions, and missingness of certain variables.