Non-Interventional Post-Authorisation Safety Study (PASS) survey to evaluate the effectiveness of the Isatuximab Educational Materials, to minimise the Risk of Interference for blood typing (minor antigen) (positive indirect Coombs’ test).

Study type

• Study type:
  Non-interventional study
• Scope of the study:
  Effectiveness study (incl. comparative)

Non-interventional study

• Non-interventional study design:
  Cross-sectional

Study drug and medical condition

• Study drug International non-proprietary name (INN) or common name:
  ISATUXIMAB
• Medical condition to be studied:
  Plasma cell myeloma

Population studied

• 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)
• Estimated number of subjects:
  384

Study design details

• Main study objective:
  The study aims to assess the effectiveness of the isatuximab Educational Materials in terms of process indicator, meaning implementation, knowledge and behaviour with respect to the safety messages conveyed in these materials.
• Outcomes:
  The primary outcome will be the % of participants who correctly respond to the key knowledge question in the assessment of education materials survey. The secondary outcomes are in addition to the primary outcome, % of prescriber HCPs who also correctly respond to at least 5 of 7 behaviour questions in the assessment of education materials survey, or % of non-prescriber HCPs who also correctly respond to at least 2 of 3 behaviour questions in the assessment of education materials survey.
• Data analysis plan:
  A description of the following outcomes of interest related to process indicators will be performed: ; • Measures of the extent of implementation of the original plan, and/or variations in its delivery, at each participating country level.; • Knowledge and Behaviour.