A Post-authorization Safety Study to Evaluate the Incidence of and Risk Factors for Severe and Fatal Infusion-related Reactions in Participants Treated with Daratumumab (Intravenous or Subcutaneous) (HALO)

Study type

• Study topic:
  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness

  Safety study (incl. comparative)

Non-interventional study

• Non-interventional study design:
  Other
• Non-interventional study design, other:
  Self-controlled case series

Study drug and medical condition

• Name of medicine:
  DARZALEX
• Study drug International non-proprietary name (INN) or common name:
  DARATUMUMAB
• Anatomical Therapeutic Chemical (ATC) code:
  (L01FC01) daratumumab

  daratumumab
• Medical condition to be studied:
  Plasma cell myeloma
• Additional medical condition(s):
  Severe and Fatal Infusion-related Reactions (IRRs)

Population studied

• Age groups:
  Adult and elderly population (≥18 years)

  Adults (18 to < 65 years)

  Adults (18 to < 46 years)

  Adults (46 to < 65 years)

  Elderly (≥ 65 years)

  Adults (65 to < 75 years)

  Adults (75 to < 85 years)

  Adults (85 years and over)
• Estimated number of subjects:
  1000

Study design details

• Main study objective:
  To assess the risk of severe (Grades 3 to 4) and fatal (Grade 5) IRRs in participants treated with IV or SC daratumumab for the treatment of MM in the clinical practice setting and to attempt to identify potential risk factors for IRRs during daratumumab use and potential mitigation strategies.
• Data analysis plan:
  Descriptive summaries will be provided. Risk factors for IRR with grade 3 or above will be evaluated through logistic models. If deemed necessary, additional machine learning approaches such as LASSO or Elastic Net logistic regression will be explored.