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 identification

• EU PAS number:
  EUPAS49827
• Study ID:
  49828
• Official title and acronym:
  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)
• DARWIN EU® study:
  No
• Study countries:
  Brazil

  Canada

  Czechia

  France

  Germany

  Italy

  Netherlands

  Poland

  Spain

  United Kingdom

  United States
• Study description:
  This single-arm, prospective observational study aims to assess the incidence of and risk factors for severe (Grades 3 to 4) and fatal (Grade 5) infusion-related reactions (IRRs) in participants treated with intravenous (IV) or subcutaneous (SC) daratumumab for the treatment of multiple myeloma (MM) in the clinical practice setting (in accordance with approved local labelling) and to characterize potential risk factors.
• Study status:
  Ongoing

Research institutions and networks

Institutions

Johnson & Johnson

Study timelines

Date when funding contract was signed

Planned:03/05/2022

Actual:10/05/2022

Study start date

Planned:28/11/2022

Actual:09/12/2022

Date of final study report

Planned:15/07/2026

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Janssen R&D, LLC

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  Non-EU RMP only