Non-interventional PASS JNJ-54767414 (daratumumab)
Research type
Research Study
Full title
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)
IRAS ID
325520
Contact name
Kamaraj Karunanithi
Contact email
Sponsor organisation
Janssen-Cilag International NV
Duration of Study in the UK
3 years, 8 months, 31 days
Research summary
Daratumumab is used for the treatment of multiple myeloma (MM) and other malignancies. Daratumumab delivered by intravenous (IV) infusion is currently approved in over 90 countries worldwide as a treatment for MM. Daratumumab subcutaneous (SC) was developed to provide several potential benefits for both patients and healthcare providers, and is currently approved in the United States (US), the European Union (EU), and the UK.
Infusion-related reactions (IRRs) are a common AE during daratumumab treatment, especially for participants receiving daratumumab IV and so this study aims to assess the risk of severe and fatal IRRs in patients with multiple myeloma who are treated with their first 3 administrations of daratumumab (whether intravenous or subcutaneous) and to attempt to identify potential risk factors.
About 1000 participants will take part in this study. Participants will be those who receive daratumumab IV or SC for the first time for the treatment of myeloma as a standard of care. The decision to start treatment with daratumumab will be independent of this study.
Only data available within routine clinical practice will be collected. Data collection will commence when a participant signs an ICF and will continue until (but not include) the fourth administration of daratumumab or 30 days after the last dose if the participant does not receive all 4 administrations of daratumumab. The duration of data collection will be for approximately 4 to 10 weeks depending on the timing of a participants enrollment visit and end of study visit. Enrollment of all participants in this study is expected to take about 3.5 years.REC name
London - Brighton & Sussex Research Ethics Committee
REC reference
23/PR/0390
Date of REC Opinion
17 May 2023
REC opinion
Further Information Favourable Opinion