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

Contact details

Anna Sitthi-Amorn

Primary lead investigator
Study timelines

Date when funding contract was signed

Planned:
Actual:

Study start date

Planned:
Actual:

Date of final study report

Planned:
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