Last updated: 05/19/2025 18:10:18
A Real-World Study to assess the safety profile of Blenrep in Korean participants
GSK study ID
219505
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Will be recruiting
Will be recruiting
Trial overview
Official title: An open label, multi-centre, observational study to observe the safety of Blenrep administered in Korean subjects in real-world practice
Trial description: The aim of this open-label, multicenter observational study is to evaluate the safety profile of Blenrep among Korean participants when used according to its approved indications in routine clinical practice.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Present rate of Adverse events (AEs), Adverse drug reactions (ADRs), Serious AEs (SAEs) and unexpected ADRs occurring after administration of Blenrep
Timeframe: At least 24 weeks (- 4 weeks window period allowed)
Secondary outcomes:
Response Evaluation Outcomes Following Blenrep Administration
Timeframe: 24 weeks after first administration of Blenrep
Interventions:
Not applicable
Enrollment:
30
Primary completion date:
2029-30-06
Observational study model:
Other
Time perspective:
Prospective
Clinical publications:
Not applicable
Medical condition
Multiple Myeloma
Product
Not applicable
Collaborators
Not applicable
Study date(s)
April 2026 to December 2032
Type
Observational
Phase
4
Participation criteria
Sex
Female & Male
Age
Not applicable
Accepts healthy volunteers
No
- Inclusion criteria will be based on the indications and usage of the marketing authorisation. For treatment of multiple myeloma (MM)
- Combination of bortezomib and dexamethasone in patients with MM who have administered one or more prior treatments
- Not applicable as no treatment is contraindicated in the precautions for use on the marketing authorisation.
Inclusion and exclusion criteria
Inclusion criteria:
- Combination of bortezomib and dexamethasone in patients with MM who have administered one or more prior treatments
- Combination of pomalidomide and dexamethasone in patients with MM who have administered one or more prior treatments including lenalidomide
Inclusion criteria will be based on the indications and usage of the marketing authorisation. For treatment of multiple myeloma (MM)
Exclusion criteria:
- Not applicable as no treatment is contraindicated in the precautions for use on the marketing authorisation.
Trial location(s)
This study does not involve prospective enrollment of participants.
Study documents
No study documents available.
Results overview
No study documents available
Recruitment status
Will be recruiting
Actual primary completion date
Not applicable
Actual study completion date
Not applicable
Plain language summaries
Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.
Additional information about the trial
Not applicable
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