Last updated: 07/15/2025 06:10:08
Survey of participants with relapsed or refractory multiple myeloma receiving Blenrep
GSK study ID
223497
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: Special drug-use investigation of Blenrep (Survey on relapsed or refractory multiple myeloma)
Trial description: This study describes the safety of Blenrep in participants with relapsed or refractory multiple myeloma (RRMM) by performing survey in routine clinical practice.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Number of participants with gastrointestinal disorders, hemorrhage and infusion reaction
Timeframe: Up to 52 Weeks
Secondary outcomes:
Number of participants with eye disorders
Timeframe: Up to 52 Weeks
Time to onset of eye disorders
Timeframe: Up to 52 Weeks
Risk factors affecting eye disorders
Timeframe: Up to 52 Weeks
Interventions:
Not applicable
Enrollment:
160
Primary completion date:
2027-30-09
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Multiple Myeloma
Product
Not applicable
Collaborators
Not applicable
Study date(s)
October 2025 to September 2027
Type
Observational
Phase
Not applicable
Participation criteria
Sex
Female & Male
Age
Not applicable
Accepts healthy volunteers
No
- Participants who have received Blenrep for the first time for relapsed or refractory multiple myeloma.
- Participants who have failed or relapsed after at least one standard therapy for multiple myeloma
- Participants who have received Blenrep including investigational product before
Inclusion and exclusion criteria
Inclusion criteria:
- Participants who have failed or relapsed after at least one standard therapy for multiple myeloma
- Participants who initiated treatment with Blenrep in combination with bortezomib and dexamethasone (BVd) or Blenrep in combination with pomalidomide and dexamethasone (BPd).
Participants who have received Blenrep for the first time for relapsed or refractory multiple myeloma.
Exclusion criteria:
Participants who have received Blenrep including investigational product before
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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