Last updated: 04/04/2025 12:30:22
Belantamab Mafodotin real-world evidence -Europe
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: BLENREP Effectiveness and Safety in Multiple Myeloma (BEaMM) – Real-World Evidence on Patients Taking Belantamab Mafodotin in Europe
Trial description: This study aims to collect real-world data on the use, safety and effectiveness of belantamab mafodotin (BLENREP®) in relapsed or refractory multiple myeloma (RRMM) participants from Europe (EU). Index date is defined as the time of the first (non-missing) dose of belantamab mafodotin (Day 1).BLENREP is a registered trademark of GlaxoSmithKline group of companies
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Number of participants with demographic characteristics
Timeframe: At Index date (Day 1)
Number of participants with disease status
Timeframe: At Index date (Day 1)
Number of participants with clinical characteristics
Timeframe: At Index date (Day 1)
Number of participants with treatment history
Timeframe: At Index date (Day 1)
Secondary outcomes:
Number of participants with ocular adverse events of special interest (AESIs)
Timeframe: Up to 15 Months post index date
Number of participants with ocular AESIs duration
Timeframe: Up to 15 Months post index date
Number of participants with ocular AESIs by severity
Timeframe: Up to 15 Months post index date
Number of participants with ophthalmic monitoring visits
Timeframe: Up to 15 Months post index date
Timing of ophthalmic monitoring visits
Timeframe: Up to 15 Months post index date
Interventions:
Not applicable
Enrollment:
150
Primary completion date:
2024-15-02
Observational study model:
Cohort
Time perspective:
Prospective
Clinical publications:
Not applicable
Medical condition
Multiple Myeloma
Product
Not applicable
Collaborators
Not applicable
Study date(s)
September 2022 to February 2024
Type
Observational
Phase
4
Participation criteria
Sex
Female & Male
Age
18+ years
Accepts healthy volunteers
No
- Participants with written informed consent
- Male or female, greater than or equal to (>=)18 years of age at the start of belantamab mafodotin treatment
- Concurrent enrollment in an interventional clinical trial involving either an investigational medicinal product (including belantamab mafodotin) or medical device.
- Concurrent enrollment in a belantamab mafodotin early access program, Named Patient Program or temporary authorization for use program.
Inclusion and exclusion criteria
Inclusion criteria:
- Participants with written informed consent
- Male or female, greater than or equal to (>=)18 years of age at the start of belantamab mafodotin treatment
- Participants with confirmed diagnosis of RRMM
- Participants received (first dose up to three months before study enrollment; if deemed required based on enrollment rate) or due to receive belantamab mafodotin treatment per routine clinical care by an oncologist or hematologist consistent with the approved labelling.
Exclusion criteria:
- Concurrent enrollment in an interventional clinical trial involving either an investigational medicinal product (including belantamab mafodotin) or medical device.
- Concurrent enrollment in a belantamab mafodotin early access program, Named Patient Program or temporary authorization for use program.
Trial location(s)
Showing 1 - 6 of 31 Results
Study documents
Protocol
Available language(s): English
Statistical analysis plan
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Study complete
Actual primary completion date
2024-15-02
Actual study completion date
2024-15-02
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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