Last updated: 02/06/2026 07:30:12
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:
Not applicable
Primary completion date:
2023-01-05
Observational study model:
Cohort
Time perspective:
Prospective
Clinical publications:
Cavo M, Schjesvold F, Dimopoulos M, Delforge M, Escalante F, Kleinman D, et al. . Real-World Effectiveness and Safety of Belantamab Mafodotin Monotherapy in Patients With Relapsed/Refractory Multiple Myeloma Treated in Europe. Haematologica. 2026; https://doi.org/10.3324/haematol.2025.289034
PMID: 41568469
DOI: 10.3324/haematol.2025.289034
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)
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
2023-01-05
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
Participate in clinical trial
Access to clinical trial data by researchers
Visit website