Last updated: 08/06/2025 11:30:48
Efficacy of Belantamab mafodotin in participants with relapsed refractory multiple myeloma and extramedullary disease
GSK study ID
218105
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: Pooled efficacy analysis of belantamab mafodotin in patients with relapsed refractory multiple myeloma and extramedullary disease
Trial description: This study will assess the efficacy of Belantamab mafodotin in participants with relapsed refractory multiple myeloma (RRMM) and extramedullary disease (EMD).
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Overall response rate
Timeframe: Up to 42 months
Clinical benefit rate
Timeframe: Up to 42 months
Duration of response
Timeframe: Up to 42 months
Progression-free survival
Timeframe: Up to 42 months
Overall survival
Timeframe: Up to 42 months
Secondary outcomes:
Not applicable
Interventions:
Not applicable
Enrollment:
0
Primary completion date:
2025-31-12
Observational study model:
Cohort
Time perspective:
Retrospective
Clinical publications:
Not applicable
Medical condition
Multiple Myeloma
Product
Not applicable
Collaborators
Not applicable
Study date(s)
October 2025 to December 2025
Type
Observational
Phase
4
Participation criteria
Sex
Female & Male
Age
18+ years
Accepts healthy volunteers
No
- DREAMM-2 and DREAMM-3 enrolled participants with EMD based on their prevalence in the RRMM setting; no eligibility criteria specific to EMD were implemented.
- In DREAMM-2 and DREAMM-3, participants were required to have a histologically or cytologically confirmed diagnosis of multiple myeloma as defined according to the International Myeloma Working Group response criteria and have undergone an autologous stem cell transplant or be considered transplant ineligible. Participants must have had measurable disease and an Eastern Cooperative Oncology Group performance status of 0-2.
- Not Available
Inclusion and exclusion criteria
Inclusion criteria:
- DREAMM-2 and DREAMM-3 enrolled participants with EMD based on their prevalence in the RRMM setting; no eligibility criteria specific to EMD were implemented.
- In DREAMM-2 and DREAMM-3, participants were required to have a histologically or cytologically confirmed diagnosis of multiple myeloma as defined according to the International Myeloma Working Group response criteria and have undergone an autologous stem cell transplant or be considered transplant ineligible. Participants must have had measurable disease and an Eastern Cooperative Oncology Group performance status of 0-2.
- In DREAMM-2, participants must have failed at least 3 prior lines of anti-myeloma treatments, including an anti-cluster of differentiation 38 (anti-CD38) antibody alone or in combination, and be refractory to an immunomodulatory drug and a proteasome inhibitor (PI).
- In DREAMM-3, participants must have received at least 2 prior lines of anti-myeloma treatments, including at least 2 consecutive cycles of both lenalidomide and a PI (given separately or in combination), and must have had documented disease progression on, or within 60 days of, completion of the last treatment.
Exclusion criteria:
- Not Available
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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