Last updated: 11/12/2025 13:50:45
Indirect Treatment Comparison of BVd versus SoC
GSK study ID
307239
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: Indirect Treatment Comparison (ITC) of Belantamab Mafodotin plus Bortezomib and Dexamethasone (BVd) versus Standard of Care (SoC)
Trial description: The key question the current study aims to address is: What is the relative efficacy (in terms of Progression-free survival [PFS] and Overall survival [OS] of BVd versus relevant comparators (in particular, pomalidomide + bortezomib + dexamethasone [PVd]) in adult participants with Relapsed/refractory multiple myeloma (RRMM) who have received at least two prior lines of therapy, including a proteasome inhibitor (PI) and an immunomodulatory agent (IMiD). The objective of the current study is to compare the relative efficacy of BVd versus other relevant comparators in adult participants with RRMM who have received at least two prior lines of therapy, including a PI and an IMiD. Unanchored indirect treatment comparisons will be employed that collectively combine data across clinical trials of BVd and other relevant treatments for RRMM.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Progression-free survival (PFS)
Timeframe: Baseline and up to 55 months (end of follow-up)
Secondary outcomes:
Overall survival (OS)
Timeframe: Baseline and up to 55 months (end of follow-up)
Interventions:
Not applicable
Enrollment:
0
Primary completion date:
2026-24-08
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)
November 2025 to August 2026
Type
Observational
Phase
Not applicable
Participation criteria
Sex
Female & Male
Age
18+ years
Accepts healthy volunteers
No
- Clinical trials of adult participants with Relapsed/refractory multiple myeloma (RRMM) who have received at least two prior lines of therapy, including a PI and an IMiD agent, and were then treated with BVd or a relevant comparator.
- Clinical trials of populations other than adult participants with RRMM who have received at least two prior lines of therapy, including a PI and an IMiD agent, and trials that did not study BVd or a relevant comparator.
Inclusion and exclusion criteria
Inclusion criteria:
- Clinical trials of adult participants with Relapsed/refractory multiple myeloma (RRMM) who have received at least two prior lines of therapy, including a PI and an IMiD agent, and were then treated with BVd or a relevant comparator.
Exclusion criteria:
- Clinical trials of populations other than adult participants with RRMM who have received at least two prior lines of therapy, including a PI and an IMiD agent, and trials that did not study BVd or a relevant comparator.
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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