TrialBridgeNCT07614360
Study of Alternative and Approved Dosing Regimens of Belantamab Mafodotin, Bortezomib, and Dexamethasone (BVd) in Participants With Relapsed/Refractory Multiple Myeloma
Not Yet Recruiting · Phase 2 · GlaxoSmithKline · registry updated 2026-06-24
Inclusion and exclusion lines below are quoted from ClinicalTrials.gov. No match score is shown, because a score needs a person's age, biomarkers, and treatment dates. Confirm the record with the study team.
The aim of this study is to assess safety, efficacy and pharmacokinetic (PK) parameters with alternative dosing schedules of belantamab mafodotin in combination with bortezomib and dexamethasone compared to the approved dosing regimen in participants with relapsed or refractory multiple myeloma (RRMM) who have received at least 2 prior lines of therapy. The study will further characterize the risk of ocular toxicity and impact on efficacy measures and PK evaluations using alternative and approved dosing regimens.
Inclusion
- Is at least 18 years of age or the legal age of consent in the jurisdiction in which the study is taking place at the time of signing the Informed consent form (ICF).
- Has histologically or cytologically confirmed diagnosis of Multiple myeloma (MM), as defined by the IMWG.
- Previously treated with at least 2 prior lines of MM therapy, including a proteasome inhibitor and an immunomodulatory agent.
- Has at least 1 aspect of measurable disease, as assessed by the central laboratory, defined as at least 1 of the following:
- Urine M-protein excretion \>=200 milligrams (mg)/24 hours (\>=0.2 grams \[g\]/24 hours)
- Serum M-protein concentration \>=0.5 grams per deciliter (g/dL) (\>=5.0 g/L)
Exclusion
- Intolerant to bortezomib
- Diagnosis of systemic amyloid light chain amyloidosis, Waldenstrom's disease, polyneuropathy, organomegaly, endocrinopathy, monoclonal plasma proliferative disorder, skin changes (POEMS) or Primary Plasma Cell Leukemia (defined as circulating plasma cells \>5%)
- Has previous or concurrent invasive malignancy other than Multiple myeloma (MM), except:
- The disease must be considered medically stable for at least 2 years; or
- The participant must not be receiving active therapy, other than hormonal therapy for this disease.
- Known immediate or delayed hypersensitivity reaction or idiosyncratic reaction to belantamab mafodotin or drugs chemically related to belantamab mafodotin, or any of the components of the study treatment.