About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Urine M-protein excretion >=200 milligrams (mg)/24 hours (>=0.2 grams [g]/24 hours)
Disqualifiers
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%)
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.
Trial design
Parallel
Treatments tested in this trial
Belantamab mafodotin
DrugBelantamab mafodotin will be administered
Dexamethasone
DrugDexamethasone will be administered.
Bortezomib
DrugBortezomib will be administered
Treatment groups
Trial outcomes
Primary outcomes
Percentage of participants with grade greater than or equal to (>=)3 corneal events assessed by keratopathy visual acuity (KVA) scale
KVA scale ranges from 0 to 4 with higher score indicating greater severity of corneal events.
Percentage of participants with grade >=3 corneal events assessed by KVA scale up to Month 6
KVA scale ranges from 0 to 4 with higher score indicating greater severity of corneal events.
Percentage of Participants With Grade >=3 Corneal Events Assessed by KVA scale from 6 to 12 months
KVA scale ranges from 0 to 4 with higher score indicating greater severity of corneal events. Data will be presented for the total number of participants with corneal events in each study group during 6 to 12 months.
Secondary outcomes
Incidence of corneal events as assessed by KVA scale accounting for time on study treatment
KVA scale ranges from 0 to 4 with higher scores indicating greater severity of corneal events.
Percentage of participants with corneal events as assessed by KVA scale
KVA scale ranges from 0 to 4 with higher scores indicating greater severity of corneal events.
Number of recurrences of corneal events as assessed by KVA scale
Number of recurrences of corneal events is defined as the total count of individual corneal event occurrences per participant over the study period. KVA scale ranges from 0 to 4 with higher scores indicating greater severity of corneal events.
Percentage of participants with post-baseline Best corrected visual acuity of 20/50, 20/100, 20/200
Best corrected visual acuity test results are expressed as a fraction, such as 20/50. The top number is the testing distance of 20 feet, and the bottom number is the distance at which a person with average vision could read the same line. 20/50 indicates mild visual impairment, 20/100 indicates moderate visual impairment and 20/200 indicates severe visual impairment.
Locations
Sponsors and contacts
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