NCT05064358 · REGISTRY CONDITION SEARCH

Study to Investigate Alternative Dosing Regimens of Belantamab Mafodotin in Participants With Relapsed or Refractory Multiple Myeloma

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase: PHASE2
Status at capture: COMPLETED
Registry last update: 2026-05-05

This study aims to evaluate alternative dosing regimens of single-agent belantamab mafodotin in participants with relapsed or refractory multiple myeloma (RRMM) to determine if an improved overall benefit/risk profile can be achieved by modifying the belantamab mafodotin dose, schedule, or both.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Percentage of Participants With Grade ≥2 Corneal Events Assessed by Keratopathy Visual Acuity (KVA) Scale

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outcome · POSTED

Number of Participants With Corneal Events up to Week 16

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outcome · POSTED

Incidence Rate of Corneal Events by Grade (KVA Scale)

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outcome · POSTED

Exposure Adjusted Incidence Rate of Corneal Events as Per CTCAE Grade

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outcome · POSTED

Median Duration of All the Dose Delays

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outcome · POSTED

Percentage of Participants Requiring Dose Reduction, Dose Interruption/Delay, Permanent Treatment Discontinuation Due to Corneal Events

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outcome · POSTED

Cumulative Incidence of Grade 2 or Above Corneal Events (KVA Scale)

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outcome · POSTED

Toxicity Index (TI)

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outcome · POSTED

Duration of Corneal Events of Grade 2 or Above

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outcome · POSTED

Percentage of Time on Study With Grade 2 or Above Corneal Events

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outcome · POSTED

Number of Participants With Change in Best Corrected Visual Acuity Test (BCVA) Scores

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outcome · POSTED

Objective Response Rate (ORR)

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outcome · POSTED

Percentage of Participants With a Confirmed VGPR or Better (i.e., VGPR, CR, and sCR)

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outcome · POSTED

Time to Response (TTR)

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outcome · POSTED

Duration of Response (DoR)

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outcome · POSTED

Time to Progression (TTP)

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outcome · POSTED

Progression Free Survival (PFS)

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outcome · POSTED

Overall Survival (OS)

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outcome · POSTED

Percentage of Participants With AEs

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outcome · POSTED

Percentage of Participants Requiring Dose Reduction, Dose Interruption/Delay, Permanent Treatment Discontinuation Due to Any AEs

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outcome · POSTED

Number of Participants With Worst-Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline

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outcome · POSTED

Number of Participants With Worst-Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline

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outcome · POSTED

Number of Participants With Post-baseline Positive Anti-drug Antibodies (ADAs) Against Belantamab Mafodotin

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outcome · POSTED

Titers of ADAs Against Belantamab Mafodotin

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outcome · POSTED

Maximum Observed Concentration (Cmax) for Belantamab Mafodotin Antibody-drug Conjugate (ADC)

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outcome · POSTED

Concentration at 21 Days for Belantamab Mafodotin ADC

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outcome · POSTED

Average Concentration Over 21 Days (Cavg) for Belantamab Mafodotin ADC

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outcome · POSTED

Area Under the Concentration-time Curve (AUC) (0-504h) of Belantamab Mafodotin ADC

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outcome · POSTED

Half-life (t1/2) of Belantamab Mafodotin ADC

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outcome · POSTED

Clearance (CL) for Belantamab Mafodotin ADC

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outcome · POSTED

Steady-state Volume of Distribution (Vss) for Belantamab Mafodotin ADC

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part

eligibility Criteria: Inclusion Criteria: * Participant must be 18 years of age inclusive at the time of signing the informed consent form (ICF). * Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2. * Histologically or cytologically confirmed diagnosis of MM and a. Has undergone stem cell transplant or is considered transplant ineligible, and b. Has failed at least 3 prior lines of anti-myeloma therapies, including an anti-cluster of differentiation (CD)38 antibody (e.g., daratumumab) alone or in combination and is refractory to an immunomodulatory agent (e.g., lenalidomide, pomalidomide) and a proteasome inhibitor (e.g., bortezomib, ixazomib, carfilzomib). * France specific: participants have failed at least 4 prior lines of anti-myeloma therapies * Participant has measurable disease per modified IMWG criteria. * Life expectancy of at least 6 months, in the opinion of the investigator. * Male and female participants agree to abide by protocol-defined contraceptive requirements. * Participant is capable of giving signed informed consent. * Participant meets country-specific inclusion criteria described in the protocol. Exclusion Criteria: * Symptomatic amyloidosis, active POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, myeloma protein, and skin changes), or active plasma cell leukemia at the time of screening. * Current corneal epithelial disease, except nonconfluent superficial punctate keratitis (SPK). * Evidence of active mucosal or internal bleeding. * Presence of an active renal condition. * Any serious and/or unstable pre-existing medical condition, psychiatric disorder, or other conditions that could interfere with the participant's safety, obtaining informed consent, or compliance with the study procedures. * Malignancies other than the disease under study, except for any other malignancy from which the participant has been disease free for \>2 years and, will not affect the evaluation of the effects of the study treatment on the currently targeted malignancy (MM). Participants with curatively treated non-melanoma skin cancer may be enrolled without a 2-year restriction. * Evidence of cardiovascular risk as per the protocol criteria. * Pregnant or lactating female. * Active infection requiring antibiotic, antiviral, or antifungal treatment. * Known human immunodeficiency virus (HIV) infection, unless the criteria in protocol can be met. * Hepatitis B and C will be excluded unless the criteria in protocol can be met. * Cirrhosis or current unstable liver or biliary disease. * Alanine aminotransferase (ALT) \>2.5× upper limit of normal (ULN). * Total Bilirubin \>1.5×ULN. * Systemic anti-MM therapy within \<=14 days or 5 half-lives, whichever is shorter. * Systemic therapy with high dose steroids within \<=14 days before the first dose of study treatment. * Prior allogenic stem cell transplant. * Prior treatment with a monoclonal antibody \<=30 days before the first dose of study treatment. Use of monoclonal antibodies for serious conditions unrelated to multiple myeloma, such as COVID, may be permitted. * Prior treatment with an anti-B cell maturation antigen (BCMA) targeted therapy or hypersensitivity reactions to any components of the study treatment. * Treatment with an antibody-drug conjugate. * Participant has received any major surgery \<=4 weeks before the first dose of study treatment. An exception may be allowed for bone stabilizing surgery. * Inadequate bone marrow reserve or organ functions as demonstrated by any of the following: a. Absolute neutrophil count \<1.0×10\^9/L, b. Hemoglobin \<8 gram/deciliter (g/dL), c. Platelet count \<50×10\^9/L, d. Spot urine (albumin/creatinine ratio) \>500 milligram/gram (mg/g), e. Estimated glomerular filtration rate (eGFR) \<30 milliliter per minute per 1.73 meter square (mL/min/1.73m\^2). * UK specific: a. Absolute neutrophil count \<1.5×10\^9/L, c. Platelet count \<75×10\^9/L
healthy Volunteers: false
minimum Age: 18 Years
sex: ALL
std Ages: ADULT
OLDER_ADULT

Treatment arms and interventions

arm Groups

intervention Names
Drug: Belantamab mafodotin
label
Cohort 1: Participants receiving belantamab mafodotin at dose level (DL) 1
type
EXPERIMENTAL
intervention Names
Drug: Belantamab mafodotin
label
Cohort 2: Participants receiving belantamab mafodotin at DL 2
type
EXPERIMENTAL
intervention Names
Drug: Belantamab mafodotin
label
Cohort 3: Participants receiving belantamab mafodotin at DL 3
type
EXPERIMENTAL
intervention Names
Drug: Belantamab mafodotin
label
Cohort 4: Participants receiving belantamab mafodotin at DL 4
type
EXPERIMENTAL
intervention Names
Drug: Belantamab mafodotin
label
Cohort 5: Participants receiving belantamab mafodotin at DL4 with alternative dose modification
type
EXPERIMENTAL

interventions

arm Group Labels
Cohort 1: Participants receiving belantamab mafodotin at dose level (DL) 1
Cohort 2: Participants receiving belantamab mafodotin at DL 2
Cohort 3: Participants receiving belantamab mafodotin at DL 3
Cohort 4: Participants receiving belantamab mafodotin at DL 4
Cohort 5: Participants receiving belantamab mafodotin at DL4 with alternative dose modification
description
Belantamab mafodotin will be administered.
name
Belantamab mafodotin
type
DRUG

Study design

allocation

RANDOMIZED

intervention Model

PARALLEL

intervention Model Description

Belantamab mafodotin will be administered using various dosing regimens.

masking Info

masking: NONE
masking Description: It is an open label study

primary Purpose

TREATMENT

Enrollment

count: 177
type: ACTUAL

Registered outcome plans (not posted results)

primary Outcomes

description
The KVA scale is based on the evaluation of corneal changes using slit lamp examination. This scale provides a standardized approach for evaluating the relationship between corneal health and visual acuity. KVA scale is defined as Grade 0: No keratopathy, normal visual acuity with no corneal abnormalities; Grade 1: Mild changes to the cornea with no significant loss in visual acuity; Grade 2: Moderate corneal changes with noticeable visual acuity reduction; Grade 3: Severe corneal changes with substantial visual acuity impairment; Grade 4: Very severe corneal changes leading to significant vision loss. Higher grade indicates greater severity of corneal events.
measure
Percentage of Participants With Grade ≥2 Corneal Events Assessed by Keratopathy Visual Acuity (KVA) Scale
time Frame
Up to 29.5 months

secondary Outcomes

description
The number of participants with corneal events were assessed using KVA scale. The KVA scale provides a standardized approach for evaluating the relationship between corneal health and visual acuity. KVA scale is defined as Grade 0: No keratopathy, normal visual acuity with no corneal abnormalities; Grade 1: Mild changes to the cornea with no significant loss in visual acuity; Grade 2: Moderate corneal changes with noticeable visual acuity reduction; Grade 3: Severe corneal changes with substantial visual acuity impairment; Grade 4: Very severe corneal changes leading to significant vision loss. Higher grade indicates greater severity of corneal events.
measure
Number of Participants With Corneal Events up to Week 16
time Frame
Up to week 16
description
Incidence rate of corneal events is defined as the percentage of participants with corneal events by grade according to the KVA scale. The KVA scale provides a standardized approach for evaluating the relationship between corneal health and visual acuity. KVA scale is defined as Grade 0: No keratopathy, normal visual acuity with no corneal abnormalities; Grade 1: Mild changes to the cornea with no significant loss in visual acuity; Grade 2: Moderate corneal changes with noticeable visual acuity reduction; Grade 3: Severe corneal changes with substantial visual acuity impairment; Grade 4: Very severe corneal changes leading to significant vision loss. Higher grade indicates greater severity of corneal events.
measure
Incidence Rate of Corneal Events by Grade (KVA Scale)
time Frame
Up to 152 weeks
description
Exposure adjusted incidence rate of corneal events is defined as the number of participants with corneal events divided by the total exposure time for all participants at risk in the treatment group. Incidence rate for corneal events was assessed using Common Terminology Criteria for Adverse Events (CTCAE). Grade 1: Mild; Grade 2: Moderate; Grade 3: Severe or medically significant but not immediately life-threatening; Grade 4: Life-threatening consequences; Grade 5: Death related to AE. Higher grades indicate greater severity. The number of participants with Grades 3,4, and 5 are presented.
measure
Exposure Adjusted Incidence Rate of Corneal Events as Per CTCAE Grade
time Frame
Up to 152 weeks
description
Median duration of dose delays is defined as the median duration in time of all the dose delays in the respective treatment group. Duration of delays is defined as period from the expected start date of dose to actual start date of current dose.
measure
Median Duration of All the Dose Delays
time Frame
Up to 152 weeks
description
The percentage of participants that required dose reduction, dose interruption/delay, permanent treatment discontinuation due to corneal events were evaluated using KVA Scale. KVA scale is defined as Grade 0: No keratopathy, normal visual acuity with no corneal abnormalities; Grade 1: Mild changes to the cornea with no significant loss in visual acuity; Grade 2: Moderate corneal changes with noticeable visual acuity reduction; Grade 3: Severe corneal changes with substantial visual acuity impairment; Grade 4: Very severe corneal changes leading to significant vision loss. Higher grade indicates greater severity of corneal events.
measure
Percentage of Participants Requiring Dose Reduction, Dose Interruption/Delay, Permanent Treatment Discontinuation Due to Corneal Events
time Frame
Up to 152 weeks
description
Cumulative incidence of Grade 2 or above corneal events is defined as the percentage of corneal events of Grade 2 or above, as assessed using the KVA scale, within a specific time interval. KVA scale is defined as Grade 0: No keratopathy, normal visual acuity with no corneal abnormalities; Grade 1: Mild changes to the cornea with no significant loss in visual acuity; Grade 2: Moderate corneal changes with noticeable visual acuity reduction; Grade 3: Severe corneal changes with substantial visual acuity impairment; Grade 4: Very severe corneal changes leading to significant vision loss. Higher grade indicates greater severity of corneal events.
measure
Cumulative Incidence of Grade 2 or Above Corneal Events (KVA Scale)
time Frame
At 3 months, 6 months, 9 months and 12 months
description
Toxicity Index is a composite score derived from the severity grades of adverse events (AEs) reported during the study, based on the Common Terminology Criteria for Adverse Events (CTCAE). A participant's score is calculated as a function of the ordered toxicity grades, represented in descending order by sequence, on a scale of 0-6, where 0 represents no toxicity and 6 represents the highest toxicity. CTCAE grades are defined as follows: Grade 1 (Mild), Grade 2 (Moderate), Grade 3 (Severe or medically significant but not immediately life-threatening), Grade 4 (Life-threatening consequences), and Grade 5 (Death related to AE). Higher grades indicate greater toxicity severity.
measure
Toxicity Index (TI)
time Frame
Up to 152 weeks
description
Duration of corneal events is defined for each participant as the sum of duration of all the corneal AEs. The duration is defined as time from onset of any corneal events (KVA scale) of Grade 2 or above to the first time resolution to baseline, Grade 1 or below. It required at least one day gap between the resolution of all events from first occurrence to the onset of next occurrence.
measure
Duration of Corneal Events of Grade 2 or Above
time Frame
Up to 152 weeks
description
It is defined as the percentage of time that a participant has corneal events out of the total time that a participant is on the study. Time with corneal events is defined as time from onset of any corneal events (KVA scale) of Grade 2 or above to the first-time resolution to baseline, Grade 1 or below.
measure
Percentage of Time on Study With Grade 2 or Above Corneal Events
time Frame
Up to 152 weeks
description
Change in BCVA is defined as change in logarithm of the minimum angle of resolution (logMAR) units compared with baseline or the first visit after the cataract surgery. BCVA score was calculated based on the Logarithm of the Minimum Angle of Resolution (logMAR score). Any change from baseline categories is presented for right and left eyes. No change/improved vision is defined as a change from baseline \<0.1; a possible worsened vision is defined as a change from baseline \>=0.1 to \<=0.3; a definite worsened vision is defined as a change from baseline \>0.3 logMAR score. Improvement in BCVA is represented by a reduction in logMAR score from baseline, while worsening in BCVA is represented by an increase in logMAR score from baseline.
measure
Number of Participants With Change in Best Corrected Visual Acuity Test (BCVA) Scores
time Frame
Baseline (Day 1) and up to 152 weeks
description
ORR was defined as the percentage of participants with a confirmed partial response (PR) or better (i.e., PR, very good partial response \[VGPR\], complete response \[CR\] and stringent complete response \[sCR\]), according to the International Myeloma Working Group (IMWG) Response Criteria. CR = negative immunofixation of serum and urine AND disappearance of any soft tissue plasmacytomas AND \<5% plasmacytomas in the bone marrow; sCR=stringent complete response, CR as above PLUS normal serum free light-chain (FLC) assay ratio and absence of clonal cells in bone marrow by immunohistochemistry or immunofluorescence; VGPR = serum and urine M-component detectable by immunofixation but not on electrophoresis OR ≥ 90% reduction in serum M-component plus urine M-component \<100 mg/24 h; PR = ≥50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by ≥90% or to \<200 mg/24 h.
measure
Objective Response Rate (ORR)
time Frame
Up to 152 weeks
description
Percentage of participants with a confirmed VGPR or better defined as percentage of participant with confirmed VGPR, CR, and sCR, according to the 2016 IMWG response criteria. CR = negative immunofixation of serum and urine AND disappearance of any soft tissue plasmacytomas AND \<5% plasmacytomas in the bone marrow; sCR=stringent complete response, CR as above PLUS normal serum free light-chain (FLC) assay ratio and absence of clonal cells in bone marrow by immunohistochemistry or immunofluorescence; VGPR = serum and urine M-component detectable by immunofixation but not on electrophoresis OR ≥ 90% reduction in serum M-component plus urine M-component \<100 mg/24 h.
measure
Percentage of Participants With a Confirmed VGPR or Better (i.e., VGPR, CR, and sCR)
time Frame
Up to 152 weeks

Full study description

brief Summary: This study aims to evaluate alternative dosing regimens of single-agent belantamab mafodotin in participants with relapsed or refractory multiple myeloma (RRMM) to determine if an improved overall benefit/risk profile can be achieved by modifying the belantamab mafodotin dose, schedule, or both.

Source references

Source notices and limitations

Discovery and provenance

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Preserved source evidence · Not medical advice