Study to Investigate Alternative Dosing Regimens of Belan... | NCT05064358 | Trialant
NCT05064358
Sponsor
GlaxoSmithKline
Status
Completed
Last Update Posted
May 5, 2026Actual
Enrollment
177Actual
Phase
Phase 2
Conditions
Multiple Myeloma
Interventions
Belantamab mafodotin
Countries
United States
Argentina
Australia
Brazil
Canada
France
Germany
Greece
Ireland
Italy
Mexico
Poland
South Korea
Spain
Switzerland
Taiwan
Thailand
United Kingdom
Protocol Section
Identification Module
NCT ID
NCT05064358
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
209628
Secondary IDs
ID
Type
Description
Link
2021-004151-16
EudraCT Number
2023-508213-16
Registry Identifier
CTIS
Brief Title
Study to Investigate Alternative Dosing Regimens of Belantamab Mafodotin in Participants With Relapsed or Refractory Multiple Myeloma
Official Title
A Phase 2, Randomized, Parallel, Open-label Study to Investigate the Safety, Efficacy, and Pharmacokinetics of Various Dosing Regimens of Single-agent Belantamab Mafodotin (GSK2857916) in Participants With Relapsed or Refractory Multiple Myeloma (DREAMM-14)
Acronym
DREAMM 14
Organization
GlaxoSmithKlineINDUSTRY
Status Module
Record Verification Date
Apr 2026
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Mar 3, 2022Actual
Primary Completion Date
Aug 19, 2024Actual
Completion Date
Feb 10, 2026Actual
First Submitted Date
Sep 22, 2021
First Submission Date that Met QC Criteria
Sep 22, 2021
First Posted Date
Oct 1, 2021Actual
Results Waived
Not provided
Results First Submitted Date
Aug 6, 2025
Results First Submitted that Met QC Criteria
Sep 18, 2025
Results First Posted Date
Oct 7, 2025Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Apr 14, 2026
Last Update Posted Date
May 5, 2026Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
GlaxoSmithKlineINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
Yes
Is FDA Regulated Drug
Yes
Is FDA Regulated Device
No
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
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.
Cohort 2: Participants receiving belantamab mafodotin at DL 2
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Percentage of Participants With Grade ≥2 Corneal Events Assessed by Keratopathy Visual Acuity (KVA) Scale
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.
Up to 29.5 months
Secondary Outcomes
Measure
Description
Time Frame
Number of Participants With Corneal Events up to Week 16
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.
Other Outcomes
Not provided
Eligibility Module
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
The results presented are based on the data cut-off date of 30 Jan 2025. Those participants still benefiting from study drug in the opinion of their treating physician continued to receive study drug in the Post Analysis Continuation of Treatment (PACT) phase. Additional safety results will be provided within one year of study completion.
Recruitment Details
Not provided
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Arm A: Belantamab Mafodotin 2.5 Milligram (mg)/Kilogram (kg) Every 3 Weeks (Q3W)
Participants with Relapsed or Refractory Multiple Myeloma (RRMM) received belantamab mafodotin as 2.5 milligram (mg)/kilogram (kg) dose on Day 1 of every 3 weeks (Q3W) as a 30-60 minute intravenous (IV) infusion until confirmed disease progression, unacceptable toxicity or death.
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
Intent-to-Treat Population included all randomized participants, whether or not randomized treatment was administered.
Baseline Characteristics Module
Baseline Analysis Population Description
Not provided
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
5
More Info Module
Limitations and Caveats
Not provided
Annotation Section
No data available
No data is available for this block.
Document Section
Large Document Module
Document Has No Statistical Analysis Plan (SAP)
Not provided
Uploaded Document Information
Type
Includes Protocol
Includes SAP
Includes ICF
Document Label
Document Date
Document Uploaded Date
Document File Name
Prot
Yes
No
No
Study Protocol
Jun 25, 2024
Aug 6, 2025
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
India
Submission Tracking
Estimated Results First Submitted Date
Not provided
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Belantamab mafodotin will be administered using various dosing regimens.
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
None (Open Label)
Masking Description
It is an open label study
Who Masked
Not provided
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
Up to week 16
Incidence Rate of Corneal Events by Grade (KVA Scale)
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.
Up to 152 weeks
Exposure Adjusted Incidence Rate of Corneal Events as Per CTCAE Grade
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.
Up to 152 weeks
Median Duration of All the Dose Delays
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.
Up to 152 weeks
Percentage of Participants Requiring Dose Reduction, Dose Interruption/Delay, Permanent Treatment Discontinuation Due to Corneal Events
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.
Up to 152 weeks
Cumulative Incidence of Grade 2 or Above Corneal Events (KVA Scale)
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.
At 3 months, 6 months, 9 months and 12 months
Toxicity Index (TI)
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.
Up to 152 weeks
Duration of Corneal Events of Grade 2 or Above
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.
Up to 152 weeks
Percentage of Time on Study With Grade 2 or Above Corneal Events
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.
Up to 152 weeks
Number of Participants With Change in Best Corrected Visual Acuity Test (BCVA) Scores
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.
Baseline (Day 1) and up to 152 weeks
Objective Response Rate (ORR)
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.
Up to 152 weeks
Percentage of Participants With a Confirmed VGPR or Better (i.e., VGPR, CR, and sCR)
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.
Up to 152 weeks
Time to Response (TTR)
TTR defined as the time between the date of randomization and the first documented evidence of response (PR or better), among participants who achieve a response (i.e., confirmed PR or better), according to the 2016 IMWG response criteria. PR = ≥50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by ≥90% or to <200 mg/24 h.
Up to 152 weeks
Duration of Response (DoR)
DoR defined as the time from first documented evidence of PR or better until disease progression (PD) among responders according to the 2016 IMWG response criteria or death due to any cause. PR = ≥50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by ≥90% or to <200 mg/24 h. PD= Increase of 25% from lowest confirmed response value in 1 or more of the following criteria: Serum M-protein with absolute increase of >= 0.5 g/dL; Serum M-protein increase >= 1 g/dL if the lowest M-component was >=5 g/dL; Urinary M-protein (absolute increase must be >= 200 mg per 24 h).
Up to 152 weeks
Time to Progression (TTP)
TTP defined as the time from randomization until the earliest date of documented PD or death due to PD, according to the 2016 IMWG response criteria. PD= Increase of 25% from lowest confirmed response value in 1 or more of the following criteria: Serum M-protein with absolute increase of >= 0.5 g/dL; Serum M-protein increase >= 1 g/dL if the lowest M-component was >=5 g/dL; Urinary M-protein (absolute increase must be >= 200 mg per 24 h).
Up to 152 weeks
Progression Free Survival (PFS)
PFS defined as the time from randomization until the earliest date of documented PD, according to the 2016 IMWG response criteria, or death due to any cause. PD= Increase of 25% from lowest confirmed response value in 1 or more of the following criteria: Serum M-protein with absolute increase of >= 0.5 g/dL; Serum M-protein increase >= 1 g/dL if the lowest M-component was >=5 g/dL; Urinary M-protein (absolute increase must be >= 200 mg per 24 h).
Up to 152 weeks
Overall Survival (OS)
OS defined as the time from randomization until the date of death due to any cause.
Up to 152 weeks
Percentage of Participants With AEs
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. AEs were coded using the standard Medical Dictionary for Regulatory Activities (MedDRA).
Up to 152 weeks
Percentage of Participants Requiring Dose Reduction, Dose Interruption/Delay, Permanent Treatment Discontinuation Due to Any AEs
Percentage of participants requiring dose reduction, dose interruption/delay, permanent treatment discontinuation due to any AEs were presented. An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. AEs were coded using the standard MedDRA.
Up to 152 weeks
Number of Participants With Worst-Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline
Blood samples were collected for the analysis of hematology parameters. The parameters were graded according to CTCAE grades. 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 and an increase in CTCAE grade was defined relative to the Baseline grade. Any worst-case post baseline increases in grade 1/2/3 to a grade of 4 are presented.
Up to 152 weeks
Number of Participants With Worst-Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline
Blood samples were collected for the analysis of clinical chemistry parameters. The parameters were graded according to CTCAE grades. 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 and an increase in CTCAE grade was defined relative to the Baseline grade. Any worst-case post baseline increases in grade 1/2/3 to a grade of 4 are presented.
Up to 152 weeks
Number of Participants With Post-baseline Positive Anti-drug Antibodies (ADAs) Against Belantamab Mafodotin
Serum samples collected for the analysis of the presence of ADAs using validated immunoassays. All samples were tested in screening assay, and positive samples were further characterized for antibody titers. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.
Baseline (Day 1) and up to 152 weeks
Titers of ADAs Against Belantamab Mafodotin
Serum samples collected for the analysis of the presence of ADAs using validated immunoassays. All samples were to be further tested in screening assay, and positive samples were further to be characterized for antibody titers.
Up to 152 weeks
Maximum Observed Concentration (Cmax) for Belantamab Mafodotin Antibody-drug Conjugate (ADC)
Plasma samples were collected for PK analysis for belantamab mafodotin antibody-drug conjugate (ADC).
Cycle(C)1 Day(D) 1 Pre-dose, End of Infusion (EOI), Start of Infusion (SOI) + 2 hours (H); C1D2 SOI+24H; C1D4; C1D8-15
Concentration at 21 Days for Belantamab Mafodotin ADC
Plasma samples were collected for PK analysis for belantamab mafodotin ADC.
At 21 days
Average Concentration Over 21 Days (Cavg) for Belantamab Mafodotin ADC
Plasma samples were collected for PK analysis for belantamab mafodotin ADC.
Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of Q3W as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death.
FG002
Arm C: Belantamab Mafodotin 2.5 mg/kg Every 6 Weeks (Q6W)
Participants with RRMM received belantamab mafodotin as 2.5 mg/kg dose on Day 1 of every 6 weeks (Q6W) as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death.
FG003
Arm D: Belantamab Mafodotin 1.9 mg/kg Q6W
Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of Q6W as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death.
FG004
Arm E: Belantamab Mafodotin 1.9 mg/kg Q6W (Based on OSDI + Visual Acuity [VA] Assessment)
Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of Q6W as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death. For this arm, dose modification decisions were determined by the results of the Ocular Surface Disease Index (OSDI) questionnaire or VA assessments using Snellen chart. The OSDI scale assesses the severity of eye symptoms and their impact and Snellen chart is for the assessment of visual acuity.
FG00040 subjects
FG00140 subjects
FG00240 subjects
FG00340 subjects
FG00417 subjects
Safety
All randomized participants who received at least 1 dose of study treatment.
FG00039 subjects
FG00140 subjects
FG00239 subjects
FG00340 subjects
FG00417 subjects
Pharmacokinetic
All participants in the Safety Population from whom at least 1 post-treatment pharmacokinetic (PK) sample was obtained and analyzed.
FG00038 subjects
FG00141 subjects1 participant was randomized in Arm A but inadvertently given Arm B treatment at Cycle 1.
FG00239 subjects
FG00340 subjects
FG00417 subjects
COMPLETED
FG00010 subjects
FG0017 subjects
FG0028 subjects
FG0039 subjects
FG0047 subjects
NOT COMPLETED
FG00030 subjects
FG00133 subjects
FG00232 subjects
FG00331 subjects
FG00410 subjects
Type
Comment
Reasons
Death
FG00023 subjects
FG00123 subjects
FG00225 subjects
FG00321 subjects
FG0045 subjects
Lost to Follow-up
FG0001 subjects
FG0012 subjects
FG0020 subjects
FG0032 subjects
FG004
Physician Decision
FG0001 subjects
FG0011 subjects
FG0022 subjects
FG0030 subjects
FG004
Withdrawal by Subject
FG0004 subjects
FG0015 subjects
FG0023 subjects
FG0036 subjects
FG004
Ongoing at the time of analysis
FG0001 subjects
FG0012 subjects
FG0022 subjects
FG0032 subjects
FG004
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Arm A: Belantamab Mafodotin 2.5 Milligram (mg)/Kilogram (kg) Every 3 Weeks (Q3W)
Participants with Relapsed or Refractory Multiple Myeloma (RRMM) received belantamab mafodotin as 2.5 milligram (mg)/kilogram (kg) dose on Day 1 of every 3 weeks (Q3W) as a 30-60 minute intravenous (IV) infusion until confirmed disease progression, unacceptable toxicity or death.
BG001
Arm B: Belantamab Mafodotin 1.9 mg/kg Q3W
Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of Q3W as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death.
BG002
Arm C: Belantamab Mafodotin 2.5 mg/kg Every 6 Weeks (Q6W)
Participants with RRMM received belantamab mafodotin as 2.5 mg/kg dose on Day 1 of every 6 weeks (Q6W) as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death.
BG003
Arm D: Belantamab Mafodotin 1.9 mg/kg Q6W
Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of Q6W as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death.
BG004
Arm E: Belantamab Mafodotin 1.9 mg/kg Q6W (Based on OSDI + Visual Acuity [VA] Assessment)
Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of Q6W as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death. For this arm, dose modification decisions were determined by the results of the Ocular Surface Disease Index (OSDI) questionnaire or VA assessments using Snellen chart. The OSDI scale assesses the severity of eye symptoms and their impact and Snellen chart is for the assessment of visual acuity.
BG005
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00040
BG00140
BG00240
BG00340
BG00417
BG005177
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Standard Deviation
YEARS
Title
Denominators
Categories
Title
Measurements
BG00066.6± 10.36
BG00163.0± 9.02
BG00263.7± 9.92
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG00019
BG00121
BG002
Race/Ethnicity, Customized
Count of Participants
Participants
Title
Denominators
Categories
Hispanic or Latino
Title
Measurements
BG00013
BG0019
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Percentage of Participants With Grade ≥2 Corneal Events Assessed by Keratopathy Visual Acuity (KVA) Scale
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.
Safety Population included all randomized participants who received at least 1 dose of study treatment. As outlined in the protocol, the objective was to examine the corneal events in Arms B to D, compared to Arm A; hence, Arm E was not included.
Posted
Number
Percentage of participants
Up to 29.5 months
ID
Title
Description
OG000
Arm A: Belantamab Mafodotin 2.5 Milligram (mg)/Kilogram (kg) Every 3 Weeks (Q3W)
Participants with Relapsed or Refractory Multiple Myeloma (RRMM) received belantamab mafodotin as 2.5 milligram (mg)/kilogram (kg) dose on Day 1 of every 3 weeks (Q3W) as a 30-60 minute intravenous (IV) infusion until confirmed disease progression, unacceptable toxicity or death.
OG001
Arm B: Belantamab Mafodotin 1.9 mg/kg Q3W
Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of Q3W as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death.
OG002
Arm C: Belantamab Mafodotin 2.5 mg/kg Every 6 Weeks (Q6W)
Participants with RRMM received belantamab mafodotin as 2.5 mg/kg dose on Day 1 of every 6 weeks (Q6W) as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death.
OG003
Arm D: Belantamab Mafodotin 1.9 mg/kg Q6W
Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of Q6W as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death.
Units
Counts
Participants
OG00039
OG00140
OG00239
OG003
Title
Denominators
Categories
Title
Measurements
OG00064
OG00140
OG00244
OG003
Secondary
Number of Participants With Corneal Events up to Week 16
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.
Safety Population.
Posted
Count of Participants
Participants
Up to week 16
ID
Title
Description
OG000
Arm A: Belantamab Mafodotin 2.5 Milligram (mg)/Kilogram (kg) Every 3 Weeks (Q3W)
Participants with Relapsed or Refractory Multiple Myeloma (RRMM) received belantamab mafodotin as 2.5 milligram (mg)/kilogram (kg) dose on Day 1 of every 3 weeks (Q3W) as a 30-60 minute intravenous (IV) infusion until confirmed disease progression, unacceptable toxicity or death.
OG001
Arm B: Belantamab Mafodotin 1.9 mg/kg Q3W
Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of Q3W as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death.
Secondary
Incidence Rate of Corneal Events by Grade (KVA Scale)
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.
Safety Population. Only those participants with data available at specified time points have been analyzed.
Posted
Number
Percentage of participants
Up to 152 weeks
ID
Title
Description
OG000
Arm A: Belantamab Mafodotin 2.5 Milligram (mg)/Kilogram (kg) Every 3 Weeks (Q3W)
Participants with Relapsed or Refractory Multiple Myeloma (RRMM) received belantamab mafodotin as 2.5 milligram (mg)/kilogram (kg) dose on Day 1 of every 3 weeks (Q3W) as a 30-60 minute intravenous (IV) infusion until confirmed disease progression, unacceptable toxicity or death.
OG001
Arm B: Belantamab Mafodotin 1.9 mg/kg Q3W
Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of Q3W as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death.
Secondary
Exposure Adjusted Incidence Rate of Corneal Events as Per CTCAE Grade
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.
Safety Population
Posted
Number
Events per 100 patient years
Up to 152 weeks
ID
Title
Description
OG000
Arm A: Belantamab Mafodotin 2.5 Milligram (mg)/Kilogram (kg) Every 3 Weeks (Q3W)
Participants with Relapsed or Refractory Multiple Myeloma (RRMM) received belantamab mafodotin as 2.5 milligram (mg)/kilogram (kg) dose on Day 1 of every 3 weeks (Q3W) as a 30-60 minute intravenous (IV) infusion until confirmed disease progression, unacceptable toxicity or death.
OG001
Arm B: Belantamab Mafodotin 1.9 mg/kg Q3W
Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of Q3W as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death.
Secondary
Median Duration of All the Dose Delays
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.
Safety Population
Posted
Median
Full Range
Days
Up to 152 weeks
ID
Title
Description
OG000
Arm A: Belantamab Mafodotin 2.5 Milligram (mg)/Kilogram (kg) Every 3 Weeks (Q3W)
Participants with Relapsed or Refractory Multiple Myeloma (RRMM) received belantamab mafodotin as 2.5 milligram (mg)/kilogram (kg) dose on Day 1 of every 3 weeks (Q3W) as a 30-60 minute intravenous (IV) infusion until confirmed disease progression, unacceptable toxicity or death.
OG001
Arm B: Belantamab Mafodotin 1.9 mg/kg Q3W
Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of Q3W as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death.
OG002
Arm C: Belantamab Mafodotin 2.5 mg/kg Every 6 Weeks (Q6W)
Participants with RRMM received belantamab mafodotin as 2.5 mg/kg dose on Day 1 of every 6 weeks (Q6W) as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death.
Secondary
Percentage of Participants Requiring Dose Reduction, Dose Interruption/Delay, Permanent Treatment Discontinuation Due to Corneal Events
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.
Safety Population. Only those participants who experienced corneal events have been analyzed.
Posted
Number
Percentage of participants
Up to 152 weeks
ID
Title
Description
OG000
Arm A: Belantamab Mafodotin 2.5 Milligram (mg)/Kilogram (kg) Every 3 Weeks (Q3W)
Participants with Relapsed or Refractory Multiple Myeloma (RRMM) received belantamab mafodotin as 2.5 milligram (mg)/kilogram (kg) dose on Day 1 of every 3 weeks (Q3W) as a 30-60 minute intravenous (IV) infusion until confirmed disease progression, unacceptable toxicity or death.
OG001
Arm B: Belantamab Mafodotin 1.9 mg/kg Q3W
Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of Q3W as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death.
Secondary
Cumulative Incidence of Grade 2 or Above Corneal Events (KVA Scale)
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.
Safety Population. Only those participants who experienced corneal events (KVA scale) of Grade 2 or above have been analyzed.
Posted
Number
Percentage of events
At 3 months, 6 months, 9 months and 12 months
ID
Title
Description
OG000
Arm A: Belantamab Mafodotin 2.5 Milligram (mg)/Kilogram (kg) Every 3 Weeks (Q3W)
Participants with Relapsed or Refractory Multiple Myeloma (RRMM) received belantamab mafodotin as 2.5 milligram (mg)/kilogram (kg) dose on Day 1 of every 3 weeks (Q3W) as a 30-60 minute intravenous (IV) infusion until confirmed disease progression, unacceptable toxicity or death.
OG001
Arm B: Belantamab Mafodotin 1.9 mg/kg Q3W
Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of Q3W as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death.
Secondary
Toxicity Index (TI)
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.
Safety Population
Posted
Mean
Standard Deviation
Score on scale
Up to 152 weeks
ID
Title
Description
OG000
Arm A: Belantamab Mafodotin 2.5 Milligram (mg)/Kilogram (kg) Every 3 Weeks (Q3W)
Participants with Relapsed or Refractory Multiple Myeloma (RRMM) received belantamab mafodotin as 2.5 milligram (mg)/kilogram (kg) dose on Day 1 of every 3 weeks (Q3W) as a 30-60 minute intravenous (IV) infusion until confirmed disease progression, unacceptable toxicity or death.
OG001
Arm B: Belantamab Mafodotin 1.9 mg/kg Q3W
Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of Q3W as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death.
Secondary
Duration of Corneal Events of Grade 2 or Above
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.
Safety Population. Only those participants who experienced corneal events (KVA Scale) of Grade 2 or above have been analyzed.
Posted
Median
Full Range
Days
Up to 152 weeks
ID
Title
Description
OG000
Arm A: Belantamab Mafodotin 2.5 Milligram (mg)/Kilogram (kg) Every 3 Weeks (Q3W)
Participants with Relapsed or Refractory Multiple Myeloma (RRMM) received belantamab mafodotin as 2.5 milligram (mg)/kilogram (kg) dose on Day 1 of every 3 weeks (Q3W) as a 30-60 minute intravenous (IV) infusion until confirmed disease progression, unacceptable toxicity or death.
OG001
Arm B: Belantamab Mafodotin 1.9 mg/kg Q3W
Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of Q3W as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death.
OG002
Arm C: Belantamab Mafodotin 2.5 mg/kg Every 6 Weeks (Q6W)
Secondary
Percentage of Time on Study With Grade 2 or Above Corneal Events
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.
Safety Population. Only those participants who experienced corneal events of Grade 2 or above have been analyzed.
Posted
Median
Full Range
Percentage of Time
Up to 152 weeks
ID
Title
Description
OG000
Arm A: Belantamab Mafodotin 2.5 Milligram (mg)/Kilogram (kg) Every 3 Weeks (Q3W)
Participants with Relapsed or Refractory Multiple Myeloma (RRMM) received belantamab mafodotin as 2.5 milligram (mg)/kilogram (kg) dose on Day 1 of every 3 weeks (Q3W) as a 30-60 minute intravenous (IV) infusion until confirmed disease progression, unacceptable toxicity or death.
OG001
Arm B: Belantamab Mafodotin 1.9 mg/kg Q3W
Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of Q3W as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death.
OG002
Arm C: Belantamab Mafodotin 2.5 mg/kg Every 6 Weeks (Q6W)
Secondary
Number of Participants With Change in Best Corrected Visual Acuity Test (BCVA) Scores
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.
Safety Population. Only those participants with data available at specified time points have been analyzed.
Posted
Count of Participants
Participants
Baseline (Day 1) and up to 152 weeks
ID
Title
Description
OG000
Arm A: Belantamab Mafodotin 2.5 Milligram (mg)/Kilogram (kg) Every 3 Weeks (Q3W)
Participants with Relapsed or Refractory Multiple Myeloma (RRMM) received belantamab mafodotin as 2.5 milligram (mg)/kilogram (kg) dose on Day 1 of every 3 weeks (Q3W) as a 30-60 minute intravenous (IV) infusion until confirmed disease progression, unacceptable toxicity or death.
OG001
Arm B: Belantamab Mafodotin 1.9 mg/kg Q3W
Secondary
Objective Response Rate (ORR)
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.
Intent-to-Treat Population included all randomized participants, whether or not randomized treatment was administered.
Posted
Number
95% Confidence Interval
Percentage of participants
Up to 152 weeks
ID
Title
Description
OG000
Arm A: Belantamab Mafodotin 2.5 Milligram (mg)/Kilogram (kg) Every 3 Weeks (Q3W)
Participants with Relapsed or Refractory Multiple Myeloma (RRMM) received belantamab mafodotin as 2.5 milligram (mg)/kilogram (kg) dose on Day 1 of every 3 weeks (Q3W) as a 30-60 minute intravenous (IV) infusion until confirmed disease progression, unacceptable toxicity or death.
OG001
Arm B: Belantamab Mafodotin 1.9 mg/kg Q3W
Secondary
Percentage of Participants With a Confirmed VGPR or Better (i.e., VGPR, CR, and sCR)
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.
Intent-to-Treat Population
Posted
Number
95% Confidence Interval
Percentage of participants
Up to 152 weeks
ID
Title
Description
OG000
Arm A: Belantamab Mafodotin 2.5 Milligram (mg)/Kilogram (kg) Every 3 Weeks (Q3W)
Participants with Relapsed or Refractory Multiple Myeloma (RRMM) received belantamab mafodotin as 2.5 milligram (mg)/kilogram (kg) dose on Day 1 of every 3 weeks (Q3W) as a 30-60 minute intravenous (IV) infusion until confirmed disease progression, unacceptable toxicity or death.
OG001
Arm B: Belantamab Mafodotin 1.9 mg/kg Q3W
Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of Q3W as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death.
Secondary
Time to Response (TTR)
TTR defined as the time between the date of randomization and the first documented evidence of response (PR or better), among participants who achieve a response (i.e., confirmed PR or better), according to the 2016 IMWG response criteria. PR = ≥50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by ≥90% or to <200 mg/24 h.
Intent-to-Treat Population. Only those participants with confirmed partial response (PR) or better (i.e., PR, VGPR, CR and sCR) have been analyzed.
Posted
Median
95% Confidence Interval
Months
Up to 152 weeks
ID
Title
Description
OG000
Arm A: Belantamab Mafodotin 2.5 Milligram (mg)/Kilogram (kg) Every 3 Weeks (Q3W)
Participants with Relapsed or Refractory Multiple Myeloma (RRMM) received belantamab mafodotin as 2.5 milligram (mg)/kilogram (kg) dose on Day 1 of every 3 weeks (Q3W) as a 30-60 minute intravenous (IV) infusion until confirmed disease progression, unacceptable toxicity or death.
OG001
Arm B: Belantamab Mafodotin 1.9 mg/kg Q3W
Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of Q3W as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death.
OG002
Arm C: Belantamab Mafodotin 2.5 mg/kg Every 6 Weeks (Q6W)
Secondary
Duration of Response (DoR)
DoR defined as the time from first documented evidence of PR or better until disease progression (PD) among responders according to the 2016 IMWG response criteria or death due to any cause. PR = ≥50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by ≥90% or to <200 mg/24 h. PD= Increase of 25% from lowest confirmed response value in 1 or more of the following criteria: Serum M-protein with absolute increase of >= 0.5 g/dL; Serum M-protein increase >= 1 g/dL if the lowest M-component was >=5 g/dL; Urinary M-protein (absolute increase must be >= 200 mg per 24 h).
Intent-to-Treat Population. Only those participants with confirmed PR or better (i.e., PR, VGPR, CR and sCR) have been analyzed.
Posted
Median
95% Confidence Interval
Months
Up to 152 weeks
ID
Title
Description
OG000
Arm A: Belantamab Mafodotin 2.5 Milligram (mg)/Kilogram (kg) Every 3 Weeks (Q3W)
Participants with Relapsed or Refractory Multiple Myeloma (RRMM) received belantamab mafodotin as 2.5 milligram (mg)/kilogram (kg) dose on Day 1 of every 3 weeks (Q3W) as a 30-60 minute intravenous (IV) infusion until confirmed disease progression, unacceptable toxicity or death.
OG001
Arm B: Belantamab Mafodotin 1.9 mg/kg Q3W
Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of Q3W as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death.
Secondary
Time to Progression (TTP)
TTP defined as the time from randomization until the earliest date of documented PD or death due to PD, according to the 2016 IMWG response criteria. PD= Increase of 25% from lowest confirmed response value in 1 or more of the following criteria: Serum M-protein with absolute increase of >= 0.5 g/dL; Serum M-protein increase >= 1 g/dL if the lowest M-component was >=5 g/dL; Urinary M-protein (absolute increase must be >= 200 mg per 24 h).
Intent-to-Treat Population. Only those participants with documented PD or death due to PD have been analyzed.
Posted
Median
95% Confidence Interval
Months
Up to 152 weeks
ID
Title
Description
OG000
Arm A: Belantamab Mafodotin 2.5 Milligram (mg)/Kilogram (kg) Every 3 Weeks (Q3W)
Participants with Relapsed or Refractory Multiple Myeloma (RRMM) received belantamab mafodotin as 2.5 milligram (mg)/kilogram (kg) dose on Day 1 of every 3 weeks (Q3W) as a 30-60 minute intravenous (IV) infusion until confirmed disease progression, unacceptable toxicity or death.
OG001
Arm B: Belantamab Mafodotin 1.9 mg/kg Q3W
Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of Q3W as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death.
OG002
Arm C: Belantamab Mafodotin 2.5 mg/kg Every 6 Weeks (Q6W)
Secondary
Progression Free Survival (PFS)
PFS defined as the time from randomization until the earliest date of documented PD, according to the 2016 IMWG response criteria, or death due to any cause. PD= Increase of 25% from lowest confirmed response value in 1 or more of the following criteria: Serum M-protein with absolute increase of >= 0.5 g/dL; Serum M-protein increase >= 1 g/dL if the lowest M-component was >=5 g/dL; Urinary M-protein (absolute increase must be >= 200 mg per 24 h).
Intent-to-Treat Population. Only those participants with documented PD or death due to any cause have been analyzed.
Posted
Median
95% Confidence Interval
Months
Up to 152 weeks
ID
Title
Description
OG000
Arm A: Belantamab Mafodotin 2.5 Milligram (mg)/Kilogram (kg) Every 3 Weeks (Q3W)
Participants with Relapsed or Refractory Multiple Myeloma (RRMM) received belantamab mafodotin as 2.5 milligram (mg)/kilogram (kg) dose on Day 1 of every 3 weeks (Q3W) as a 30-60 minute intravenous (IV) infusion until confirmed disease progression, unacceptable toxicity or death.
OG001
Arm B: Belantamab Mafodotin 1.9 mg/kg Q3W
Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of Q3W as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death.
OG002
Arm C: Belantamab Mafodotin 2.5 mg/kg Every 6 Weeks (Q6W)
Secondary
Overall Survival (OS)
OS defined as the time from randomization until the date of death due to any cause.
Intent-to-Treat Population. Only those participants with documented death due to any cause have been analyzed.
Posted
Median
95% Confidence Interval
Months
Up to 152 weeks
ID
Title
Description
OG000
Arm A: Belantamab Mafodotin 2.5 Milligram (mg)/Kilogram (kg) Every 3 Weeks (Q3W)
Participants with Relapsed or Refractory Multiple Myeloma (RRMM) received belantamab mafodotin as 2.5 milligram (mg)/kilogram (kg) dose on Day 1 of every 3 weeks (Q3W) as a 30-60 minute intravenous (IV) infusion until confirmed disease progression, unacceptable toxicity or death.
OG001
Arm B: Belantamab Mafodotin 1.9 mg/kg Q3W
Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of Q3W as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death.
OG002
Arm C: Belantamab Mafodotin 2.5 mg/kg Every 6 Weeks (Q6W)
Participants with RRMM received belantamab mafodotin as 2.5 mg/kg dose on Day 1 of every 6 weeks (Q6W) as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death.
Secondary
Percentage of Participants With AEs
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. AEs were coded using the standard Medical Dictionary for Regulatory Activities (MedDRA).
Safety Population
Posted
Number
Percentage of participants
Up to 152 weeks
ID
Title
Description
OG000
Arm A: Belantamab Mafodotin 2.5 Milligram (mg)/Kilogram (kg) Every 3 Weeks (Q3W)
Participants with Relapsed or Refractory Multiple Myeloma (RRMM) received belantamab mafodotin as 2.5 milligram (mg)/kilogram (kg) dose on Day 1 of every 3 weeks (Q3W) as a 30-60 minute intravenous (IV) infusion until confirmed disease progression, unacceptable toxicity or death.
OG001
Arm B: Belantamab Mafodotin 1.9 mg/kg Q3W
Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of Q3W as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death.
OG002
Arm C: Belantamab Mafodotin 2.5 mg/kg Every 6 Weeks (Q6W)
Participants with RRMM received belantamab mafodotin as 2.5 mg/kg dose on Day 1 of every 6 weeks (Q6W) as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death.
Secondary
Percentage of Participants Requiring Dose Reduction, Dose Interruption/Delay, Permanent Treatment Discontinuation Due to Any AEs
Percentage of participants requiring dose reduction, dose interruption/delay, permanent treatment discontinuation due to any AEs were presented. An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. AEs were coded using the standard MedDRA.
Safety Population
Posted
Number
Percentage of participants
Up to 152 weeks
ID
Title
Description
OG000
Arm A: Belantamab Mafodotin 2.5 Milligram (mg)/Kilogram (kg) Every 3 Weeks (Q3W)
Participants with Relapsed or Refractory Multiple Myeloma (RRMM) received belantamab mafodotin as 2.5 milligram (mg)/kilogram (kg) dose on Day 1 of every 3 weeks (Q3W) as a 30-60 minute intravenous (IV) infusion until confirmed disease progression, unacceptable toxicity or death.
OG001
Arm B: Belantamab Mafodotin 1.9 mg/kg Q3W
Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of Q3W as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death.
OG002
Arm C: Belantamab Mafodotin 2.5 mg/kg Every 6 Weeks (Q6W)
Secondary
Number of Participants With Worst-Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline
Blood samples were collected for the analysis of hematology parameters. The parameters were graded according to CTCAE grades. 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 and an increase in CTCAE grade was defined relative to the Baseline grade. Any worst-case post baseline increases in grade 1/2/3 to a grade of 4 are presented.
Safety Population. Only those participants with data available for specified categories have been analyzed. Participants were counted more than once within some categories, so the percentages may not add to 100 percent (%).
Posted
Count of Participants
Participants
Up to 152 weeks
ID
Title
Description
OG000
Arm A: Belantamab Mafodotin 2.5 Milligram (mg)/Kilogram (kg) Every 3 Weeks (Q3W)
Participants with Relapsed or Refractory Multiple Myeloma (RRMM) received belantamab mafodotin as 2.5 milligram (mg)/kilogram (kg) dose on Day 1 of every 3 weeks (Q3W) as a 30-60 minute intravenous (IV) infusion until confirmed disease progression, unacceptable toxicity or death.
OG001
Arm B: Belantamab Mafodotin 1.9 mg/kg Q3W
Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of Q3W as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death.
Secondary
Number of Participants With Worst-Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline
Blood samples were collected for the analysis of clinical chemistry parameters. The parameters were graded according to CTCAE grades. 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 and an increase in CTCAE grade was defined relative to the Baseline grade. Any worst-case post baseline increases in grade 1/2/3 to a grade of 4 are presented.
Safety Population. Only those participants with data available for specified categories have been analyzed. Participants were counted more than once within some categories, so the percentages may not add to 100 percent (%)
Posted
Count of Participants
Participants
Up to 152 weeks
ID
Title
Description
OG000
Arm A: Belantamab Mafodotin 2.5 Milligram (mg)/Kilogram (kg) Every 3 Weeks (Q3W)
Participants with Relapsed or Refractory Multiple Myeloma (RRMM) received belantamab mafodotin as 2.5 milligram (mg)/kilogram (kg) dose on Day 1 of every 3 weeks (Q3W) as a 30-60 minute intravenous (IV) infusion until confirmed disease progression, unacceptable toxicity or death.
OG001
Arm B: Belantamab Mafodotin 1.9 mg/kg Q3W
Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of Q3W as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death.
Secondary
Number of Participants With Post-baseline Positive Anti-drug Antibodies (ADAs) Against Belantamab Mafodotin
Serum samples collected for the analysis of the presence of ADAs using validated immunoassays. All samples were tested in screening assay, and positive samples were further characterized for antibody titers. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.
Safety Population. Only those participants with data available at specified time points have been analyzed.
Posted
Count of Participants
Participants
Baseline (Day 1) and up to 152 weeks
ID
Title
Description
OG000
Arm A: Belantamab Mafodotin 2.5 Milligram (mg)/Kilogram (kg) Every 3 Weeks (Q3W)
Participants with Relapsed or Refractory Multiple Myeloma (RRMM) received belantamab mafodotin as 2.5 milligram (mg)/kilogram (kg) dose on Day 1 of every 3 weeks (Q3W) as a 30-60 minute intravenous (IV) infusion until confirmed disease progression, unacceptable toxicity or death.
OG001
Arm B: Belantamab Mafodotin 1.9 mg/kg Q3W
Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of Q3W as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death.
OG002
Arm C: Belantamab Mafodotin 2.5 mg/kg Every 6 Weeks (Q6W)
Secondary
Titers of ADAs Against Belantamab Mafodotin
Serum samples collected for the analysis of the presence of ADAs using validated immunoassays. All samples were to be further tested in screening assay, and positive samples were further to be characterized for antibody titers.
Safety Population. There were no participants with positive ADA results. Hence the titer (concentration) of ADA was not collected.
Posted
Up to 152 weeks
ID
Title
Description
OG000
Arm A: Belantamab Mafodotin 2.5 Milligram (mg)/Kilogram (kg) Every 3 Weeks (Q3W)
Participants with Relapsed or Refractory Multiple Myeloma (RRMM) received belantamab mafodotin as 2.5 milligram (mg)/kilogram (kg) dose on Day 1 of every 3 weeks (Q3W) as a 30-60 minute intravenous (IV) infusion until confirmed disease progression, unacceptable toxicity or death.
OG001
Arm B: Belantamab Mafodotin 1.9 mg/kg Q3W
Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of Q3W as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death.
OG002
Arm C: Belantamab Mafodotin 2.5 mg/kg Every 6 Weeks (Q6W)
Participants with RRMM received belantamab mafodotin as 2.5 mg/kg dose on Day 1 of every 6 weeks (Q6W) as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death.
Secondary
Maximum Observed Concentration (Cmax) for Belantamab Mafodotin Antibody-drug Conjugate (ADC)
Plasma samples were collected for PK analysis for belantamab mafodotin antibody-drug conjugate (ADC).
Pharmacokinetic (PK) Population included all participants in the Safety Population from whom at least 1 post-treatment PK sample was obtained and analyzed. One Participant was randomized in Arm A but inadvertently given Arm B treatment at Cycle 1. Hence included in Arm B for PK analyses.
Posted
Geometric Mean
Geometric Coefficient of Variation
Microgram/ millilitre (ug/mL)
Cycle(C)1 Day(D) 1 Pre-dose, End of Infusion (EOI), Start of Infusion (SOI) + 2 hours (H); C1D2 SOI+24H; C1D4; C1D8-15
ID
Title
Description
OG000
Arm A: Belantamab Mafodotin 2.5 Milligram (mg)/Kilogram (kg) Every 3 Weeks (Q3W)
Participants with Relapsed or Refractory Multiple Myeloma (RRMM) received belantamab mafodotin as 2.5 milligram (mg)/kilogram (kg) dose on Day 1 of every 3 weeks (Q3W) as a 30-60 minute intravenous (IV) infusion until confirmed disease progression, unacceptable toxicity or death.
OG001
Arm B: Belantamab Mafodotin 1.9 mg/kg Q3W
Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of Q3W as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death.
OG002
Secondary
Concentration at 21 Days for Belantamab Mafodotin ADC
Plasma samples were collected for PK analysis for belantamab mafodotin ADC.
Pharmacokinetic (PK) Population. One Participant was randomized in Arm A but inadvertently given Arm B treatment at Cycle 1. Hence included in Arm B for PK analyses.
Posted
Geometric Mean
Geometric Coefficient of Variation
ug/mL
At 21 days
ID
Title
Description
OG000
Arm A: Belantamab Mafodotin 2.5 Milligram (mg)/Kilogram (kg) Every 3 Weeks (Q3W)
Participants with Relapsed or Refractory Multiple Myeloma (RRMM) received belantamab mafodotin as 2.5 milligram (mg)/kilogram (kg) dose on Day 1 of every 3 weeks (Q3W) as a 30-60 minute intravenous (IV) infusion until confirmed disease progression, unacceptable toxicity or death.
OG001
Arm B: Belantamab Mafodotin 1.9 mg/kg Q3W
Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of Q3W as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death.
OG002
Arm C: Belantamab Mafodotin 2.5 mg/kg Every 6 Weeks (Q6W)
Participants with RRMM received belantamab mafodotin as 2.5 mg/kg dose on Day 1 of every 6 weeks (Q6W) as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death.
Secondary
Average Concentration Over 21 Days (Cavg) for Belantamab Mafodotin ADC
Plasma samples were collected for PK analysis for belantamab mafodotin ADC.
Pharmacokinetic (PK) Population. One Participant was randomized in Arm A but inadvertently given Arm B treatment at Cycle 1. Hence included in Arm B for PK analyses.
Arm A: Belantamab Mafodotin 2.5 Milligram (mg)/Kilogram (kg) Every 3 Weeks (Q3W)
Participants with Relapsed or Refractory Multiple Myeloma (RRMM) received belantamab mafodotin as 2.5 milligram (mg)/kilogram (kg) dose on Day 1 of every 3 weeks (Q3W) as a 30-60 minute intravenous (IV) infusion until confirmed disease progression, unacceptable toxicity or death.
OG001
Arm B: Belantamab Mafodotin 1.9 mg/kg Q3W
Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of Q3W as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death.
OG002
Arm C: Belantamab Mafodotin 2.5 mg/kg Every 6 Weeks (Q6W)
Participants with RRMM received belantamab mafodotin as 2.5 mg/kg dose on Day 1 of every 6 weeks (Q6W) as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death.
Secondary
Area Under the Concentration-time Curve (AUC) (0-504h) of Belantamab Mafodotin ADC
Plasma samples were collected to determine the area under the concentration-time curve (AUC) (0-504h) of Belantamab mafodotin ADC.
Pharmacokinetic (PK) Population. One Participant was randomized in Arm A but inadvertently given Arm B treatment at Cycle 1. Hence included in Arm B for PK analyses.
Arm A: Belantamab Mafodotin 2.5 Milligram (mg)/Kilogram (kg) Every 3 Weeks (Q3W)
Participants with Relapsed or Refractory Multiple Myeloma (RRMM) received belantamab mafodotin as 2.5 milligram (mg)/kilogram (kg) dose on Day 1 of every 3 weeks (Q3W) as a 30-60 minute intravenous (IV) infusion until confirmed disease progression, unacceptable toxicity or death.
OG001
Arm B: Belantamab Mafodotin 1.9 mg/kg Q3W
Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of Q3W as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death.
OG002
Arm C: Belantamab Mafodotin 2.5 mg/kg Every 6 Weeks (Q6W)
Secondary
Half-life (t1/2) of Belantamab Mafodotin ADC
Plasma samples were collected for PK analysis of Belantamab mafodotin ADC
Pharmacokinetic (PK) Population. One Participant was randomized in Arm A but inadvertently given Arm B treatment at Cycle 1. Hence included in Arm B for PK analyses.
Arm A: Belantamab Mafodotin 2.5 Milligram (mg)/Kilogram (kg) Every 3 Weeks (Q3W)
Participants with Relapsed or Refractory Multiple Myeloma (RRMM) received belantamab mafodotin as 2.5 milligram (mg)/kilogram (kg) dose on Day 1 of every 3 weeks (Q3W) as a 30-60 minute intravenous (IV) infusion until confirmed disease progression, unacceptable toxicity or death.
OG001
Arm B: Belantamab Mafodotin 1.9 mg/kg Q3W
Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of Q3W as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death.
OG002
Arm C: Belantamab Mafodotin 2.5 mg/kg Every 6 Weeks (Q6W)
Participants with RRMM received belantamab mafodotin as 2.5 mg/kg dose on Day 1 of every 6 weeks (Q6W) as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death.
Secondary
Clearance (CL) for Belantamab Mafodotin ADC
Plasma samples were collected for PK analysis for belantamab mafodotin ADC.
Pharmacokinetic (PK) Population. One Participant was randomized in Arm A but inadvertently given Arm B treatment at Cycle 1. Hence included in Arm B for PK analyses.
Arm A: Belantamab Mafodotin 2.5 Milligram (mg)/Kilogram (kg) Every 3 Weeks (Q3W)
Participants with Relapsed or Refractory Multiple Myeloma (RRMM) received belantamab mafodotin as 2.5 milligram (mg)/kilogram (kg) dose on Day 1 of every 3 weeks (Q3W) as a 30-60 minute intravenous (IV) infusion until confirmed disease progression, unacceptable toxicity or death.
OG001
Arm B: Belantamab Mafodotin 1.9 mg/kg Q3W
Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of Q3W as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death.
OG002
Arm C: Belantamab Mafodotin 2.5 mg/kg Every 6 Weeks (Q6W)
Participants with RRMM received belantamab mafodotin as 2.5 mg/kg dose on Day 1 of every 6 weeks (Q6W) as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death.
Secondary
Steady-state Volume of Distribution (Vss) for Belantamab Mafodotin ADC
Plasma samples were collected for PK analysis for belantamab mafodotin ADC.
Pharmacokinetic (PK) Population. One Participant was randomized in Arm A but inadvertently given Arm B treatment at Cycle 1. Hence included in Arm B for PK analyses.
Arm A: Belantamab Mafodotin 2.5 Milligram (mg)/Kilogram (kg) Every 3 Weeks (Q3W)
Participants with Relapsed or Refractory Multiple Myeloma (RRMM) received belantamab mafodotin as 2.5 milligram (mg)/kilogram (kg) dose on Day 1 of every 3 weeks (Q3W) as a 30-60 minute intravenous (IV) infusion until confirmed disease progression, unacceptable toxicity or death.
OG001
Arm B: Belantamab Mafodotin 1.9 mg/kg Q3W
Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of Q3W as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death.
OG002
Arm C: Belantamab Mafodotin 2.5 mg/kg Every 6 Weeks (Q6W)
Participants with RRMM received belantamab mafodotin as 2.5 mg/kg dose on Day 1 of every 6 weeks (Q6W) as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death.
Time Frame
All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks.
Description
All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Arm A: Belantamab Mafodotin 2.5 Milligram (mg)/Kilogram (kg) Every 3 Weeks (Q3W)
Participants with Relapsed or Refractory Multiple Myeloma (RRMM) received belantamab mafodotin as 2.5 milligram (mg)/kilogram (kg) dose on Day 1 of every 3 weeks (Q3W) as a 30-60 minute intravenous (IV) infusion until confirmed disease progression, unacceptable toxicity or death.
23
40
17
39
38
39
EG001
Arm B: Belantamab Mafodotin 1.9 mg/kg Q3W
Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of Q3W as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death.
23
40
17
40
36
40
EG002
Arm C: Belantamab Mafodotin 2.5 mg/kg Every 6 Weeks (Q6W)
Participants with RRMM received belantamab mafodotin as 2.5 mg/kg dose on Day 1 of every 6 weeks (Q6W) as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death.
25
40
21
39
36
39
EG003
Arm D: Belantamab Mafodotin 1.9 mg/kg Q6W
Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of Q6W as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death.
21
40
16
40
40
40
EG004
Arm E: Belantamab Mafodotin 1.9 mg/kg Q6W (Based on OSDI + Visual Acuity [VA] Assessment)
Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of Q6W as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death. For this arm, dose modification decisions were determined by the results of the Ocular Surface Disease Index (OSDI) questionnaire or VA assessments using Snellen chart. The OSDI scale assesses the severity of eye symptoms and their impact and Snellen chart is for the assessment of visual acuity.
5
17
4
17
16
17
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Pneumonia
Infections and infestations
MedDRA v27.0
Systematic Assessment
EG0002 events2 affected39 at risk
EG0015 events3 affected40 at risk
EG0023 events3 affected39 at risk
EG0032 events2 affected40 at risk
EG0042 events1 affected17 at risk
Pneumonia bacterial
Infections and infestations
MedDRA v27.0
Systematic Assessment
EG0001 events1 affected39 at risk
EG0013 events2 affected40 at risk
EG0020 events0 affected39 at risk
EG003
COVID-19
Infections and infestations
MedDRA v27.0
Systematic Assessment
EG0000 events0 affected39 at risk
EG0011 events1 affected40 at risk
EG0021 events1 affected39 at risk
EG003
Kidney infection
Infections and infestations
MedDRA v27.0
Systematic Assessment
EG0000 events0 affected39 at risk
EG0011 events1 affected40 at risk
EG0020 events0 affected39 at risk
EG003
Respiratory tract infection
Infections and infestations
MedDRA v27.0
Systematic Assessment
EG0000 events0 affected39 at risk
EG0012 events1 affected40 at risk
EG0020 events0 affected39 at risk
EG003
Respiratory tract infection viral
Infections and infestations
MedDRA v27.0
Systematic Assessment
EG0000 events0 affected39 at risk
EG0011 events1 affected40 at risk
EG0020 events0 affected39 at risk
EG003
Sepsis
Infections and infestations
MedDRA v27.0
Systematic Assessment
EG0003 events3 affected39 at risk
EG0011 events1 affected40 at risk
EG0020 events0 affected39 at risk
EG003
Septic shock
Infections and infestations
MedDRA v27.0
Systematic Assessment
EG0000 events0 affected39 at risk
EG0011 events1 affected40 at risk
EG0021 events1 affected39 at risk
EG003
Streptococcal sepsis
Infections and infestations
MedDRA v27.0
Systematic Assessment
EG0000 events0 affected39 at risk
EG0011 events1 affected40 at risk
EG0020 events0 affected39 at risk
EG003
Bacteraemia
Infections and infestations
MedDRA v27.0
Systematic Assessment
EG0000 events0 affected39 at risk
EG0010 events0 affected40 at risk
EG0022 events2 affected39 at risk
EG003
COVID-19 pneumonia
Infections and infestations
MedDRA v27.0
Systematic Assessment
EG0000 events0 affected39 at risk
EG0010 events0 affected40 at risk
EG0021 events1 affected39 at risk
EG003
Cellulitis
Infections and infestations
MedDRA v27.0
Systematic Assessment
EG0000 events0 affected39 at risk
EG0010 events0 affected40 at risk
EG0020 events0 affected39 at risk
EG003
Coronavirus infection
Infections and infestations
MedDRA v27.0
Systematic Assessment
EG0000 events0 affected39 at risk
EG0010 events0 affected40 at risk
EG0021 events1 affected39 at risk
EG003
Diverticulitis
Infections and infestations
MedDRA v27.0
Systematic Assessment
EG0001 events1 affected39 at risk
EG0010 events0 affected40 at risk
EG0020 events0 affected39 at risk
EG003
Gingivitis
Infections and infestations
MedDRA v27.0
Systematic Assessment
EG0000 events0 affected39 at risk
EG0010 events0 affected40 at risk
EG0020 events0 affected39 at risk
EG003
Hepatitis B reactivation
Infections and infestations
MedDRA v27.0
Systematic Assessment
EG0000 events0 affected39 at risk
EG0010 events0 affected40 at risk
EG0021 events1 affected39 at risk
EG003
Herpes zoster
Infections and infestations
MedDRA v27.0
Systematic Assessment
EG0000 events0 affected39 at risk
EG0010 events0 affected40 at risk
EG0020 events0 affected39 at risk
EG003
Infection
Infections and infestations
MedDRA v27.0
Systematic Assessment
EG0001 events1 affected39 at risk
EG0010 events0 affected40 at risk
EG0021 events1 affected39 at risk
EG003
Influenza
Infections and infestations
MedDRA v27.0
Systematic Assessment
EG0001 events1 affected39 at risk
EG0010 events0 affected40 at risk
EG0020 events0 affected39 at risk
EG003
Lower respiratory tract infection
Infections and infestations
MedDRA v27.0
Systematic Assessment
EG0000 events0 affected39 at risk
EG0010 events0 affected40 at risk
EG0020 events0 affected39 at risk
EG003
Metapneumovirus infection
Infections and infestations
MedDRA v27.0
Systematic Assessment
EG0001 events1 affected39 at risk
EG0010 events0 affected40 at risk
EG0020 events0 affected39 at risk
EG003
Pneumonia cytomegaloviral
Infections and infestations
MedDRA v27.0
Systematic Assessment
EG0000 events0 affected39 at risk
EG0010 events0 affected40 at risk
EG0020 events0 affected39 at risk
EG003
Pneumonia parainfluenzae viral
Infections and infestations
MedDRA v27.0
Systematic Assessment
EG0000 events0 affected39 at risk
EG0010 events0 affected40 at risk
EG0020 events0 affected39 at risk
EG003
Pneumonia pneumococcal
Infections and infestations
MedDRA v27.0
Systematic Assessment
EG0000 events0 affected39 at risk
EG0010 events0 affected40 at risk
EG0021 events1 affected39 at risk
EG003
Pulmonary sepsis
Infections and infestations
MedDRA v27.0
Systematic Assessment
EG0000 events0 affected39 at risk
EG0010 events0 affected40 at risk
EG0021 events1 affected39 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA v27.0
Systematic Assessment
EG0000 events0 affected39 at risk
EG0010 events0 affected40 at risk
EG0020 events0 affected39 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA v27.0
Systematic Assessment
EG0002 events2 affected39 at risk
EG0010 events0 affected40 at risk
EG0020 events0 affected39 at risk
EG003
Vascular device infection
Infections and infestations
MedDRA v27.0
Systematic Assessment
EG0000 events0 affected39 at risk
EG0010 events0 affected40 at risk
EG0021 events1 affected39 at risk
EG003
Thrombocytopenia
Blood and lymphatic system disorders
MedDRA v27.0
Systematic Assessment
EG0002 events2 affected39 at risk
EG0014 events4 affected40 at risk
EG0022 events2 affected39 at risk
EG003
Anaemia
Blood and lymphatic system disorders
MedDRA v27.0
Systematic Assessment
EG0000 events0 affected39 at risk
EG0011 events1 affected40 at risk
EG0021 events1 affected39 at risk
EG003
Anaemia macrocytic
Blood and lymphatic system disorders
MedDRA v27.0
Systematic Assessment
EG0000 events0 affected39 at risk
EG0010 events0 affected40 at risk
EG0020 events0 affected39 at risk
EG003
Febrile neutropenia
Blood and lymphatic system disorders
MedDRA v27.0
Systematic Assessment
EG0000 events0 affected39 at risk
EG0010 events0 affected40 at risk
EG0021 events1 affected39 at risk
EG003
General physical health deterioration
General disorders
MedDRA v27.0
Systematic Assessment
EG0000 events0 affected39 at risk
EG0012 events2 affected40 at risk
EG0020 events0 affected39 at risk
EG003
Non-cardiac chest pain
General disorders
MedDRA v27.0
Systematic Assessment
EG0000 events0 affected39 at risk
EG0011 events1 affected40 at risk
EG0020 events0 affected39 at risk
EG003
Pain
General disorders
MedDRA v27.0
Systematic Assessment
EG0000 events0 affected39 at risk
EG0011 events1 affected40 at risk
EG0020 events0 affected39 at risk
EG003
Disease progression
General disorders
MedDRA v27.0
Systematic Assessment
EG0001 events1 affected39 at risk
EG0010 events0 affected40 at risk
EG0020 events0 affected39 at risk
EG003
Organ failure
General disorders
MedDRA v27.0
Systematic Assessment
EG0000 events0 affected39 at risk
EG0010 events0 affected40 at risk
EG0020 events0 affected39 at risk
EG003
Pyrexia
General disorders
MedDRA v27.0
Systematic Assessment
EG0000 events0 affected39 at risk
EG0010 events0 affected40 at risk
EG0020 events0 affected39 at risk
EG003
Systemic inflammatory response syndrome
General disorders
MedDRA v27.0
Systematic Assessment
EG0000 events0 affected39 at risk
EG0010 events0 affected40 at risk
EG0020 events0 affected39 at risk
EG003
Neoplasm malignant
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA v27.0
Systematic Assessment
EG0000 events0 affected39 at risk
EG0011 events1 affected40 at risk
EG0020 events0 affected39 at risk
EG003
Plasma cell myeloma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA v27.0
Systematic Assessment
EG0000 events0 affected39 at risk
EG0011 events1 affected40 at risk
EG0021 events1 affected39 at risk
EG003
Colon cancer metastatic
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA v27.0
Systematic Assessment
EG0000 events0 affected39 at risk
EG0010 events0 affected40 at risk
EG0021 events1 affected39 at risk
EG003
Colon neoplasm
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA v27.0
Systematic Assessment
EG0000 events0 affected39 at risk
EG0010 events0 affected40 at risk
EG0020 events0 affected39 at risk
EG003
Infected neoplasm
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA v27.0
Systematic Assessment
EG0000 events0 affected39 at risk
EG0010 events0 affected40 at risk
EG0021 events1 affected39 at risk
EG003
Rectal adenocarcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA v27.0
Systematic Assessment
EG0001 events1 affected39 at risk
EG0010 events0 affected40 at risk
EG0020 events0 affected39 at risk
EG003
Squamous cell carcinoma of skin
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA v27.0
Systematic Assessment
EG0000 events0 affected39 at risk
EG0010 events0 affected40 at risk
EG0020 events0 affected39 at risk
EG003
Tumour haemorrhage
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA v27.0
Systematic Assessment
EG0001 events1 affected39 at risk
EG0010 events0 affected40 at risk
EG0020 events0 affected39 at risk
EG003
Tumour pain
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA v27.0
Systematic Assessment
EG0000 events0 affected39 at risk
EG0010 events0 affected40 at risk
EG0021 events1 affected39 at risk
EG003
Femur fracture
Injury, poisoning and procedural complications
MedDRA v27.0
Systematic Assessment
EG0000 events0 affected39 at risk
EG0011 events1 affected40 at risk
EG0020 events0 affected39 at risk
EG003
Infusion related reaction
Injury, poisoning and procedural complications
MedDRA v27.0
Systematic Assessment
EG0000 events0 affected39 at risk
EG0011 events1 affected40 at risk
EG0020 events0 affected39 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA v27.0
Systematic Assessment
EG0000 events0 affected39 at risk
EG0010 events0 affected40 at risk
EG0021 events1 affected39 at risk
EG003
Humerus fracture
Injury, poisoning and procedural complications
MedDRA v27.0
Systematic Assessment
EG0000 events0 affected39 at risk
EG0010 events0 affected40 at risk
EG0020 events0 affected39 at risk
EG003
Post procedural haemorrhage
Injury, poisoning and procedural complications
MedDRA v27.0
Systematic Assessment
EG0000 events0 affected39 at risk
EG0010 events0 affected40 at risk
EG0021 events1 affected39 at risk
EG003
Subdural haematoma
Injury, poisoning and procedural complications
MedDRA v27.0
Systematic Assessment
EG0001 events1 affected39 at risk
EG0010 events0 affected40 at risk
EG0020 events0 affected39 at risk
EG003
Transfusion reaction
Injury, poisoning and procedural complications
MedDRA v27.0
Systematic Assessment
EG0000 events0 affected39 at risk
EG0010 events0 affected40 at risk
EG0021 events1 affected39 at risk
EG003
Hypercalcaemia
Metabolism and nutrition disorders
MedDRA v27.0
Systematic Assessment
EG0001 events1 affected39 at risk
EG0011 events1 affected40 at risk
EG0021 events1 affected39 at risk
EG003
Hypernatraemia
Metabolism and nutrition disorders
MedDRA v27.0
Systematic Assessment
EG0001 events1 affected39 at risk
EG0010 events0 affected40 at risk
EG0020 events0 affected39 at risk
EG003
Hypovolaemia
Metabolism and nutrition disorders
MedDRA v27.0
Systematic Assessment
EG0000 events0 affected39 at risk
EG0010 events0 affected40 at risk
EG0021 events1 affected39 at risk
EG003
Groin pain
Musculoskeletal and connective tissue disorders
MedDRA v27.0
Systematic Assessment
EG0000 events0 affected39 at risk
EG0011 events1 affected40 at risk
EG0020 events0 affected39 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA v27.0
Systematic Assessment
EG0001 events1 affected39 at risk
EG0010 events0 affected40 at risk
EG0020 events0 affected39 at risk
EG003
Bone lesion
Musculoskeletal and connective tissue disorders
MedDRA v27.0
Systematic Assessment
EG0000 events0 affected39 at risk
EG0010 events0 affected40 at risk
EG0021 events1 affected39 at risk
EG003
Muscular weakness
Musculoskeletal and connective tissue disorders
MedDRA v27.0
Systematic Assessment
EG0002 events1 affected39 at risk
EG0010 events0 affected40 at risk
EG0020 events0 affected39 at risk
EG003
Musculoskeletal chest pain
Musculoskeletal and connective tissue disorders
MedDRA v27.0
Systematic Assessment
EG0001 events1 affected39 at risk
EG0010 events0 affected40 at risk
EG0020 events0 affected39 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA v27.0
Systematic Assessment
EG0001 events1 affected39 at risk
EG0010 events0 affected40 at risk
EG0020 events0 affected39 at risk
EG003
Colitis
Gastrointestinal disorders
MedDRA v27.0
Systematic Assessment
EG0001 events1 affected39 at risk
EG0010 events0 affected40 at risk
EG0020 events0 affected39 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA v27.0
Systematic Assessment
EG0000 events0 affected39 at risk
EG0010 events0 affected40 at risk
EG0020 events0 affected39 at risk
EG003
Gingival bleeding
Gastrointestinal disorders
MedDRA v27.0
Systematic Assessment
EG0000 events0 affected39 at risk
EG0010 events0 affected40 at risk
EG0020 events0 affected39 at risk
EG003
Photophobia
Eye disorders
MedDRA v27.0
Systematic Assessment
EG0001 events1 affected39 at risk
EG0010 events0 affected40 at risk
EG0020 events0 affected39 at risk
EG003
Drug-induced liver injury
Hepatobiliary disorders
MedDRA v27.0
Systematic Assessment
EG0001 events1 affected39 at risk
EG0010 events0 affected40 at risk
EG0020 events0 affected39 at risk
EG003
Jaundice cholestatic
Hepatobiliary disorders
MedDRA v27.0
Systematic Assessment
EG0000 events0 affected39 at risk
EG0010 events0 affected40 at risk
EG0021 events1 affected39 at risk
EG003
Cytokine release syndrome
Immune system disorders
MedDRA v27.0
Systematic Assessment
EG0000 events0 affected39 at risk
EG0011 events1 affected40 at risk
EG0020 events0 affected39 at risk
EG003
Blood creatinine increased
Investigations
MedDRA v27.0
Systematic Assessment
EG0000 events0 affected39 at risk
EG0011 events1 affected40 at risk
EG0020 events0 affected39 at risk
EG003
Blood lactate dehydrogenase increased
Investigations
MedDRA v27.0
Systematic Assessment
EG0000 events0 affected39 at risk
EG0010 events0 affected40 at risk
EG0020 events0 affected39 at risk
EG003
Spinal cord compression
Nervous system disorders
MedDRA v27.0
Systematic Assessment
EG0000 events0 affected39 at risk
EG0011 events1 affected40 at risk
EG0020 events0 affected39 at risk
EG003
Somnolence
Nervous system disorders
MedDRA v27.0
Systematic Assessment
EG0000 events0 affected39 at risk
EG0010 events0 affected40 at risk
EG0021 events1 affected39 at risk
EG003
Confusional state
Psychiatric disorders
MedDRA v27.0
Systematic Assessment
EG0000 events0 affected39 at risk
EG0011 events1 affected40 at risk
EG0020 events0 affected39 at risk
EG003
Delirium
Psychiatric disorders
MedDRA v27.0
Systematic Assessment
EG0000 events0 affected39 at risk
EG0010 events0 affected40 at risk
EG0021 events1 affected39 at risk
EG003
Acute kidney injury
Renal and urinary disorders
MedDRA v27.0
Systematic Assessment
EG0000 events0 affected39 at risk
EG0010 events0 affected40 at risk
EG0021 events1 affected39 at risk
EG003
Chronic kidney disease
Renal and urinary disorders
MedDRA v27.0
Systematic Assessment
EG0001 events1 affected39 at risk
EG0010 events0 affected40 at risk
EG0020 events0 affected39 at risk
EG003
Epistaxis
Respiratory, thoracic and mediastinal disorders
MedDRA v27.0
Systematic Assessment
EG0002 events1 affected39 at risk
EG0010 events0 affected40 at risk
EG0020 events0 affected39 at risk
EG003
Haemoptysis
Respiratory, thoracic and mediastinal disorders
MedDRA v27.0
Systematic Assessment
EG0000 events0 affected39 at risk
EG0010 events0 affected40 at risk
EG0021 events1 affected39 at risk
EG003
Pleural effusion
Respiratory, thoracic and mediastinal disorders
MedDRA v27.0
Systematic Assessment
EG0000 events0 affected39 at risk
EG0010 events0 affected40 at risk
EG0021 events1 affected39 at risk
EG003
Respiratory distress
Respiratory, thoracic and mediastinal disorders
MedDRA v27.0
Systematic Assessment
EG0000 events0 affected39 at risk
EG0010 events0 affected40 at risk
EG0020 events0 affected39 at risk
EG003
Deep vein thrombosis
Vascular disorders
MedDRA v27.0
Systematic Assessment
EG0001 events1 affected39 at risk
EG0010 events0 affected40 at risk
EG0020 events0 affected39 at risk
EG003
Pelvic venous thrombosis
Vascular disorders
MedDRA v27.0
Systematic Assessment
EG0000 events0 affected39 at risk
EG0010 events0 affected40 at risk
EG0021 events1 affected39 at risk
EG003
Cardiac failure
Cardiac disorders
MedDRA v27.0
Systematic Assessment
EG0000 events0 affected39 at risk
EG0010 events0 affected40 at risk
EG0021 events1 affected39 at risk
EG003
Cardio-respiratory arrest
Cardiac disorders
MedDRA v27.0
Systematic Assessment
EG0000 events0 affected39 at risk
EG0010 events0 affected40 at risk
EG0021 events1 affected39 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA v27.0
Systematic Assessment
EG00016 events9 affected39 at risk
EG00115 events12 affected40 at risk
EG00213 events12 affected39 at risk
EG00323 events15 affected40 at risk
EG0044 events4 affected17 at risk
Iron deficiency anaemia
Blood and lymphatic system disorders
MedDRA v27.0
Systematic Assessment
EG0000 events0 affected39 at risk
EG0010 events0 affected40 at risk
EG0020 events0 affected39 at risk
EG003
Leukopenia
Blood and lymphatic system disorders
MedDRA v27.0
Systematic Assessment
EG0000 events0 affected39 at risk
EG0012 events2 affected40 at risk
EG0020 events0 affected39 at risk
EG003
Lymphopenia
Blood and lymphatic system disorders
MedDRA v27.0
Systematic Assessment
EG0002 events2 affected39 at risk
EG0010 events0 affected40 at risk
EG0022 events2 affected39 at risk
EG003
Neutropenia
Blood and lymphatic system disorders
MedDRA v27.0
Systematic Assessment
EG0003 events3 affected39 at risk
EG00111 events8 affected40 at risk
EG0023 events3 affected39 at risk
EG003
Thrombocytopenia
Blood and lymphatic system disorders
MedDRA v27.0
Systematic Assessment
EG00017 events11 affected39 at risk
EG00126 events17 affected40 at risk
EG00220 events13 affected39 at risk
EG003
Vertigo
Ear and labyrinth disorders
MedDRA v27.0
Systematic Assessment
EG0000 events0 affected39 at risk
EG0010 events0 affected40 at risk
EG0021 events1 affected39 at risk
EG003
Cataract
Eye disorders
MedDRA v27.0
Systematic Assessment
EG0007 events5 affected39 at risk
EG0014 events4 affected40 at risk
EG0023 events2 affected39 at risk
EG003
Corneal epithelial microcysts
Eye disorders
MedDRA v27.0
Systematic Assessment
EG0000 events0 affected39 at risk
EG0010 events0 affected40 at risk
EG0020 events0 affected39 at risk
EG003
Corneal erosion
Eye disorders
MedDRA v27.0
Systematic Assessment
EG0000 events0 affected39 at risk
EG0013 events2 affected40 at risk
EG0020 events0 affected39 at risk
EG003
Dry eye
Eye disorders
MedDRA v27.0
Systematic Assessment
EG00025 events15 affected39 at risk
EG00117 events12 affected40 at risk
EG00233 events12 affected39 at risk
EG003
Eye irritation
Eye disorders
MedDRA v27.0
Systematic Assessment
EG00020 events11 affected39 at risk
EG00119 events9 affected40 at risk
EG00232 events11 affected39 at risk
EG003
Eye pain
Eye disorders
MedDRA v27.0
Systematic Assessment
EG00013 events9 affected39 at risk
EG0013 events2 affected40 at risk
EG00225 events6 affected39 at risk
EG003
Eye pruritus
Eye disorders
MedDRA v27.0
Systematic Assessment
EG0003 events3 affected39 at risk
EG0010 events0 affected40 at risk
EG0020 events0 affected39 at risk
EG003
Eyelid irritation
Eye disorders
MedDRA v27.0
Systematic Assessment
EG0000 events0 affected39 at risk
EG0010 events0 affected40 at risk
EG0020 events0 affected39 at risk
EG003
Foreign body sensation in eyes
Eye disorders
MedDRA v27.0
Systematic Assessment
EG00012 events7 affected39 at risk
EG00114 events7 affected40 at risk
EG00235 events11 affected39 at risk
EG003
Lacrimation increased
Eye disorders
MedDRA v27.0
Systematic Assessment
EG0004 events3 affected39 at risk
EG0014 events4 affected40 at risk
EG0020 events0 affected39 at risk
EG003
Photophobia
Eye disorders
MedDRA v27.0
Systematic Assessment
EG00012 events8 affected39 at risk
EG00119 events10 affected40 at risk
EG00219 events10 affected39 at risk
EG003
Punctate keratitis
Eye disorders
MedDRA v27.0
Systematic Assessment
EG0000 events0 affected39 at risk
EG0010 events0 affected40 at risk
EG0020 events0 affected39 at risk
EG003
Trichiasis
Eye disorders
MedDRA v27.0
Systematic Assessment
EG0000 events0 affected39 at risk
EG0010 events0 affected40 at risk
EG0020 events0 affected39 at risk
EG003
Ulcerative keratitis
Eye disorders
MedDRA v27.0
Systematic Assessment
EG0000 events0 affected39 at risk
EG0010 events0 affected40 at risk
EG0020 events0 affected39 at risk
EG003
Vision blurred
Eye disorders
MedDRA v27.0
Systematic Assessment
EG00036 events16 affected39 at risk
EG00133 events12 affected40 at risk
EG00253 events18 affected39 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA v27.0
Systematic Assessment
EG0002 events2 affected39 at risk
EG0011 events1 affected40 at risk
EG0021 events1 affected39 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
MedDRA v27.0
Systematic Assessment
EG0001 events1 affected39 at risk
EG0010 events0 affected40 at risk
EG0020 events0 affected39 at risk
EG003
Anal incontinence
Gastrointestinal disorders
MedDRA v27.0
Systematic Assessment
EG0000 events0 affected39 at risk
EG0010 events0 affected40 at risk
EG0020 events0 affected39 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA v27.0
Systematic Assessment
EG0007 events6 affected39 at risk
EG0012 events2 affected40 at risk
EG0026 events6 affected39 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA v27.0
Systematic Assessment
EG0004 events4 affected39 at risk
EG0013 events2 affected40 at risk
EG0024 events4 affected39 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA v27.0
Systematic Assessment
EG0004 events3 affected39 at risk
EG0014 events3 affected40 at risk
EG0029 events8 affected39 at risk
EG003
Stomatitis
Gastrointestinal disorders
MedDRA v27.0
Systematic Assessment
EG0000 events0 affected39 at risk
EG0010 events0 affected40 at risk
EG0020 events0 affected39 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA v27.0
Systematic Assessment
EG0000 events0 affected39 at risk
EG0012 events2 affected40 at risk
EG0023 events3 affected39 at risk
EG003
Asthenia
General disorders
MedDRA v27.0
Systematic Assessment
EG0002 events2 affected39 at risk
EG0013 events3 affected40 at risk
EG0023 events3 affected39 at risk
EG003
Chest pain
General disorders
MedDRA v27.0
Systematic Assessment
EG0000 events0 affected39 at risk
EG0010 events0 affected40 at risk
EG0022 events2 affected39 at risk
EG003
Fatigue
General disorders
MedDRA v27.0
Systematic Assessment
EG0006 events6 affected39 at risk
EG0016 events6 affected40 at risk
EG0025 events4 affected39 at risk
EG003
Pyrexia
General disorders
MedDRA v27.0
Systematic Assessment
EG0004 events4 affected39 at risk
EG0013 events3 affected40 at risk
EG0027 events7 affected39 at risk
EG003
Sensation of foreign body
General disorders
MedDRA v27.0
Systematic Assessment
EG0000 events0 affected39 at risk
EG0010 events0 affected40 at risk
EG0020 events0 affected39 at risk
EG003
Swelling
General disorders
MedDRA v27.0
Systematic Assessment
EG0000 events0 affected39 at risk
EG0010 events0 affected40 at risk
EG0022 events2 affected39 at risk
EG003
Cytokine release syndrome
Immune system disorders
MedDRA v27.0
Systematic Assessment
EG0000 events0 affected39 at risk
EG0013 events3 affected40 at risk
EG0020 events0 affected39 at risk
EG003
COVID-19
Infections and infestations
MedDRA v27.0
Systematic Assessment
EG0005 events5 affected39 at risk
EG0011 events1 affected40 at risk
EG0022 events2 affected39 at risk
EG003
Candida infection
Infections and infestations
MedDRA v27.0
Systematic Assessment
EG0000 events0 affected39 at risk
EG0010 events0 affected40 at risk
EG0021 events1 affected39 at risk
EG003
Conjunctivitis
Infections and infestations
MedDRA v27.0
Systematic Assessment
EG0000 events0 affected39 at risk
EG0011 events1 affected40 at risk
EG0021 events1 affected39 at risk
EG003
Cystitis
Infections and infestations
MedDRA v27.0
Systematic Assessment
EG0000 events0 affected39 at risk
EG0011 events1 affected40 at risk
EG0022 events2 affected39 at risk
EG003
Gastroenteritis
Infections and infestations
MedDRA v27.0
Systematic Assessment
EG0000 events0 affected39 at risk
EG0011 events1 affected40 at risk
EG0020 events0 affected39 at risk
EG003
Influenza
Infections and infestations
MedDRA v27.0
Systematic Assessment
EG0000 events0 affected39 at risk
EG0013 events3 affected40 at risk
EG0020 events0 affected39 at risk
EG003
Periorbital cellulitis
Infections and infestations
MedDRA v27.0
Systematic Assessment
EG0000 events0 affected39 at risk
EG0010 events0 affected40 at risk
EG0020 events0 affected39 at risk
EG003
Pharyngitis
Infections and infestations
MedDRA v27.0
Systematic Assessment
EG0000 events0 affected39 at risk
EG0012 events2 affected40 at risk
EG0020 events0 affected39 at risk
EG003
Pneumonia
Infections and infestations
MedDRA v27.0
Systematic Assessment
EG0004 events3 affected39 at risk
EG0011 events1 affected40 at risk
EG0020 events0 affected39 at risk
EG003
Respiratory tract infection
Infections and infestations
MedDRA v27.0
Systematic Assessment
EG0000 events0 affected39 at risk
EG0012 events2 affected40 at risk
EG0020 events0 affected39 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA v27.0
Systematic Assessment
EG0009 events8 affected39 at risk
EG0015 events4 affected40 at risk
EG0023 events3 affected39 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA v27.0
Systematic Assessment
EG0006 events6 affected39 at risk
EG0013 events3 affected40 at risk
EG0021 events1 affected39 at risk
EG003
Eye injury
Injury, poisoning and procedural complications
MedDRA v27.0
Systematic Assessment
EG0000 events0 affected39 at risk
EG0010 events0 affected40 at risk
EG0020 events0 affected39 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA v27.0
Systematic Assessment
EG0003 events3 affected39 at risk
EG0010 events0 affected40 at risk
EG0020 events0 affected39 at risk
EG003
Humerus fracture
Injury, poisoning and procedural complications
MedDRA v27.0
Systematic Assessment
EG0001 events1 affected39 at risk
EG0010 events0 affected40 at risk
EG0020 events0 affected39 at risk
EG003
Infusion related reaction
Injury, poisoning and procedural complications
MedDRA v27.0
Systematic Assessment
EG0006 events5 affected39 at risk
EG0013 events2 affected40 at risk
EG0023 events2 affected39 at risk
EG003
Rib fracture
Injury, poisoning and procedural complications
MedDRA v27.0
Systematic Assessment
EG0002 events2 affected39 at risk
EG0010 events0 affected40 at risk
EG0020 events0 affected39 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA v27.0
Systematic Assessment
EG0003 events3 affected39 at risk
EG0012 events2 affected40 at risk
EG0022 events2 affected39 at risk
EG003
Aspartate aminotransferase increased
Investigations
MedDRA v27.0
Systematic Assessment
EG0006 events4 affected39 at risk
EG0018 events6 affected40 at risk
EG0025 events4 affected39 at risk
EG003
Blood alkaline phosphatase increased
Investigations
MedDRA v27.0
Systematic Assessment
EG0001 events1 affected39 at risk
EG0013 events2 affected40 at risk
EG0023 events1 affected39 at risk
EG003
Blood bilirubin increased
Investigations
MedDRA v27.0
Systematic Assessment
EG0000 events0 affected39 at risk
EG0010 events0 affected40 at risk
EG0020 events0 affected39 at risk
EG003
Blood creatine phosphokinase increased
Investigations
MedDRA v27.0
Systematic Assessment
EG0002 events2 affected39 at risk
EG0018 events2 affected40 at risk
EG0020 events0 affected39 at risk
EG003
Blood creatinine increased
Investigations
MedDRA v27.0
Systematic Assessment
EG0002 events1 affected39 at risk
EG0013 events3 affected40 at risk
EG0020 events0 affected39 at risk
EG003
Blood lactate dehydrogenase increased
Investigations
MedDRA v27.0
Systematic Assessment
EG0006 events6 affected39 at risk
EG0018 events3 affected40 at risk
EG0023 events3 affected39 at risk
EG003
Gamma-glutamyltransferase increased
Investigations
MedDRA v27.0
Systematic Assessment
EG0003 events3 affected39 at risk
EG0014 events4 affected40 at risk
EG0023 events3 affected39 at risk
EG003
Neutrophil count decreased
Investigations
MedDRA v27.0
Systematic Assessment
EG0001 events1 affected39 at risk
EG0010 events0 affected40 at risk
EG0020 events0 affected39 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA v27.0
Systematic Assessment
EG0003 events3 affected39 at risk
EG0010 events0 affected40 at risk
EG0024 events4 affected39 at risk
EG003
Hypercalcaemia
Metabolism and nutrition disorders
MedDRA v27.0
Systematic Assessment
EG0002 events2 affected39 at risk
EG0011 events1 affected40 at risk
EG0021 events1 affected39 at risk
EG003
Hyperkalaemia
Metabolism and nutrition disorders
MedDRA v27.0
Systematic Assessment
EG0000 events0 affected39 at risk
EG0014 events4 affected40 at risk
EG0021 events1 affected39 at risk
EG003
Hyperphosphataemia
Metabolism and nutrition disorders
MedDRA v27.0
Systematic Assessment
EG0000 events0 affected39 at risk
EG0012 events2 affected40 at risk
EG0020 events0 affected39 at risk
EG003
Hyperuricaemia
Metabolism and nutrition disorders
MedDRA v27.0
Systematic Assessment
EG0003 events3 affected39 at risk
EG0011 events1 affected40 at risk
EG0022 events2 affected39 at risk
EG003
Hypocalcaemia
Metabolism and nutrition disorders
MedDRA v27.0
Systematic Assessment
EG0002 events2 affected39 at risk
EG0012 events2 affected40 at risk
EG0021 events1 affected39 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
MedDRA v27.0
Systematic Assessment
EG0000 events0 affected39 at risk
EG0015 events2 affected40 at risk
EG0027 events5 affected39 at risk
EG003
Hypomagnesaemia
Metabolism and nutrition disorders
MedDRA v27.0
Systematic Assessment
EG0000 events0 affected39 at risk
EG0011 events1 affected40 at risk
EG0021 events1 affected39 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
MedDRA v27.0
Systematic Assessment
EG0000 events0 affected39 at risk
EG0013 events3 affected40 at risk
EG0022 events2 affected39 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA v27.0
Systematic Assessment
EG0003 events3 affected39 at risk
EG0014 events3 affected40 at risk
EG0025 events4 affected39 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA v27.0
Systematic Assessment
EG0002 events2 affected39 at risk
EG0014 events4 affected40 at risk
EG0023 events3 affected39 at risk
EG003
Bone pain
Musculoskeletal and connective tissue disorders
MedDRA v27.0
Systematic Assessment
EG0004 events3 affected39 at risk
EG0015 events5 affected40 at risk
EG0023 events2 affected39 at risk
EG003
Musculoskeletal chest pain
Musculoskeletal and connective tissue disorders
MedDRA v27.0
Systematic Assessment
EG0002 events2 affected39 at risk
EG0010 events0 affected40 at risk
EG0022 events2 affected39 at risk
EG003
Osteolysis
Musculoskeletal and connective tissue disorders
MedDRA v27.0
Systematic Assessment
EG0000 events0 affected39 at risk
EG0010 events0 affected40 at risk
EG0020 events0 affected39 at risk
EG003
Osteoporotic fracture
Musculoskeletal and connective tissue disorders
MedDRA v27.0
Systematic Assessment
EG0000 events0 affected39 at risk
EG0010 events0 affected40 at risk
EG0020 events0 affected39 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA v27.0
Systematic Assessment
EG0001 events1 affected39 at risk
EG0012 events2 affected40 at risk
EG0020 events0 affected39 at risk
EG003
Spinal pain
Musculoskeletal and connective tissue disorders
MedDRA v27.0
Systematic Assessment
EG0002 events2 affected39 at risk
EG0012 events2 affected40 at risk
EG0021 events1 affected39 at risk
EG003
Ocular neoplasm
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA v27.0
Systematic Assessment
EG0000 events0 affected39 at risk
EG0010 events0 affected40 at risk
EG0020 events0 affected39 at risk
EG003
Squamous cell carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA v27.0
Systematic Assessment
EG0000 events0 affected39 at risk
EG0010 events0 affected40 at risk
EG0020 events0 affected39 at risk
EG003
Dizziness
Nervous system disorders
MedDRA v27.0
Systematic Assessment
EG0001 events1 affected39 at risk
EG0010 events0 affected40 at risk
EG0022 events2 affected39 at risk
EG003
Headache
Nervous system disorders
MedDRA v27.0
Systematic Assessment
EG0001 events1 affected39 at risk
EG0012 events2 affected40 at risk
EG0021 events1 affected39 at risk
EG003
Somnolence
Nervous system disorders
MedDRA v27.0
Systematic Assessment
EG0000 events0 affected39 at risk
EG0010 events0 affected40 at risk
EG0022 events2 affected39 at risk
EG003
Anxiety
Psychiatric disorders
MedDRA v27.0
Systematic Assessment
EG0000 events0 affected39 at risk
EG0010 events0 affected40 at risk
EG0022 events2 affected39 at risk
EG003
Insomnia
Psychiatric disorders
MedDRA v27.0
Systematic Assessment
EG0000 events0 affected39 at risk
EG0012 events2 affected40 at risk
EG0023 events3 affected39 at risk
EG003
Intensive care unit delirium
Psychiatric disorders
MedDRA v27.0
Systematic Assessment
EG0000 events0 affected39 at risk
EG0010 events0 affected40 at risk
EG0020 events0 affected39 at risk
EG003
Acute kidney injury
Renal and urinary disorders
MedDRA v27.0
Systematic Assessment
EG0002 events2 affected39 at risk
EG0010 events0 affected40 at risk
EG0021 events1 affected39 at risk
EG003
Haematuria
Renal and urinary disorders
MedDRA v27.0
Systematic Assessment
EG0004 events4 affected39 at risk
EG0010 events0 affected40 at risk
EG0020 events0 affected39 at risk
EG003
Proteinuria
Renal and urinary disorders
MedDRA v27.0
Systematic Assessment
EG0003 events2 affected39 at risk
EG0012 events2 affected40 at risk
EG0021 events1 affected39 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA v27.0
Systematic Assessment
EG0003 events3 affected39 at risk
EG0012 events2 affected40 at risk
EG0020 events0 affected39 at risk
EG003
Epistaxis
Respiratory, thoracic and mediastinal disorders
MedDRA v27.0
Systematic Assessment
EG0001 events1 affected39 at risk
EG0014 events4 affected40 at risk
EG0022 events2 affected39 at risk
EG003
Pleural effusion
Respiratory, thoracic and mediastinal disorders
MedDRA v27.0
Systematic Assessment
EG0001 events1 affected39 at risk
EG0010 events0 affected40 at risk
EG0022 events2 affected39 at risk
EG003
Pneumonitis
Respiratory, thoracic and mediastinal disorders
MedDRA v27.0
Systematic Assessment
EG0000 events0 affected39 at risk
EG0010 events0 affected40 at risk
EG0020 events0 affected39 at risk
EG003
Productive cough
Respiratory, thoracic and mediastinal disorders
MedDRA v27.0
Systematic Assessment
EG0000 events0 affected39 at risk
EG0010 events0 affected40 at risk
EG0022 events2 affected39 at risk
EG003
Decubitus ulcer
Skin and subcutaneous tissue disorders
MedDRA v27.0
Systematic Assessment
EG0002 events2 affected39 at risk
EG0010 events0 affected40 at risk
EG0020 events0 affected39 at risk
EG003
Skin ulcer
Skin and subcutaneous tissue disorders
MedDRA v27.0
Systematic Assessment
EG0002 events2 affected39 at risk
EG0011 events1 affected40 at risk
EG0020 events0 affected39 at risk
EG003
Hypertension
Vascular disorders
MedDRA v27.0
Systematic Assessment
EG0003 events3 affected39 at risk
EG0011 events1 affected40 at risk
EG0023 events3 affected39 at risk
EG003
Hypotension
Vascular disorders
MedDRA v27.0
Systematic Assessment
EG0002 events2 affected39 at risk
EG0010 events0 affected40 at risk
EG0021 events1 affected39 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single site data not precede the primary publication of the entire clinical trial.
Arm C: Belantamab Mafodotin 2.5 mg/kg Every 6 Weeks (Q6W)
Participants with RRMM received belantamab mafodotin as 2.5 mg/kg dose on Day 1 of every 6 weeks (Q6W) as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death.
OG003
Arm D: Belantamab Mafodotin 1.9 mg/kg Q6W
Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of Q6W as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death.
OG004
Arm E: Belantamab Mafodotin 1.9 mg/kg Q6W (Based on OSDI + Visual Acuity [VA] Assessment)
Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of Q6W as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death. For this arm, dose modification decisions were determined by the results of the Ocular Surface Disease Index (OSDI) questionnaire or VA assessments using Snellen chart. The OSDI scale assesses the severity of eye symptoms and their impact and Snellen chart is for the assessment of visual acuity.
Units
Counts
Participants
OG00039
OG00140
OG00239
OG00340
OG00417
Title
Denominators
Categories
Title
Measurements
OG00026
OG00125
OG00223
OG00324
OG00412
OG002
Arm C: Belantamab Mafodotin 2.5 mg/kg Every 6 Weeks (Q6W)
Participants with RRMM received belantamab mafodotin as 2.5 mg/kg dose on Day 1 of every 6 weeks (Q6W) as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death.
OG003
Arm D: Belantamab Mafodotin 1.9 mg/kg Q6W
Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of Q6W as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death.
OG004
Arm E: Belantamab Mafodotin 1.9 mg/kg Q6W (Based on OSDI + Visual Acuity [VA] Assessment)
Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of Q6W as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death. For this arm, dose modification decisions were determined by the results of the Ocular Surface Disease Index (OSDI) questionnaire or VA assessments using Snellen chart. The OSDI scale assesses the severity of eye symptoms and their impact and Snellen chart is for the assessment of visual acuity.
Units
Counts
Participants
OG00039
OG00140
OG00239
OG00340
OG00412
Title
Denominators
Categories
Grade 1
Title
Measurements
OG0003
OG00110
OG0027
OG00310
OG0042
Grade 2
Title
Measurements
OG00010
OG0014
OG0025
OG003
Grade 3
Title
Measurements
OG00015
OG0019
OG00211
OG003
Grade 4
Title
Measurements
OG0000
OG0013
OG0021
OG003
OG002
Arm C: Belantamab Mafodotin 2.5 mg/kg Every 6 Weeks (Q6W)
Participants with RRMM received belantamab mafodotin as 2.5 mg/kg dose on Day 1 of every 6 weeks (Q6W) as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death.
OG003
Arm D: Belantamab Mafodotin 1.9 mg/kg Q6W
Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of Q6W as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death.
OG004
Arm E: Belantamab Mafodotin 1.9 mg/kg Q6W (Based on OSDI + Visual Acuity [VA] Assessment)
Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of Q6W as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death. For this arm, dose modification decisions were determined by the results of the Ocular Surface Disease Index (OSDI) questionnaire or VA assessments using Snellen chart. The OSDI scale assesses the severity of eye symptoms and their impact and Snellen chart is for the assessment of visual acuity.
Units
Counts
Participants
OG00039
OG00140
OG00239
OG00340
OG00417
Title
Denominators
Categories
Grade 3
Title
Measurements
OG0004
OG0012
OG0024
OG0030
OG0043
Grade 4
Title
Measurements
OG0000
OG0010
OG0020
OG003
Grade 5
Title
Measurements
OG0000
OG0010
OG0020
OG003
OG003
Arm D: Belantamab Mafodotin 1.9 mg/kg Q6W
Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of Q6W as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death.
OG004
Arm E: Belantamab Mafodotin 1.9 mg/kg Q6W (Based on OSDI + Visual Acuity [VA] Assessment)
Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of Q6W as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death. For this arm, dose modification decisions were determined by the results of the Ocular Surface Disease Index (OSDI) questionnaire or VA assessments using Snellen chart. The OSDI scale assesses the severity of eye symptoms and their impact and Snellen chart is for the assessment of visual acuity.
Units
Counts
Participants
OG00039
OG00140
OG00239
OG00340
OG00417
Title
Denominators
Categories
Title
Measurements
OG00039.0(16 to 144)
OG00118.0(4 to 125)
OG00251.0(18 to 163)
OG00360.0(34 to 103)
OG00459.0(25 to 88)
OG002
Arm C: Belantamab Mafodotin 2.5 mg/kg Every 6 Weeks (Q6W)
Participants with RRMM received belantamab mafodotin as 2.5 mg/kg dose on Day 1 of every 6 weeks (Q6W) as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death.
OG003
Arm D: Belantamab Mafodotin 1.9 mg/kg Q6W
Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of Q6W as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death.
OG004
Arm E: Belantamab Mafodotin 1.9 mg/kg Q6W (Based on OSDI + Visual Acuity [VA] Assessment)
Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of Q6W as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death. For this arm, dose modification decisions were determined by the results of the Ocular Surface Disease Index (OSDI) questionnaire or VA assessments using Snellen chart. The OSDI scale assesses the severity of eye symptoms and their impact and Snellen chart is for the assessment of visual acuity.
Units
Counts
Participants
OG00026
OG00125
OG00223
OG00324
OG00412
Title
Denominators
Categories
Dose Reduction
Title
Measurements
OG00031
OG00128
OG00226
OG00323
OG00435
Dose Interruption/Delay
Title
Measurements
OG00059
OG00135
OG00228
OG003
Permanent Treatment Discontinuation
Title
Measurements
OG0000
OG0013
OG0020
OG003
OG002
Arm C: Belantamab Mafodotin 2.5 mg/kg Every 6 Weeks (Q6W)
Participants with RRMM received belantamab mafodotin as 2.5 mg/kg dose on Day 1 of every 6 weeks (Q6W) as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death.
OG003
Arm D: Belantamab Mafodotin 1.9 mg/kg Q6W
Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of Q6W as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death.
OG004
Arm E: Belantamab Mafodotin 1.9 mg/kg Q6W (Based on OSDI + Visual Acuity [VA] Assessment)
Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of Q6W as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death. For this arm, dose modification decisions were determined by the results of the Ocular Surface Disease Index (OSDI) questionnaire or VA assessments using Snellen chart. The OSDI scale assesses the severity of eye symptoms and their impact and Snellen chart is for the assessment of visual acuity.
Units
Counts
Participants
OG00025
OG00116
OG00217
OG00315
OG00411
Title
Denominators
Categories
At 3 months
Title
Measurements
OG00059
OG00132
OG00236
OG00333
OG00453
At 6 months
Title
Measurements
OG00064
OG00137
OG00241
OG003
At 9 months
Title
Measurements
OG00064
OG00140
OG00241
OG003
At 12 months
Title
Measurements
OG00064
OG00140
OG00244
OG003
OG002
Arm C: Belantamab Mafodotin 2.5 mg/kg Every 6 Weeks (Q6W)
Participants with RRMM received belantamab mafodotin as 2.5 mg/kg dose on Day 1 of every 6 weeks (Q6W) as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death.
OG003
Arm D: Belantamab Mafodotin 1.9 mg/kg Q6W
Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of Q6W as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death.
OG004
Arm E: Belantamab Mafodotin 1.9 mg/kg Q6W (Based on OSDI + Visual Acuity [VA] Assessment)
Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of Q6W as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death. For this arm, dose modification decisions were determined by the results of the Ocular Surface Disease Index (OSDI) questionnaire or VA assessments using Snellen chart. The OSDI scale assesses the severity of eye symptoms and their impact and Snellen chart is for the assessment of visual acuity.
Units
Counts
Participants
OG00039
OG00140
OG00239
OG00340
OG00417
Title
Denominators
Categories
Title
Measurements
OG0003.68± 1.078
OG0013.83± 1.017
OG0023.87± 1.092
OG0033.43± 1.031
OG0043.64± 0.892
Participants with RRMM received belantamab mafodotin as 2.5 mg/kg dose on Day 1 of every 6 weeks (Q6W) as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death.
OG003
Arm D: Belantamab Mafodotin 1.9 mg/kg Q6W
Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of Q6W as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death.
OG004
Arm E: Belantamab Mafodotin 1.9 mg/kg Q6W (Based on OSDI + Visual Acuity [VA] Assessment)
Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of Q6W as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death. For this arm, dose modification decisions were determined by the results of the Ocular Surface Disease Index (OSDI) questionnaire or VA assessments using Snellen chart. The OSDI scale assesses the severity of eye symptoms and their impact and Snellen chart is for the assessment of visual acuity.
Units
Counts
Participants
OG00025
OG00116
OG00217
OG00315
OG00411
Title
Denominators
Categories
Title
Measurements
OG00063.0(22 to 296)
OG00167.5(13 to 233)
OG00246.5(20 to 162)
OG00353.5(20 to 148)
OG00444.0(21 to 274)
Participants with RRMM received belantamab mafodotin as 2.5 mg/kg dose on Day 1 of every 6 weeks (Q6W) as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death.
OG003
Arm D: Belantamab Mafodotin 1.9 mg/kg Q6W
Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of Q6W as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death.
OG004
Arm E: Belantamab Mafodotin 1.9 mg/kg Q6W (Based on OSDI + Visual Acuity [VA] Assessment)
Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of Q6W as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death. For this arm, dose modification decisions were determined by the results of the Ocular Surface Disease Index (OSDI) questionnaire or VA assessments using Snellen chart. The OSDI scale assesses the severity of eye symptoms and their impact and Snellen chart is for the assessment of visual acuity.
Units
Counts
Participants
OG00025
OG00116
OG00217
OG00315
OG00411
Title
Denominators
Categories
Title
Measurements
OG00023.27(0.5 to 76.7)
OG00124.86(5.1 to 69.1)
OG00218.99(0.4 to 78.1)
OG00323.67(5.5 to 85.6)
OG00435.63(3.9 to 61.6)
Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of Q3W as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death.
OG002
Arm C: Belantamab Mafodotin 2.5 mg/kg Every 6 Weeks (Q6W)
Participants with RRMM received belantamab mafodotin as 2.5 mg/kg dose on Day 1 of every 6 weeks (Q6W) as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death.
OG003
Arm D: Belantamab Mafodotin 1.9 mg/kg Q6W
Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of Q6W as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death.
OG004
Arm E: Belantamab Mafodotin 1.9 mg/kg Q6W (Based on OSDI + Visual Acuity [VA] Assessment)
Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of Q6W as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death. For this arm, dose modification decisions were determined by the results of the Ocular Surface Disease Index (OSDI) questionnaire or VA assessments using Snellen chart. The OSDI scale assesses the severity of eye symptoms and their impact and Snellen chart is for the assessment of visual acuity.
Units
Counts
Participants
OG00022
OG00124
OG00223
OG00329
OG00411
Title
Denominators
Categories
Left Eye
ParticipantsOG00022
ParticipantsOG00124
ParticipantsOG00223
ParticipantsOG00329
ParticipantsOG00411
Title
Measurements
No change
OG00016
OG00120
OG00219
OG003
Right Eye
ParticipantsOG00021
ParticipantsOG00124
ParticipantsOG00223
ParticipantsOG00329
Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of Q3W as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death.
OG002
Arm C: Belantamab Mafodotin 2.5 mg/kg Every 6 Weeks (Q6W)
Participants with RRMM received belantamab mafodotin as 2.5 mg/kg dose on Day 1 of every 6 weeks (Q6W) as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death.
OG003
Arm D: Belantamab Mafodotin 1.9 mg/kg Q6W
Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of Q6W as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death.
OG004
Arm E: Belantamab Mafodotin 1.9 mg/kg Q6W (Based on OSDI + Visual Acuity [VA] Assessment)
Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of Q6W as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death. For this arm, dose modification decisions were determined by the results of the Ocular Surface Disease Index (OSDI) questionnaire or VA assessments using Snellen chart. The OSDI scale assesses the severity of eye symptoms and their impact and Snellen chart is for the assessment of visual acuity.
Units
Counts
Participants
OG00040
OG00140
OG00240
OG00340
OG00417
Title
Denominators
Categories
Title
Measurements
OG00033(18.6 to 49.1)
OG00125(12.7 to 41.2)
OG00228(14.6 to 43.9)
OG00325(12.7 to 41.2)
OG00418(3.8 to 43.4)
OG002
Arm C: Belantamab Mafodotin 2.5 mg/kg Every 6 Weeks (Q6W)
Participants with RRMM received belantamab mafodotin as 2.5 mg/kg dose on Day 1 of every 6 weeks (Q6W) as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death.
OG003
Arm D: Belantamab Mafodotin 1.9 mg/kg Q6W
Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of Q6W as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death.
OG004
Arm E: Belantamab Mafodotin 1.9 mg/kg Q6W (Based on OSDI + Visual Acuity [VA] Assessment)
Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of Q6W as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death. For this arm, dose modification decisions were determined by the results of the Ocular Surface Disease Index (OSDI) questionnaire or VA assessments using Snellen chart. The OSDI scale assesses the severity of eye symptoms and their impact and Snellen chart is for the assessment of visual acuity.
Units
Counts
Participants
OG00040
OG00140
OG00240
OG00340
OG00417
Title
Denominators
Categories
Title
Measurements
OG00025(12.7 to 41.2)
OG00118(7.3 to 32.8)
OG0028(1.6 to 20.4)
OG00315(5.7 to 29.8)
OG00418(3.8 to 43.4)
Participants with RRMM received belantamab mafodotin as 2.5 mg/kg dose on Day 1 of every 6 weeks (Q6W) as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death.
OG003
Arm D: Belantamab Mafodotin 1.9 mg/kg Q6W
Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of Q6W as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death.
OG004
Arm E: Belantamab Mafodotin 1.9 mg/kg Q6W (Based on OSDI + Visual Acuity [VA] Assessment)
Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of Q6W as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death. For this arm, dose modification decisions were determined by the results of the Ocular Surface Disease Index (OSDI) questionnaire or VA assessments using Snellen chart. The OSDI scale assesses the severity of eye symptoms and their impact and Snellen chart is for the assessment of visual acuity.
Units
Counts
Participants
OG00013
OG00110
OG00211
OG00310
OG0043
Title
Denominators
Categories
Title
Measurements
OG0000.8(0.7 to 1.4)
OG0011.1(0.7 to 2.1)
OG0020.7(0.7 to 0.9)
OG0030.8(0.7 to 2.2)
OG0041.5(0.8 to NA)The upper limit of the 95% confidence interval was not estimable at the time of the final analysis due to an insufficient number of participants with events within the length of follow-up in assessing the number of events
OG002
Arm C: Belantamab Mafodotin 2.5 mg/kg Every 6 Weeks (Q6W)
Participants with RRMM received belantamab mafodotin as 2.5 mg/kg dose on Day 1 of every 6 weeks (Q6W) as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death.
OG003
Arm D: Belantamab Mafodotin 1.9 mg/kg Q6W
Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of Q6W as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death.
OG004
Arm E: Belantamab Mafodotin 1.9 mg/kg Q6W (Based on OSDI + Visual Acuity [VA] Assessment)
Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of Q6W as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death. For this arm, dose modification decisions were determined by the results of the Ocular Surface Disease Index (OSDI) questionnaire or VA assessments using Snellen chart. The OSDI scale assesses the severity of eye symptoms and their impact and Snellen chart is for the assessment of visual acuity.
Units
Counts
Participants
OG00013
OG00110
OG00211
OG00310
OG0043
Title
Denominators
Categories
Title
Measurements
OG00015.9(4.9 to 21.4)
OG00122.1(4.2 to NA)The upper limit of 95% confidence interval was not estimable at the time of the final analysis due to an insufficient number of participants with events within the length of follow-up in assessing the number of events
OG0026.2(2.1 to 20.7)
OG0037.8(2.8 to 13.3)
OG00415.9(NA to NA)The lower and upper limit 95% confidence interval were not estimable at the time of the final analysis due to an insufficient number of participants with events within the length of follow-up in assessing the number of events
Participants with RRMM received belantamab mafodotin as 2.5 mg/kg dose on Day 1 of every 6 weeks (Q6W) as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death.
OG003
Arm D: Belantamab Mafodotin 1.9 mg/kg Q6W
Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of Q6W as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death.
OG004
Arm E: Belantamab Mafodotin 1.9 mg/kg Q6W (Based on OSDI + Visual Acuity [VA] Assessment)
Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of Q6W as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death. For this arm, dose modification decisions were determined by the results of the Ocular Surface Disease Index (OSDI) questionnaire or VA assessments using Snellen chart. The OSDI scale assesses the severity of eye symptoms and their impact and Snellen chart is for the assessment of visual acuity.
Units
Counts
Participants
OG00026
OG00129
OG00228
OG00332
OG00410
Title
Denominators
Categories
Title
Measurements
OG0006.0(2.8 to 10.4)
OG0012.1(1.0 to 9.1)
OG0022.8(1.7 to 4.2)
OG0032.7(1.9 to 5.6)
OG0042.9(0.8 to 17.3)
Participants with RRMM received belantamab mafodotin as 2.5 mg/kg dose on Day 1 of every 6 weeks (Q6W) as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death.
OG003
Arm D: Belantamab Mafodotin 1.9 mg/kg Q6W
Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of Q6W as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death.
OG004
Arm E: Belantamab Mafodotin 1.9 mg/kg Q6W (Based on OSDI + Visual Acuity [VA] Assessment)
Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of Q6W as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death. For this arm, dose modification decisions were determined by the results of the Ocular Surface Disease Index (OSDI) questionnaire or VA assessments using Snellen chart. The OSDI scale assesses the severity of eye symptoms and their impact and Snellen chart is for the assessment of visual acuity.
Units
Counts
Participants
OG00029
OG00130
OG00230
OG00334
OG00411
Title
Denominators
Categories
Title
Measurements
OG0005.7(2.8 to 9.0)
OG0012.1(1.0 to 3.6)
OG0022.8(1.4 to 3.5)
OG0032.7(1.9 to 4.2)
OG0042.8(0.8 to 17.3)
OG003
Arm D: Belantamab Mafodotin 1.9 mg/kg Q6W
Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of Q6W as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death.
OG004
Arm E: Belantamab Mafodotin 1.9 mg/kg Q6W (Based on OSDI + Visual Acuity [VA] Assessment)
Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of Q6W as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death. For this arm, dose modification decisions were determined by the results of the Ocular Surface Disease Index (OSDI) questionnaire or VA assessments using Snellen chart. The OSDI scale assesses the severity of eye symptoms and their impact and Snellen chart is for the assessment of visual acuity.
Units
Counts
Participants
OG00023
OG00123
OG00225
OG00321
OG0045
Title
Denominators
Categories
Title
Measurements
OG00020.9(8.1 to NA)The upper limit of 95% confidence interval was not estimable at the time of the final analysis due to an insufficient number of participants with events within the length of follow-up in assessing the number of events.
OG00115.0(7.6 to 20.1)
OG00213.5(7.5 to 21.2)
OG00314.5(7.7 to NA)The upper limit of 95% confidence interval was not estimable at the time of the final analysis due to an insufficient number of participants with events within the length of follow-up in assessing the number of events.
OG004NA(4.8 to NA)The median and upper limit 95% confidence interval was not estimable at the time of the final analysis due to an insufficient number of participants with events within the length of follow-up in assessing the number of events.
OG003
Arm D: Belantamab Mafodotin 1.9 mg/kg Q6W
Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of Q6W as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death.
OG004
Arm E: Belantamab Mafodotin 1.9 mg/kg Q6W (Based on OSDI + Visual Acuity [VA] Assessment)
Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of Q6W as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death. For this arm, dose modification decisions were determined by the results of the Ocular Surface Disease Index (OSDI) questionnaire or VA assessments using Snellen chart. The OSDI scale assesses the severity of eye symptoms and their impact and Snellen chart is for the assessment of visual acuity.
Units
Counts
Participants
OG00039
OG00140
OG00239
OG00340
OG00417
Title
Denominators
Categories
Title
Measurements
OG000100
OG001100
OG002100
OG003100
OG004100
Participants with RRMM received belantamab mafodotin as 2.5 mg/kg dose on Day 1 of every 6 weeks (Q6W) as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death.
OG003
Arm D: Belantamab Mafodotin 1.9 mg/kg Q6W
Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of Q6W as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death.
OG004
Arm E: Belantamab Mafodotin 1.9 mg/kg Q6W (Based on OSDI + Visual Acuity [VA] Assessment)
Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of Q6W as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death. For this arm, dose modification decisions were determined by the results of the Ocular Surface Disease Index (OSDI) questionnaire or VA assessments using Snellen chart. The OSDI scale assesses the severity of eye symptoms and their impact and Snellen chart is for the assessment of visual acuity.
Units
Counts
Participants
OG00039
OG00140
OG00239
OG00340
OG00417
Title
Denominators
Categories
Dose Reduction
Title
Measurements
OG0008
OG00113
OG0025
OG0035
OG00418
Dose Interruption/Delay
Title
Measurements
OG00031
OG00123
OG00213
OG003
Permanent Treatment Discontinuation
Title
Measurements
OG00010
OG0018
OG00210
OG003
OG002
Arm C: Belantamab Mafodotin 2.5 mg/kg Every 6 Weeks (Q6W)
Participants with RRMM received belantamab mafodotin as 2.5 mg/kg dose on Day 1 of every 6 weeks (Q6W) as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death.
OG003
Arm D: Belantamab Mafodotin 1.9 mg/kg Q6W
Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of Q6W as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death.
OG004
Arm E: Belantamab Mafodotin 1.9 mg/kg Q6W (Based on OSDI + Visual Acuity [VA] Assessment)
Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of Q6W as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death. For this arm, dose modification decisions were determined by the results of the Ocular Surface Disease Index (OSDI) questionnaire or VA assessments using Snellen chart. The OSDI scale assesses the severity of eye symptoms and their impact and Snellen chart is for the assessment of visual acuity.
Units
Counts
Participants
OG00038
OG00139
OG00238
OG00340
OG00416
Title
Denominators
Categories
Eosinophilia, Increase to Grades 1 to 4
ParticipantsOG00032
ParticipantsOG00125
ParticipantsOG00231
ParticipantsOG00322
ParticipantsOG00415
Title
Measurements
OG0003
OG0011
OG0022
OG003
Eosinophilia, Increase to Grades 2 to 4
ParticipantsOG00032
ParticipantsOG00125
ParticipantsOG00231
ParticipantsOG00322
Eosinophilia, Increase to Grades 3 to 4
ParticipantsOG00032
ParticipantsOG00125
ParticipantsOG00231
ParticipantsOG00322
Anemia, Increase to Grades 1 to 4
ParticipantsOG00038
ParticipantsOG00139
ParticipantsOG00238
ParticipantsOG00340
Anemia, Increase to Grades 2 to 4
ParticipantsOG00038
ParticipantsOG00139
ParticipantsOG00238
ParticipantsOG00340
Anemia, Increase to Grades 3 to 4
ParticipantsOG00038
ParticipantsOG00139
ParticipantsOG00238
ParticipantsOG00340
Hemoglobin increased, Increase to Grades 1 to 4
ParticipantsOG00038
ParticipantsOG00139
ParticipantsOG00238
ParticipantsOG003
Hemoglobin increased, Increase to Grades 2 to 4
ParticipantsOG00038
ParticipantsOG00139
ParticipantsOG00238
ParticipantsOG003
Hemoglobin increased, Increase to Grades 3 to 4
ParticipantsOG00038
ParticipantsOG00139
ParticipantsOG00238
ParticipantsOG003
Leukocytosis, Increase to Grades 1 to 4
ParticipantsOG00038
ParticipantsOG00139
ParticipantsOG00237
ParticipantsOG00340
Leukocytosis, Increase to Grades 2 to 4
ParticipantsOG00038
ParticipantsOG00139
ParticipantsOG00237
ParticipantsOG00340
Leukocytosis, Increase to Grades 3 to 4
ParticipantsOG00038
ParticipantsOG00139
ParticipantsOG00237
ParticipantsOG00340
White blood cell decreased, Increase to Grades 1 to 4
ParticipantsOG00038
ParticipantsOG00139
ParticipantsOG00237
ParticipantsOG003
White blood cell decreased, Increase to Grades 2 to 4
ParticipantsOG00038
ParticipantsOG00139
ParticipantsOG00237
ParticipantsOG003
White blood cell decreased, Increase to Grades 3 to 4
ParticipantsOG00038
ParticipantsOG00139
ParticipantsOG00237
ParticipantsOG003
Lymphocyte count decreased, Increase to Grades 1 to 4
ParticipantsOG00033
ParticipantsOG00128
ParticipantsOG00232
ParticipantsOG003
Lymphocyte count decreased, Increase to Grades 2 to 4
ParticipantsOG00033
ParticipantsOG00128
ParticipantsOG00232
ParticipantsOG003
Lymphocyte count decreased, Increase to Grades 3 to 4
ParticipantsOG00033
ParticipantsOG00128
ParticipantsOG00232
ParticipantsOG003
Lymphocyte count increased, Increase to Grades 1 to 4
ParticipantsOG00033
ParticipantsOG00128
ParticipantsOG00232
ParticipantsOG003
Lymphocyte count increased, Increase to Grades 2 to 4
ParticipantsOG00033
ParticipantsOG00128
ParticipantsOG00232
ParticipantsOG003
Lymphocyte count increased, Increase to Grades 3 to 4
ParticipantsOG00033
ParticipantsOG00128
ParticipantsOG00232
ParticipantsOG003
Neutrophil count decreased, Increase to Grades 1 to 4
ParticipantsOG00035
ParticipantsOG00129
ParticipantsOG00232
ParticipantsOG003
Neutrophil count decreased, Increase to Grades 2 to 4
ParticipantsOG00035
ParticipantsOG00129
ParticipantsOG00232
ParticipantsOG003
Neutrophil count decreased, Increase to Grades 3 to 4
ParticipantsOG00035
ParticipantsOG00129
ParticipantsOG00232
ParticipantsOG003
Platelet count decreased, Increase to Grades 1 to 4
ParticipantsOG00038
ParticipantsOG00139
ParticipantsOG00237
ParticipantsOG003
Platelet count decreased, Increase to Grades 2 to 4
ParticipantsOG00038
ParticipantsOG00139
ParticipantsOG00237
ParticipantsOG003
Platelet count decreased, Increase to Grades 3 to 4
ParticipantsOG00038
ParticipantsOG00139
ParticipantsOG00237
ParticipantsOG003
OG002
Arm C: Belantamab Mafodotin 2.5 mg/kg Every 6 Weeks (Q6W)
Participants with RRMM received belantamab mafodotin as 2.5 mg/kg dose on Day 1 of every 6 weeks (Q6W) as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death.
OG003
Arm D: Belantamab Mafodotin 1.9 mg/kg Q6W
Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of Q6W as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death.
OG004
Arm E: Belantamab Mafodotin 1.9 mg/kg Q6W (Based on OSDI + Visual Acuity [VA] Assessment)
Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of Q6W as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death. For this arm, dose modification decisions were determined by the results of the Ocular Surface Disease Index (OSDI) questionnaire or VA assessments using Snellen chart. The OSDI scale assesses the severity of eye symptoms and their impact and Snellen chart is for the assessment of visual acuity.
Units
Counts
Participants
OG00038
OG00138
OG00237
OG00340
OG00415
Title
Denominators
Categories
Alanine aminotransferase increased, Increase to Grades 1 to 4
ParticipantsOG00038
ParticipantsOG00136
ParticipantsOG00237
ParticipantsOG00340
ParticipantsOG00415
Title
Measurements
OG0009
OG00114
OG00212
OG003
Alanine aminotransferase increased, Increase to Grades 2 to 4
ParticipantsOG00038
ParticipantsOG00136
ParticipantsOG00237
ParticipantsOG003
Alanine aminotransferase increased, Increase to Grades 3 to 4
ParticipantsOG00038
ParticipantsOG00136
ParticipantsOG00237
ParticipantsOG003
Hypoalbuminemia, Increase to Grades 1 to 4
ParticipantsOG00038
ParticipantsOG00138
ParticipantsOG00236
ParticipantsOG00339
Hypoalbuminemia, Increase to Grades 2 to 4
ParticipantsOG00038
ParticipantsOG00138
ParticipantsOG00236
ParticipantsOG00339
Hypoalbuminemia, Increase to Grades 3 to 4
ParticipantsOG00038
ParticipantsOG00138
ParticipantsOG00236
ParticipantsOG00339
Alkaline phosphatase increased, Increase to Grades 1 to 4
ParticipantsOG00038
ParticipantsOG00136
ParticipantsOG00235
ParticipantsOG003
Alkaline phosphatase increased, Increase to Grades 2 to 4
ParticipantsOG00038
ParticipantsOG00136
ParticipantsOG00235
ParticipantsOG003
Alkaline phosphatase increased, Increase to Grades 3 to 4
ParticipantsOG00038
ParticipantsOG00136
ParticipantsOG00235
ParticipantsOG003
Aspartate aminotransferase increased, Increase to Grades 1 to 4
ParticipantsOG00038
ParticipantsOG00136
ParticipantsOG00236
ParticipantsOG003
Aspartate aminotransferase increased, Increase to Grades 2 to 4
ParticipantsOG00038
ParticipantsOG00136
ParticipantsOG00236
ParticipantsOG003
Aspartate aminotransferase increased, Increase to Grades 3 to 4
ParticipantsOG00038
ParticipantsOG00136
ParticipantsOG00236
ParticipantsOG003
Blood bilirubin increased, Increase to Grades 1 to 4
ParticipantsOG00038
ParticipantsOG00137
ParticipantsOG00236
ParticipantsOG003
Blood bilirubin increased, Increase to Grades 2 to 4
ParticipantsOG00038
ParticipantsOG00137
ParticipantsOG00236
ParticipantsOG003
Blood bilirubin increased, Increase to Grades 3 to 4
ParticipantsOG00038
ParticipantsOG00137
ParticipantsOG00236
ParticipantsOG003
Hypercalcemia, Increase to Grades 1 to 4
ParticipantsOG00038
ParticipantsOG00138
ParticipantsOG00236
ParticipantsOG00339
Hypercalcemia, Increase to Grades 2 to 4
ParticipantsOG00038
ParticipantsOG00138
ParticipantsOG00236
ParticipantsOG00339
Hypercalcemia, Increase to Grades 3 to 4
ParticipantsOG00038
ParticipantsOG00138
ParticipantsOG00236
ParticipantsOG00339
Hypocalcemia, Increase to Grades 1 to 4
ParticipantsOG00038
ParticipantsOG00138
ParticipantsOG00236
ParticipantsOG00339
Hypocalcemia, Increase to Grades 2 to 4
ParticipantsOG00038
ParticipantsOG00138
ParticipantsOG00236
ParticipantsOG00339
Hypocalcemia, Increase to Grades 3 to 4
ParticipantsOG00038
ParticipantsOG00138
ParticipantsOG00236
ParticipantsOG00339
CPK increased, Increase to Grades 1 to 4
ParticipantsOG00038
ParticipantsOG00136
ParticipantsOG00232
ParticipantsOG00338
CPK increased, Increase to Grades 2 to 4
ParticipantsOG00038
ParticipantsOG00136
ParticipantsOG00232
ParticipantsOG00338
CPK increased, Increase to Grades 3 to 4
ParticipantsOG00038
ParticipantsOG00136
ParticipantsOG00232
ParticipantsOG00338
Creatinine increased, Increase to Grades 1 to 4
ParticipantsOG00038
ParticipantsOG00138
ParticipantsOG00237
ParticipantsOG003
Creatinine increased, Increase to Grades 2 to 4
ParticipantsOG00038
ParticipantsOG00138
ParticipantsOG00237
ParticipantsOG003
Creatinine increased, Increase to Grades 3 to 4
ParticipantsOG00038
ParticipantsOG00138
ParticipantsOG00237
ParticipantsOG003
Chronic Kidney Disease, Increase to Grades 1 to 4
ParticipantsOG00019
ParticipantsOG00120
ParticipantsOG00221
ParticipantsOG003
Chronic Kidney Disease, Increase to Grades 2 to 4
ParticipantsOG00019
ParticipantsOG00120
ParticipantsOG00221
ParticipantsOG003
Chronic Kidney Disease, Increase to Grades 3 to 4
ParticipantsOG00019
ParticipantsOG00120
ParticipantsOG00221
ParticipantsOG003
GGT increased, Increase to Grades 1 to 4
ParticipantsOG00038
ParticipantsOG00136
ParticipantsOG00236
ParticipantsOG00340
GGT increased, Increase to Grades 2 to 4
ParticipantsOG00038
ParticipantsOG00136
ParticipantsOG00236
ParticipantsOG00340
GGT increased, Increase to Grades 3 to 4
ParticipantsOG00038
ParticipantsOG00136
ParticipantsOG00236
ParticipantsOG00340
Blood lactate dehydrogenase increased, Increase to Grades 1 to 4
ParticipantsOG00038
ParticipantsOG00137
ParticipantsOG00236
ParticipantsOG003
Blood lactate dehydrogenase increased, Increase to Grades 2 to 4
ParticipantsOG00038
ParticipantsOG00137
ParticipantsOG00236
ParticipantsOG003
Blood lactate dehydrogenase increased, Increase to Grades 3 to 4
ParticipantsOG00038
ParticipantsOG00137
ParticipantsOG00236
ParticipantsOG003
Hypermagnesemia, Increase to Grades 1 to 4
ParticipantsOG00038
ParticipantsOG00136
ParticipantsOG00235
ParticipantsOG00339
Hypermagnesemia, Increase to Grades 2 to 4
ParticipantsOG00038
ParticipantsOG00136
ParticipantsOG00235
ParticipantsOG00339
Hypermagnesemia, Increase to Grades 3 to 4
ParticipantsOG00038
ParticipantsOG00136
ParticipantsOG00235
ParticipantsOG00339
Hypomagnesemia, Increase to Grades 1 to 4
ParticipantsOG00038
ParticipantsOG00136
ParticipantsOG00235
ParticipantsOG00339
Hypomagnesemia, Increase to Grades 2 to 4
ParticipantsOG00038
ParticipantsOG00136
ParticipantsOG00235
ParticipantsOG00339
Hypomagnesemia, Increase to Grades 3 to 4
ParticipantsOG00038
ParticipantsOG00136
ParticipantsOG00235
ParticipantsOG00339
Hyperkalemia, Increase to Grades 1 to 4
ParticipantsOG00038
ParticipantsOG00137
ParticipantsOG00237
ParticipantsOG00340
Hyperkalemia, Increase to Grades 2 to 4
ParticipantsOG00038
ParticipantsOG00137
ParticipantsOG00237
ParticipantsOG00340
Hyperkalemia, Increase to Grades 3 to 4
ParticipantsOG00038
ParticipantsOG00137
ParticipantsOG00237
ParticipantsOG00340
Hypernatremia, Increase to Grades 1 to 4
ParticipantsOG00038
ParticipantsOG00138
ParticipantsOG00237
ParticipantsOG00340
Hypernatremia, Increase to Grades 2 to 4
ParticipantsOG00038
ParticipantsOG00138
ParticipantsOG00237
ParticipantsOG00340
Hypernatremia, Increase to Grades 3 to 4
ParticipantsOG00038
ParticipantsOG00138
ParticipantsOG00237
ParticipantsOG00340
Participants with RRMM received belantamab mafodotin as 2.5 mg/kg dose on Day 1 of every 6 weeks (Q6W) as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death.
OG003
Arm D: Belantamab Mafodotin 1.9 mg/kg Q6W
Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of Q6W as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death.
OG004
Arm E: Belantamab Mafodotin 1.9 mg/kg Q6W (Based on OSDI + Visual Acuity [VA] Assessment)
Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of Q6W as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death. For this arm, dose modification decisions were determined by the results of the Ocular Surface Disease Index (OSDI) questionnaire or VA assessments using Snellen chart. The OSDI scale assesses the severity of eye symptoms and their impact and Snellen chart is for the assessment of visual acuity.
Units
Counts
Participants
OG00037
OG00137
OG00232
OG00336
OG00415
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG003
Arm D: Belantamab Mafodotin 1.9 mg/kg Q6W
Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of Q6W as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death.
OG004
Arm E: Belantamab Mafodotin 1.9 mg/kg Q6W (Based on OSDI + Visual Acuity [VA] Assessment)
Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of Q6W as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death. For this arm, dose modification decisions were determined by the results of the Ocular Surface Disease Index (OSDI) questionnaire or VA assessments using Snellen chart. The OSDI scale assesses the severity of eye symptoms and their impact and Snellen chart is for the assessment of visual acuity.
Units
Counts
Participants
OG0000
OG0010
OG0020
OG0030
OG0040
Arm C: Belantamab Mafodotin 2.5 mg/kg Every 6 Weeks (Q6W)
Participants with RRMM received belantamab mafodotin as 2.5 mg/kg dose on Day 1 of every 6 weeks (Q6W) as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death.
OG003
Arm D: Belantamab Mafodotin 1.9 mg/kg Q6W
Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of Q6W as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death.
OG004
Arm E: Belantamab Mafodotin 1.9 mg/kg Q6W (Based on OSDI + Visual Acuity [VA] Assessment)
Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of Q6W as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death. For this arm, dose modification decisions were determined by the results of the Ocular Surface Disease Index (OSDI) questionnaire or VA assessments using Snellen chart. The OSDI scale assesses the severity of eye symptoms and their impact and Snellen chart is for the assessment of visual acuity.
Units
Counts
Participants
OG00038
OG00141
OG00239
OG00340
OG00417
Title
Denominators
Categories
Title
Measurements
OG00044.8± 22.8
OG00133.1± 23.2
OG00242.1± 24.7
OG00333.1± 18.3
OG00434.1± 26.8
OG003
Arm D: Belantamab Mafodotin 1.9 mg/kg Q6W
Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of Q6W as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death.
OG004
Arm E: Belantamab Mafodotin 1.9 mg/kg Q6W (Based on OSDI + Visual Acuity [VA] Assessment)
Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of Q6W as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death. For this arm, dose modification decisions were determined by the results of the Ocular Surface Disease Index (OSDI) questionnaire or VA assessments using Snellen chart. The OSDI scale assesses the severity of eye symptoms and their impact and Snellen chart is for the assessment of visual acuity.
Units
Counts
Participants
OG00038
OG00141
OG00239
OG00340
OG00417
Title
Denominators
Categories
Title
Measurements
OG0002.28± 56.7
OG0011.5± 62.4
OG0021.94± 69.3
OG0031.69± 50.2
OG0041.53± 62.1
OG003
Arm D: Belantamab Mafodotin 1.9 mg/kg Q6W
Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of Q6W as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death.
OG004
Arm E: Belantamab Mafodotin 1.9 mg/kg Q6W (Based on OSDI + Visual Acuity [VA] Assessment)
Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of Q6W as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death. For this arm, dose modification decisions were determined by the results of the Ocular Surface Disease Index (OSDI) questionnaire or VA assessments using Snellen chart. The OSDI scale assesses the severity of eye symptoms and their impact and Snellen chart is for the assessment of visual acuity.
Units
Counts
Participants
OG00038
OG00141
OG00239
OG00340
OG00417
Title
Denominators
Categories
Title
Measurements
OG0008.4± 32.2
OG0015.98± 34.6
OG0027.71± 38.6
OG0036.3± 27.1
OG0046.11± 40.6
Participants with RRMM received belantamab mafodotin as 2.5 mg/kg dose on Day 1 of every 6 weeks (Q6W) as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death.
OG003
Arm D: Belantamab Mafodotin 1.9 mg/kg Q6W
Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of Q6W as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death.
OG004
Arm E: Belantamab Mafodotin 1.9 mg/kg Q6W (Based on OSDI + Visual Acuity [VA] Assessment)
Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of Q6W as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death. For this arm, dose modification decisions were determined by the results of the Ocular Surface Disease Index (OSDI) questionnaire or VA assessments using Snellen chart. The OSDI scale assesses the severity of eye symptoms and their impact and Snellen chart is for the assessment of visual acuity.
Units
Counts
Participants
OG00038
OG00141
OG00239
OG00340
OG00417
Title
Denominators
Categories
Title
Measurements
OG0004233± 32.2
OG0013013± 34.6
OG0023886± 38.6
OG0033173± 27.1
OG0043079± 40.6
OG003
Arm D: Belantamab Mafodotin 1.9 mg/kg Q6W
Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of Q6W as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death.
OG004
Arm E: Belantamab Mafodotin 1.9 mg/kg Q6W (Based on OSDI + Visual Acuity [VA] Assessment)
Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of Q6W as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death. For this arm, dose modification decisions were determined by the results of the Ocular Surface Disease Index (OSDI) questionnaire or VA assessments using Snellen chart. The OSDI scale assesses the severity of eye symptoms and their impact and Snellen chart is for the assessment of visual acuity.
Units
Counts
Participants
OG00038
OG00141
OG00239
OG00340
OG00417
Title
Denominators
Categories
Title
Measurements
OG00013± 30.5
OG00112± 32.1
OG00212± 40
OG00312± 34.2
OG00413± 41.3
OG003
Arm D: Belantamab Mafodotin 1.9 mg/kg Q6W
Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of Q6W as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death.
OG004
Arm E: Belantamab Mafodotin 1.9 mg/kg Q6W (Based on OSDI + Visual Acuity [VA] Assessment)
Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of Q6W as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death. For this arm, dose modification decisions were determined by the results of the Ocular Surface Disease Index (OSDI) questionnaire or VA assessments using Snellen chart. The OSDI scale assesses the severity of eye symptoms and their impact and Snellen chart is for the assessment of visual acuity.
Units
Counts
Participants
OG00038
OG00141
OG00239
OG00340
OG00417
Title
Denominators
Categories
Title
Measurements
OG0000.8± 38.3
OG0010.83± 57.1
OG0020.84± 47.7
OG0030.74± 53.3
OG0040.86± 59.7
OG003
Arm D: Belantamab Mafodotin 1.9 mg/kg Q6W
Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of Q6W as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death.
OG004
Arm E: Belantamab Mafodotin 1.9 mg/kg Q6W (Based on OSDI + Visual Acuity [VA] Assessment)
Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of Q6W as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death. For this arm, dose modification decisions were determined by the results of the Ocular Surface Disease Index (OSDI) questionnaire or VA assessments using Snellen chart. The OSDI scale assesses the severity of eye symptoms and their impact and Snellen chart is for the assessment of visual acuity.