Study to Investigate Alternative Dosing Regimens of Belantamab Mafodotin in Participants With Relapsed or Refractory Multiple Myeloma (DREAMM 14)

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)

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.

Study Overview

• Status: Completed
• Conditions: Multiple Myeloma
• Intervention / Treatment: Drug: Belantamab mafodotin

• Study Type: Interventional
• Enrollment (Actual): 177
• Phase: Phase 2

Contacts and Locations

Study Locations

• Argentina
  • Buenos Aires, Argentina, C1181ACH
    • GSK Investigational Site
  • Capital Federal, Argentina, C1426ANZ
    • GSK Investigational Site
  • Ciudad Autonoma de Buenos Aire, Argentina, 1414
    • GSK Investigational Site
  • Pilar, Argentina, B1629AHJ
    • GSK Investigational Site
  • Rosario, Argentina, S2002
    • GSK Investigational Site
• Australia
  • New South Wales
    • Liverpool, New South Wales, Australia, 2170
      • GSK Investigational Site
    • Newcastle, New South Wales, Australia, 2298
      • GSK Investigational Site
  • South Australia
    • Woodville, South Australia, Australia, 5011
      • GSK Investigational Site
  • Victoria
    • East Melbourne, Victoria, Australia, 3002
      • GSK Investigational Site
• Brazil
  • Joinville, Brazil, 89201-260
    • GSK Investigational Site
  • Porto Alegre, Brazil, 90850-170
    • GSK Investigational Site
  • Rio de Janeiro, Brazil, 22271-110
    • GSK Investigational Site
  • Salvador, Brazil, 41253-190
    • GSK Investigational Site
  • São Paulo, Brazil, 04537-080
    • GSK Investigational Site
  • São Paulo, Brazil, 01236-030
    • GSK Investigational Site
• Canada
  • Quebec
    • Montreal, Quebec, Canada, H4J 1C5
      • GSK Investigational Site
• France
  • Avignon, France, 84902
    • GSK Investigational Site
  • Nice, France, 06189
    • GSK Investigational Site
  • Orléans, France, 45100
    • GSK Investigational Site
• Germany
  • Cottbus, Germany, 03048
    • GSK Investigational Site
  • Dresden, Germany, 01307
    • GSK Investigational Site
  • Greifswald, Germany, 17475
    • GSK Investigational Site
  • Hamburg, Germany, 22763
    • GSK Investigational Site
• Greece
  • Athens, Greece, 11528
    • GSK Investigational Site
  • Athens, Greece, 106 76
    • GSK Investigational Site
  • Athens, Greece, 12462
    • GSK Investigational Site
  • Rio Patras, Greece, 26504
    • GSK Investigational Site
• Ireland
  • Dublin, Ireland, 8
    • GSK Investigational Site
  • Dublin, Ireland, D09 V2N0
    • GSK Investigational Site
• Italy
  • Alessandria, Italy, 15121
    • GSK Investigational Site
  • Ascoli Piceno, Italy, 63100
    • GSK Investigational Site
  • Ferrara, Italy, 44124
    • GSK Investigational Site
  • Genova, Italy, 16132
    • GSK Investigational Site
  • Meldola FC, Italy, 47014
    • GSK Investigational Site
  • Reggio Emilia, Italy, 42123
    • GSK Investigational Site
  • Rimini, Italy, 47900
    • GSK Investigational Site
• Mexico
  • Mexico City, Mexico, 03720
    • GSK Investigational Site
  • Mexico City, Mexico, 03100
    • GSK Investigational Site
• Poland
  • Bydgoszcz, Poland, 85-168
    • GSK Investigational Site
  • Gdansk, Poland, 80-214
    • GSK Investigational Site
  • Katowice, Poland, 40-519
    • GSK Investigational Site
  • Lublin, Poland, 20-081
    • GSK Investigational Site
  • Poznan, Poland, 60-569
    • GSK Investigational Site
  • Torun, Poland, 87-100
    • GSK Investigational Site
  • Warsaw, Poland, 02-781
    • GSK Investigational Site
  • Wałbrzych, Poland, 58-309
    • GSK Investigational Site
  • Wroclaw, Poland, 50-367
    • GSK Investigational Site
• South Korea
  • Hwasun, South Korea, 58128
    • GSK Investigational Site
  • Pusan, South Korea, 49241
    • GSK Investigational Site
  • Seoul, South Korea, 03080
    • GSK Investigational Site
  • Seoul, South Korea, 06591
    • GSK Investigational Site
• Spain
  • Albacete, Spain, 02006
    • GSK Investigational Site
  • Barcelona, Spain, 08026
    • GSK Investigational Site
  • Córdoba, Spain, 140044
    • GSK Investigational Site
  • Girona, Spain, 17007
    • GSK Investigational Site
  • Oviedo, Spain, 33011
    • GSK Investigational Site
  • Terrassa - Barcelona, Spain, 08221
    • GSK Investigational Site
  • Valencia, Spain, 46010
    • GSK Investigational Site
• Switzerland
  • Bern, Switzerland, 3010
    • GSK Investigational Site
• Taiwan
  • Taichung, Taiwan, 404
    • GSK Investigational Site
  • Taichung, Taiwan, 40705
    • GSK Investigational Site
  • Tainan, Taiwan, 704
    • GSK Investigational Site
  • Taipei, Taiwan, 100
    • GSK Investigational Site
  • Taipei, Taiwan, 112
    • GSK Investigational Site
• Thailand
  • Bangkok, Thailand, 10330
    • GSK Investigational Site
  • Bangkok, Thailand, 10210
    • GSK Investigational Site
  • Chiang Mai, Thailand, 50200
    • GSK Investigational Site
  • Khon Kaen, Thailand, 40002
    • GSK Investigational Site
• United Kingdom
  • Leicester, United Kingdom, LE1 5WW
    • GSK Investigational Site
  • London, United Kingdom, W12 0HS
    • GSK Investigational Site
  • Stoke-on-Trent, United Kingdom, ST4 6QG
    • GSK Investigational Site
• United States
  • Florida
    • West Palm Beach, Florida, United States, 33401
      • GSK Investigational Site
  • Missouri
    • Kansas City, Missouri, United States, 64114
      • GSK Investigational Site
  • New York
    • New York, New York, United States, 10065
      • GSK Investigational Site
  • Tennessee
    • Chattanooga, Tennessee, United States, 37404
      • GSK Investigational Site
    • Nashville, Tennessee, United States, 37203
      • GSK Investigational Site
  • Texas
    • Houston, Texas, United States, 77090
      • GSK Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cohort 1: Participants receiving belantamab mafodotin at dose level (DL) 1	Drug: Belantamab mafodotin; Belantamab mafodotin will be administered.
Experimental: Cohort 2: Participants receiving belantamab mafodotin at DL 2	Drug: Belantamab mafodotin; Belantamab mafodotin will be administered.
Experimental: Cohort 3: Participants receiving belantamab mafodotin at DL 3	Drug: Belantamab mafodotin; Belantamab mafodotin will be administered.
Experimental: Cohort 4: Participants receiving belantamab mafodotin at DL 4	Drug: Belantamab mafodotin; Belantamab mafodotin will be administered.
Experimental: Cohort 5: Participants receiving belantamab mafodotin at DL4 with alternative dose modification	Drug: Belantamab mafodotin; Belantamab mafodotin will be administered.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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 Outcome Measures

Outcome Measure	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.	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.	C1 D1 Pre-dose, EOI, SOI + 2H; C1D2 SOI+24H; C1D4; C1D8-15, D21
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.	C1 D1 Pre-dose, EOI, SOI + 2H; C1D2 SOI+24H; C1D4; C1D8-15, D21
Half-life (t1/2) of Belantamab Mafodotin ADC	Plasma samples were collected for PK analysis of Belantamab mafodotin ADC	C1 D1 Pre-dose, EOI, SOI + 2H; C1D2 SOI+24H; C1D4; C1D8-15
Clearance (CL) for Belantamab Mafodotin ADC	Plasma samples were collected for PK analysis for belantamab mafodotin ADC.	C1 D1 Pre-dose, EOI, SOI + 2H; C1D2 SOI+24H; C1D4; C1D8-15
Steady-state Volume of Distribution (Vss) for Belantamab Mafodotin ADC	Plasma samples were collected for PK analysis for belantamab mafodotin ADC.	C1 D1 Pre-dose, EOI, SOI + 2H; C1D2 SOI+24H; C1D4; C1D8-15

Collaborators and Investigators

• Sponsor: GlaxoSmithKline
• Investigators: Study Director: GSK Clinical Trials, GlaxoSmithKline

Study record dates

Study Major Dates

• Study Start (Actual): March 3, 2022
• Primary Completion (Actual): August 19, 2024
• Study Completion (Actual): February 10, 2026

Study Registration Dates

• First Submitted: September 22, 2021
• First Submitted That Met QC Criteria: September 22, 2021
• First Posted (Actual): October 1, 2021

Study Record Updates

• Last Update Posted (Actual): May 5, 2026
• Last Update Submitted That Met QC Criteria: April 14, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: RRMM; Antibody drug conjugate; Relapsed or refractory multiple myeloma; Belantamab mafodotin; BLENREP; DREAMM14; GSK2857916; Alternative dosing
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Neoplasms; Disease Attributes; Immune System Diseases; Neoplasms by Histologic Type; Hematologic Diseases; Lymphoproliferative Disorders; Immunoproliferative Disorders; Neoplasms, Plasma Cell; Hemostatic Disorders; Paraproteinemias; Blood Protein Disorders; Hemorrhagic Disorders; Pathological Conditions, Signs and Symptoms; Hemic and Lymphatic Diseases; Recurrence; Multiple Myeloma; belantamab mafodotin
• Other Study ID Numbers: 209628; 2021-004151-16 (EudraCT Number); 2023-508213-16 (Registry Identifier: CTIS)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: GSK will assess requests from qualified researchers for anonymized individual patient-level data and related study documents. Data sharing is subject to certain criteria, conditions, and exceptions. For further information, refer to https://www.gsk-studyregister.com/About_GSK_Patient_Level_Data_Sharing_Final_13July2023.pdf.
• IPD Sharing Time Frame: IPD will be made available within 6 months of publishing the results of the primary endpoints, a key secondary endpoints and safety data of the study.
• IPD Sharing Access Criteria: Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No