DE Phase: Plasma Concentrations of Belantamab Mafodotin Antibody-Drug Conjugate (ADC)
Sub-study of Belantamab Mafodotin (GSK2857916) in Combination With Nirogacestat, Lenalidomide, and Dexamethasone in Participants With RRMM · Source last updated 2026-06-16
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
Measure
MEDIAN
Unit
Nanogram/ millilitre (ng/mL)
Interval / dispersion
Full Range
Time frame
Predose, end of infusion (EOI), and 2 hours postdose on Cycle 1 Day 1; anytime samples at Cycle 1 Day 4, 8, 29; Predose and EOI on Day 1 of Cycle 2, 4, 6, 9, 12; Predose on Cycle 18 Day 1; and end of treatment (~143 weeks)
What was measured
Blood samples were collected for PK analysis of belantamab mafodotin Antibody-Drug Conjugate (ADC). Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field. 'Number Analyzed' signifies participants evaluable for the specified timepoints.
Analysis population: Pharmacokinetic (PK) population included all participants in the safety population from whom at least one PK sample has been obtained and analyzed. The "0" participants analyzed represents that data was not collected or available for analysis at that particular time point for the respective Arms/Groups.
Participants with Relapsed/Refractory Multiple Myeloma (RRMM) received 0.5 mg/kg belantamab mafodotin intravenous (IV) infusion as powder for solution once every 4 weeks (Q4W) infused over 30- 60 minutes on day 1 of each 28-day cycle in combination with 100 mg Nirogacestat administered orally twice a day (BID) up to Day 28; with Lenalidomide 25 mg (10 mg if Estimated Glomerular Filtration (eGFR) is 40-60 milliLitre (mL)/minute/1.73 square meter (m)\^2) administered orally once daily (QD) from Day 1 to Day 21; and Dexamethasone 40 mg (20 mg for participants \>75 years old or BMI \<18.5 kg/m\^2) administered orally on days 1, 8, 15 and 22 of each 28-day cycle.
Participants with Relapsed/Refractory Multiple Myeloma (RRMM) received 1.0 mg/kg belantamab mafodotin intravenous (IV) infusion as powder for solution infused over 30- 60 minutes Q4W for cycle 1 and then Q8W for cycle 2 onwards on day 1 of 28-day cycle in Q4W and 56-day cycle in Q8W in combination with 100 mg Nirogacestat administered orally twice a day (BID) up to Day 28; with Lenalidomide 25 mg (10 mg if Estimated Glomerular Filtration (eGFR) is 40-60 milliLitre (mL)/minute/1.73 square meter (m)\^2) administered orally once daily (QD) from Day 1 to Day 21; and Dexamethasone 40 mg (20 mg for participants \>75 years old or BMI \<18.5 kg/m\^2) administered orally on days 1, 8, 15 and 22 of each 28-day cycle.
Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.
Full range is not applicable as only a single participant was analyzed.
group Id
OG001
lower Limit
NA
upper Limit
NA
value
666.0
denoms
counts
group Id
OG000
value
3
group Id
OG001
value
1
units
Participants
title
CYCLE 1 DAY 29, ANYTIME SAMPLE
categories
measurements
group Id
OG000
lower Limit
0
upper Limit
663
value
0.0
group Id
OG001
lower Limit
0
upper Limit
1820
value
0.0
denoms
counts
group Id
OG000
value
8
group Id
OG001
value
9
units
Participants
title
CYCLE 2 DAY 1, PRE-DOSE
categories
measurements
group Id
OG000
lower Limit
3370
upper Limit
15300
value
11700.0
group Id
OG001
lower Limit
19000
upper Limit
93800
value
23200.0
denoms
counts
group Id
OG000
value
9
group Id
OG001
value
9
units
Participants
title
CYCLE 2 DAY 1, END OF INFUSION
categories
measurements
group Id
OG000
lower Limit
0
upper Limit
0
value
0.0
group Id
OG001
lower Limit
0
upper Limit
2220
value
0.0
denoms
counts
group Id
OG000
value
5
group Id
OG001
value
6
units
Participants
title
CYCLE 4 DAY 1, PRE-DOSE
categories
measurements
group Id
OG000
lower Limit
7420
upper Limit
23100
value
17300.0
group Id
OG001
lower Limit
6720
upper Limit
25200
value
18350.0
denoms
counts
group Id
OG000
value
5
group Id
OG001
value
6
units
Participants
title
CYCLE 4 DAY 1, END OF INFUSION
categories
measurements
group Id
OG000
lower Limit
0
upper Limit
830
value
535.0
group Id
OG001
lower Limit
0
upper Limit
933
value
0.0
denoms
counts
group Id
OG000
value
3
group Id
OG001
value
5
units
Participants
title
CYCLE 6 DAY 1, PRE-DOSE
categories
measurements
group Id
OG000
lower Limit
11600
upper Limit
31400
value
15900.0
group Id
OG001
lower Limit
10600
upper Limit
22600
value
18400.0
denoms
counts
group Id
OG000
value
3
group Id
OG001
value
5
units
Participants
title
CYCLE 6 DAY 1, END OF INFUSION
denoms
counts
group Id
OG000
value
10
group Id
OG001
value
10
units
Participants
description
Blood samples were collected for PK analysis of belantamab mafodotin Antibody-Drug Conjugate (ADC). Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field. 'Number Analyzed' signifies participants evaluable for the specified timepoints.
dispersion Type
Full Range
groups
description
Participants with Relapsed/Refractory Multiple Myeloma (RRMM) received 0.5 mg/kg belantamab mafodotin intravenous (IV) infusion as powder for solution once every 4 weeks (Q4W) infused over 30- 60 minutes on day 1 of each 28-day cycle in combination with 100 mg Nirogacestat administered orally twice a day (BID) up to Day 28; with Lenalidomide 25 mg (10 mg if Estimated Glomerular Filtration (eGFR) is 40-60 milliLitre (mL)/minute/1.73 square meter (m)\^2) administered orally once daily (QD) from Day 1 to Day 21; and Dexamethasone 40 mg (20 mg for participants \>75 years old or BMI \<18.5 kg/m\^2) administered orally on days 1, 8, 15 and 22 of each 28-day cycle.
Participants with Relapsed/Refractory Multiple Myeloma (RRMM) received 1.0 mg/kg belantamab mafodotin intravenous (IV) infusion as powder for solution infused over 30- 60 minutes Q4W for cycle 1 and then Q8W for cycle 2 onwards on day 1 of 28-day cycle in Q4W and 56-day cycle in Q8W in combination with 100 mg Nirogacestat administered orally twice a day (BID) up to Day 28; with Lenalidomide 25 mg (10 mg if Estimated Glomerular Filtration (eGFR) is 40-60 milliLitre (mL)/minute/1.73 square meter (m)\^2) administered orally once daily (QD) from Day 1 to Day 21; and Dexamethasone 40 mg (20 mg for participants \>75 years old or BMI \<18.5 kg/m\^2) administered orally on days 1, 8, 15 and 22 of each 28-day cycle.
Pharmacokinetic (PK) population included all participants in the safety population from whom at least one PK sample has been obtained and analyzed. The "0" participants analyzed represents that data was not collected or available for analysis at that particular time point for the respective Arms/Groups.
reporting Status
POSTED
time Frame
Predose, end of infusion (EOI), and 2 hours postdose on Cycle 1 Day 1; anytime samples at Cycle 1 Day 4, 8, 29; Predose and EOI on Day 1 of Cycle 2, 4, 6, 9, 12; Predose on Cycle 18 Day 1; and end of treatment (~143 weeks)
title
DE Phase: Plasma Concentrations of Belantamab Mafodotin Antibody-Drug Conjugate (ADC)