DE Phase: Plasma Concentrations of Belantamab Mafodotin Cys- Monomethyl Auristatin-F (Cys-mcMMAF)
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
Picogram / millilitre (pg/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 cys- monomethyl auristatin-F (cys-mcMMAF).
Analysis population: PK population. 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. 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
OG000
lower Limit
NA
upper Limit
NA
value
0.00
comment
Full range is not applicable as only a single participant was analyzed.
group Id
OG001
lower Limit
NA
upper Limit
NA
value
0.00
denoms
counts
group Id
OG000
value
1
group Id
OG001
value
1
units
Participants
title
CYCLE 1 DAY 29, ANYTIME SAMPLE
categories
measurements
group Id
OG000
lower Limit
0.0
upper Limit
0.0
value
0.00
group Id
OG001
lower Limit
0.0
upper Limit
0.0
value
0.00
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
84.0
upper Limit
177.0
value
118.50
group Id
OG001
lower Limit
95.6
upper Limit
229.0
value
163.00
denoms
counts
group Id
OG000
value
8
group Id
OG001
value
9
units
Participants
title
CYCLE 2 DAY 1, END OF INFUSION
categories
measurements
group Id
OG000
lower Limit
0.0
upper Limit
0.0
value
0.00
group Id
OG001
lower Limit
0.0
upper Limit
0.0
value
0.00
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
95.9
upper Limit
161.0
value
127.00
group Id
OG001
lower Limit
50.3
upper Limit
185.0
value
83.15
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
0.0
upper Limit
0.0
value
0.00
group Id
OG001
lower Limit
0.0
upper Limit
0.0
value
0.00
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
53.0
upper Limit
395.0
value
108.00
group Id
OG001
lower Limit
115.0
upper Limit
183.0
value
166.00
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 cys- monomethyl auristatin-F (cys-mcMMAF).
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.
PK population. 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. 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 Cys- Monomethyl Auristatin-F (Cys-mcMMAF)