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NCT07084896 · OUTCOME

DE Phase: Plasma Concentration of Belantamab Mafodotin Total Antibody

Sub-study of Belantamab Mafodotin (GSK2857916) in Combination With Nirogacestat in Participants With RRMM · Source last updated 2026-05-06

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
MEDIAN
Unit
ng/mL
Interval / dispersion
Full Range
Time frame
PRE-DOSE(PD), END OF INFUSION (EOI), EOI+2 HOURS(H), EOI+ 24H on Day(D) 1 of Cycle (C) 1; ANYTIME on C1 D4, D8, D22, and D29; PD and EOI on D1 of C2, C4, C6, C9, C12; PD on D1 of C18 and C30; End of Treatment (approximately 157 weeks)

What was measured

Blood samples were collected for PK analysis of Belantamab mafodotin total antibody.

Analysis population: Pharmacokinetic 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.

Groups in this outcome

DE Phase: 0.95 mg/kg Belantamab Mafodotin + Nirogacestat

In DE Phase, participants with Relapsed/Refractory Multiple Myeloma (RRMM) received 0.95 milligram (mg)/kilogram (kg) belantamab mafodotin intravenous (IV) infusion as powder for solution once every 3 weeks (Q3W) infused over 30- 60 minutes on day 1 of 21-day cycles in combination with 100 mg nirogacestat administered twice a day (BID) on day 1, 4, 8 and 15 of 21-day cycles. Treatment was administered until disease progression, intolerable toxicity, informed consent withdrawal, the end of the sub-study or death.

DE Phase: 1.9 mg/kg Belantamab Mafodotin+ Nirogacestat

In DE Phase, participants with RRMM received 1.9 mg/ kg belantamab mafodotin IV infusion as powder for solution once Q3W infused over 30- 60 minutes on day 1 of 21-day cycles in combination with 100 mg nirogacestat administered BID on day 1, 4, 8 and 15 of 21-day cycles. Treatment was administered until disease progression, intolerable toxicity, informed consent withdrawal, the end of the sub-study or death.

DE Phase: 1.0 mg/kg Belantamab Mafodotin Q4W/Q8W + Nirogacestat BID

In DE Phase, participants with RRMM received 1.0 mg/ kg belantamab mafodotin IV infusion as powder for solution once every 4 weeks (Q4W) for Cycle 1-2 and then once every 8 weeks (Q8W) from Cycle 2 onwards, infused over 30- 60 minutes on day 1 of 28-day cycles in Q4W and 56-day cycle in Q8W in combination with 100 mg nirogacestat BID on day 1, 4, 8 and 15 of 21-day cycles. Treatment was administered until disease progression, intolerable toxicity, informed consent withdrawal, the end of the sub-study or death.

DE Phase: 1.4 mg/kg Belantamab Mafodotin Q4W/Q8W + Nirogacestat BID

In DE Phase, participants with RRMM received 1.4 mg/ kg belantamab mafodotin IV infusion as powder for solution Q4W for Cycle 1 and then Q8W from Cycle2 onwards, infused over 30- 60 minutes on day 1 of 21-day cycles in combination with 100 mg nirogacestat BID on day 1, 4, 8 and 15 of 21-day cycles. Treatment was administered until disease progression, intolerable toxicity, informed consent withdrawal, the end of the sub-study or death.

DE Phase: 1.4 mg/kg Belantamab Mafodotin Q4W + Nirogacestat BID

In DE Phase, participants with RRMM received 1.4 mg/ kg belantamab mafodotin IV infusion as powder for solution Q4W, infused over 30- 60 minutes on day 1 of 28-day cycles in combination with 100 mg nirogacestat BID on day 1, 4, 8 and 15 of 21-day cycles. Treatment was administered until disease progression, intolerable toxicity, informed consent withdrawal, the end of the sub-study or death.

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
DE Phase: 0.95 mg/kg Belantamab Mafodotin + Nirogacestat10
DE Phase: 1.9 mg/kg Belantamab Mafodotin+ Nirogacestat4
DE Phase: 1.0 mg/kg Belantamab Mafodotin Q4W/Q8W + Nirogacestat BID10
DE Phase: 1.4 mg/kg Belantamab Mafodotin Q4W/Q8W + Nirogacestat BID10
DE Phase: 1.4 mg/kg Belantamab Mafodotin Q4W + Nirogacestat BID1

Reported measurements

CYCLE 1 DAY 1, PRE-DOSE

Analysis denominator · Participants

GroupSource count
DE Phase: 0.95 mg/kg Belantamab Mafodotin + Nirogacestat5
DE Phase: 1.9 mg/kg Belantamab Mafodotin+ Nirogacestat2
DE Phase: 1.0 mg/kg Belantamab Mafodotin Q4W/Q8W + Nirogacestat BID8
DE Phase: 1.4 mg/kg Belantamab Mafodotin Q4W/Q8W + Nirogacestat BID9
DE Phase: 1.4 mg/kg Belantamab Mafodotin Q4W + Nirogacestat BID1
Values in ng/mL · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
DE Phase: 0.95 mg/kg Belantamab Mafodotin + Nirogacestat0.0Not reported00Not reported
DE Phase: 1.9 mg/kg Belantamab Mafodotin+ Nirogacestat0.0Not reported00Not reported
DE Phase: 1.0 mg/kg Belantamab Mafodotin Q4W/Q8W + Nirogacestat BID0.0Not reported00Not reported
DE Phase: 1.4 mg/kg Belantamab Mafodotin Q4W/Q8W + Nirogacestat BID0.0Not reported02330Not reported
DE Phase: 1.4 mg/kg Belantamab Mafodotin Q4W + Nirogacestat BID0.0Not reportedNANAFull range is not applicable as only a single participant was analyzed. Median value presented here is the actual concentration for this single participant.
CYCLE 1 DAY 1, END OF INFUSION

Analysis denominator · Participants

GroupSource count
DE Phase: 0.95 mg/kg Belantamab Mafodotin + Nirogacestat9
DE Phase: 1.9 mg/kg Belantamab Mafodotin+ Nirogacestat4
DE Phase: 1.0 mg/kg Belantamab Mafodotin Q4W/Q8W + Nirogacestat BID10
DE Phase: 1.4 mg/kg Belantamab Mafodotin Q4W/Q8W + Nirogacestat BID10
DE Phase: 1.4 mg/kg Belantamab Mafodotin Q4W + Nirogacestat BID1
Values in ng/mL · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
DE Phase: 0.95 mg/kg Belantamab Mafodotin + Nirogacestat16500.0Not reported1010026800Not reported
DE Phase: 1.9 mg/kg Belantamab Mafodotin+ Nirogacestat37750.0Not reported2780043400Not reported
DE Phase: 1.0 mg/kg Belantamab Mafodotin Q4W/Q8W + Nirogacestat BID21300.0Not reported873032000Not reported
DE Phase: 1.4 mg/kg Belantamab Mafodotin Q4W/Q8W + Nirogacestat BID27850.0Not reported1270046200Not reported
DE Phase: 1.4 mg/kg Belantamab Mafodotin Q4W + Nirogacestat BID32500.0Not reportedNANAFull range is not applicable as only a single participant was analyzed. Median value presented here is the actual concentration for this single participant.
CYCLE 1 DAY 1, 2 HOURS

Analysis denominator · Participants

GroupSource count
DE Phase: 0.95 mg/kg Belantamab Mafodotin + Nirogacestat9
DE Phase: 1.9 mg/kg Belantamab Mafodotin+ Nirogacestat4
DE Phase: 1.0 mg/kg Belantamab Mafodotin Q4W/Q8W + Nirogacestat BID10
DE Phase: 1.4 mg/kg Belantamab Mafodotin Q4W/Q8W + Nirogacestat BID10
DE Phase: 1.4 mg/kg Belantamab Mafodotin Q4W + Nirogacestat BID1
Values in ng/mL · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
DE Phase: 0.95 mg/kg Belantamab Mafodotin + Nirogacestat16900.0Not reported1280026700Not reported
DE Phase: 1.9 mg/kg Belantamab Mafodotin+ Nirogacestat35450.0Not reported2680043900Not reported
DE Phase: 1.0 mg/kg Belantamab Mafodotin Q4W/Q8W + Nirogacestat BID21800.0Not reported926028400Not reported
DE Phase: 1.4 mg/kg Belantamab Mafodotin Q4W/Q8W + Nirogacestat BID27250.0Not reported994050600Not reported
DE Phase: 1.4 mg/kg Belantamab Mafodotin Q4W + Nirogacestat BID33800.0Not reportedNANAFull range is not applicable as only a single participant was analyzed. Median value presented here is the actual concentration for this single participant.
CYCLE 1 DAY 1, 24 HOURS

Analysis denominator · Participants

GroupSource count
DE Phase: 0.95 mg/kg Belantamab Mafodotin + Nirogacestat10
DE Phase: 1.9 mg/kg Belantamab Mafodotin+ Nirogacestat2
DE Phase: 1.0 mg/kg Belantamab Mafodotin Q4W/Q8W + Nirogacestat BID0
DE Phase: 1.4 mg/kg Belantamab Mafodotin Q4W/Q8W + Nirogacestat BID0
DE Phase: 1.4 mg/kg Belantamab Mafodotin Q4W + Nirogacestat BID0
Values in ng/mL · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
DE Phase: 0.95 mg/kg Belantamab Mafodotin + Nirogacestat10950.0Not reported813018400Not reported
DE Phase: 1.9 mg/kg Belantamab Mafodotin+ Nirogacestat21300.0Not reported1660026000Not reported
CYCLE 1 DAY 4, ANYTIME SAMPLE

Analysis denominator · Participants

GroupSource count
DE Phase: 0.95 mg/kg Belantamab Mafodotin + Nirogacestat9
DE Phase: 1.9 mg/kg Belantamab Mafodotin+ Nirogacestat4
DE Phase: 1.0 mg/kg Belantamab Mafodotin Q4W/Q8W + Nirogacestat BID10
DE Phase: 1.4 mg/kg Belantamab Mafodotin Q4W/Q8W + Nirogacestat BID9
DE Phase: 1.4 mg/kg Belantamab Mafodotin Q4W + Nirogacestat BID1
Values in ng/mL · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
DE Phase: 0.95 mg/kg Belantamab Mafodotin + Nirogacestat6220.0Not reported363013200Not reported
DE Phase: 1.9 mg/kg Belantamab Mafodotin+ Nirogacestat13400.0Not reported1010018400Not reported
DE Phase: 1.0 mg/kg Belantamab Mafodotin Q4W/Q8W + Nirogacestat BID8500.0Not reported506014100Not reported
DE Phase: 1.4 mg/kg Belantamab Mafodotin Q4W/Q8W + Nirogacestat BID13600.0Not reported337034600Not reported
DE Phase: 1.4 mg/kg Belantamab Mafodotin Q4W + Nirogacestat BID18800.0Not reportedNANAFull range is not applicable as only a single participant was analyzed. Median value presented here is the actual concentration for this single participant.
CYCLE 1 DAY 8, ANYTIME SAMPLE

Analysis denominator · Participants

GroupSource count
DE Phase: 0.95 mg/kg Belantamab Mafodotin + Nirogacestat10
DE Phase: 1.9 mg/kg Belantamab Mafodotin+ Nirogacestat4
DE Phase: 1.0 mg/kg Belantamab Mafodotin Q4W/Q8W + Nirogacestat BID8
DE Phase: 1.4 mg/kg Belantamab Mafodotin Q4W/Q8W + Nirogacestat BID9
DE Phase: 1.4 mg/kg Belantamab Mafodotin Q4W + Nirogacestat BID1
Values in ng/mL · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
DE Phase: 0.95 mg/kg Belantamab Mafodotin + Nirogacestat3565.0Not reported22808570Not reported
DE Phase: 1.9 mg/kg Belantamab Mafodotin+ Nirogacestat9320.0Not reported69309640Not reported
DE Phase: 1.0 mg/kg Belantamab Mafodotin Q4W/Q8W + Nirogacestat BID5335.0Not reported36207870Not reported
DE Phase: 1.4 mg/kg Belantamab Mafodotin Q4W/Q8W + Nirogacestat BID8300.0Not reported147016700Not reported
DE Phase: 1.4 mg/kg Belantamab Mafodotin Q4W + Nirogacestat BID7210.0Not reportedNANAFull range is not applicable as only a single participant was analyzed. Median value presented here is the actual concentration for this single participant.
CYCLE 1 DAY 22, ANYTIME SAMPLE

Analysis denominator · Participants

GroupSource count
DE Phase: 0.95 mg/kg Belantamab Mafodotin + Nirogacestat0
DE Phase: 1.9 mg/kg Belantamab Mafodotin+ Nirogacestat0
DE Phase: 1.0 mg/kg Belantamab Mafodotin Q4W/Q8W + Nirogacestat BID0
DE Phase: 1.4 mg/kg Belantamab Mafodotin Q4W/Q8W + Nirogacestat BID2
DE Phase: 1.4 mg/kg Belantamab Mafodotin Q4W + Nirogacestat BID0
Values in ng/mL · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
DE Phase: 1.4 mg/kg Belantamab Mafodotin Q4W/Q8W + Nirogacestat BID1605.0Not reported12301980Not reported
CYCLE 1 DAY 29, ANYTIME SAMPLE

Analysis denominator · Participants

GroupSource count
DE Phase: 0.95 mg/kg Belantamab Mafodotin + Nirogacestat0
DE Phase: 1.9 mg/kg Belantamab Mafodotin+ Nirogacestat0
DE Phase: 1.0 mg/kg Belantamab Mafodotin Q4W/Q8W + Nirogacestat BID3
DE Phase: 1.4 mg/kg Belantamab Mafodotin Q4W/Q8W + Nirogacestat BID1
DE Phase: 1.4 mg/kg Belantamab Mafodotin Q4W + Nirogacestat BID0
Values in ng/mL · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
DE Phase: 1.0 mg/kg Belantamab Mafodotin Q4W/Q8W + Nirogacestat BID3030.0Not reported7593070Not reported
DE Phase: 1.4 mg/kg Belantamab Mafodotin Q4W/Q8W + Nirogacestat BID7020.0Not reportedNANAFull range is not applicable as only a single participant was analyzed. Median value presented here is the actual concentration for this single participant.
CYCLE 2 DAY 1, PRE-DOSE

Analysis denominator · Participants

GroupSource count
DE Phase: 0.95 mg/kg Belantamab Mafodotin + Nirogacestat6
DE Phase: 1.9 mg/kg Belantamab Mafodotin+ Nirogacestat3
DE Phase: 1.0 mg/kg Belantamab Mafodotin Q4W/Q8W + Nirogacestat BID6
DE Phase: 1.4 mg/kg Belantamab Mafodotin Q4W/Q8W + Nirogacestat BID8
DE Phase: 1.4 mg/kg Belantamab Mafodotin Q4W + Nirogacestat BID1
Values in ng/mL · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
DE Phase: 0.95 mg/kg Belantamab Mafodotin + Nirogacestat1700.0Not reported8233490Not reported
DE Phase: 1.9 mg/kg Belantamab Mafodotin+ Nirogacestat2310.0Not reported14403120Not reported
DE Phase: 1.0 mg/kg Belantamab Mafodotin Q4W/Q8W + Nirogacestat BID1440.0Not reported06350Not reported
DE Phase: 1.4 mg/kg Belantamab Mafodotin Q4W/Q8W + Nirogacestat BID2060.0Not reported03830Not reported
DE Phase: 1.4 mg/kg Belantamab Mafodotin Q4W + Nirogacestat BID1600.0Not reportedNANAFull range is not applicable as only a single participant was analyzed. Median value presented here is the actual concentration for this single participant.
CYCLE 2 DAY 1, END OF INFUSION

Analysis denominator · Participants

GroupSource count
DE Phase: 0.95 mg/kg Belantamab Mafodotin + Nirogacestat8
DE Phase: 1.9 mg/kg Belantamab Mafodotin+ Nirogacestat4
DE Phase: 1.0 mg/kg Belantamab Mafodotin Q4W/Q8W + Nirogacestat BID7
DE Phase: 1.4 mg/kg Belantamab Mafodotin Q4W/Q8W + Nirogacestat BID8
DE Phase: 1.4 mg/kg Belantamab Mafodotin Q4W + Nirogacestat BID1
Values in ng/mL · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
DE Phase: 0.95 mg/kg Belantamab Mafodotin + Nirogacestat21250.0Not reported74729400Not reported
DE Phase: 1.9 mg/kg Belantamab Mafodotin+ Nirogacestat32900.0Not reported2450035600Not reported
DE Phase: 1.0 mg/kg Belantamab Mafodotin Q4W/Q8W + Nirogacestat BID25200.0Not reported1380034700Not reported
DE Phase: 1.4 mg/kg Belantamab Mafodotin Q4W/Q8W + Nirogacestat BID26700.0Not reported1440042800Not reported
DE Phase: 1.4 mg/kg Belantamab Mafodotin Q4W + Nirogacestat BID25200.0Not reportedNANAFull range is not applicable as only a single participant was analyzed. Median value presented here is the actual concentration for this single participant.
CYCLE 4 DAY 1, PRE-DOSE

Analysis denominator · Participants

GroupSource count
DE Phase: 0.95 mg/kg Belantamab Mafodotin + Nirogacestat6
DE Phase: 1.9 mg/kg Belantamab Mafodotin+ Nirogacestat1
DE Phase: 1.0 mg/kg Belantamab Mafodotin Q4W/Q8W + Nirogacestat BID6
DE Phase: 1.4 mg/kg Belantamab Mafodotin Q4W/Q8W + Nirogacestat BID4
DE Phase: 1.4 mg/kg Belantamab Mafodotin Q4W + Nirogacestat BID0
Values in ng/mL · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
DE Phase: 0.95 mg/kg Belantamab Mafodotin + Nirogacestat4860.0Not reported31809250Not reported
DE Phase: 1.9 mg/kg Belantamab Mafodotin+ Nirogacestat3730.0Not reportedNANAFull range is not applicable as only a single participant was analyzed. Median value presented here is the actual concentration for this single participant.
DE Phase: 1.0 mg/kg Belantamab Mafodotin Q4W/Q8W + Nirogacestat BID792.0Not reported01440Not reported
DE Phase: 1.4 mg/kg Belantamab Mafodotin Q4W/Q8W + Nirogacestat BID1898.5Not reported7785610Not reported
CYCLE 4 DAY 1, END OF INFUSION

Analysis denominator · Participants

GroupSource count
DE Phase: 0.95 mg/kg Belantamab Mafodotin + Nirogacestat6
DE Phase: 1.9 mg/kg Belantamab Mafodotin+ Nirogacestat1
DE Phase: 1.0 mg/kg Belantamab Mafodotin Q4W/Q8W + Nirogacestat BID6
DE Phase: 1.4 mg/kg Belantamab Mafodotin Q4W/Q8W + Nirogacestat BID4
DE Phase: 1.4 mg/kg Belantamab Mafodotin Q4W + Nirogacestat BID0
Values in ng/mL · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
DE Phase: 0.95 mg/kg Belantamab Mafodotin + Nirogacestat23200.0Not reported1820033300Not reported
DE Phase: 1.9 mg/kg Belantamab Mafodotin+ Nirogacestat40200.0Not reportedNANAFull range is not applicable as only a single participant was analyzed. Median value presented here is the actual concentration for this single participant.
DE Phase: 1.0 mg/kg Belantamab Mafodotin Q4W/Q8W + Nirogacestat BID25300.0Not reported1310033800Not reported
DE Phase: 1.4 mg/kg Belantamab Mafodotin Q4W/Q8W + Nirogacestat BID24550.0Not reported424039700Not reported
CYCLE 6 DAY 1, PRE-DOSE

Analysis denominator · Participants

GroupSource count
DE Phase: 0.95 mg/kg Belantamab Mafodotin + Nirogacestat6
DE Phase: 1.9 mg/kg Belantamab Mafodotin+ Nirogacestat1
DE Phase: 1.0 mg/kg Belantamab Mafodotin Q4W/Q8W + Nirogacestat BID5
DE Phase: 1.4 mg/kg Belantamab Mafodotin Q4W/Q8W + Nirogacestat BID4
DE Phase: 1.4 mg/kg Belantamab Mafodotin Q4W + Nirogacestat BID0
Values in ng/mL · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
DE Phase: 0.95 mg/kg Belantamab Mafodotin + Nirogacestat8600.0Not reported429010200Not reported
DE Phase: 1.9 mg/kg Belantamab Mafodotin+ Nirogacestat3450.0Not reportedNANAFull range is not applicable as only a single participant was analyzed. Median value presented here is the actual concentration for this single participant.
DE Phase: 1.0 mg/kg Belantamab Mafodotin Q4W/Q8W + Nirogacestat BID1310.0Not reported01560Not reported
DE Phase: 1.4 mg/kg Belantamab Mafodotin Q4W/Q8W + Nirogacestat BID2115.0Not reported13205490Not reported
CYCLE 6 DAY 1, END OF INFUSION

Analysis denominator · Participants

GroupSource count
DE Phase: 0.95 mg/kg Belantamab Mafodotin + Nirogacestat6
DE Phase: 1.9 mg/kg Belantamab Mafodotin+ Nirogacestat1
DE Phase: 1.0 mg/kg Belantamab Mafodotin Q4W/Q8W + Nirogacestat BID5
DE Phase: 1.4 mg/kg Belantamab Mafodotin Q4W/Q8W + Nirogacestat BID4
DE Phase: 1.4 mg/kg Belantamab Mafodotin Q4W + Nirogacestat BID0
Values in ng/mL · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
DE Phase: 0.95 mg/kg Belantamab Mafodotin + Nirogacestat27400.0Not reported2020036800Not reported
DE Phase: 1.9 mg/kg Belantamab Mafodotin+ Nirogacestat35500.0Not reportedNANAFull range is not applicable as only a single participant was analyzed. Median value presented here is the actual concentration for this single participant.
DE Phase: 1.0 mg/kg Belantamab Mafodotin Q4W/Q8W + Nirogacestat BID20800.0Not reported1550023500Not reported
DE Phase: 1.4 mg/kg Belantamab Mafodotin Q4W/Q8W + Nirogacestat BID21400.0Not reported1470029700Not reported
CYCLE 9 DAY 1, PRE-DOSE

Analysis denominator · Participants

GroupSource count
DE Phase: 0.95 mg/kg Belantamab Mafodotin + Nirogacestat5
DE Phase: 1.9 mg/kg Belantamab Mafodotin+ Nirogacestat1
DE Phase: 1.0 mg/kg Belantamab Mafodotin Q4W/Q8W + Nirogacestat BID2
DE Phase: 1.4 mg/kg Belantamab Mafodotin Q4W/Q8W + Nirogacestat BID2
DE Phase: 1.4 mg/kg Belantamab Mafodotin Q4W + Nirogacestat BID0
Values in ng/mL · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
DE Phase: 0.95 mg/kg Belantamab Mafodotin + Nirogacestat12200.0Not reported018100Not reported
DE Phase: 1.9 mg/kg Belantamab Mafodotin+ Nirogacestat4990.0Not reportedNANAFull range is not applicable as only a single participant was analyzed. Median value presented here is the actual concentration for this single participant.
DE Phase: 1.0 mg/kg Belantamab Mafodotin Q4W/Q8W + Nirogacestat BID373.0Not reported0746Not reported
DE Phase: 1.4 mg/kg Belantamab Mafodotin Q4W/Q8W + Nirogacestat BID2220.0Not reported11803260Not reported
CYCLE 9 DAY 1, END OF INFUSION

Analysis denominator · Participants

GroupSource count
DE Phase: 0.95 mg/kg Belantamab Mafodotin + Nirogacestat5
DE Phase: 1.9 mg/kg Belantamab Mafodotin+ Nirogacestat1
DE Phase: 1.0 mg/kg Belantamab Mafodotin Q4W/Q8W + Nirogacestat BID2
DE Phase: 1.4 mg/kg Belantamab Mafodotin Q4W/Q8W + Nirogacestat BID2
DE Phase: 1.4 mg/kg Belantamab Mafodotin Q4W + Nirogacestat BID0
Values in ng/mL · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
DE Phase: 0.95 mg/kg Belantamab Mafodotin + Nirogacestat33200.0Not reported1530044800Not reported
DE Phase: 1.9 mg/kg Belantamab Mafodotin+ Nirogacestat48200.0Not reportedNANAFull range is not applicable as only a single participant was analyzed. Median value presented here is the actual concentration for this single participant.
DE Phase: 1.0 mg/kg Belantamab Mafodotin Q4W/Q8W + Nirogacestat BID19250.0Not reported1860019900Not reported
DE Phase: 1.4 mg/kg Belantamab Mafodotin Q4W/Q8W + Nirogacestat BID10475.0Not reported125019700Not reported
CYCLE 12 DAY 1, PRE-DOSE

Analysis denominator · Participants

GroupSource count
DE Phase: 0.95 mg/kg Belantamab Mafodotin + Nirogacestat4
DE Phase: 1.9 mg/kg Belantamab Mafodotin+ Nirogacestat1
DE Phase: 1.0 mg/kg Belantamab Mafodotin Q4W/Q8W + Nirogacestat BID0
DE Phase: 1.4 mg/kg Belantamab Mafodotin Q4W/Q8W + Nirogacestat BID2
DE Phase: 1.4 mg/kg Belantamab Mafodotin Q4W + Nirogacestat BID0
Values in ng/mL · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
DE Phase: 0.95 mg/kg Belantamab Mafodotin + Nirogacestat8765.0Not reported278017200Not reported
DE Phase: 1.9 mg/kg Belantamab Mafodotin+ Nirogacestat7560.0Not reportedNANAFull range is not applicable as only a single participant was analyzed. Median value presented here is the actual concentration for this single participant.
DE Phase: 1.4 mg/kg Belantamab Mafodotin Q4W/Q8W + Nirogacestat BID2958.5Not reported8975020Not reported
CYCLE 12 DAY 1, END OF INFUSION

Analysis denominator · Participants

GroupSource count
DE Phase: 0.95 mg/kg Belantamab Mafodotin + Nirogacestat5
DE Phase: 1.9 mg/kg Belantamab Mafodotin+ Nirogacestat1
DE Phase: 1.0 mg/kg Belantamab Mafodotin Q4W/Q8W + Nirogacestat BID0
DE Phase: 1.4 mg/kg Belantamab Mafodotin Q4W/Q8W + Nirogacestat BID2
DE Phase: 1.4 mg/kg Belantamab Mafodotin Q4W + Nirogacestat BID0
Values in ng/mL · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
DE Phase: 0.95 mg/kg Belantamab Mafodotin + Nirogacestat35600.0Not reported1610048200Not reported
DE Phase: 1.9 mg/kg Belantamab Mafodotin+ Nirogacestat50500.0Not reportedNANAFull range is not applicable as only a single participant was analyzed. Median value presented here is the actual concentration for this single participant.
DE Phase: 1.4 mg/kg Belantamab Mafodotin Q4W/Q8W + Nirogacestat BID12335.0Not reported687017800Not reported
CYCLE 18 DAY 1, PRE-DOSE

Analysis denominator · Participants

GroupSource count
DE Phase: 0.95 mg/kg Belantamab Mafodotin + Nirogacestat1
DE Phase: 1.9 mg/kg Belantamab Mafodotin+ Nirogacestat0
DE Phase: 1.0 mg/kg Belantamab Mafodotin Q4W/Q8W + Nirogacestat BID0
DE Phase: 1.4 mg/kg Belantamab Mafodotin Q4W/Q8W + Nirogacestat BID0
DE Phase: 1.4 mg/kg Belantamab Mafodotin Q4W + Nirogacestat BID0
Values in ng/mL · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
DE Phase: 0.95 mg/kg Belantamab Mafodotin + Nirogacestat2340.0Not reportedNANAFull range is not applicable as only a single participant was analyzed. Median value presented here is the actual concentration for this single participant.
CYCLE 30 DAY 1, PRE-DOSE

Analysis denominator · Participants

GroupSource count
DE Phase: 0.95 mg/kg Belantamab Mafodotin + Nirogacestat1
DE Phase: 1.9 mg/kg Belantamab Mafodotin+ Nirogacestat0
DE Phase: 1.0 mg/kg Belantamab Mafodotin Q4W/Q8W + Nirogacestat BID0
DE Phase: 1.4 mg/kg Belantamab Mafodotin Q4W/Q8W + Nirogacestat BID0
DE Phase: 1.4 mg/kg Belantamab Mafodotin Q4W + Nirogacestat BID0
Values in ng/mL · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
DE Phase: 0.95 mg/kg Belantamab Mafodotin + Nirogacestat2370.0Not reportedNANAFull range is not applicable as only a single participant was analyzed. Median value presented here is the actual concentration for this single participant.
END OF TREATMENT (~157 weeks)

Analysis denominator · Participants

GroupSource count
DE Phase: 0.95 mg/kg Belantamab Mafodotin + Nirogacestat7
DE Phase: 1.9 mg/kg Belantamab Mafodotin+ Nirogacestat4
DE Phase: 1.0 mg/kg Belantamab Mafodotin Q4W/Q8W + Nirogacestat BID5
DE Phase: 1.4 mg/kg Belantamab Mafodotin Q4W/Q8W + Nirogacestat BID6
DE Phase: 1.4 mg/kg Belantamab Mafodotin Q4W + Nirogacestat BID1
Values in ng/mL · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
DE Phase: 0.95 mg/kg Belantamab Mafodotin + Nirogacestat1890.0Not reported024300Not reported
DE Phase: 1.9 mg/kg Belantamab Mafodotin+ Nirogacestat2980.0Not reported09290Not reported
DE Phase: 1.0 mg/kg Belantamab Mafodotin Q4W/Q8W + Nirogacestat BID2390.0Not reported20304720Not reported
DE Phase: 1.4 mg/kg Belantamab Mafodotin Q4W/Q8W + Nirogacestat BID1285.0Not reported03170Not reported
DE Phase: 1.4 mg/kg Belantamab Mafodotin Q4W + Nirogacestat BID0.0Not reportedNANAFull range is not applicable as only a single participant was analyzed. Median value presented here is the actual concentration for this single participant.
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0
        upper Limit
        0
        value
        0.0
      2. group Id
        OG001
        lower Limit
        0
        upper Limit
        0
        value
        0.0
      3. group Id
        OG002
        lower Limit
        0
        upper Limit
        0
        value
        0.0
      4. group Id
        OG003
        lower Limit
        0
        upper Limit
        2330
        value
        0.0
      5. comment
        Full range is not applicable as only a single participant was analyzed. Median value presented here is the actual concentration for this single participant.
        group Id
        OG004
        lower Limit
        NA
        upper Limit
        NA
        value
        0.0
    denoms
    1. counts
      1. group Id
        OG000
        value
        5
      2. group Id
        OG001
        value
        2
      3. group Id
        OG002
        value
        8
      4. group Id
        OG003
        value
        9
      5. group Id
        OG004
        value
        1
      units
      Participants
    title
    CYCLE 1 DAY 1, PRE-DOSE
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        10100
        upper Limit
        26800
        value
        16500.0
      2. group Id
        OG001
        lower Limit
        27800
        upper Limit
        43400
        value
        37750.0
      3. group Id
        OG002
        lower Limit
        8730
        upper Limit
        32000
        value
        21300.0
      4. group Id
        OG003
        lower Limit
        12700
        upper Limit
        46200
        value
        27850.0
      5. comment
        Full range is not applicable as only a single participant was analyzed. Median value presented here is the actual concentration for this single participant.
        group Id
        OG004
        lower Limit
        NA
        upper Limit
        NA
        value
        32500.0
    denoms
    1. counts
      1. group Id
        OG000
        value
        9
      2. group Id
        OG001
        value
        4
      3. group Id
        OG002
        value
        10
      4. group Id
        OG003
        value
        10
      5. group Id
        OG004
        value
        1
      units
      Participants
    title
    CYCLE 1 DAY 1, END OF INFUSION
  3. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        12800
        upper Limit
        26700
        value
        16900.0
      2. group Id
        OG001
        lower Limit
        26800
        upper Limit
        43900
        value
        35450.0
      3. group Id
        OG002
        lower Limit
        9260
        upper Limit
        28400
        value
        21800.0
      4. group Id
        OG003
        lower Limit
        9940
        upper Limit
        50600
        value
        27250.0
      5. comment
        Full range is not applicable as only a single participant was analyzed. Median value presented here is the actual concentration for this single participant.
        group Id
        OG004
        lower Limit
        NA
        upper Limit
        NA
        value
        33800.0
    denoms
    1. counts
      1. group Id
        OG000
        value
        9
      2. group Id
        OG001
        value
        4
      3. group Id
        OG002
        value
        10
      4. group Id
        OG003
        value
        10
      5. group Id
        OG004
        value
        1
      units
      Participants
    title
    CYCLE 1 DAY 1, 2 HOURS
  4. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        8130
        upper Limit
        18400
        value
        10950.0
      2. group Id
        OG001
        lower Limit
        16600
        upper Limit
        26000
        value
        21300.0
    denoms
    1. counts
      1. group Id
        OG000
        value
        10
      2. group Id
        OG001
        value
        2
      3. group Id
        OG002
        value
        0
      4. group Id
        OG003
        value
        0
      5. group Id
        OG004
        value
        0
      units
      Participants
    title
    CYCLE 1 DAY 1, 24 HOURS
  5. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        3630
        upper Limit
        13200
        value
        6220.0
      2. group Id
        OG001
        lower Limit
        10100
        upper Limit
        18400
        value
        13400.0
      3. group Id
        OG002
        lower Limit
        5060
        upper Limit
        14100
        value
        8500.0
      4. group Id
        OG003
        lower Limit
        3370
        upper Limit
        34600
        value
        13600.0
      5. comment
        Full range is not applicable as only a single participant was analyzed. Median value presented here is the actual concentration for this single participant.
        group Id
        OG004
        lower Limit
        NA
        upper Limit
        NA
        value
        18800.0
    denoms
    1. counts
      1. group Id
        OG000
        value
        9
      2. group Id
        OG001
        value
        4
      3. group Id
        OG002
        value
        10
      4. group Id
        OG003
        value
        9
      5. group Id
        OG004
        value
        1
      units
      Participants
    title
    CYCLE 1 DAY 4, ANYTIME SAMPLE
  6. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        2280
        upper Limit
        8570
        value
        3565.0
      2. group Id
        OG001
        lower Limit
        6930
        upper Limit
        9640
        value
        9320.0
      3. group Id
        OG002
        lower Limit
        3620
        upper Limit
        7870
        value
        5335.0
      4. group Id
        OG003
        lower Limit
        1470
        upper Limit
        16700
        value
        8300.0
      5. comment
        Full range is not applicable as only a single participant was analyzed. Median value presented here is the actual concentration for this single participant.
        group Id
        OG004
        lower Limit
        NA
        upper Limit
        NA
        value
        7210.0
    denoms
    1. counts
      1. group Id
        OG000
        value
        10
      2. group Id
        OG001
        value
        4
      3. group Id
        OG002
        value
        8
      4. group Id
        OG003
        value
        9
      5. group Id
        OG004
        value
        1
      units
      Participants
    title
    CYCLE 1 DAY 8, ANYTIME SAMPLE
  7. categories
    1. measurements
      1. group Id
        OG003
        lower Limit
        1230
        upper Limit
        1980
        value
        1605.0
    denoms
    1. counts
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
      4. group Id
        OG003
        value
        2
      5. group Id
        OG004
        value
        0
      units
      Participants
    title
    CYCLE 1 DAY 22, ANYTIME SAMPLE
  8. categories
    1. measurements
      1. group Id
        OG002
        lower Limit
        759
        upper Limit
        3070
        value
        3030.0
      2. comment
        Full range is not applicable as only a single participant was analyzed. Median value presented here is the actual concentration for this single participant.
        group Id
        OG003
        lower Limit
        NA
        upper Limit
        NA
        value
        7020.0
    denoms
    1. counts
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        3
      4. group Id
        OG003
        value
        1
      5. group Id
        OG004
        value
        0
      units
      Participants
    title
    CYCLE 1 DAY 29, ANYTIME SAMPLE
  9. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        823
        upper Limit
        3490
        value
        1700.0
      2. group Id
        OG001
        lower Limit
        1440
        upper Limit
        3120
        value
        2310.0
      3. group Id
        OG002
        lower Limit
        0
        upper Limit
        6350
        value
        1440.0
      4. group Id
        OG003
        lower Limit
        0
        upper Limit
        3830
        value
        2060.0
      5. comment
        Full range is not applicable as only a single participant was analyzed. Median value presented here is the actual concentration for this single participant.
        group Id
        OG004
        lower Limit
        NA
        upper Limit
        NA
        value
        1600.0
    denoms
    1. counts
      1. group Id
        OG000
        value
        6
      2. group Id
        OG001
        value
        3
      3. group Id
        OG002
        value
        6
      4. group Id
        OG003
        value
        8
      5. group Id
        OG004
        value
        1
      units
      Participants
    title
    CYCLE 2 DAY 1, PRE-DOSE
  10. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        747
        upper Limit
        29400
        value
        21250.0
      2. group Id
        OG001
        lower Limit
        24500
        upper Limit
        35600
        value
        32900.0
      3. group Id
        OG002
        lower Limit
        13800
        upper Limit
        34700
        value
        25200.0
      4. group Id
        OG003
        lower Limit
        14400
        upper Limit
        42800
        value
        26700.0
      5. comment
        Full range is not applicable as only a single participant was analyzed. Median value presented here is the actual concentration for this single participant.
        group Id
        OG004
        lower Limit
        NA
        upper Limit
        NA
        value
        25200.0
    denoms
    1. counts
      1. group Id
        OG000
        value
        8
      2. group Id
        OG001
        value
        4
      3. group Id
        OG002
        value
        7
      4. group Id
        OG003
        value
        8
      5. group Id
        OG004
        value
        1
      units
      Participants
    title
    CYCLE 2 DAY 1, END OF INFUSION
  11. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        3180
        upper Limit
        9250
        value
        4860.0
      2. comment
        Full range is not applicable as only a single participant was analyzed. Median value presented here is the actual concentration for this single participant.
        group Id
        OG001
        lower Limit
        NA
        upper Limit
        NA
        value
        3730.0
      3. group Id
        OG002
        lower Limit
        0
        upper Limit
        1440
        value
        792.0
      4. group Id
        OG003
        lower Limit
        778
        upper Limit
        5610
        value
        1898.5
    denoms
    1. counts
      1. group Id
        OG000
        value
        6
      2. group Id
        OG001
        value
        1
      3. group Id
        OG002
        value
        6
      4. group Id
        OG003
        value
        4
      5. group Id
        OG004
        value
        0
      units
      Participants
    title
    CYCLE 4 DAY 1, PRE-DOSE
  12. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        18200
        upper Limit
        33300
        value
        23200.0
      2. comment
        Full range is not applicable as only a single participant was analyzed. Median value presented here is the actual concentration for this single participant.
        group Id
        OG001
        lower Limit
        NA
        upper Limit
        NA
        value
        40200.0
      3. group Id
        OG002
        lower Limit
        13100
        upper Limit
        33800
        value
        25300.0
      4. group Id
        OG003
        lower Limit
        4240
        upper Limit
        39700
        value
        24550.0
    denoms
    1. counts
      1. group Id
        OG000
        value
        6
      2. group Id
        OG001
        value
        1
      3. group Id
        OG002
        value
        6
      4. group Id
        OG003
        value
        4
      5. group Id
        OG004
        value
        0
      units
      Participants
    title
    CYCLE 4 DAY 1, END OF INFUSION
denoms
  1. counts
    1. group Id
      OG000
      value
      10
    2. group Id
      OG001
      value
      4
    3. group Id
      OG002
      value
      10
    4. group Id
      OG003
      value
      10
    5. group Id
      OG004
      value
      1
    units
    Participants
description
Blood samples were collected for PK analysis of Belantamab mafodotin total antibody.
dispersion Type
Full Range
groups
  1. description
    In DE Phase, participants with Relapsed/Refractory Multiple Myeloma (RRMM) received 0.95 milligram (mg)/kilogram (kg) belantamab mafodotin intravenous (IV) infusion as powder for solution once every 3 weeks (Q3W) infused over 30- 60 minutes on day 1 of 21-day cycles in combination with 100 mg nirogacestat administered twice a day (BID) on day 1, 4, 8 and 15 of 21-day cycles. Treatment was administered until disease progression, intolerable toxicity, informed consent withdrawal, the end of the sub-study or death.
    id
    OG000
    title
    DE Phase: 0.95 mg/kg Belantamab Mafodotin + Nirogacestat
  2. description
    In DE Phase, participants with RRMM received 1.9 mg/ kg belantamab mafodotin IV infusion as powder for solution once Q3W infused over 30- 60 minutes on day 1 of 21-day cycles in combination with 100 mg nirogacestat administered BID on day 1, 4, 8 and 15 of 21-day cycles. Treatment was administered until disease progression, intolerable toxicity, informed consent withdrawal, the end of the sub-study or death.
    id
    OG001
    title
    DE Phase: 1.9 mg/kg Belantamab Mafodotin+ Nirogacestat
  3. description
    In DE Phase, participants with RRMM received 1.0 mg/ kg belantamab mafodotin IV infusion as powder for solution once every 4 weeks (Q4W) for Cycle 1-2 and then once every 8 weeks (Q8W) from Cycle 2 onwards, infused over 30- 60 minutes on day 1 of 28-day cycles in Q4W and 56-day cycle in Q8W in combination with 100 mg nirogacestat BID on day 1, 4, 8 and 15 of 21-day cycles. Treatment was administered until disease progression, intolerable toxicity, informed consent withdrawal, the end of the sub-study or death.
    id
    OG002
    title
    DE Phase: 1.0 mg/kg Belantamab Mafodotin Q4W/Q8W + Nirogacestat BID
  4. description
    In DE Phase, participants with RRMM received 1.4 mg/ kg belantamab mafodotin IV infusion as powder for solution Q4W for Cycle 1 and then Q8W from Cycle2 onwards, infused over 30- 60 minutes on day 1 of 21-day cycles in combination with 100 mg nirogacestat BID on day 1, 4, 8 and 15 of 21-day cycles. Treatment was administered until disease progression, intolerable toxicity, informed consent withdrawal, the end of the sub-study or death.
    id
    OG003
    title
    DE Phase: 1.4 mg/kg Belantamab Mafodotin Q4W/Q8W + Nirogacestat BID
  5. description
    In DE Phase, participants with RRMM received 1.4 mg/ kg belantamab mafodotin IV infusion as powder for solution Q4W, infused over 30- 60 minutes on day 1 of 28-day cycles in combination with 100 mg nirogacestat BID on day 1, 4, 8 and 15 of 21-day cycles. Treatment was administered until disease progression, intolerable toxicity, informed consent withdrawal, the end of the sub-study or death.
    id
    OG004
    title
    DE Phase: 1.4 mg/kg Belantamab Mafodotin Q4W + Nirogacestat BID
param Type
MEDIAN
population Description
Pharmacokinetic 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
PRE-DOSE(PD), END OF INFUSION (EOI), EOI+2 HOURS(H), EOI+ 24H on Day(D) 1 of Cycle (C) 1; ANYTIME on C1 D4, D8, D22, and D29; PD and EOI on D1 of C2, C4, C6, C9, C12; PD on D1 of C18 and C30; End of Treatment (approximately 157 weeks)
title
DE Phase: Plasma Concentration of Belantamab Mafodotin Total Antibody
type
SECONDARY
unit Of Measure
ng/mL

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Preserved source evidence · Not medical advice