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NCT07084896 · OUTCOME

DE Phase: Plasma Concentration of Nirogacestat When Administered in Combination With Belantamab Mafodotin

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), Post-dose 30 Minutes, 1H, 2H, and 4H on Cycle (C) 1 Day (D) -2; PRE-DOSE (PD), Post-dose 30 Minutes, 1H, 2H, 4H, 8H on C1D1; PD on C1D4 and D8 ; PD, Post-dose 30 Minutes, 1H, 2H, 4H, 8H on C2D1

What was measured

Blood samples were collected for PK analysis of Nirogacestat when administered orally in combination with belantamab mafodotin.

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 -2, PRE-DOSE

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 BID9
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: 1.0 mg/kg Belantamab Mafodotin Q4W/Q8W + Nirogacestat BID0.00Not reported0.00.0Not reported
DE Phase: 1.4 mg/kg Belantamab Mafodotin Q4W/Q8W + Nirogacestat BID0.00Not reported0.0579.0Not reported
DE Phase: 1.4 mg/kg Belantamab Mafodotin Q4W + Nirogacestat BID0.00Not 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 -2, 30 MINUTES

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 BID9
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: 1.0 mg/kg Belantamab Mafodotin Q4W/Q8W + Nirogacestat BID377.00Not reported0.0769.0Not reported
DE Phase: 1.4 mg/kg Belantamab Mafodotin Q4W/Q8W + Nirogacestat BID251.50Not reported0.81270.0Not reported
DE Phase: 1.4 mg/kg Belantamab Mafodotin Q4W + Nirogacestat BID272.00Not 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 -2, 1 HOUR

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 BID9
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: 1.0 mg/kg Belantamab Mafodotin Q4W/Q8W + Nirogacestat BID371.00Not reported4.3804.0Not reported
DE Phase: 1.4 mg/kg Belantamab Mafodotin Q4W/Q8W + Nirogacestat BID343.50Not reported21.2968.0Not reported
DE Phase: 1.4 mg/kg Belantamab Mafodotin Q4W + Nirogacestat BID345.00Not 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 -2, 2 HOURS

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 BID9
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: 1.0 mg/kg Belantamab Mafodotin Q4W/Q8W + Nirogacestat BID307.00Not reported19.3688.0Not reported
DE Phase: 1.4 mg/kg Belantamab Mafodotin Q4W/Q8W + Nirogacestat BID319.00Not reported124.01360.0Not reported
DE Phase: 1.4 mg/kg Belantamab Mafodotin Q4W + Nirogacestat BID153.00Not 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 -2, 4 HOURS

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 BID9
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: 1.0 mg/kg Belantamab Mafodotin Q4W/Q8W + Nirogacestat BID168.00Not reported75.3278.0Not reported
DE Phase: 1.4 mg/kg Belantamab Mafodotin Q4W/Q8W + Nirogacestat BID161.50Not reported67.1611.0Not reported
DE Phase: 1.4 mg/kg Belantamab Mafodotin Q4W + Nirogacestat BID52.30Not 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, PRE-DOSE

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 BID0
Values in ng/mL · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
DE Phase: 0.95 mg/kg Belantamab Mafodotin + Nirogacestat0.00Not reported0.00.0Not reported
DE Phase: 1.9 mg/kg Belantamab Mafodotin+ Nirogacestat0.00Not reported0.00.0Not reported
DE Phase: 1.0 mg/kg Belantamab Mafodotin Q4W/Q8W + Nirogacestat BID98.55Not reported34.7564.0Not reported
DE Phase: 1.4 mg/kg Belantamab Mafodotin Q4W/Q8W + Nirogacestat BID88.25Not reported41.31000.0Not reported
CYCLE 1 DAY 1, 30 MINUTES

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 BID1
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 + Nirogacestat244.00Not reported7.91560.0Not reported
DE Phase: 1.9 mg/kg Belantamab Mafodotin+ Nirogacestat348.00Not reported78.5914.0Not reported
DE Phase: 1.0 mg/kg Belantamab Mafodotin Q4W/Q8W + Nirogacestat BID253.00Not 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 BID670.00Not reported188.0998.0Not reported
DE Phase: 1.4 mg/kg Belantamab Mafodotin Q4W + Nirogacestat BID585.00Not 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, 1 HOUR

Analysis denominator · Participants

GroupSource count
DE Phase: 0.95 mg/kg Belantamab Mafodotin + Nirogacestat10
DE Phase: 1.9 mg/kg Belantamab Mafodotin+ Nirogacestat3
DE Phase: 1.0 mg/kg Belantamab Mafodotin Q4W/Q8W + Nirogacestat BID1
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 + Nirogacestat306.50Not reported122.01680.0Not reported
DE Phase: 1.9 mg/kg Belantamab Mafodotin+ Nirogacestat490.00Not reported108.0923.0Not reported
DE Phase: 1.0 mg/kg Belantamab Mafodotin Q4W/Q8W + Nirogacestat BID465.00Not 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 BID651.00Not reported389.01240.0Not reported
DE Phase: 1.4 mg/kg Belantamab Mafodotin Q4W + Nirogacestat BID547.00Not 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 + Nirogacestat10
DE Phase: 1.9 mg/kg Belantamab Mafodotin+ Nirogacestat4
DE Phase: 1.0 mg/kg Belantamab Mafodotin Q4W/Q8W + Nirogacestat BID1
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 + Nirogacestat265.50Not reported126.01060.0Not reported
DE Phase: 1.9 mg/kg Belantamab Mafodotin+ Nirogacestat325.00Not reported252.0369.0Not reported
DE Phase: 1.0 mg/kg Belantamab Mafodotin Q4W/Q8W + Nirogacestat BID726.00Not 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 BID413.50Not reported217.01100.0Not reported
DE Phase: 1.4 mg/kg Belantamab Mafodotin Q4W + Nirogacestat BID207.00Not 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, 4 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 BID1
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 + Nirogacestat110.00Not reported58.4431.0Not reported
DE Phase: 1.9 mg/kg Belantamab Mafodotin+ Nirogacestat127.00Not reported50.6149.0Not reported
DE Phase: 1.0 mg/kg Belantamab Mafodotin Q4W/Q8W + Nirogacestat BID366.00Not 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 BID215.00Not reported103.0625.0Not reported
DE Phase: 1.4 mg/kg Belantamab Mafodotin Q4W + Nirogacestat BID113.00Not 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, 8 HOURS

Analysis denominator · Participants

GroupSource count
DE Phase: 0.95 mg/kg Belantamab Mafodotin + Nirogacestat7
DE Phase: 1.9 mg/kg Belantamab Mafodotin+ Nirogacestat3
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 + Nirogacestat50.90Not reported32.7254.0Not reported
DE Phase: 1.9 mg/kg Belantamab Mafodotin+ Nirogacestat74.80Not reported30.4102.0Not reported
CYCLE 1 DAY 4, PRE-DOSE

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 BID9
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 + Nirogacestat176.00Not reported93.5409.0Not reported
DE Phase: 1.9 mg/kg Belantamab Mafodotin+ Nirogacestat161.00Not reported72.3309.0Not reported
DE Phase: 1.0 mg/kg Belantamab Mafodotin Q4W/Q8W + Nirogacestat BID152.00Not reported42.9339.0Not reported
DE Phase: 1.4 mg/kg Belantamab Mafodotin Q4W/Q8W + Nirogacestat BID171.50Not reported80.01390.0Not reported
DE Phase: 1.4 mg/kg Belantamab Mafodotin Q4W + Nirogacestat BID138.00Not 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, PRE-DOSE

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 + Nirogacestat129.00Not reported60.5490.0Not reported
DE Phase: 1.9 mg/kg Belantamab Mafodotin+ Nirogacestat379.50Not reported20.61070.0Not reported
DE Phase: 1.0 mg/kg Belantamab Mafodotin Q4W/Q8W + Nirogacestat BID174.50Not reported53.9403.0Not reported
DE Phase: 1.4 mg/kg Belantamab Mafodotin Q4W/Q8W + Nirogacestat BID218.00Not reported144.01140.0Not reported
DE Phase: 1.4 mg/kg Belantamab Mafodotin Q4W + Nirogacestat BID117.00Not 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 + Nirogacestat9
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 + Nirogacestat86.60Not reported38.3761.0Not reported
DE Phase: 1.9 mg/kg Belantamab Mafodotin+ Nirogacestat63.73Not reported2.1195.0Not reported
DE Phase: 1.0 mg/kg Belantamab Mafodotin Q4W/Q8W + Nirogacestat BID1.83Not reported0.0149.0Not reported
DE Phase: 1.4 mg/kg Belantamab Mafodotin Q4W/Q8W + Nirogacestat BID54.30Not reported0.0724.0Not reported
DE Phase: 1.4 mg/kg Belantamab Mafodotin Q4W + Nirogacestat BID24.00Not 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, 30 MINUTES

Analysis denominator · Participants

GroupSource count
DE Phase: 0.95 mg/kg Belantamab Mafodotin + Nirogacestat8
DE Phase: 1.9 mg/kg Belantamab Mafodotin+ Nirogacestat3
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 + Nirogacestat228.00Not reported37.31830.0Not reported
DE Phase: 1.9 mg/kg Belantamab Mafodotin+ Nirogacestat12.70Not reported6.2789.0Not reported
DE Phase: 1.0 mg/kg Belantamab Mafodotin Q4W/Q8W + Nirogacestat BID122.00Not reported1.2550.0Not reported
DE Phase: 1.4 mg/kg Belantamab Mafodotin Q4W/Q8W + Nirogacestat BID484.50Not reported58.71190.0Not reported
DE Phase: 1.4 mg/kg Belantamab Mafodotin Q4W + Nirogacestat BID74.00Not 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, 1 HOUR

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 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 + Nirogacestat253.00Not reported78.62260.0Not reported
DE Phase: 1.9 mg/kg Belantamab Mafodotin+ Nirogacestat186.50Not reported33.9773.0Not reported
DE Phase: 1.0 mg/kg Belantamab Mafodotin Q4W/Q8W + Nirogacestat BID220.00Not reported13.6726.0Not reported
DE Phase: 1.4 mg/kg Belantamab Mafodotin Q4W/Q8W + Nirogacestat BID422.00Not reported81.81330.0Not reported
DE Phase: 1.4 mg/kg Belantamab Mafodotin Q4W + Nirogacestat BID171.00Not 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, 2 HOURS

Analysis denominator · Participants

GroupSource count
DE Phase: 0.95 mg/kg Belantamab Mafodotin + Nirogacestat8
DE Phase: 1.9 mg/kg Belantamab Mafodotin+ Nirogacestat3
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 + Nirogacestat236.50Not reported102.01400.0Not reported
DE Phase: 1.9 mg/kg Belantamab Mafodotin+ Nirogacestat162.00Not reported54.9704.0Not reported
DE Phase: 1.0 mg/kg Belantamab Mafodotin Q4W/Q8W + Nirogacestat BID274.00Not reported81.9523.0Not reported
DE Phase: 1.4 mg/kg Belantamab Mafodotin Q4W/Q8W + Nirogacestat BID334.50Not reported119.0472.0Not reported
DE Phase: 1.4 mg/kg Belantamab Mafodotin Q4W + Nirogacestat BID124.00Not 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, 4 HOURS

Analysis denominator · Participants

GroupSource count
DE Phase: 0.95 mg/kg Belantamab Mafodotin + Nirogacestat8
DE Phase: 1.9 mg/kg Belantamab Mafodotin+ Nirogacestat3
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 + Nirogacestat170.00Not reported64.5941.0Not reported
DE Phase: 1.9 mg/kg Belantamab Mafodotin+ Nirogacestat357.00Not reported173.0400.0Not reported
DE Phase: 1.0 mg/kg Belantamab Mafodotin Q4W/Q8W + Nirogacestat BID196.00Not reported48.0426.0Not reported
DE Phase: 1.4 mg/kg Belantamab Mafodotin Q4W/Q8W + Nirogacestat BID179.50Not reported109.0326.0Not reported
DE Phase: 1.4 mg/kg Belantamab Mafodotin Q4W + Nirogacestat BID58.20Not 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, 8 HOURS

Analysis denominator · Participants

GroupSource count
DE Phase: 0.95 mg/kg Belantamab Mafodotin + Nirogacestat4
DE Phase: 1.9 mg/kg Belantamab Mafodotin+ Nirogacestat3
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 + Nirogacestat109.50Not reported36.8823.0Not reported
DE Phase: 1.9 mg/kg Belantamab Mafodotin+ Nirogacestat183.00Not reported58.6203.0Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG002
        lower Limit
        0.0
        upper Limit
        0.0
        value
        0.00
      2. group Id
        OG003
        lower Limit
        0.0
        upper Limit
        579.0
        value
        0.00
      3. 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
        0.00
    denoms
    1. counts
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        9
      4. group Id
        OG003
        value
        10
      5. group Id
        OG004
        value
        1
      units
      Participants
    title
    CYCLE 1 DAY -2, PRE-DOSE
  2. categories
    1. measurements
      1. group Id
        OG002
        lower Limit
        0.0
        upper Limit
        769.0
        value
        377.00
      2. group Id
        OG003
        lower Limit
        0.8
        upper Limit
        1270.0
        value
        251.50
      3. 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
        272.00
    denoms
    1. counts
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        9
      4. group Id
        OG003
        value
        10
      5. group Id
        OG004
        value
        1
      units
      Participants
    title
    CYCLE 1 DAY -2, 30 MINUTES
  3. categories
    1. measurements
      1. group Id
        OG002
        lower Limit
        4.3
        upper Limit
        804.0
        value
        371.00
      2. group Id
        OG003
        lower Limit
        21.2
        upper Limit
        968.0
        value
        343.50
      3. 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
        345.00
    denoms
    1. counts
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        9
      4. group Id
        OG003
        value
        10
      5. group Id
        OG004
        value
        1
      units
      Participants
    title
    CYCLE 1 DAY -2, 1 HOUR
  4. categories
    1. measurements
      1. group Id
        OG002
        lower Limit
        19.3
        upper Limit
        688.0
        value
        307.00
      2. group Id
        OG003
        lower Limit
        124.0
        upper Limit
        1360.0
        value
        319.00
      3. 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
        153.00
    denoms
    1. counts
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        9
      4. group Id
        OG003
        value
        10
      5. group Id
        OG004
        value
        1
      units
      Participants
    title
    CYCLE 1 DAY -2, 2 HOURS
  5. categories
    1. measurements
      1. group Id
        OG002
        lower Limit
        75.3
        upper Limit
        278.0
        value
        168.00
      2. group Id
        OG003
        lower Limit
        67.1
        upper Limit
        611.0
        value
        161.50
      3. 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
        52.30
    denoms
    1. counts
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        9
      4. group Id
        OG003
        value
        10
      5. group Id
        OG004
        value
        1
      units
      Participants
    title
    CYCLE 1 DAY -2, 4 HOURS
  6. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.0
        upper Limit
        0.0
        value
        0.00
      2. group Id
        OG001
        lower Limit
        0.0
        upper Limit
        0.0
        value
        0.00
      3. group Id
        OG002
        lower Limit
        34.7
        upper Limit
        564.0
        value
        98.55
      4. group Id
        OG003
        lower Limit
        41.3
        upper Limit
        1000.0
        value
        88.25
    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
        0
      units
      Participants
    title
    CYCLE 1 DAY 1, PRE-DOSE
  7. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        7.9
        upper Limit
        1560.0
        value
        244.00
      2. group Id
        OG001
        lower Limit
        78.5
        upper Limit
        914.0
        value
        348.00
      3. 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
        OG002
        lower Limit
        NA
        upper Limit
        NA
        value
        253.00
      4. group Id
        OG003
        lower Limit
        188.0
        upper Limit
        998.0
        value
        670.00
      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
        585.00
    denoms
    1. counts
      1. group Id
        OG000
        value
        10
      2. group Id
        OG001
        value
        4
      3. group Id
        OG002
        value
        1
      4. group Id
        OG003
        value
        6
      5. group Id
        OG004
        value
        1
      units
      Participants
    title
    CYCLE 1 DAY 1, 30 MINUTES
  8. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        122.0
        upper Limit
        1680.0
        value
        306.50
      2. group Id
        OG001
        lower Limit
        108.0
        upper Limit
        923.0
        value
        490.00
      3. 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
        OG002
        lower Limit
        NA
        upper Limit
        NA
        value
        465.00
      4. group Id
        OG003
        lower Limit
        389.0
        upper Limit
        1240.0
        value
        651.00
      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
        547.00
    denoms
    1. counts
      1. group Id
        OG000
        value
        10
      2. group Id
        OG001
        value
        3
      3. group Id
        OG002
        value
        1
      4. group Id
        OG003
        value
        6
      5. group Id
        OG004
        value
        1
      units
      Participants
    title
    CYCLE 1 DAY 1, 1 HOUR
  9. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        126.0
        upper Limit
        1060.0
        value
        265.50
      2. group Id
        OG001
        lower Limit
        252.0
        upper Limit
        369.0
        value
        325.00
      3. 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
        OG002
        lower Limit
        NA
        upper Limit
        NA
        value
        726.00
      4. group Id
        OG003
        lower Limit
        217.0
        upper Limit
        1100.0
        value
        413.50
      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
        207.00
    denoms
    1. counts
      1. group Id
        OG000
        value
        10
      2. group Id
        OG001
        value
        4
      3. group Id
        OG002
        value
        1
      4. group Id
        OG003
        value
        6
      5. group Id
        OG004
        value
        1
      units
      Participants
    title
    CYCLE 1 DAY 1, 2 HOURS
  10. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        58.4
        upper Limit
        431.0
        value
        110.00
      2. group Id
        OG001
        lower Limit
        50.6
        upper Limit
        149.0
        value
        127.00
      3. 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
        OG002
        lower Limit
        NA
        upper Limit
        NA
        value
        366.00
      4. group Id
        OG003
        lower Limit
        103.0
        upper Limit
        625.0
        value
        215.00
      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
        113.00
    denoms
    1. counts
      1. group Id
        OG000
        value
        9
      2. group Id
        OG001
        value
        4
      3. group Id
        OG002
        value
        1
      4. group Id
        OG003
        value
        6
      5. group Id
        OG004
        value
        1
      units
      Participants
    title
    CYCLE 1 DAY 1, 4 HOURS
  11. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        32.7
        upper Limit
        254.0
        value
        50.90
      2. group Id
        OG001
        lower Limit
        30.4
        upper Limit
        102.0
        value
        74.80
    denoms
    1. counts
      1. group Id
        OG000
        value
        7
      2. group Id
        OG001
        value
        3
      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, 8 HOURS
  12. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        93.5
        upper Limit
        409.0
        value
        176.00
      2. group Id
        OG001
        lower Limit
        72.3
        upper Limit
        309.0
        value
        161.00
      3. group Id
        OG002
        lower Limit
        42.9
        upper Limit
        339.0
        value
        152.00
      4. group Id
        OG003
        lower Limit
        80.0
        upper Limit
        1390.0
        value
        171.50
      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
        138.00
    denoms
    1. counts
      1. group Id
        OG000
        value
        9
      2. group Id
        OG001
        value
        4
      3. group Id
        OG002
        value
        9
      4. group Id
        OG003
        value
        8
      5. group Id
        OG004
        value
        1
      units
      Participants
    title
    CYCLE 1 DAY 4, PRE-DOSE
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 Nirogacestat when administered orally in combination with belantamab mafodotin.
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), Post-dose 30 Minutes, 1H, 2H, and 4H on Cycle (C) 1 Day (D) -2; PRE-DOSE (PD), Post-dose 30 Minutes, 1H, 2H, 4H, 8H on C1D1; PD on C1D4 and D8 ; PD, Post-dose 30 Minutes, 1H, 2H, 4H, 8H on C2D1
title
DE Phase: Plasma Concentration of Nirogacestat When Administered in Combination With Belantamab Mafodotin
type
SECONDARY
unit Of Measure
ng/mL

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Preserved source evidence · Not medical advice