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NCT07084896 · OUTCOME

DE Phase: Plasma Concentrations of Belantamab Mafodotin Antibody-Drug Conjugate (ADC)

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
Nanogram/millilitre (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 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 population included all participants in the safety population from whom at least one PK sample has been obtained and analysed. 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 + Nirogacestat8
DE Phase: 1.9 mg/kg Belantamab Mafodotin+ Nirogacestat3
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 Nanogram/millilitre (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 reported00Not 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 + 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
Values in Nanogram/millilitre (ng/mL) · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
DE Phase: 0.95 mg/kg Belantamab Mafodotin + Nirogacestat15750.0Not reported1230024200Not reported
DE Phase: 1.9 mg/kg Belantamab Mafodotin+ Nirogacestat55350.0Not reported3080073900Not reported
DE Phase: 1.0 mg/kg Belantamab Mafodotin Q4W/Q8W + Nirogacestat BID21750.0Not reported1100038300Not reported
DE Phase: 1.4 mg/kg Belantamab Mafodotin Q4W/Q8W + Nirogacestat BID33400.0Not reported1680049400Not reported
DE Phase: 1.4 mg/kg Belantamab Mafodotin Q4W + Nirogacestat BID27600.0Not 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 + 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
Values in Nanogram/millilitre (ng/mL) · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
DE Phase: 0.95 mg/kg Belantamab Mafodotin + Nirogacestat16550.0Not reported1110024100Not reported
DE Phase: 1.9 mg/kg Belantamab Mafodotin+ Nirogacestat50300.0Not reported2610067500Not reported
DE Phase: 1.0 mg/kg Belantamab Mafodotin Q4W/Q8W + Nirogacestat BID21100.0Not reported1100047200Not reported
DE Phase: 1.4 mg/kg Belantamab Mafodotin Q4W/Q8W + Nirogacestat BID29300.0Not reported1710050700Not reported
DE Phase: 1.4 mg/kg Belantamab Mafodotin Q4W + Nirogacestat BID26900.0Not 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 Nanogram/millilitre (ng/mL) · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
DE Phase: 0.95 mg/kg Belantamab Mafodotin + Nirogacestat9235.0Not reported632014500Not reported
DE Phase: 1.9 mg/kg Belantamab Mafodotin+ Nirogacestat27150.0Not reported1680037500Not 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 Nanogram/millilitre (ng/mL) · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
DE Phase: 0.95 mg/kg Belantamab Mafodotin + Nirogacestat4680.0Not reported17209580Not reported
DE Phase: 1.9 mg/kg Belantamab Mafodotin+ Nirogacestat13000.0Not reported780017900Not reported
DE Phase: 1.0 mg/kg Belantamab Mafodotin Q4W/Q8W + Nirogacestat BID7370.0Not reported358013900Not reported
DE Phase: 1.4 mg/kg Belantamab Mafodotin Q4W/Q8W + Nirogacestat BID10000.0Not reported240023500Not reported
DE Phase: 1.4 mg/kg Belantamab Mafodotin Q4W + Nirogacestat BID13300.0Not 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 + Nirogacestat9
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 Nanogram/millilitre (ng/mL) · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
DE Phase: 0.95 mg/kg Belantamab Mafodotin + Nirogacestat2320.0Not reported12905080Not reported
DE Phase: 1.9 mg/kg Belantamab Mafodotin+ Nirogacestat5545.0Not reported38006760Not reported
DE Phase: 1.0 mg/kg Belantamab Mafodotin Q4W/Q8W + Nirogacestat BID3910.0Not reported15205930Not reported
DE Phase: 1.4 mg/kg Belantamab Mafodotin Q4W/Q8W + Nirogacestat BID4690.0Not reported170011100Not reported
DE Phase: 1.4 mg/kg Belantamab Mafodotin Q4W + Nirogacestat BID4870.0Not 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 Nanogram/millilitre (ng/mL) · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
DE Phase: 1.4 mg/kg Belantamab Mafodotin Q4W/Q8W + Nirogacestat BID476.0Not reported0952Not 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 BID4
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 Nanogram/millilitre (ng/mL) · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
DE Phase: 1.0 mg/kg Belantamab Mafodotin Q4W/Q8W + Nirogacestat BID570.0Not reported01270Not reported
DE Phase: 1.4 mg/kg Belantamab Mafodotin Q4W/Q8W + Nirogacestat BID2350.0Not 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 + Nirogacestat7
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 Nanogram/millilitre (ng/mL) · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
DE Phase: 0.95 mg/kg Belantamab Mafodotin + Nirogacestat0.0Not reported06520Not reported
DE Phase: 1.9 mg/kg Belantamab Mafodotin+ Nirogacestat1230.0Not reported5251600Not reported
DE Phase: 1.0 mg/kg Belantamab Mafodotin Q4W/Q8W + Nirogacestat BID326.5Not reported01510Not reported
DE Phase: 1.4 mg/kg Belantamab Mafodotin Q4W/Q8W + Nirogacestat BID308.5Not reported01880Not 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 2 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 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 Nanogram/millilitre (ng/mL) · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
DE Phase: 0.95 mg/kg Belantamab Mafodotin + Nirogacestat16900.0Not reported025800Not reported
DE Phase: 1.9 mg/kg Belantamab Mafodotin+ Nirogacestat47150.0Not reported2700065900Not reported
DE Phase: 1.0 mg/kg Belantamab Mafodotin Q4W/Q8W + Nirogacestat BID23100.0Not reported1400028600Not reported
DE Phase: 1.4 mg/kg Belantamab Mafodotin Q4W/Q8W + Nirogacestat BID30350.0Not reported2050064700Not reported
DE Phase: 1.4 mg/kg Belantamab Mafodotin Q4W + Nirogacestat BID31400.0Not 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 Nanogram/millilitre (ng/mL) · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
DE Phase: 0.95 mg/kg Belantamab Mafodotin + Nirogacestat1380.0Not reported8632980Not reported
DE Phase: 1.9 mg/kg Belantamab Mafodotin+ Nirogacestat1390.0Not 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 BID0.0Not reported028900Not reported
DE Phase: 1.4 mg/kg Belantamab Mafodotin Q4W/Q8W + Nirogacestat BID287.5Not reported01150Not 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 Nanogram/millilitre (ng/mL) · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
DE Phase: 0.95 mg/kg Belantamab Mafodotin + Nirogacestat20300.0Not reported1360026300Not reported
DE Phase: 1.9 mg/kg Belantamab Mafodotin+ Nirogacestat56600.0Not 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 BID22450.0Not reported1770027700Not reported
DE Phase: 1.4 mg/kg Belantamab Mafodotin Q4W/Q8W + Nirogacestat BID20050.0Not reported344032200Not 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 Nanogram/millilitre (ng/mL) · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
DE Phase: 0.95 mg/kg Belantamab Mafodotin + Nirogacestat2495.0Not reported14503570Not reported
DE Phase: 1.9 mg/kg Belantamab Mafodotin+ Nirogacestat1430.0Not 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 BID0.0Not reported0523Not reported
DE Phase: 1.4 mg/kg Belantamab Mafodotin Q4W/Q8W + Nirogacestat BID780.0Not reported01280Not 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 Nanogram/millilitre (ng/mL) · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
DE Phase: 0.95 mg/kg Belantamab Mafodotin + Nirogacestat20050.0Not reported1430030600Not reported
DE Phase: 1.9 mg/kg Belantamab Mafodotin+ Nirogacestat55900.0Not 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 BID24600.0Not reported2010027700Not reported
DE Phase: 1.4 mg/kg Belantamab Mafodotin Q4W/Q8W + Nirogacestat BID22450.0Not reported1670029000Not 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 Nanogram/millilitre (ng/mL) · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
DE Phase: 0.95 mg/kg Belantamab Mafodotin + Nirogacestat2810.0Not reported05190Not reported
DE Phase: 1.9 mg/kg Belantamab Mafodotin+ Nirogacestat1570.0Not 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 BID0.0Not reported00Not reported
DE Phase: 1.4 mg/kg Belantamab Mafodotin Q4W/Q8W + Nirogacestat BID530.0Not reported507553Not 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 Nanogram/millilitre (ng/mL) · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
DE Phase: 0.95 mg/kg Belantamab Mafodotin + Nirogacestat19100.0Not reported1590030100Not reported
DE Phase: 1.9 mg/kg Belantamab Mafodotin+ Nirogacestat53200.0Not 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 BID21550.0Not reported2030022800Not reported
DE Phase: 1.4 mg/kg Belantamab Mafodotin Q4W/Q8W + Nirogacestat BID7950.0Not reported015900Not 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 Nanogram/millilitre (ng/mL) · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
DE Phase: 0.95 mg/kg Belantamab Mafodotin + Nirogacestat2225.0Not reported11604790Not reported
DE Phase: 1.9 mg/kg Belantamab Mafodotin+ Nirogacestat2510.0Not 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 BID1010.0Not reported02020Not 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 Nanogram/millilitre (ng/mL) · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
DE Phase: 0.95 mg/kg Belantamab Mafodotin + Nirogacestat27000.0Not reported1940031600Not reported
DE Phase: 1.9 mg/kg Belantamab Mafodotin+ Nirogacestat35000.0Not 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 BID10735.0Not reported767013800Not 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 Nanogram/millilitre (ng/mL) · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
DE Phase: 0.95 mg/kg Belantamab Mafodotin + Nirogacestat1500.0Not 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 Nanogram/millilitre (ng/mL) · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
DE Phase: 0.95 mg/kg Belantamab Mafodotin + Nirogacestat790.0Not 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 + Nirogacestat6
DE Phase: 1.9 mg/kg Belantamab Mafodotin+ Nirogacestat4
DE Phase: 1.0 mg/kg Belantamab Mafodotin Q4W/Q8W + Nirogacestat BID6
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 Nanogram/millilitre (ng/mL) · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
DE Phase: 0.95 mg/kg Belantamab Mafodotin + Nirogacestat570.0Not reported06240Not reported
DE Phase: 1.9 mg/kg Belantamab Mafodotin+ Nirogacestat1130.0Not reported04070Not reported
DE Phase: 1.0 mg/kg Belantamab Mafodotin Q4W/Q8W + Nirogacestat BID994.5Not reported02380Not reported
DE Phase: 1.4 mg/kg Belantamab Mafodotin Q4W/Q8W + Nirogacestat BID302.5Not reported01850Not 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
        0
        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
        8
      2. group Id
        OG001
        value
        3
      3. group Id
        OG002
        value
        9
      4. group Id
        OG003
        value
        10
      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
        12300
        upper Limit
        24200
        value
        15750.0
      2. group Id
        OG001
        lower Limit
        30800
        upper Limit
        73900
        value
        55350.0
      3. group Id
        OG002
        lower Limit
        11000
        upper Limit
        38300
        value
        21750.0
      4. group Id
        OG003
        lower Limit
        16800
        upper Limit
        49400
        value
        33400.0
      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
        27600.0
    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
    title
    CYCLE 1 DAY 1, END OF INFUSION
  3. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        11100
        upper Limit
        24100
        value
        16550.0
      2. group Id
        OG001
        lower Limit
        26100
        upper Limit
        67500
        value
        50300.0
      3. group Id
        OG002
        lower Limit
        11000
        upper Limit
        47200
        value
        21100.0
      4. group Id
        OG003
        lower Limit
        17100
        upper Limit
        50700
        value
        29300.0
      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
        26900.0
    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
    title
    CYCLE 1 DAY 1, 2 HOURS
  4. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        6320
        upper Limit
        14500
        value
        9235.0
      2. group Id
        OG001
        lower Limit
        16800
        upper Limit
        37500
        value
        27150.0
    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
        1720
        upper Limit
        9580
        value
        4680.0
      2. group Id
        OG001
        lower Limit
        7800
        upper Limit
        17900
        value
        13000.0
      3. group Id
        OG002
        lower Limit
        3580
        upper Limit
        13900
        value
        7370.0
      4. group Id
        OG003
        lower Limit
        2400
        upper Limit
        23500
        value
        10000.0
      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
        13300.0
    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
        1290
        upper Limit
        5080
        value
        2320.0
      2. group Id
        OG001
        lower Limit
        3800
        upper Limit
        6760
        value
        5545.0
      3. group Id
        OG002
        lower Limit
        1520
        upper Limit
        5930
        value
        3910.0
      4. group Id
        OG003
        lower Limit
        1700
        upper Limit
        11100
        value
        4690.0
      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
        4870.0
    denoms
    1. counts
      1. group Id
        OG000
        value
        9
      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
        0
        upper Limit
        952
        value
        476.0
    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
        0
        upper Limit
        1270
        value
        570.0
      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
        2350.0
    denoms
    1. counts
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        4
      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
        0
        upper Limit
        6520
        value
        0.0
      2. group Id
        OG001
        lower Limit
        525
        upper Limit
        1600
        value
        1230.0
      3. group Id
        OG002
        lower Limit
        0
        upper Limit
        1510
        value
        326.5
      4. group Id
        OG003
        lower Limit
        0
        upper Limit
        1880
        value
        308.5
      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
        7
      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
        0
        upper Limit
        25800
        value
        16900.0
      2. group Id
        OG001
        lower Limit
        27000
        upper Limit
        65900
        value
        47150.0
      3. group Id
        OG002
        lower Limit
        14000
        upper Limit
        28600
        value
        23100.0
      4. group Id
        OG003
        lower Limit
        20500
        upper Limit
        64700
        value
        30350.0
      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
        31400.0
    denoms
    1. counts
      1. group Id
        OG000
        value
        9
      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
        863
        upper Limit
        2980
        value
        1380.0
      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
        1390.0
      3. group Id
        OG002
        lower Limit
        0
        upper Limit
        28900
        value
        0.0
      4. group Id
        OG003
        lower Limit
        0
        upper Limit
        1150
        value
        287.5
    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
        13600
        upper Limit
        26300
        value
        20300.0
      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
        56600.0
      3. group Id
        OG002
        lower Limit
        17700
        upper Limit
        27700
        value
        22450.0
      4. group Id
        OG003
        lower Limit
        3440
        upper Limit
        32200
        value
        20050.0
    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 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
  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 included all participants in the safety population from whom at least one PK sample has been obtained and analysed. 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 Concentrations of Belantamab Mafodotin Antibody-Drug Conjugate (ADC)
type
SECONDARY
unit Of Measure
Nanogram/millilitre (ng/mL)

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Preserved source evidence · Not medical advice