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NCT07084896 · OUTCOME

DE Phase: Plasma Concentrations of Belantamab Mafodotin Cys- Monomethyl Auristatin-F (Cys-mcMMAF)

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
Picogram / millilitre (pg/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 cys- monomethyl auristatin-F (cys-mcMMAF).

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 + Nirogacestat10
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 BID10
DE Phase: 1.4 mg/kg Belantamab Mafodotin Q4W + Nirogacestat BID1
Values in Picogram / millilitre (pg/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 BID0.00Not reported0.00.0Not reported
DE Phase: 1.4 mg/kg Belantamab Mafodotin Q4W/Q8W + Nirogacestat BID0.00Not reported0.00.0Not 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 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 BID8
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 Picogram / millilitre (pg/mL) · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
DE Phase: 0.95 mg/kg Belantamab Mafodotin + Nirogacestat163.50Not reported99.4338.0Not reported
DE Phase: 1.9 mg/kg Belantamab Mafodotin+ Nirogacestat175.00Not reported168.0317.0Not reported
DE Phase: 1.0 mg/kg Belantamab Mafodotin Q4W/Q8W + Nirogacestat BID96.55Not reported68.2190.0Not reported
DE Phase: 1.4 mg/kg Belantamab Mafodotin Q4W/Q8W + Nirogacestat BID165.50Not reported99.31040.0Not reported
DE Phase: 1.4 mg/kg Belantamab Mafodotin Q4W + Nirogacestat BID155.00Not 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 BID8
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 Picogram / millilitre (pg/mL) · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
DE Phase: 0.95 mg/kg Belantamab Mafodotin + Nirogacestat191.00Not reported119.0351.0Not reported
DE Phase: 1.9 mg/kg Belantamab Mafodotin+ Nirogacestat322.00Not reported225.0388.0Not reported
DE Phase: 1.0 mg/kg Belantamab Mafodotin Q4W/Q8W + Nirogacestat BID137.50Not reported86.9270.0Not reported
DE Phase: 1.4 mg/kg Belantamab Mafodotin Q4W/Q8W + Nirogacestat BID299.00Not reported156.01150.0Not 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, 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 Picogram / millilitre (pg/mL) · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
DE Phase: 0.95 mg/kg Belantamab Mafodotin + Nirogacestat387.50Not reported196.0855.0Not reported
DE Phase: 1.9 mg/kg Belantamab Mafodotin+ Nirogacestat1697.50Not reported675.02720.0Not 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 BID5
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 Picogram / millilitre (pg/mL) · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
DE Phase: 0.95 mg/kg Belantamab Mafodotin + Nirogacestat232.00Not reported145.0711.0Not reported
DE Phase: 1.9 mg/kg Belantamab Mafodotin+ Nirogacestat528.50Not reported393.0909.0Not reported
DE Phase: 1.0 mg/kg Belantamab Mafodotin Q4W/Q8W + Nirogacestat BID144.00Not reported115.0358.0Not reported
DE Phase: 1.4 mg/kg Belantamab Mafodotin Q4W/Q8W + Nirogacestat BID432.00Not reported202.02950.0Not reported
DE Phase: 1.4 mg/kg Belantamab Mafodotin Q4W + Nirogacestat BID244.00Not 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, 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 BID4
DE Phase: 1.4 mg/kg Belantamab Mafodotin Q4W/Q8W + Nirogacestat BID9
DE Phase: 1.4 mg/kg Belantamab Mafodotin Q4W + Nirogacestat BID0
Values in Picogram / millilitre (pg/mL) · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
DE Phase: 0.95 mg/kg Belantamab Mafodotin + Nirogacestat71.20Not reported0.0122.0Not reported
DE Phase: 1.9 mg/kg Belantamab Mafodotin+ Nirogacestat177.00Not reported163.0193.0Not reported
DE Phase: 1.0 mg/kg Belantamab Mafodotin Q4W/Q8W + Nirogacestat BID88.45Not reported63.3137.0Not reported
DE Phase: 1.4 mg/kg Belantamab Mafodotin Q4W/Q8W + Nirogacestat BID132.00Not reported71.4245.0Not reported
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 Picogram / millilitre (pg/mL) · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
DE Phase: 1.4 mg/kg Belantamab Mafodotin Q4W/Q8W + Nirogacestat BID0.00Not reported0.00.0Not 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 BID2
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 Picogram / millilitre (pg/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 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 BID5
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 Picogram / millilitre (pg/mL) · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
DE Phase: 0.95 mg/kg Belantamab Mafodotin + Nirogacestat0.00Not reported0.0122.0Not 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 BID0.00Not reported0.00.0Not reported
DE Phase: 1.4 mg/kg Belantamab Mafodotin Q4W/Q8W + Nirogacestat BID0.00Not reported0.00.0Not 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 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 BID5
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 Picogram / millilitre (pg/mL) · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
DE Phase: 0.95 mg/kg Belantamab Mafodotin + Nirogacestat131.00Not reported0.0330.0Not reported
DE Phase: 1.9 mg/kg Belantamab Mafodotin+ Nirogacestat291.50Not reported201.0369.0Not reported
DE Phase: 1.0 mg/kg Belantamab Mafodotin Q4W/Q8W + Nirogacestat BID142.00Not reported0.0152.0Not reported
DE Phase: 1.4 mg/kg Belantamab Mafodotin Q4W/Q8W + Nirogacestat BID231.50Not reported126.0907.0Not reported
DE Phase: 1.4 mg/kg Belantamab Mafodotin Q4W + Nirogacestat BID122.00Not 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 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 BID2
DE Phase: 1.4 mg/kg Belantamab Mafodotin Q4W + Nirogacestat BID0
Values in Picogram / millilitre (pg/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 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 BID0.00Not reported0.00.0Not reported
DE Phase: 1.4 mg/kg Belantamab Mafodotin Q4W/Q8W + Nirogacestat BID0.00Not reported0.00.0Not 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 BID2
DE Phase: 1.4 mg/kg Belantamab Mafodotin Q4W + Nirogacestat BID0
Values in Picogram / millilitre (pg/mL) · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
DE Phase: 0.95 mg/kg Belantamab Mafodotin + Nirogacestat190.00Not reported113.0312.0Not reported
DE Phase: 1.9 mg/kg Belantamab Mafodotin+ Nirogacestat5620.00Not 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: 1.0 mg/kg Belantamab Mafodotin Q4W/Q8W + Nirogacestat BID91.70Not reported0.0121.0Not reported
DE Phase: 1.4 mg/kg Belantamab Mafodotin Q4W/Q8W + Nirogacestat BID88.00Not reported0.0176.0Not 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 Picogram / millilitre (pg/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 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 BID0.00Not reported0.00.0Not reported
DE Phase: 1.4 mg/kg Belantamab Mafodotin Q4W/Q8W + Nirogacestat BID0.00Not reported0.00.0Not 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 Picogram / millilitre (pg/mL) · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
DE Phase: 0.95 mg/kg Belantamab Mafodotin + Nirogacestat164.50Not reported84.2301.0Not reported
DE Phase: 1.9 mg/kg Belantamab Mafodotin+ Nirogacestat226.00Not 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: 1.0 mg/kg Belantamab Mafodotin Q4W/Q8W + Nirogacestat BID145.00Not reported81.0171.0Not reported
DE Phase: 1.4 mg/kg Belantamab Mafodotin Q4W/Q8W + Nirogacestat BID133.50Not reported102.0214.0Not 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 Picogram / millilitre (pg/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 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 BID0.00Not reported0.00.0Not reported
DE Phase: 1.4 mg/kg Belantamab Mafodotin Q4W/Q8W + Nirogacestat BID0.00Not reported0.00.0Not 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 Picogram / millilitre (pg/mL) · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
DE Phase: 0.95 mg/kg Belantamab Mafodotin + Nirogacestat128.00Not reported113.0223.0Not reported
DE Phase: 1.9 mg/kg Belantamab Mafodotin+ Nirogacestat243.00Not 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: 1.0 mg/kg Belantamab Mafodotin Q4W/Q8W + Nirogacestat BID100.85Not reported90.7111.0Not reported
DE Phase: 1.4 mg/kg Belantamab Mafodotin Q4W/Q8W + Nirogacestat BID55.50Not reported0.0111.0Not reported
CYCLE 12 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 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 Picogram / millilitre (pg/mL) · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
DE Phase: 0.95 mg/kg Belantamab Mafodotin + Nirogacestat0.00Not reported0.0188.0Not reported
DE Phase: 1.9 mg/kg Belantamab Mafodotin+ Nirogacestat0.00Not 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 BID0.00Not reported0.00.0Not reported
CYCLE 12 DAY 1, END OF INFUSION

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 Picogram / millilitre (pg/mL) · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
DE Phase: 0.95 mg/kg Belantamab Mafodotin + Nirogacestat166.00Not reported114.0229.0Not reported
DE Phase: 1.9 mg/kg Belantamab Mafodotin+ Nirogacestat285.00Not 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 BID100.50Not reported0.0201.0Not 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 Picogram / millilitre (pg/mL) · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
DE Phase: 0.95 mg/kg Belantamab Mafodotin + Nirogacestat0.00Not 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 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 Picogram / millilitre (pg/mL) · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
DE Phase: 0.95 mg/kg Belantamab Mafodotin + Nirogacestat0.00Not reportedNANAFull range is not applicable as only a single participant was analyzed. Median value presented here is the actual concentration for this single participant.
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 BID7
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 Picogram / millilitre (pg/mL) · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
DE Phase: 0.95 mg/kg Belantamab Mafodotin + Nirogacestat0.00Not reported0.074.6Not reported
DE Phase: 1.9 mg/kg Belantamab Mafodotin+ Nirogacestat0.00Not reported0.073.8Not reported
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 reported0.071.2Not 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.
Complete source fields
classes
  1. 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
        0.0
        upper Limit
        0.0
        value
        0.00
      4. group Id
        OG003
        lower Limit
        0.0
        upper Limit
        0.0
        value
        0.00
      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
        0.00
    denoms
    1. counts
      1. group Id
        OG000
        value
        10
      2. group Id
        OG001
        value
        4
      3. group Id
        OG002
        value
        7
      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
        99.4
        upper Limit
        338.0
        value
        163.50
      2. group Id
        OG001
        lower Limit
        168.0
        upper Limit
        317.0
        value
        175.00
      3. group Id
        OG002
        lower Limit
        68.2
        upper Limit
        190.0
        value
        96.55
      4. group Id
        OG003
        lower Limit
        99.3
        upper Limit
        1040.0
        value
        165.50
      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
        155.00
    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
        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
        119.0
        upper Limit
        351.0
        value
        191.00
      2. group Id
        OG001
        lower Limit
        225.0
        upper Limit
        388.0
        value
        322.00
      3. group Id
        OG002
        lower Limit
        86.9
        upper Limit
        270.0
        value
        137.50
      4. group Id
        OG003
        lower Limit
        156.0
        upper Limit
        1150.0
        value
        299.00
      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
        10
      2. group Id
        OG001
        value
        4
      3. group Id
        OG002
        value
        8
      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
        196.0
        upper Limit
        855.0
        value
        387.50
      2. group Id
        OG001
        lower Limit
        675.0
        upper Limit
        2720.0
        value
        1697.50
    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
        145.0
        upper Limit
        711.0
        value
        232.00
      2. group Id
        OG001
        lower Limit
        393.0
        upper Limit
        909.0
        value
        528.50
      3. group Id
        OG002
        lower Limit
        115.0
        upper Limit
        358.0
        value
        144.00
      4. group Id
        OG003
        lower Limit
        202.0
        upper Limit
        2950.0
        value
        432.00
      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
        244.00
    denoms
    1. counts
      1. group Id
        OG000
        value
        9
      2. group Id
        OG001
        value
        4
      3. group Id
        OG002
        value
        5
      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
        0.0
        upper Limit
        122.0
        value
        71.20
      2. group Id
        OG001
        lower Limit
        163.0
        upper Limit
        193.0
        value
        177.00
      3. group Id
        OG002
        lower Limit
        63.3
        upper Limit
        137.0
        value
        88.45
      4. group Id
        OG003
        lower Limit
        71.4
        upper Limit
        245.0
        value
        132.00
    denoms
    1. counts
      1. group Id
        OG000
        value
        10
      2. group Id
        OG001
        value
        4
      3. group Id
        OG002
        value
        4
      4. group Id
        OG003
        value
        9
      5. group Id
        OG004
        value
        0
      units
      Participants
    title
    CYCLE 1 DAY 8, ANYTIME SAMPLE
  7. categories
    1. measurements
      1. group Id
        OG003
        lower Limit
        0.0
        upper Limit
        0.0
        value
        0.00
    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
        0.0
        upper Limit
        0.0
        value
        0.00
      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
        0.00
    denoms
    1. counts
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        2
      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
        0.0
        upper Limit
        122.0
        value
        0.00
      2. group Id
        OG001
        lower Limit
        0.0
        upper Limit
        0.0
        value
        0.00
      3. group Id
        OG002
        lower Limit
        0.0
        upper Limit
        0.0
        value
        0.00
      4. group Id
        OG003
        lower Limit
        0.0
        upper Limit
        0.0
        value
        0.00
      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
        0.00
    denoms
    1. counts
      1. group Id
        OG000
        value
        9
      2. group Id
        OG001
        value
        4
      3. group Id
        OG002
        value
        5
      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
        0.0
        upper Limit
        330.0
        value
        131.00
      2. group Id
        OG001
        lower Limit
        201.0
        upper Limit
        369.0
        value
        291.50
      3. group Id
        OG002
        lower Limit
        0.0
        upper Limit
        152.0
        value
        142.00
      4. group Id
        OG003
        lower Limit
        126.0
        upper Limit
        907.0
        value
        231.50
      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
        122.00
    denoms
    1. counts
      1. group Id
        OG000
        value
        9
      2. group Id
        OG001
        value
        4
      3. group Id
        OG002
        value
        5
      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
        0.0
        upper Limit
        0.0
        value
        0.00
      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
        0.00
      3. group Id
        OG002
        lower Limit
        0.0
        upper Limit
        0.0
        value
        0.00
      4. group Id
        OG003
        lower Limit
        0.0
        upper Limit
        0.0
        value
        0.00
    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
        2
      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
        113.0
        upper Limit
        312.0
        value
        190.00
      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
        5620.00
      3. group Id
        OG002
        lower Limit
        0.0
        upper Limit
        121.0
        value
        91.70
      4. group Id
        OG003
        lower Limit
        0.0
        upper Limit
        176.0
        value
        88.00
    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
        2
      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 cys- monomethyl auristatin-F (cys-mcMMAF).
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 Concentrations of Belantamab Mafodotin Cys- Monomethyl Auristatin-F (Cys-mcMMAF)
type
SECONDARY
unit Of Measure
Picogram / millilitre (pg/mL)

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Preserved source evidence · Not medical advice