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NCT07217184 · OUTCOME

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

Sub-study of Belantamab Mafodotin (GSK2857916) in Combination With Isatuximab in Participants With RRMM · Source last updated 2026-06-25

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

Measure: MEAN
Unit: Nanogram/ millilitre (ng/mL)
Interval / dispersion: Standard Deviation
Time frame: Predose (PD), end of infusion (EOI), and 2-hour and 24-hour postdose on Cycle 1 Day 1; predose on C1D8, C1D15 and C1D22, anytime samples on C1D8 and C1D22; predose and EOI on Day 1 of Cycles 2, 4, 6, 9 and 12; and end of treatment (~194 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 (PK) 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 for analysis at that particular time point for the respective Arms/Groups.

Groups in this outcome

1.9 Milligram (mg)/Kilogram (kg) Belantamab Mafodotin (Q4W) + Isatuximab

Participants with Relapsed/Refractory Multiple Myeloma (RRMM) received 1.9 milligram (mg)/kilogram (kg) of belantamab mafodotin intravenous (IV) infusion once every 4 weeks (Q4W) infused over 30- 60 minutes on day 1 of each 28-day cycle in combination with 10 mg/kg isatuximab, given 1 hour after belantamab mafodotin end of infusion (EOI), administered as an IV infusion once weekly (Q1W) for 5 doses, then every 2 weeks (Q2W), and thereafter on day 1, 8, 15 and 22 of each 28-day cycle.

1.4 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab

Participants with RRMM received 1.4 mg/kg of belantamab mafodotin IV infusion, once every 8 weeks (Q8W) infused over 30- 60 minutes on day 1 of each 56 day cycle in combination with 10 mg/kg isatuximab, given 1 hour after belantamab mafodotin EOI administered as an IV infusion once weekly (Q1W) for 5 doses, then every 2 weeks (Q2W) and thereafter on days 1, 8, 15, and 22 of each 28-day cycle.

1.9 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab

Participants with RRMM received 1.9 mg/kg of belantamab mafodotin IV infusion, Q8W infused over 30- 60 minutes on day 1 of each 56 day cycle in combination with 10 mg/kg isatuximab, given 1 hour after belantamab mafodotin EOI administered as an IV infusion once weekly (Q1W) for 5 doses, then every 2 weeks (Q2W) and thereafter on days 1, 8, 15, and 22 of each 28-day cycle.

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

Analysis denominator · Participants

Group	Source count
1.9 Milligram (mg)/Kilogram (kg) Belantamab Mafodotin (Q4W) + Isatuximab	10
1.4 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab	10
1.9 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab	10

Reported measurements

CYCLE 1 DAY 1, PRE-DOSE

Analysis denominator · Participants

Group	Source count
1.9 Milligram (mg)/Kilogram (kg) Belantamab Mafodotin (Q4W) + Isatuximab	10
1.4 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab	9
1.9 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab	9

Values in Nanogram/ millilitre (ng/mL) · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
1.9 Milligram (mg)/Kilogram (kg) Belantamab Mafodotin (Q4W) + Isatuximab	1820.0	5755.35	Not reported	Not reported	Not reported
1.4 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab	4022.2	12066.67	Not reported	Not reported	Not reported
1.9 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab	0.0	0.00	Not reported	Not reported	Not reported

CYCLE 1 DAY 1, END OF INFUSION

Analysis denominator · Participants

Group	Source count
1.9 Milligram (mg)/Kilogram (kg) Belantamab Mafodotin (Q4W) + Isatuximab	10
1.4 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab	9
1.9 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab	10

Values in Nanogram/ millilitre (ng/mL) · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
1.9 Milligram (mg)/Kilogram (kg) Belantamab Mafodotin (Q4W) + Isatuximab	41880.0	22286.21	Not reported	Not reported	Not reported
1.4 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab	30588.9	7258.52	Not reported	Not reported	Not reported
1.9 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab	41230.0	6797.56	Not reported	Not reported	Not reported

CYCLE 1 DAY 1, 2 HOURS

Analysis denominator · Participants

Group	Source count
1.9 Milligram (mg)/Kilogram (kg) Belantamab Mafodotin (Q4W) + Isatuximab	10
1.4 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab	10
1.9 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab	10

Values in Nanogram/ millilitre (ng/mL) · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
1.9 Milligram (mg)/Kilogram (kg) Belantamab Mafodotin (Q4W) + Isatuximab	33920.0	8211.08	Not reported	Not reported	Not reported
1.4 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab	29490.0	7515.98	Not reported	Not reported	Not reported
1.9 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab	43770.0	5907.44	Not reported	Not reported	Not reported

CYCLE 1 DAY 1, 24 HOURS

Analysis denominator · Participants

Group	Source count
1.9 Milligram (mg)/Kilogram (kg) Belantamab Mafodotin (Q4W) + Isatuximab	9
1.4 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab	8
1.9 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab	9

Values in Nanogram/ millilitre (ng/mL) · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
1.9 Milligram (mg)/Kilogram (kg) Belantamab Mafodotin (Q4W) + Isatuximab	25100.0	11220.85	Not reported	Not reported	Not reported
1.4 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab	19350.0	5464.43	Not reported	Not reported	Not reported
1.9 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab	34544.4	12441.78	Not reported	Not reported	Not reported

CYCLE 1 DAY 8, PRE-DOSE

Analysis denominator · Participants

Group	Source count
1.9 Milligram (mg)/Kilogram (kg) Belantamab Mafodotin (Q4W) + Isatuximab	6
1.4 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab	8
1.9 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab	9

Values in Nanogram/ millilitre (ng/mL) · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
1.9 Milligram (mg)/Kilogram (kg) Belantamab Mafodotin (Q4W) + Isatuximab	4635.0	1552.77	Not reported	Not reported	Not reported
1.4 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab	4790.0	1335.47	Not reported	Not reported	Not reported
1.9 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab	7250.0	2129.57	Not reported	Not reported	Not reported

CYCLE 1 DAY 8, ANYTIME SAMPLE

Analysis denominator · Participants

Group	Source count
1.9 Milligram (mg)/Kilogram (kg) Belantamab Mafodotin (Q4W) + Isatuximab	1
1.4 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab	0
1.9 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab	0

Values in Nanogram/ millilitre (ng/mL) · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
1.9 Milligram (mg)/Kilogram (kg) Belantamab Mafodotin (Q4W) + Isatuximab	8210.0	NA	Not reported	Not reported	SD is not applicable as only a single participant was analyzed. Mean value presented here is the actual concentration for this single participant.

CYCLE 1 DAY 15, PRE-DOSE

Analysis denominator · Participants

Group	Source count
1.9 Milligram (mg)/Kilogram (kg) Belantamab Mafodotin (Q4W) + Isatuximab	7
1.4 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab	8
1.9 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab	9

Values in Nanogram/ millilitre (ng/mL) · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
1.9 Milligram (mg)/Kilogram (kg) Belantamab Mafodotin (Q4W) + Isatuximab	3410.0	1265.35	Not reported	Not reported	Not reported
1.4 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab	2216.3	958.11	Not reported	Not reported	Not reported
1.9 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab	2988.9	561.10	Not reported	Not reported	Not reported

CYCLE 1 DAY 22, PRE-DOSE

Analysis denominator · Participants

Group	Source count
1.9 Milligram (mg)/Kilogram (kg) Belantamab Mafodotin (Q4W) + Isatuximab	6
1.4 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab	8
1.9 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab	9

Values in Nanogram/ millilitre (ng/mL) · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
1.9 Milligram (mg)/Kilogram (kg) Belantamab Mafodotin (Q4W) + Isatuximab	2785.0	1516.58	Not reported	Not reported	Not reported
1.4 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab	1348.1	775.55	Not reported	Not reported	Not reported
1.9 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab	1932.2	319.13	Not reported	Not reported	Not reported

CYCLE 1 DAY 22, ANYTIME SAMPLE

Analysis denominator · Participants

Group	Source count
1.9 Milligram (mg)/Kilogram (kg) Belantamab Mafodotin (Q4W) + Isatuximab	0
1.4 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab	0
1.9 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab	1

Values in Nanogram/ millilitre (ng/mL) · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
1.9 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab	1460.0	NA	Not reported	Not reported	SD is not applicable as only a single participant was analyzed. Mean value presented here is the actual concentration for this single participant.

CYCLE 2 DAY 1, PRE-DOSE

Analysis denominator · Participants

Group	Source count
1.9 Milligram (mg)/Kilogram (kg) Belantamab Mafodotin (Q4W) + Isatuximab	8
1.4 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab	7
1.9 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab	6

Values in Nanogram/ millilitre (ng/mL) · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
1.9 Milligram (mg)/Kilogram (kg) Belantamab Mafodotin (Q4W) + Isatuximab	1217.9	935.53	Not reported	Not reported	Not reported
1.4 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab	0.0	0.00	Not reported	Not reported	Not reported
1.9 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab	90.7	222.09	Not reported	Not reported	Not reported

CYCLE 2 DAY 1, END OF INFUSION

Analysis denominator · Participants

Group	Source count
1.9 Milligram (mg)/Kilogram (kg) Belantamab Mafodotin (Q4W) + Isatuximab	8
1.4 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab	8
1.9 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab	7

Values in Nanogram/ millilitre (ng/mL) · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
1.9 Milligram (mg)/Kilogram (kg) Belantamab Mafodotin (Q4W) + Isatuximab	42587.5	24069.39	Not reported	Not reported	Not reported
1.4 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab	37387.5	8927.08	Not reported	Not reported	Not reported
1.9 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab	42614.3	13248.32	Not reported	Not reported	Not reported

CYCLE 4 DAY 1, PRE-DOSE

Analysis denominator · Participants

Group	Source count
1.9 Milligram (mg)/Kilogram (kg) Belantamab Mafodotin (Q4W) + Isatuximab	3
1.4 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab	2
1.9 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab	6

Values in Nanogram/ millilitre (ng/mL) · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
1.9 Milligram (mg)/Kilogram (kg) Belantamab Mafodotin (Q4W) + Isatuximab	1516.7	1355.52	Not reported	Not reported	Not reported
1.4 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab	0.0	0.00	Not reported	Not reported	Not reported
1.9 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab	569.2	721.04	Not reported	Not reported	Not reported

CYCLE 4 DAY 1, END OF INFUSION

Analysis denominator · Participants

Group	Source count
1.9 Milligram (mg)/Kilogram (kg) Belantamab Mafodotin (Q4W) + Isatuximab	3
1.4 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab	2
1.9 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab	6

Values in Nanogram/ millilitre (ng/mL) · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
1.9 Milligram (mg)/Kilogram (kg) Belantamab Mafodotin (Q4W) + Isatuximab	29456.7	22500.15	Not reported	Not reported	Not reported
1.4 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab	32850.0	8414.57	Not reported	Not reported	Not reported
1.9 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab	32566.7	11944.65	Not reported	Not reported	Not reported

CYCLE 6 DAY 1, PRE-DOSE

Analysis denominator · Participants

Group	Source count
1.9 Milligram (mg)/Kilogram (kg) Belantamab Mafodotin (Q4W) + Isatuximab	3
1.4 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab	1
1.9 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab	4

Values in Nanogram/ millilitre (ng/mL) · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
1.9 Milligram (mg)/Kilogram (kg) Belantamab Mafodotin (Q4W) + Isatuximab	1343.3	1455.69	Not reported	Not reported	Not reported
1.4 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab	0.0	NA	Not reported	Not reported	SD is not applicable as only a single participant was analyzed. Mean value presented here is the actual concentration for this single participant.
1.9 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab	1001.8	817.23	Not reported	Not reported	Not reported

CYCLE 6 DAY 1, END OF INFUSION

Analysis denominator · Participants

Group	Source count
1.9 Milligram (mg)/Kilogram (kg) Belantamab Mafodotin (Q4W) + Isatuximab	3
1.4 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab	1
1.9 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab	4

Values in Nanogram/ millilitre (ng/mL) · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
1.9 Milligram (mg)/Kilogram (kg) Belantamab Mafodotin (Q4W) + Isatuximab	35733.3	20713.84	Not reported	Not reported	Not reported
1.4 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab	37400.0	NA	Not reported	Not reported	SD is not applicable as only a single participant was analyzed. Mean value presented here is the actual concentration for this single participant.
1.9 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab	31725.0	18434.28	Not reported	Not reported	Not reported

CYCLE 9 DAY 1, PRE-DOSE

Analysis denominator · Participants

Group	Source count
1.9 Milligram (mg)/Kilogram (kg) Belantamab Mafodotin (Q4W) + Isatuximab	2
1.4 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab	0
1.9 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab	2

Values in Nanogram/ millilitre (ng/mL) · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
1.9 Milligram (mg)/Kilogram (kg) Belantamab Mafodotin (Q4W) + Isatuximab	595.0	841.46	Not reported	Not reported	Not reported
1.9 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab	705.0	997.02	Not reported	Not reported	Not reported

CYCLE 9 DAY 1, END OF INFUSION

Analysis denominator · Participants

Group	Source count
1.9 Milligram (mg)/Kilogram (kg) Belantamab Mafodotin (Q4W) + Isatuximab	2
1.4 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab	0
1.9 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab	2

Values in Nanogram/ millilitre (ng/mL) · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
1.9 Milligram (mg)/Kilogram (kg) Belantamab Mafodotin (Q4W) + Isatuximab	23250.0	8131.73	Not reported	Not reported	Not reported
1.9 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab	31500.0	2687.01	Not reported	Not reported	Not reported

CYCLE 12 DAY 1, PRE-DOSE

Analysis denominator · Participants

Group	Source count
1.9 Milligram (mg)/Kilogram (kg) Belantamab Mafodotin (Q4W) + Isatuximab	0
1.4 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab	0
1.9 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab	1

Values in Nanogram/ millilitre (ng/mL) · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
1.9 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab	606.0	NA	Not reported	Not reported	SD is not applicable as only a single participant was analyzed. Mean value presented here is the actual concentration for this single participant.

CYCLE 12 DAY 1, END OF INFUSION

Analysis denominator · Participants

Group	Source count
1.9 Milligram (mg)/Kilogram (kg) Belantamab Mafodotin (Q4W) + Isatuximab	0
1.4 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab	0
1.9 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab	1

Values in Nanogram/ millilitre (ng/mL) · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
1.9 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab	52400.0	NA	Not reported	Not reported	SD is not applicable as only a single participant was analyzed. Mean value presented here is the actual concentration for this single participant.

END OF TREATMENT (~ 194weeks)

Analysis denominator · Participants

Group	Source count
1.9 Milligram (mg)/Kilogram (kg) Belantamab Mafodotin (Q4W) + Isatuximab	6
1.4 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab	7
1.9 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab	6

Values in Nanogram/ millilitre (ng/mL) · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
1.9 Milligram (mg)/Kilogram (kg) Belantamab Mafodotin (Q4W) + Isatuximab	2211.0	1654.48	Not reported	Not reported	Not reported
1.4 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab	2566.1	5976.04	Not reported	Not reported	Not reported
1.9 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab	1312.7	1965.46	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
spread
5755.35
value
1820.0
group Id
OG001
spread
12066.67
value
4022.2
group Id
OG002
spread
0.00
value
0.0
denoms
counts
group Id
OG000
value
10
group Id
OG001
value
9
group Id
OG002
value
9
units
Participants
title
CYCLE 1 DAY 1, PRE-DOSE
categories
measurements
group Id
OG000
spread
22286.21
value
41880.0
group Id
OG001
spread
7258.52
value
30588.9
group Id
OG002
spread
6797.56
value
41230.0
denoms
counts
group Id
OG000
value
10
group Id
OG001
value
9
group Id
OG002
value
10
units
Participants
title
CYCLE 1 DAY 1, END OF INFUSION
categories
measurements
group Id
OG000
spread
8211.08
value
33920.0
group Id
OG001
spread
7515.98
value
29490.0
group Id
OG002
spread
5907.44
value
43770.0
denoms
counts
group Id
OG000
value
10
group Id
OG001
value
10
group Id
OG002
value
10
units
Participants
title
CYCLE 1 DAY 1, 2 HOURS
categories
measurements
group Id
OG000
spread
11220.85
value
25100.0
group Id
OG001
spread
5464.43
value
19350.0
group Id
OG002
spread
12441.78
value
34544.4
denoms
counts
group Id
OG000
value
9
group Id
OG001
value
8
group Id
OG002
value
9
units
Participants
title
CYCLE 1 DAY 1, 24 HOURS
categories
measurements
group Id
OG000
spread
1552.77
value
4635.0
group Id
OG001
spread
1335.47
value
4790.0
group Id
OG002
spread
2129.57
value
7250.0
denoms
counts
group Id
OG000
value
6
group Id
OG001
value
8
group Id
OG002
value
9
units
Participants
title
CYCLE 1 DAY 8, PRE-DOSE
categories
measurements
comment
SD is not applicable as only a single participant was analyzed. Mean value presented here is the actual concentration for this single participant.
group Id
OG000
spread
NA
value
8210.0
denoms
counts
group Id
OG000
value
1
group Id
OG001
value
0
group Id
OG002
value
0
units
Participants
title
CYCLE 1 DAY 8, ANYTIME SAMPLE
categories
measurements
group Id
OG000
spread
1265.35
value
3410.0
group Id
OG001
spread
958.11
value
2216.3
group Id
OG002
spread
561.10
value
2988.9
denoms
counts
group Id
OG000
value
7
group Id
OG001
value
8
group Id
OG002
value
9
units
Participants
title
CYCLE 1 DAY 15, PRE-DOSE
categories
measurements
group Id
OG000
spread
1516.58
value
2785.0
group Id
OG001
spread
775.55
value
1348.1
group Id
OG002
spread
319.13
value
1932.2
denoms
counts
group Id
OG000
value
6
group Id
OG001
value
8
group Id
OG002
value
9
units
Participants
title
CYCLE 1 DAY 22, PRE-DOSE
categories
measurements
comment
SD is not applicable as only a single participant was analyzed. Mean value presented here is the actual concentration for this single participant.
group Id
OG002
spread
NA
value
1460.0
denoms
counts
group Id
OG000
value
0
group Id
OG001
value
0
group Id
OG002
value
1
units
Participants
title
CYCLE 1 DAY 22, ANYTIME SAMPLE
categories
measurements
group Id
OG000
spread
935.53
value
1217.9
group Id
OG001
spread
0.00
value
0.0
group Id
OG002
spread
222.09
value
90.7
denoms
counts
group Id
OG000
value
8
group Id
OG001
value
7
group Id
OG002
value
6
units
Participants
title
CYCLE 2 DAY 1, PRE-DOSE
categories
measurements
group Id
OG000
spread
24069.39
value
42587.5
group Id
OG001
spread
8927.08
value
37387.5
group Id
OG002
spread
13248.32
value
42614.3
denoms
counts
group Id
OG000
value
8
group Id
OG001
value
8
group Id
OG002
value
7
units
Participants
title
CYCLE 2 DAY 1, END OF INFUSION
categories
measurements
group Id
OG000
spread
1355.52
value
1516.7
group Id
OG001
spread
0.00
value
0.0
group Id
OG002
spread
721.04
value
569.2
denoms
counts
group Id
OG000
value
3
group Id
OG001
value
2
group Id
OG002
value
6
units
Participants
title
CYCLE 4 DAY 1, PRE-DOSE

denoms

counts
group Id
OG000
value
10
group Id
OG001
value
10
group Id
OG002
value
10
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

Standard Deviation

groups

description
Participants with Relapsed/Refractory Multiple Myeloma (RRMM) received 1.9 milligram (mg)/kilogram (kg) of belantamab mafodotin intravenous (IV) infusion once every 4 weeks (Q4W) infused over 30- 60 minutes on day 1 of each 28-day cycle in combination with 10 mg/kg isatuximab, given 1 hour after belantamab mafodotin end of infusion (EOI), administered as an IV infusion once weekly (Q1W) for 5 doses, then every 2 weeks (Q2W), and thereafter on day 1, 8, 15 and 22 of each 28-day cycle.
id
OG000
title
1.9 Milligram (mg)/Kilogram (kg) Belantamab Mafodotin (Q4W) + Isatuximab
description
Participants with RRMM received 1.4 mg/kg of belantamab mafodotin IV infusion, once every 8 weeks (Q8W) infused over 30- 60 minutes on day 1 of each 56 day cycle in combination with 10 mg/kg isatuximab, given 1 hour after belantamab mafodotin EOI administered as an IV infusion once weekly (Q1W) for 5 doses, then every 2 weeks (Q2W) and thereafter on days 1, 8, 15, and 22 of each 28-day cycle.
id
OG001
title
1.4 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab
description
Participants with RRMM received 1.9 mg/kg of belantamab mafodotin IV infusion, Q8W infused over 30- 60 minutes on day 1 of each 56 day cycle in combination with 10 mg/kg isatuximab, given 1 hour after belantamab mafodotin EOI administered as an IV infusion once weekly (Q1W) for 5 doses, then every 2 weeks (Q2W) and thereafter on days 1, 8, 15, and 22 of each 28-day cycle.
id
OG002
title
1.9 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab

param Type

MEAN

population Description

Pharmacokinetic (PK) 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 for analysis at that particular time point for the respective Arms/Groups.

reporting Status

POSTED

time Frame

Predose (PD), end of infusion (EOI), and 2-hour and 24-hour postdose on Cycle 1 Day 1; predose on C1D8, C1D15 and C1D22, anytime samples on C1D8 and C1D22; predose and EOI on Day 1 of Cycles 2, 4, 6, 9 and 12; and end of treatment (~194 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