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NCT07217184 · OUTCOME

DE Phase: Plasma Concentration of Belantamab Mafodotin Total Antibody

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, end of infusion (EOI), and 2-hour and 24-hour on Cycle 1 Day 1; predose and anytime samples on Cycle 1 Days 8 and 22; predose on Cycle 1 Day 15; 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 total antibody.

Analysis population: PK 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 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	7
1.4 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab	7
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	1485.7	3930.83	Not reported	Not reported	Not reported
1.4 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab	6257.1	16554.84	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	37630.0	12088.20	Not reported	Not reported	Not reported
1.4 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab	30522.2	9544.21	Not reported	Not reported	Not reported
1.9 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab	39220.0	12263.66	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	36620.0	11797.72	Not reported	Not reported	Not reported
1.4 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab	28860.0	12571.06	Not reported	Not reported	Not reported
1.9 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab	37160.0	12550.45	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	27633.3	12155.45	Not reported	Not reported	Not reported
1.4 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab	22537.5	10444.13	Not reported	Not reported	Not reported
1.9 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab	28122.2	7035.05	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	8268.3	3033.69	Not reported	Not reported	Not reported
1.4 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab	8102.5	2232.90	Not reported	Not reported	Not reported
1.9 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab	10854.4	3857.33	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	19200.0	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	7934.3	3718.86	Not reported	Not reported	Not reported
1.4 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab	5600.0	2818.82	Not reported	Not reported	Not reported
1.9 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab	8818.9	2204.73	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	7168.3	3151.22	Not reported	Not reported	Not reported
1.4 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab	3701.3	1999.53	Not reported	Not reported	Not reported
1.9 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab	5627.8	1211.40	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	5150.0	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	5

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	3488.8	2152.26	Not reported	Not reported	Not reported
1.4 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab	719.6	811.62	Not reported	Not reported	Not reported
1.9 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab	1175.2	557.36	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	37287.5	13044.92	Not reported	Not reported	Not reported
1.4 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab	36112.5	11768.90	Not reported	Not reported	Not reported
1.9 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab	41871.4	21465.61	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	5

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	4080.0	1967.31	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	2731.2	1657.96	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	29370.0	19920.71	Not reported	Not reported	Not reported
1.4 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab	24650.0	1767.77	Not reported	Not reported	Not reported
1.9 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab	35833.3	16467.87	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	3673.3	1639.71	Not reported	Not reported	Not reported
1.4 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab	647.0	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	3835.0	2787.04	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	33633.3	15669.18	Not reported	Not reported	Not reported
1.4 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab	28300.0	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	33225.0	20486.15	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	2495.0	1492.00	Not reported	Not reported	Not reported
1.9 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab	3875.0	4037.58	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	26350.0	18031.22	Not reported	Not reported	Not reported
1.9 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab	31050.0	18314.07	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	1450.0	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	24400.0	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 (~194 weeks)

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	6
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	5191.4	3742.27	Not reported	Not reported	Not reported
1.4 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab	3536.7	5112.31	Not reported	Not reported	Not reported
1.9 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab	3063.3	3509.67	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
spread
3930.83
value
1485.7
group Id
OG001
spread
16554.84
value
6257.1
group Id
OG002
spread
0.00
value
0.0
denoms
counts
group Id
OG000
value
7
group Id
OG001
value
7
group Id
OG002
value
7
units
Participants
title
CYCLE 1 DAY 1, PRE-DOSE
categories
measurements
group Id
OG000
spread
12088.20
value
37630.0
group Id
OG001
spread
9544.21
value
30522.2
group Id
OG002
spread
12263.66
value
39220.0
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
11797.72
value
36620.0
group Id
OG001
spread
12571.06
value
28860.0
group Id
OG002
spread
12550.45
value
37160.0
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
12155.45
value
27633.3
group Id
OG001
spread
10444.13
value
22537.5
group Id
OG002
spread
7035.05
value
28122.2
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
3033.69
value
8268.3
group Id
OG001
spread
2232.90
value
8102.5
group Id
OG002
spread
3857.33
value
10854.4
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
19200.0
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
3718.86
value
7934.3
group Id
OG001
spread
2818.82
value
5600.0
group Id
OG002
spread
2204.73
value
8818.9
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
3151.22
value
7168.3
group Id
OG001
spread
1999.53
value
3701.3
group Id
OG002
spread
1211.40
value
5627.8
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
5150.0
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
2152.26
value
3488.8
group Id
OG001
spread
811.62
value
719.6
group Id
OG002
spread
557.36
value
1175.2
denoms
counts
group Id
OG000
value
8
group Id
OG001
value
7
group Id
OG002
value
5
units
Participants
title
CYCLE 2 DAY 1, PRE-DOSE
categories
measurements
group Id
OG000
spread
13044.92
value
37287.5
group Id
OG001
spread
11768.90
value
36112.5
group Id
OG002
spread
21465.61
value
41871.4
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
1967.31
value
4080.0
group Id
OG001
spread
0.00
value
0.0
group Id
OG002
spread
1657.96
value
2731.2
denoms
counts
group Id
OG000
value
3
group Id
OG001
value
2
group Id
OG002
value
5
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 total antibody.

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

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

reporting Status

POSTED

time Frame

Predose, end of infusion (EOI), and 2-hour and 24-hour on Cycle 1 Day 1; predose and anytime samples on Cycle 1 Days 8 and 22; predose on Cycle 1 Day 15; predose and EOI on Day 1 of Cycles 2, 4, 6, 9, and 12; and end of treatment (~194 weeks).

title

DE Phase: Plasma Concentration of Belantamab Mafodotin Total Antibody

type

SECONDARY

unit Of Measure

Nanogram/ millilitre (ng/mL)

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Preserved source evidence · Not medical advice