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NCT07217184 · OUTCOME

DE Phase: Isatuximab Concentration When Administered in Combination With Belantamab Mafodotin

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: ng/mL
Interval / dispersion: Standard Deviation
Time frame: Predose on Cycle (C)1 Day (D)1, D8, D15 and D22; predose on C2D1 and C2D15; predose on C3D1 and C3D15; predose on C4D1 and C4D15; predose on C5D1, C6D1, C7D1, C8D1, C9D1 and C10D1; and end of treatment (~194 weeks).

What was measured

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

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	10
1.4 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab	9
1.9 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab	10

Values in ng/mL · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
1.9 Milligram (mg)/Kilogram (kg) Belantamab Mafodotin (Q4W) + Isatuximab	0.000	0.0000	Not reported	Not reported	Not reported
1.4 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab	0.000	0.0000	Not reported	Not reported	Not reported
1.9 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab	0.000	0.0000	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	7
1.4 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab	8
1.9 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab	9

Values in ng/mL · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
1.9 Milligram (mg)/Kilogram (kg) Belantamab Mafodotin (Q4W) + Isatuximab	92.757	38.4678	Not reported	Not reported	Not reported
1.4 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab	83.566	35.0687	Not reported	Not reported	Not reported
1.9 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab	106.944	16.3712	Not reported	Not reported	Not reported

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 ng/mL · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
1.9 Milligram (mg)/Kilogram (kg) Belantamab Mafodotin (Q4W) + Isatuximab	187.171	99.5832	Not reported	Not reported	Not reported
1.4 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab	181.600	72.2766	Not reported	Not reported	Not reported
1.9 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab	223.956	80.4607	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	7
1.4 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab	8
1.9 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab	9

Values in ng/mL · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
1.9 Milligram (mg)/Kilogram (kg) Belantamab Mafodotin (Q4W) + Isatuximab	306.243	271.6850	Not reported	Not reported	Not reported
1.4 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab	238.788	94.5186	Not reported	Not reported	Not reported
1.9 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab	305.444	87.6985	Not reported	Not reported	Not reported

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	8
1.9 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab	7

Values in ng/mL · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
1.9 Milligram (mg)/Kilogram (kg) Belantamab Mafodotin (Q4W) + Isatuximab	297.850	143.1613	Not reported	Not reported	Not reported
1.4 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab	235.865	206.5359	Not reported	Not reported	Not reported
1.9 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab	346.957	182.0090	Not reported	Not reported	Not reported

CYCLE 2 DAY 15, PRE-DOSE

Analysis denominator · Participants

Group	Source count
1.9 Milligram (mg)/Kilogram (kg) Belantamab Mafodotin (Q4W) + Isatuximab	5
1.4 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab	5
1.9 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab	4

Values in ng/mL · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
1.9 Milligram (mg)/Kilogram (kg) Belantamab Mafodotin (Q4W) + Isatuximab	368.400	180.6967	Not reported	Not reported	Not reported
1.4 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab	267.740	158.6950	Not reported	Not reported	Not reported
1.9 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab	260.250	104.3532	Not reported	Not reported	Not reported

CYCLE 3 DAY 1, PRE-DOSE

Analysis denominator · Participants

Group	Source count
1.9 Milligram (mg)/Kilogram (kg) Belantamab Mafodotin (Q4W) + Isatuximab	4
1.4 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab	5
1.9 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab	6

Values in ng/mL · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
1.9 Milligram (mg)/Kilogram (kg) Belantamab Mafodotin (Q4W) + Isatuximab	478.250	258.3001	Not reported	Not reported	Not reported
1.4 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab	249.040	195.5971	Not reported	Not reported	Not reported
1.9 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab	388.500	144.9341	Not reported	Not reported	Not reported

CYCLE 3 DAY 15, PRE-DOSE

Analysis denominator · Participants

Group	Source count
1.9 Milligram (mg)/Kilogram (kg) Belantamab Mafodotin (Q4W) + Isatuximab	4
1.4 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab	2
1.9 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab	5

Values in ng/mL · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
1.9 Milligram (mg)/Kilogram (kg) Belantamab Mafodotin (Q4W) + Isatuximab	423.250	158.3759	Not reported	Not reported	Not reported
1.4 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab	309.000	49.4975	Not reported	Not reported	Not reported
1.9 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab	413.600	197.7291	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 ng/mL · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
1.9 Milligram (mg)/Kilogram (kg) Belantamab Mafodotin (Q4W) + Isatuximab	555.333	471.7121	Not reported	Not reported	Not reported
1.4 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab	162.580	216.9686	Not reported	Not reported	Not reported
1.9 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab	460.333	108.4706	Not reported	Not reported	Not reported

CYCLE 4 DAY 15, 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 ng/mL · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
1.9 Milligram (mg)/Kilogram (kg) Belantamab Mafodotin (Q4W) + Isatuximab	459.333	337.5001	Not reported	Not reported	Not reported
1.4 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab	179.900	219.3445	Not reported	Not reported	Not reported
1.9 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab	446.600	115.0795	Not reported	Not reported	Not reported

CYCLE 5 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 ng/mL · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
1.9 Milligram (mg)/Kilogram (kg) Belantamab Mafodotin (Q4W) + Isatuximab	403.333	224.0855	Not reported	Not reported	Not reported
1.4 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab	171.700	216.7989	Not reported	Not reported	Not reported
1.9 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab	440.400	136.8843	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 ng/mL · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
1.9 Milligram (mg)/Kilogram (kg) Belantamab Mafodotin (Q4W) + Isatuximab	351.000	228.0592	Not reported	Not reported	Not reported
1.4 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab	420.000	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	468.750	45.1101	Not reported	Not reported	Not reported

CYCLE 7 DAY 1, PRE-DOSE

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	1
1.9 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab	4

Values in ng/mL · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
1.9 Milligram (mg)/Kilogram (kg) Belantamab Mafodotin (Q4W) + Isatuximab	649.000	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.
1.4 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab	304.000	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	503.000	54.9121	Not reported	Not reported	Not reported

CYCLE 8 DAY 1, PRE-DOSE

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	1
1.9 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab	4

Values in ng/mL · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
1.9 Milligram (mg)/Kilogram (kg) Belantamab Mafodotin (Q4W) + Isatuximab	665.000	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.
1.4 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab	121.000	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	447.250	87.2788	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 ng/mL · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
1.9 Milligram (mg)/Kilogram (kg) Belantamab Mafodotin (Q4W) + Isatuximab	493.000	113.1371	Not reported	Not reported	Not reported
1.9 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab	449.000	114.5513	Not reported	Not reported	Not reported

CYCLE 10 DAY 1, PRE-DOSE

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	2

Values in ng/mL · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
1.9 Milligram (mg)/Kilogram (kg) Belantamab Mafodotin (Q4W) + Isatuximab	413.000	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	458.000	114.5513	Not reported	Not reported	Not reported

END OF TREATMENT (~194 weeks)

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	6

Values in ng/mL · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
1.9 Milligram (mg)/Kilogram (kg) Belantamab Mafodotin (Q4W) + Isatuximab	289.490	212.0699	Not reported	Not reported	Not reported
1.4 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab	202.613	200.3017	Not reported	Not reported	Not reported
1.9 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab	276.717	202.2553	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
spread
0.0000
value
0.000
group Id
OG001
spread
0.0000
value
0.000
group Id
OG002
spread
0.0000
value
0.000
denoms
counts
group Id
OG000
value
10
group Id
OG001
value
9
group Id
OG002
value
10
units
Participants
title
CYCLE 1 DAY 1, PRE-DOSE
categories
measurements
group Id
OG000
spread
38.4678
value
92.757
group Id
OG001
spread
35.0687
value
83.566
group Id
OG002
spread
16.3712
value
106.944
denoms
counts
group Id
OG000
value
7
group Id
OG001
value
8
group Id
OG002
value
9
units
Participants
title
CYCLE 1 DAY 8, PRE-DOSE
categories
measurements
group Id
OG000
spread
99.5832
value
187.171
group Id
OG001
spread
72.2766
value
181.600
group Id
OG002
spread
80.4607
value
223.956
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
271.6850
value
306.243
group Id
OG001
spread
94.5186
value
238.788
group Id
OG002
spread
87.6985
value
305.444
denoms
counts
group Id
OG000
value
7
group Id
OG001
value
8
group Id
OG002
value
9
units
Participants
title
CYCLE 1 DAY 22, PRE-DOSE
categories
measurements
group Id
OG000
spread
143.1613
value
297.850
group Id
OG001
spread
206.5359
value
235.865
group Id
OG002
spread
182.0090
value
346.957
denoms
counts
group Id
OG000
value
8
group Id
OG001
value
8
group Id
OG002
value
7
units
Participants
title
CYCLE 2 DAY 1, PRE-DOSE
categories
measurements
group Id
OG000
spread
180.6967
value
368.400
group Id
OG001
spread
158.6950
value
267.740
group Id
OG002
spread
104.3532
value
260.250
denoms
counts
group Id
OG000
value
5
group Id
OG001
value
5
group Id
OG002
value
4
units
Participants
title
CYCLE 2 DAY 15, PRE-DOSE
categories
measurements
group Id
OG000
spread
258.3001
value
478.250
group Id
OG001
spread
195.5971
value
249.040
group Id
OG002
spread
144.9341
value
388.500
denoms
counts
group Id
OG000
value
4
group Id
OG001
value
5
group Id
OG002
value
6
units
Participants
title
CYCLE 3 DAY 1, PRE-DOSE
categories
measurements
group Id
OG000
spread
158.3759
value
423.250
group Id
OG001
spread
49.4975
value
309.000
group Id
OG002
spread
197.7291
value
413.600
denoms
counts
group Id
OG000
value
4
group Id
OG001
value
2
group Id
OG002
value
5
units
Participants
title
CYCLE 3 DAY 15, PRE-DOSE
categories
measurements
group Id
OG000
spread
471.7121
value
555.333
group Id
OG001
spread
216.9686
value
162.580
group Id
OG002
spread
108.4706
value
460.333
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
categories
measurements
group Id
OG000
spread
337.5001
value
459.333
group Id
OG001
spread
219.3445
value
179.900
group Id
OG002
spread
115.0795
value
446.600
denoms
counts
group Id
OG000
value
3
group Id
OG001
value
2
group Id
OG002
value
5
units
Participants
title
CYCLE 4 DAY 15, PRE-DOSE
categories
measurements
group Id
OG000
spread
224.0855
value
403.333
group Id
OG001
spread
216.7989
value
171.700
group Id
OG002
spread
136.8843
value
440.400
denoms
counts
group Id
OG000
value
3
group Id
OG001
value
2
group Id
OG002
value
5
units
Participants
title
CYCLE 5 DAY 1, PRE-DOSE
categories
measurements
group Id
OG000
spread
228.0592
value
351.000
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
OG001
spread
NA
value
420.000
group Id
OG002
spread
45.1101
value
468.750
denoms
counts
group Id
OG000
value
3
group Id
OG001
value
1
group Id
OG002
value
4
units
Participants
title
CYCLE 6 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 Isatuximab when administered intravenously in combination with belantamab mafodotin.

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 on Cycle (C)1 Day (D)1, D8, D15 and D22; predose on C2D1 and C2D15; predose on C3D1 and C3D15; predose on C4D1 and C4D15; predose on C5D1, C6D1, C7D1, C8D1, C9D1 and C10D1; and end of treatment (~194 weeks).

title

DE Phase: Isatuximab Concentration When Administered in Combination With Belantamab Mafodotin

type

SECONDARY

unit Of Measure

ng/mL

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Preserved source evidence · Not medical advice