Part 1 and Part 2: Change From Baseline (CFB) in Vital Signs: Heart Rate
A Study of Belantamab Mafodotin Monotherapy in Multiple Myeloma Participants With Normal and Varying Degree of Impaired Renal Function · Source last updated 2026-07-01
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
Measure
MEAN
Unit
Beats per minute
Interval / dispersion
Standard Deviation
Time frame
Baseline (Day 1) and up to approx. 236 weeks
What was measured
Heart rate was measured after resting for at least 5 minutes in a supine or semi-recumbent position. Baseline (Day 1) was defined as latest pre-dose assessment with a non-missing value, including unscheduled visits. Change from Baseline was calculated as post-dose visit value minus Baseline value.
Analysis population: Safety population. Only those participants who were measured and analyzed (i.e., contributed to 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
Part 1: Belantamab Mafodotin 2.5 mg/kg (Normal/Mildly Impaired Renal Function)
Participants with Relapsed/Refractory Multiple Myeloma (RRMM) who have had at least 3 lines of prior treatment (or at least 2 lines of prior treatment if ineligible for autologous stem cell transplantation) and normal/mildly impaired renal function received intravenous (IV) infusion of 2.5 milligram (mg)/kilogram (kg) belantamab mafodotin for 30 minutes on Day 1 of every 21-day Cycle until disease progression, withdrawal of consent, withdrawal due to adverse event (AE), lost to follow-up, death, whichever occurs first.
Part 1: Belantamab Mafodotin 2.5 mg/kg (Severely Impaired Renal Function)
Participants with RRMM who have had at least 3 lines of prior treatment (or at least 2 lines of prior treatment if ineligible for autologous stem cell transplantation) and severe renal impairment renal function received IV infusion of 2.5 mg/kg belantamab mafodotin for 30 minutes on Day 1 of every 21-day Cycle until disease progression, withdrawal of consent, withdrawal due to AE, lost to follow-up, death, whichever occurs first.
Part 1: Belantamab Mafodotin 2.5 mg/kg (Other Renal Function)
Participants with RRMM who have had at least 3 lines of prior treatment (or at least 2 lines of prior treatment if ineligible for autologous stem cell transplantation) and other renal impairment renal function received IV infusion of 2.5 mg/kg belantamab mafodotin for 30 minutes on Day 1 of every 21-day Cycle until disease progression, withdrawal of consent, withdrawal due to AE, lost to follow-up, death, whichever occurs first.
Part 2: Belantamab Mafodotin 2.5 mg/kg End Stage Renal Disease (Not on Dialysis)
Participants with RRMM who have had at least 3 lines of prior treatment (or at least 2 lines of prior treatment if ineligible for autologous stem cell transplantation) and end stage renal disease (ESRD) (not on hemodialysis) received IV infusion of 2.5 mg/kg belantamab mafodotin for 30 minutes on Day 1 of every 21-day Cycle until disease progression, withdrawal of consent, withdrawal due to AE, lost to follow-up, death, whichever occurs first.
Part 2: Belantamab Mafodotin 2.5 mg/kg ESRD (On Dialysis)
Participants with RRMM who have had at least 3 lines of prior treatment (or at least 2 lines of prior treatment if ineligible for autologous stem cell transplantation) and ESRD (on hemodialysis) received IV infusion of 2.5 mg/kg belantamab mafodotin for 30 minutes on Day 1 of every 21-day Cycle until disease progression, withdrawal of consent, withdrawal due to AE, lost to follow-up, death, whichever occurs first.
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
Part 1: Belantamab Mafodotin 2.5 mg/kg (Normal/Mildly Impaired Renal Function)
10
Part 1: Belantamab Mafodotin 2.5 mg/kg (Severely Impaired Renal Function)
9
Part 1: Belantamab Mafodotin 2.5 mg/kg (Other Renal Function)
4
Part 2: Belantamab Mafodotin 2.5 mg/kg End Stage Renal Disease (Not on Dialysis)
5
Part 2: Belantamab Mafodotin 2.5 mg/kg ESRD (On Dialysis)
8
Reported measurements
Baseline (Day 1)
Analysis denominator · Participants
Group
Source count
Part 1: Belantamab Mafodotin 2.5 mg/kg (Normal/Mildly Impaired Renal Function)
10
Part 1: Belantamab Mafodotin 2.5 mg/kg (Severely Impaired Renal Function)
9
Part 1: Belantamab Mafodotin 2.5 mg/kg (Other Renal Function)
4
Part 2: Belantamab Mafodotin 2.5 mg/kg End Stage Renal Disease (Not on Dialysis)
5
Part 2: Belantamab Mafodotin 2.5 mg/kg ESRD (On Dialysis)
8
Values in Beats per minute · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Part 1: Belantamab Mafodotin 2.5 mg/kg (Normal/Mildly Impaired Renal Function)
77.2
14.67
Not reported
Not reported
Not reported
Part 1: Belantamab Mafodotin 2.5 mg/kg (Severely Impaired Renal Function)
74.9
15.34
Not reported
Not reported
Not reported
Part 1: Belantamab Mafodotin 2.5 mg/kg (Other Renal Function)
71.8
4.57
Not reported
Not reported
Not reported
Part 2: Belantamab Mafodotin 2.5 mg/kg End Stage Renal Disease (Not on Dialysis)
69.0
11.05
Not reported
Not reported
Not reported
Part 2: Belantamab Mafodotin 2.5 mg/kg ESRD (On Dialysis)
67.4
6.78
Not reported
Not reported
Not reported
CFB to Cycle 1 Day 1, 15 MINS AFTER SOI
Analysis denominator · Participants
Group
Source count
Part 1: Belantamab Mafodotin 2.5 mg/kg (Normal/Mildly Impaired Renal Function)
10
Part 1: Belantamab Mafodotin 2.5 mg/kg (Severely Impaired Renal Function)
9
Part 1: Belantamab Mafodotin 2.5 mg/kg (Other Renal Function)
4
Part 2: Belantamab Mafodotin 2.5 mg/kg End Stage Renal Disease (Not on Dialysis)
5
Part 2: Belantamab Mafodotin 2.5 mg/kg ESRD (On Dialysis)
7
Values in Beats per minute · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Part 1: Belantamab Mafodotin 2.5 mg/kg (Normal/Mildly Impaired Renal Function)
-1.3
3.65
Not reported
Not reported
Not reported
Part 1: Belantamab Mafodotin 2.5 mg/kg (Severely Impaired Renal Function)
-4.0
6.22
Not reported
Not reported
Not reported
Part 1: Belantamab Mafodotin 2.5 mg/kg (Other Renal Function)
2.0
2.94
Not reported
Not reported
Not reported
Part 2: Belantamab Mafodotin 2.5 mg/kg End Stage Renal Disease (Not on Dialysis)
1.2
5.45
Not reported
Not reported
Not reported
Part 2: Belantamab Mafodotin 2.5 mg/kg ESRD (On Dialysis)
2.3
2.87
Not reported
Not reported
Not reported
CFB to Cycle 1 Day 1, WITHIN 15 MINS AFTER EOI
Analysis denominator · Participants
Group
Source count
Part 1: Belantamab Mafodotin 2.5 mg/kg (Normal/Mildly Impaired Renal Function)
10
Part 1: Belantamab Mafodotin 2.5 mg/kg (Severely Impaired Renal Function)
9
Part 1: Belantamab Mafodotin 2.5 mg/kg (Other Renal Function)
4
Part 2: Belantamab Mafodotin 2.5 mg/kg End Stage Renal Disease (Not on Dialysis)
5
Part 2: Belantamab Mafodotin 2.5 mg/kg ESRD (On Dialysis)
7
Values in Beats per minute · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Part 1: Belantamab Mafodotin 2.5 mg/kg (Normal/Mildly Impaired Renal Function)
-1.1
6.03
Not reported
Not reported
Not reported
Part 1: Belantamab Mafodotin 2.5 mg/kg (Severely Impaired Renal Function)
-0.9
4.04
Not reported
Not reported
Not reported
Part 1: Belantamab Mafodotin 2.5 mg/kg (Other Renal Function)
4.3
7.41
Not reported
Not reported
Not reported
Part 2: Belantamab Mafodotin 2.5 mg/kg End Stage Renal Disease (Not on Dialysis)
1.8
7.19
Not reported
Not reported
Not reported
Part 2: Belantamab Mafodotin 2.5 mg/kg ESRD (On Dialysis)
2.1
2.27
Not reported
Not reported
Not reported
CFB to Cycle 1 Day 1, 1 HOUR AFTER EOI
Analysis denominator · Participants
Group
Source count
Part 1: Belantamab Mafodotin 2.5 mg/kg (Normal/Mildly Impaired Renal Function)
10
Part 1: Belantamab Mafodotin 2.5 mg/kg (Severely Impaired Renal Function)
9
Part 1: Belantamab Mafodotin 2.5 mg/kg (Other Renal Function)
4
Part 2: Belantamab Mafodotin 2.5 mg/kg End Stage Renal Disease (Not on Dialysis)
5
Part 2: Belantamab Mafodotin 2.5 mg/kg ESRD (On Dialysis)
8
Values in Beats per minute · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Part 1: Belantamab Mafodotin 2.5 mg/kg (Normal/Mildly Impaired Renal Function)
3.0
5.72
Not reported
Not reported
Not reported
Part 1: Belantamab Mafodotin 2.5 mg/kg (Severely Impaired Renal Function)
-1.0
4.30
Not reported
Not reported
Not reported
Part 1: Belantamab Mafodotin 2.5 mg/kg (Other Renal Function)
4.8
10.37
Not reported
Not reported
Not reported
Part 2: Belantamab Mafodotin 2.5 mg/kg End Stage Renal Disease (Not on Dialysis)
-1.2
6.91
Not reported
Not reported
Not reported
Part 2: Belantamab Mafodotin 2.5 mg/kg ESRD (On Dialysis)
0.9
3.56
Not reported
Not reported
Not reported
CFB to Cycle 2 Day 1, PRE-INFUSION
Analysis denominator · Participants
Group
Source count
Part 1: Belantamab Mafodotin 2.5 mg/kg (Normal/Mildly Impaired Renal Function)
9
Part 1: Belantamab Mafodotin 2.5 mg/kg (Severely Impaired Renal Function)
8
Part 1: Belantamab Mafodotin 2.5 mg/kg (Other Renal Function)
3
Part 2: Belantamab Mafodotin 2.5 mg/kg End Stage Renal Disease (Not on Dialysis)
5
Part 2: Belantamab Mafodotin 2.5 mg/kg ESRD (On Dialysis)
6
Values in Beats per minute · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Part 1: Belantamab Mafodotin 2.5 mg/kg (Normal/Mildly Impaired Renal Function)
1.2
10.03
Not reported
Not reported
Not reported
Part 1: Belantamab Mafodotin 2.5 mg/kg (Severely Impaired Renal Function)
-5.0
5.50
Not reported
Not reported
Not reported
Part 1: Belantamab Mafodotin 2.5 mg/kg (Other Renal Function)
1.3
9.29
Not reported
Not reported
Not reported
Part 2: Belantamab Mafodotin 2.5 mg/kg End Stage Renal Disease (Not on Dialysis)
-0.2
9.15
Not reported
Not reported
Not reported
Part 2: Belantamab Mafodotin 2.5 mg/kg ESRD (On Dialysis)
1.2
7.96
Not reported
Not reported
Not reported
CFB to Cycle 2 Day 1, WITHIN 15 MINS AFTER EOI
Analysis denominator · Participants
Group
Source count
Part 1: Belantamab Mafodotin 2.5 mg/kg (Normal/Mildly Impaired Renal Function)
9
Part 1: Belantamab Mafodotin 2.5 mg/kg (Severely Impaired Renal Function)
8
Part 1: Belantamab Mafodotin 2.5 mg/kg (Other Renal Function)
3
Part 2: Belantamab Mafodotin 2.5 mg/kg End Stage Renal Disease (Not on Dialysis)
5
Part 2: Belantamab Mafodotin 2.5 mg/kg ESRD (On Dialysis)
5
Values in Beats per minute · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Part 1: Belantamab Mafodotin 2.5 mg/kg (Normal/Mildly Impaired Renal Function)
-2.2
13.34
Not reported
Not reported
Not reported
Part 1: Belantamab Mafodotin 2.5 mg/kg (Severely Impaired Renal Function)
-3.8
7.67
Not reported
Not reported
Not reported
Part 1: Belantamab Mafodotin 2.5 mg/kg (Other Renal Function)
-0.3
7.37
Not reported
Not reported
Not reported
Part 2: Belantamab Mafodotin 2.5 mg/kg End Stage Renal Disease (Not on Dialysis)
-1.0
10.49
Not reported
Not reported
Not reported
Part 2: Belantamab Mafodotin 2.5 mg/kg ESRD (On Dialysis)
6.4
8.53
Not reported
Not reported
Not reported
CFB to Cycle 3 Day 1, PRE-INFUSION
Analysis denominator · Participants
Group
Source count
Part 1: Belantamab Mafodotin 2.5 mg/kg (Normal/Mildly Impaired Renal Function)
4
Part 1: Belantamab Mafodotin 2.5 mg/kg (Severely Impaired Renal Function)
5
Part 1: Belantamab Mafodotin 2.5 mg/kg (Other Renal Function)
2
Part 2: Belantamab Mafodotin 2.5 mg/kg End Stage Renal Disease (Not on Dialysis)
4
Part 2: Belantamab Mafodotin 2.5 mg/kg ESRD (On Dialysis)
7
Values in Beats per minute · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Part 1: Belantamab Mafodotin 2.5 mg/kg (Normal/Mildly Impaired Renal Function)
-12.3
7.85
Not reported
Not reported
Not reported
Part 1: Belantamab Mafodotin 2.5 mg/kg (Severely Impaired Renal Function)
-2.4
11.48
Not reported
Not reported
Not reported
Part 1: Belantamab Mafodotin 2.5 mg/kg (Other Renal Function)
7.5
9.19
Not reported
Not reported
Not reported
Part 2: Belantamab Mafodotin 2.5 mg/kg End Stage Renal Disease (Not on Dialysis)
5.3
19.05
Not reported
Not reported
Not reported
Part 2: Belantamab Mafodotin 2.5 mg/kg ESRD (On Dialysis)
2.9
9.12
Not reported
Not reported
Not reported
CFB to Cycle 3 Day 1, WITHIN 15 MINS AFTER EOI
Analysis denominator · Participants
Group
Source count
Part 1: Belantamab Mafodotin 2.5 mg/kg (Normal/Mildly Impaired Renal Function)
4
Part 1: Belantamab Mafodotin 2.5 mg/kg (Severely Impaired Renal Function)
5
Part 1: Belantamab Mafodotin 2.5 mg/kg (Other Renal Function)
2
Part 2: Belantamab Mafodotin 2.5 mg/kg End Stage Renal Disease (Not on Dialysis)
4
Part 2: Belantamab Mafodotin 2.5 mg/kg ESRD (On Dialysis)
5
Values in Beats per minute · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Part 1: Belantamab Mafodotin 2.5 mg/kg (Normal/Mildly Impaired Renal Function)
-9.0
9.45
Not reported
Not reported
Not reported
Part 1: Belantamab Mafodotin 2.5 mg/kg (Severely Impaired Renal Function)
0.6
13.50
Not reported
Not reported
Not reported
Part 1: Belantamab Mafodotin 2.5 mg/kg (Other Renal Function)
4.5
6.36
Not reported
Not reported
Not reported
Part 2: Belantamab Mafodotin 2.5 mg/kg End Stage Renal Disease (Not on Dialysis)
-5.0
7.79
Not reported
Not reported
Not reported
Part 2: Belantamab Mafodotin 2.5 mg/kg ESRD (On Dialysis)
5.8
10.23
Not reported
Not reported
Not reported
CFB to Cycle 4 Day 1, PRE-INFUSION
Analysis denominator · Participants
Group
Source count
Part 1: Belantamab Mafodotin 2.5 mg/kg (Normal/Mildly Impaired Renal Function)
3
Part 1: Belantamab Mafodotin 2.5 mg/kg (Severely Impaired Renal Function)
3
Part 1: Belantamab Mafodotin 2.5 mg/kg (Other Renal Function)
2
Part 2: Belantamab Mafodotin 2.5 mg/kg End Stage Renal Disease (Not on Dialysis)
4
Part 2: Belantamab Mafodotin 2.5 mg/kg ESRD (On Dialysis)
6
Values in Beats per minute · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Part 1: Belantamab Mafodotin 2.5 mg/kg (Normal/Mildly Impaired Renal Function)
0.0
6.00
Not reported
Not reported
Not reported
Part 1: Belantamab Mafodotin 2.5 mg/kg (Severely Impaired Renal Function)
-12.3
25.74
Not reported
Not reported
Not reported
Part 1: Belantamab Mafodotin 2.5 mg/kg (Other Renal Function)
5.5
14.85
Not reported
Not reported
Not reported
Part 2: Belantamab Mafodotin 2.5 mg/kg End Stage Renal Disease (Not on Dialysis)
-6.5
11.47
Not reported
Not reported
Not reported
Part 2: Belantamab Mafodotin 2.5 mg/kg ESRD (On Dialysis)
4.0
5.37
Not reported
Not reported
Not reported
CFB to Cycle 4 Day 1, WITHIN 15 MINS AFTER EOI
Analysis denominator · Participants
Group
Source count
Part 1: Belantamab Mafodotin 2.5 mg/kg (Normal/Mildly Impaired Renal Function)
3
Part 1: Belantamab Mafodotin 2.5 mg/kg (Severely Impaired Renal Function)
3
Part 1: Belantamab Mafodotin 2.5 mg/kg (Other Renal Function)
2
Part 2: Belantamab Mafodotin 2.5 mg/kg End Stage Renal Disease (Not on Dialysis)
4
Part 2: Belantamab Mafodotin 2.5 mg/kg ESRD (On Dialysis)
5
Values in Beats per minute · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Part 1: Belantamab Mafodotin 2.5 mg/kg (Normal/Mildly Impaired Renal Function)
-1.3
9.07
Not reported
Not reported
Not reported
Part 1: Belantamab Mafodotin 2.5 mg/kg (Severely Impaired Renal Function)
-15.7
22.94
Not reported
Not reported
Not reported
Part 1: Belantamab Mafodotin 2.5 mg/kg (Other Renal Function)
1.0
11.31
Not reported
Not reported
Not reported
Part 2: Belantamab Mafodotin 2.5 mg/kg End Stage Renal Disease (Not on Dialysis)
-8.5
12.87
Not reported
Not reported
Not reported
Part 2: Belantamab Mafodotin 2.5 mg/kg ESRD (On Dialysis)
6.0
5.52
Not reported
Not reported
Not reported
CFB to Cycle 5 Day 1, PRE-INFUSION
Analysis denominator · Participants
Group
Source count
Part 1: Belantamab Mafodotin 2.5 mg/kg (Normal/Mildly Impaired Renal Function)
3
Part 1: Belantamab Mafodotin 2.5 mg/kg (Severely Impaired Renal Function)
3
Part 1: Belantamab Mafodotin 2.5 mg/kg (Other Renal Function)
1
Part 2: Belantamab Mafodotin 2.5 mg/kg End Stage Renal Disease (Not on Dialysis)
4
Part 2: Belantamab Mafodotin 2.5 mg/kg ESRD (On Dialysis)
6
Values in Beats per minute · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Part 1: Belantamab Mafodotin 2.5 mg/kg (Normal/Mildly Impaired Renal Function)
-3.7
19.14
Not reported
Not reported
Not reported
Part 1: Belantamab Mafodotin 2.5 mg/kg (Severely Impaired Renal Function)
-3.3
9.29
Not reported
Not reported
Not reported
Part 1: Belantamab Mafodotin 2.5 mg/kg (Other Renal Function)
0.0
NA
Not reported
Not reported
Standard Deviation is not evaluable as only a single participant was analyzed.
Part 2: Belantamab Mafodotin 2.5 mg/kg End Stage Renal Disease (Not on Dialysis)
-5.8
8.96
Not reported
Not reported
Not reported
Part 2: Belantamab Mafodotin 2.5 mg/kg ESRD (On Dialysis)
5.7
10.65
Not reported
Not reported
Not reported
CFB to Cycle 5 Day 1, WITHIN 15 MINS AFTER EOI
Analysis denominator · Participants
Group
Source count
Part 1: Belantamab Mafodotin 2.5 mg/kg (Normal/Mildly Impaired Renal Function)
3
Part 1: Belantamab Mafodotin 2.5 mg/kg (Severely Impaired Renal Function)
3
Part 1: Belantamab Mafodotin 2.5 mg/kg (Other Renal Function)
1
Part 2: Belantamab Mafodotin 2.5 mg/kg End Stage Renal Disease (Not on Dialysis)
4
Part 2: Belantamab Mafodotin 2.5 mg/kg ESRD (On Dialysis)
5
Values in Beats per minute · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Part 1: Belantamab Mafodotin 2.5 mg/kg (Normal/Mildly Impaired Renal Function)
-6.0
11.14
Not reported
Not reported
Not reported
Part 1: Belantamab Mafodotin 2.5 mg/kg (Severely Impaired Renal Function)
-5.7
9.07
Not reported
Not reported
Not reported
Part 1: Belantamab Mafodotin 2.5 mg/kg (Other Renal Function)
-2.0
NA
Not reported
Not reported
Standard Deviation is not evaluable as only a single participant was analyzed.
Part 2: Belantamab Mafodotin 2.5 mg/kg End Stage Renal Disease (Not on Dialysis)
-5.0
9.24
Not reported
Not reported
Not reported
Part 2: Belantamab Mafodotin 2.5 mg/kg ESRD (On Dialysis)
4.2
3.83
Not reported
Not reported
Not reported
CFB to Cycle 6 Day 1, PRE-INFUSION
Analysis denominator · Participants
Group
Source count
Part 1: Belantamab Mafodotin 2.5 mg/kg (Normal/Mildly Impaired Renal Function)
3
Part 1: Belantamab Mafodotin 2.5 mg/kg (Severely Impaired Renal Function)
2
Part 1: Belantamab Mafodotin 2.5 mg/kg (Other Renal Function)
1
Part 2: Belantamab Mafodotin 2.5 mg/kg End Stage Renal Disease (Not on Dialysis)
4
Part 2: Belantamab Mafodotin 2.5 mg/kg ESRD (On Dialysis)
5
Values in Beats per minute · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Part 1: Belantamab Mafodotin 2.5 mg/kg (Normal/Mildly Impaired Renal Function)
-6.0
13.11
Not reported
Not reported
Not reported
Part 1: Belantamab Mafodotin 2.5 mg/kg (Severely Impaired Renal Function)
8.5
7.78
Not reported
Not reported
Not reported
Part 1: Belantamab Mafodotin 2.5 mg/kg (Other Renal Function)
-3.0
NA
Not reported
Not reported
Standard Deviation is not evaluable as only a single participant was analyzed.
Part 2: Belantamab Mafodotin 2.5 mg/kg End Stage Renal Disease (Not on Dialysis)
-0.3
7.41
Not reported
Not reported
Not reported
Part 2: Belantamab Mafodotin 2.5 mg/kg ESRD (On Dialysis)
6.2
7.92
Not reported
Not reported
Not reported
CFB to Cycle 6 Day 1, WITHIN 15 MINS AFTER EOI
Analysis denominator · Participants
Group
Source count
Part 1: Belantamab Mafodotin 2.5 mg/kg (Normal/Mildly Impaired Renal Function)
3
Part 1: Belantamab Mafodotin 2.5 mg/kg (Severely Impaired Renal Function)
2
Part 1: Belantamab Mafodotin 2.5 mg/kg (Other Renal Function)
1
Part 2: Belantamab Mafodotin 2.5 mg/kg End Stage Renal Disease (Not on Dialysis)
4
Part 2: Belantamab Mafodotin 2.5 mg/kg ESRD (On Dialysis)
4
Values in Beats per minute · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Part 1: Belantamab Mafodotin 2.5 mg/kg (Normal/Mildly Impaired Renal Function)
-7.7
9.61
Not reported
Not reported
Not reported
Part 1: Belantamab Mafodotin 2.5 mg/kg (Severely Impaired Renal Function)
3.5
3.54
Not reported
Not reported
Not reported
Part 1: Belantamab Mafodotin 2.5 mg/kg (Other Renal Function)
-4.0
NA
Not reported
Not reported
Standard Deviation is not evaluable as only a single participant was analyzed.
Part 2: Belantamab Mafodotin 2.5 mg/kg End Stage Renal Disease (Not on Dialysis)
1.8
7.27
Not reported
Not reported
Not reported
Part 2: Belantamab Mafodotin 2.5 mg/kg ESRD (On Dialysis)
4.5
7.42
Not reported
Not reported
Not reported
CFB to Cycle 7 Day 1, PRE-INFUSION
Analysis denominator · Participants
Group
Source count
Part 1: Belantamab Mafodotin 2.5 mg/kg (Normal/Mildly Impaired Renal Function)
3
Part 1: Belantamab Mafodotin 2.5 mg/kg (Severely Impaired Renal Function)
2
Part 1: Belantamab Mafodotin 2.5 mg/kg (Other Renal Function)
1
Part 2: Belantamab Mafodotin 2.5 mg/kg End Stage Renal Disease (Not on Dialysis)
2
Part 2: Belantamab Mafodotin 2.5 mg/kg ESRD (On Dialysis)
2
Values in Beats per minute · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Part 1: Belantamab Mafodotin 2.5 mg/kg (Normal/Mildly Impaired Renal Function)
-5.3
7.09
Not reported
Not reported
Not reported
Part 1: Belantamab Mafodotin 2.5 mg/kg (Severely Impaired Renal Function)
3.5
2.12
Not reported
Not reported
Not reported
Part 1: Belantamab Mafodotin 2.5 mg/kg (Other Renal Function)
-8.0
NA
Not reported
Not reported
Standard Deviation is not evaluable as only a single participant was analyzed.
Part 2: Belantamab Mafodotin 2.5 mg/kg End Stage Renal Disease (Not on Dialysis)
-1.5
6.36
Not reported
Not reported
Not reported
Part 2: Belantamab Mafodotin 2.5 mg/kg ESRD (On Dialysis)
5.5
0.71
Not reported
Not reported
Not reported
CFB to Cycle 7 Day 1, WITHIN 15 MINS AFTER EOI
Analysis denominator · Participants
Group
Source count
Part 1: Belantamab Mafodotin 2.5 mg/kg (Normal/Mildly Impaired Renal Function)
3
Part 1: Belantamab Mafodotin 2.5 mg/kg (Severely Impaired Renal Function)
2
Part 1: Belantamab Mafodotin 2.5 mg/kg (Other Renal Function)
1
Part 2: Belantamab Mafodotin 2.5 mg/kg End Stage Renal Disease (Not on Dialysis)
2
Part 2: Belantamab Mafodotin 2.5 mg/kg ESRD (On Dialysis)
2
Values in Beats per minute · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Part 1: Belantamab Mafodotin 2.5 mg/kg (Normal/Mildly Impaired Renal Function)
-8.3
12.86
Not reported
Not reported
Not reported
Part 1: Belantamab Mafodotin 2.5 mg/kg (Severely Impaired Renal Function)
2.5
2.12
Not reported
Not reported
Not reported
Part 1: Belantamab Mafodotin 2.5 mg/kg (Other Renal Function)
-3.0
NA
Not reported
Not reported
Standard Deviation is not evaluable as only a single participant was analyzed.
Part 2: Belantamab Mafodotin 2.5 mg/kg End Stage Renal Disease (Not on Dialysis)
2.0
9.90
Not reported
Not reported
Not reported
Part 2: Belantamab Mafodotin 2.5 mg/kg ESRD (On Dialysis)
6.5
0.71
Not reported
Not reported
Not reported
CFB to Cycle 8 Day 1, PRE-INFUSION
Analysis denominator · Participants
Group
Source count
Part 1: Belantamab Mafodotin 2.5 mg/kg (Normal/Mildly Impaired Renal Function)
3
Part 1: Belantamab Mafodotin 2.5 mg/kg (Severely Impaired Renal Function)
2
Part 1: Belantamab Mafodotin 2.5 mg/kg (Other Renal Function)
1
Part 2: Belantamab Mafodotin 2.5 mg/kg End Stage Renal Disease (Not on Dialysis)
1
Part 2: Belantamab Mafodotin 2.5 mg/kg ESRD (On Dialysis)
1
Values in Beats per minute · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Part 1: Belantamab Mafodotin 2.5 mg/kg (Normal/Mildly Impaired Renal Function)
-9.7
12.58
Not reported
Not reported
Not reported
Part 1: Belantamab Mafodotin 2.5 mg/kg (Severely Impaired Renal Function)
14.5
16.26
Not reported
Not reported
Not reported
Part 1: Belantamab Mafodotin 2.5 mg/kg (Other Renal Function)
-4.0
NA
Not reported
Not reported
Standard Deviation is not evaluable as only a single participant was analyzed.
Part 2: Belantamab Mafodotin 2.5 mg/kg End Stage Renal Disease (Not on Dialysis)
-17.0
NA
Not reported
Not reported
Standard Deviation is not evaluable as only a single participant was analyzed.
Part 2: Belantamab Mafodotin 2.5 mg/kg ESRD (On Dialysis)
6.0
NA
Not reported
Not reported
Standard Deviation is not evaluable as only a single participant was analyzed.
CFB to Cycle 8 Day 1, WITHIN 15 MINS AFTER EOI
Analysis denominator · Participants
Group
Source count
Part 1: Belantamab Mafodotin 2.5 mg/kg (Normal/Mildly Impaired Renal Function)
3
Part 1: Belantamab Mafodotin 2.5 mg/kg (Severely Impaired Renal Function)
2
Part 1: Belantamab Mafodotin 2.5 mg/kg (Other Renal Function)
1
Part 2: Belantamab Mafodotin 2.5 mg/kg End Stage Renal Disease (Not on Dialysis)
1
Part 2: Belantamab Mafodotin 2.5 mg/kg ESRD (On Dialysis)
1
Values in Beats per minute · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Part 1: Belantamab Mafodotin 2.5 mg/kg (Normal/Mildly Impaired Renal Function)
-11.3
9.29
Not reported
Not reported
Not reported
Part 1: Belantamab Mafodotin 2.5 mg/kg (Severely Impaired Renal Function)
15.0
18.38
Not reported
Not reported
Not reported
Part 1: Belantamab Mafodotin 2.5 mg/kg (Other Renal Function)
-2.0
NA
Not reported
Not reported
Standard Deviation is not evaluable as only a single participant was analyzed.
Part 2: Belantamab Mafodotin 2.5 mg/kg End Stage Renal Disease (Not on Dialysis)
-18.0
NA
Not reported
Not reported
Standard Deviation is not evaluable as only a single participant was analyzed.
Part 2: Belantamab Mafodotin 2.5 mg/kg ESRD (On Dialysis)
8.0
NA
Not reported
Not reported
Standard Deviation is not evaluable as only a single participant was analyzed.
CFB to Cycle 9 Day 1, PRE-INFUSION
Analysis denominator · Participants
Group
Source count
Part 1: Belantamab Mafodotin 2.5 mg/kg (Normal/Mildly Impaired Renal Function)
1
Part 1: Belantamab Mafodotin 2.5 mg/kg (Severely Impaired Renal Function)
1
Part 1: Belantamab Mafodotin 2.5 mg/kg (Other Renal Function)
1
Part 2: Belantamab Mafodotin 2.5 mg/kg End Stage Renal Disease (Not on Dialysis)
1
Part 2: Belantamab Mafodotin 2.5 mg/kg ESRD (On Dialysis)
1
Values in Beats per minute · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Part 1: Belantamab Mafodotin 2.5 mg/kg (Normal/Mildly Impaired Renal Function)
-20.0
NA
Not reported
Not reported
Standard Deviation is not evaluable as only a single participant was analyzed.
Part 1: Belantamab Mafodotin 2.5 mg/kg (Severely Impaired Renal Function)
5.0
NA
Not reported
Not reported
Standard Deviation is not evaluable as only a single participant was analyzed.
Part 1: Belantamab Mafodotin 2.5 mg/kg (Other Renal Function)
-8.0
NA
Not reported
Not reported
Standard Deviation is not evaluable as only a single participant was analyzed.
Part 2: Belantamab Mafodotin 2.5 mg/kg End Stage Renal Disease (Not on Dialysis)
-22.0
NA
Not reported
Not reported
Standard Deviation is not evaluable as only a single participant was analyzed.
Part 2: Belantamab Mafodotin 2.5 mg/kg ESRD (On Dialysis)
10.0
NA
Not reported
Not reported
Standard Deviation is not evaluable as only a single participant was analyzed.
CFB to Cycle 9 Day 1, WITHIN 15 MINS AFTER EOI
Analysis denominator · Participants
Group
Source count
Part 1: Belantamab Mafodotin 2.5 mg/kg (Normal/Mildly Impaired Renal Function)
1
Part 1: Belantamab Mafodotin 2.5 mg/kg (Severely Impaired Renal Function)
1
Part 1: Belantamab Mafodotin 2.5 mg/kg (Other Renal Function)
1
Part 2: Belantamab Mafodotin 2.5 mg/kg End Stage Renal Disease (Not on Dialysis)
1
Part 2: Belantamab Mafodotin 2.5 mg/kg ESRD (On Dialysis)
1
Values in Beats per minute · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Part 1: Belantamab Mafodotin 2.5 mg/kg (Normal/Mildly Impaired Renal Function)
-22.0
NA
Not reported
Not reported
Standard Deviation is not evaluable as only a single participant was analyzed.
Part 1: Belantamab Mafodotin 2.5 mg/kg (Severely Impaired Renal Function)
4.0
NA
Not reported
Not reported
Standard Deviation is not evaluable as only a single participant was analyzed.
Part 1: Belantamab Mafodotin 2.5 mg/kg (Other Renal Function)
-10.0
NA
Not reported
Not reported
Standard Deviation is not evaluable as only a single participant was analyzed.
Part 2: Belantamab Mafodotin 2.5 mg/kg End Stage Renal Disease (Not on Dialysis)
-17.0
NA
Not reported
Not reported
Standard Deviation is not evaluable as only a single participant was analyzed.
Part 2: Belantamab Mafodotin 2.5 mg/kg ESRD (On Dialysis)
12.0
NA
Not reported
Not reported
Standard Deviation is not evaluable as only a single participant was analyzed.
CFB to Cycle 10 Day 1, PRE-INFUSION
Analysis denominator · Participants
Group
Source count
Part 1: Belantamab Mafodotin 2.5 mg/kg (Normal/Mildly Impaired Renal Function)
1
Part 1: Belantamab Mafodotin 2.5 mg/kg (Severely Impaired Renal Function)
1
Part 1: Belantamab Mafodotin 2.5 mg/kg (Other Renal Function)
1
Part 2: Belantamab Mafodotin 2.5 mg/kg End Stage Renal Disease (Not on Dialysis)
1
Part 2: Belantamab Mafodotin 2.5 mg/kg ESRD (On Dialysis)
1
Values in Beats per minute · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Part 1: Belantamab Mafodotin 2.5 mg/kg (Normal/Mildly Impaired Renal Function)
-23.0
NA
Not reported
Not reported
Standard Deviation is not evaluable as only a single participant was analyzed.
Part 1: Belantamab Mafodotin 2.5 mg/kg (Severely Impaired Renal Function)
6.0
NA
Not reported
Not reported
Standard Deviation is not evaluable as only a single participant was analyzed.
Part 1: Belantamab Mafodotin 2.5 mg/kg (Other Renal Function)
-5.0
NA
Not reported
Not reported
Standard Deviation is not evaluable as only a single participant was analyzed.
Part 2: Belantamab Mafodotin 2.5 mg/kg End Stage Renal Disease (Not on Dialysis)
-17.0
NA
Not reported
Not reported
Standard Deviation is not evaluable as only a single participant was analyzed.
Part 2: Belantamab Mafodotin 2.5 mg/kg ESRD (On Dialysis)
5.0
NA
Not reported
Not reported
Standard Deviation is not evaluable as only a single participant was analyzed.
CFB to Cycle 10 Day 1, WITHIN 15 MINS AFTER EOI
Analysis denominator · Participants
Group
Source count
Part 1: Belantamab Mafodotin 2.5 mg/kg (Normal/Mildly Impaired Renal Function)
1
Part 1: Belantamab Mafodotin 2.5 mg/kg (Severely Impaired Renal Function)
1
Part 1: Belantamab Mafodotin 2.5 mg/kg (Other Renal Function)
1
Part 2: Belantamab Mafodotin 2.5 mg/kg End Stage Renal Disease (Not on Dialysis)
1
Part 2: Belantamab Mafodotin 2.5 mg/kg ESRD (On Dialysis)
1
Values in Beats per minute · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Part 1: Belantamab Mafodotin 2.5 mg/kg (Normal/Mildly Impaired Renal Function)
-24.0
NA
Not reported
Not reported
Standard Deviation is not evaluable as only a single participant was analyzed.
Part 1: Belantamab Mafodotin 2.5 mg/kg (Severely Impaired Renal Function)
4.0
NA
Not reported
Not reported
Standard Deviation is not evaluable as only a single participant was analyzed.
Part 1: Belantamab Mafodotin 2.5 mg/kg (Other Renal Function)
-2.0
NA
Not reported
Not reported
Standard Deviation is not evaluable as only a single participant was analyzed.
Part 2: Belantamab Mafodotin 2.5 mg/kg End Stage Renal Disease (Not on Dialysis)
-16.0
NA
Not reported
Not reported
Standard Deviation is not evaluable as only a single participant was analyzed.
Part 2: Belantamab Mafodotin 2.5 mg/kg ESRD (On Dialysis)
0.0
NA
Not reported
Not reported
Standard Deviation is not evaluable as only a single participant was analyzed.
CFB to Cycle 11 Day 1, PRE-INFUSION
Analysis denominator · Participants
Group
Source count
Part 1: Belantamab Mafodotin 2.5 mg/kg (Normal/Mildly Impaired Renal Function)
1
Part 1: Belantamab Mafodotin 2.5 mg/kg (Severely Impaired Renal Function)
1
Part 1: Belantamab Mafodotin 2.5 mg/kg (Other Renal Function)
1
Part 2: Belantamab Mafodotin 2.5 mg/kg End Stage Renal Disease (Not on Dialysis)
1
Part 2: Belantamab Mafodotin 2.5 mg/kg ESRD (On Dialysis)
1
Values in Beats per minute · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Part 1: Belantamab Mafodotin 2.5 mg/kg (Normal/Mildly Impaired Renal Function)
-9.0
NA
Not reported
Not reported
Standard Deviation is not evaluable as only a single participant was analyzed.
Part 1: Belantamab Mafodotin 2.5 mg/kg (Severely Impaired Renal Function)
7.0
NA
Not reported
Not reported
Standard Deviation is not evaluable as only a single participant was analyzed.
Part 1: Belantamab Mafodotin 2.5 mg/kg (Other Renal Function)
-4.0
NA
Not reported
Not reported
Standard Deviation is not evaluable as only a single participant was analyzed.
Part 2: Belantamab Mafodotin 2.5 mg/kg End Stage Renal Disease (Not on Dialysis)
-12.0
NA
Not reported
Not reported
Standard Deviation is not evaluable as only a single participant was analyzed.
Part 2: Belantamab Mafodotin 2.5 mg/kg ESRD (On Dialysis)
0.0
NA
Not reported
Not reported
Standard Deviation is not evaluable as only a single participant was analyzed.
CFB to Cycle 11 Day 1, WITHIN 15 MINS AFTER EOI
Analysis denominator · Participants
Group
Source count
Part 1: Belantamab Mafodotin 2.5 mg/kg (Normal/Mildly Impaired Renal Function)
1
Part 1: Belantamab Mafodotin 2.5 mg/kg (Severely Impaired Renal Function)
1
Part 1: Belantamab Mafodotin 2.5 mg/kg (Other Renal Function)
1
Part 2: Belantamab Mafodotin 2.5 mg/kg End Stage Renal Disease (Not on Dialysis)
1
Part 2: Belantamab Mafodotin 2.5 mg/kg ESRD (On Dialysis)
1
Values in Beats per minute · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Part 1: Belantamab Mafodotin 2.5 mg/kg (Normal/Mildly Impaired Renal Function)
-20.0
NA
Not reported
Not reported
Standard Deviation is not evaluable as only a single participant was analyzed.
Part 1: Belantamab Mafodotin 2.5 mg/kg (Severely Impaired Renal Function)
5.0
NA
Not reported
Not reported
Standard Deviation is not evaluable as only a single participant was analyzed.
Part 1: Belantamab Mafodotin 2.5 mg/kg (Other Renal Function)
-8.0
NA
Not reported
Not reported
Standard Deviation is not evaluable as only a single participant was analyzed.
Part 2: Belantamab Mafodotin 2.5 mg/kg End Stage Renal Disease (Not on Dialysis)
-10.0
NA
Not reported
Not reported
Standard Deviation is not evaluable as only a single participant was analyzed.
Part 2: Belantamab Mafodotin 2.5 mg/kg ESRD (On Dialysis)
1.0
NA
Not reported
Not reported
Standard Deviation is not evaluable as only a single participant was analyzed.
CFB to Cycle 12 Day 1, PRE-INFUSION
Analysis denominator · Participants
Group
Source count
Part 1: Belantamab Mafodotin 2.5 mg/kg (Normal/Mildly Impaired Renal Function)
1
Part 1: Belantamab Mafodotin 2.5 mg/kg (Severely Impaired Renal Function)
1
Part 1: Belantamab Mafodotin 2.5 mg/kg (Other Renal Function)
1
Part 2: Belantamab Mafodotin 2.5 mg/kg End Stage Renal Disease (Not on Dialysis)
1
Part 2: Belantamab Mafodotin 2.5 mg/kg ESRD (On Dialysis)
1
Values in Beats per minute · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Part 1: Belantamab Mafodotin 2.5 mg/kg (Normal/Mildly Impaired Renal Function)
-10.0
NA
Not reported
Not reported
Standard Deviation is not evaluable as only a single participant was analyzed.
Part 1: Belantamab Mafodotin 2.5 mg/kg (Severely Impaired Renal Function)
2.0
NA
Not reported
Not reported
Standard Deviation is not evaluable as only a single participant was analyzed.
Part 1: Belantamab Mafodotin 2.5 mg/kg (Other Renal Function)
1.0
NA
Not reported
Not reported
Standard Deviation is not evaluable as only a single participant was analyzed.
Part 2: Belantamab Mafodotin 2.5 mg/kg End Stage Renal Disease (Not on Dialysis)
-2.0
NA
Not reported
Not reported
Standard Deviation is not evaluable as only a single participant was analyzed.
Part 2: Belantamab Mafodotin 2.5 mg/kg ESRD (On Dialysis)
4.0
NA
Not reported
Not reported
Standard Deviation is not evaluable as only a single participant was analyzed.
CFB to Cycle 12 Day 1, WITHIN 15 MINS AFTER EOI
Analysis denominator · Participants
Group
Source count
Part 1: Belantamab Mafodotin 2.5 mg/kg (Normal/Mildly Impaired Renal Function)
1
Part 1: Belantamab Mafodotin 2.5 mg/kg (Severely Impaired Renal Function)
1
Part 1: Belantamab Mafodotin 2.5 mg/kg (Other Renal Function)
1
Part 2: Belantamab Mafodotin 2.5 mg/kg End Stage Renal Disease (Not on Dialysis)
1
Part 2: Belantamab Mafodotin 2.5 mg/kg ESRD (On Dialysis)
1
Values in Beats per minute · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Part 1: Belantamab Mafodotin 2.5 mg/kg (Normal/Mildly Impaired Renal Function)
-9.0
NA
Not reported
Not reported
Standard Deviation is not evaluable as only a single participant was analyzed.
Part 1: Belantamab Mafodotin 2.5 mg/kg (Severely Impaired Renal Function)
7.0
NA
Not reported
Not reported
Standard Deviation is not evaluable as only a single participant was analyzed.
Part 1: Belantamab Mafodotin 2.5 mg/kg (Other Renal Function)
2.0
NA
Not reported
Not reported
Standard Deviation is not evaluable as only a single participant was analyzed.
Part 2: Belantamab Mafodotin 2.5 mg/kg End Stage Renal Disease (Not on Dialysis)
-5.0
NA
Not reported
Not reported
Standard Deviation is not evaluable as only a single participant was analyzed.
Part 2: Belantamab Mafodotin 2.5 mg/kg ESRD (On Dialysis)
2.0
NA
Not reported
Not reported
Standard Deviation is not evaluable as only a single participant was analyzed.
CFB to Cycle 13 Day 1, PRE-INFUSION
Analysis denominator · Participants
Group
Source count
Part 1: Belantamab Mafodotin 2.5 mg/kg (Normal/Mildly Impaired Renal Function)
1
Part 1: Belantamab Mafodotin 2.5 mg/kg (Severely Impaired Renal Function)
1
Part 1: Belantamab Mafodotin 2.5 mg/kg (Other Renal Function)
1
Part 2: Belantamab Mafodotin 2.5 mg/kg End Stage Renal Disease (Not on Dialysis)
1
Part 2: Belantamab Mafodotin 2.5 mg/kg ESRD (On Dialysis)
1
Values in Beats per minute · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Part 1: Belantamab Mafodotin 2.5 mg/kg (Normal/Mildly Impaired Renal Function)
-22.0
NA
Not reported
Not reported
Standard Deviation is not evaluable as only a single participant was analyzed.
Part 1: Belantamab Mafodotin 2.5 mg/kg (Severely Impaired Renal Function)
3.0
NA
Not reported
Not reported
Standard Deviation is not evaluable as only a single participant was analyzed.
Part 1: Belantamab Mafodotin 2.5 mg/kg (Other Renal Function)
-2.0
NA
Not reported
Not reported
Standard Deviation is not evaluable as only a single participant was analyzed.
Part 2: Belantamab Mafodotin 2.5 mg/kg End Stage Renal Disease (Not on Dialysis)
-6.0
NA
Not reported
Not reported
Standard Deviation is not evaluable as only a single participant was analyzed.
Part 2: Belantamab Mafodotin 2.5 mg/kg ESRD (On Dialysis)
4.0
NA
Not reported
Not reported
Standard Deviation is not evaluable as only a single participant was analyzed.
CFB to Cycle 13 Day 1, WITHIN 15 MINS AFTER EOI
Analysis denominator · Participants
Group
Source count
Part 1: Belantamab Mafodotin 2.5 mg/kg (Normal/Mildly Impaired Renal Function)
1
Part 1: Belantamab Mafodotin 2.5 mg/kg (Severely Impaired Renal Function)
1
Part 1: Belantamab Mafodotin 2.5 mg/kg (Other Renal Function)
1
Part 2: Belantamab Mafodotin 2.5 mg/kg End Stage Renal Disease (Not on Dialysis)
1
Part 2: Belantamab Mafodotin 2.5 mg/kg ESRD (On Dialysis)
1
Values in Beats per minute · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Part 1: Belantamab Mafodotin 2.5 mg/kg (Normal/Mildly Impaired Renal Function)
-33.0
NA
Not reported
Not reported
Standard Deviation is not evaluable as only a single participant was analyzed.
Part 1: Belantamab Mafodotin 2.5 mg/kg (Severely Impaired Renal Function)
4.0
NA
Not reported
Not reported
Standard Deviation is not evaluable as only a single participant was analyzed.
Part 1: Belantamab Mafodotin 2.5 mg/kg (Other Renal Function)
1.0
NA
Not reported
Not reported
Standard Deviation is not evaluable as only a single participant was analyzed.
Part 2: Belantamab Mafodotin 2.5 mg/kg End Stage Renal Disease (Not on Dialysis)
2.0
NA
Not reported
Not reported
Standard Deviation is not evaluable as only a single participant was analyzed.
Part 2: Belantamab Mafodotin 2.5 mg/kg ESRD (On Dialysis)
2.0
NA
Not reported
Not reported
Standard Deviation is not evaluable as only a single participant was analyzed.
CFB to Cycle 14 Day 1, PRE-INFUSION
Analysis denominator · Participants
Group
Source count
Part 1: Belantamab Mafodotin 2.5 mg/kg (Normal/Mildly Impaired Renal Function)
1
Part 1: Belantamab Mafodotin 2.5 mg/kg (Severely Impaired Renal Function)
1
Part 1: Belantamab Mafodotin 2.5 mg/kg (Other Renal Function)
1
Part 2: Belantamab Mafodotin 2.5 mg/kg End Stage Renal Disease (Not on Dialysis)
1
Part 2: Belantamab Mafodotin 2.5 mg/kg ESRD (On Dialysis)
1
Values in Beats per minute · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Part 1: Belantamab Mafodotin 2.5 mg/kg (Normal/Mildly Impaired Renal Function)
-28.0
NA
Not reported
Not reported
Standard Deviation is not evaluable as only a single participant was analyzed.
Part 1: Belantamab Mafodotin 2.5 mg/kg (Severely Impaired Renal Function)
3.0
NA
Not reported
Not reported
Standard Deviation is not evaluable as only a single participant was analyzed.
Part 1: Belantamab Mafodotin 2.5 mg/kg (Other Renal Function)
-8.0
NA
Not reported
Not reported
Standard Deviation is not evaluable as only a single participant was analyzed.
Part 2: Belantamab Mafodotin 2.5 mg/kg End Stage Renal Disease (Not on Dialysis)
-6.0
NA
Not reported
Not reported
Standard Deviation is not evaluable as only a single participant was analyzed.
Part 2: Belantamab Mafodotin 2.5 mg/kg ESRD (On Dialysis)
6.0
NA
Not reported
Not reported
Standard Deviation is not evaluable as only a single participant was analyzed.
CFB to Cycle 14 Day 1, WITHIN 15 MINS AFTER EOI
Analysis denominator · Participants
Group
Source count
Part 1: Belantamab Mafodotin 2.5 mg/kg (Normal/Mildly Impaired Renal Function)
1
Part 1: Belantamab Mafodotin 2.5 mg/kg (Severely Impaired Renal Function)
1
Part 1: Belantamab Mafodotin 2.5 mg/kg (Other Renal Function)
1
Part 2: Belantamab Mafodotin 2.5 mg/kg End Stage Renal Disease (Not on Dialysis)
1
Part 2: Belantamab Mafodotin 2.5 mg/kg ESRD (On Dialysis)
1
Values in Beats per minute · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Part 1: Belantamab Mafodotin 2.5 mg/kg (Normal/Mildly Impaired Renal Function)
-30.0
NA
Not reported
Not reported
Standard Deviation is not evaluable as only a single participant was analyzed.
Part 1: Belantamab Mafodotin 2.5 mg/kg (Severely Impaired Renal Function)
4.0
NA
Not reported
Not reported
Standard Deviation is not evaluable as only a single participant was analyzed.
Part 1: Belantamab Mafodotin 2.5 mg/kg (Other Renal Function)
-6.0
NA
Not reported
Not reported
Standard Deviation is not evaluable as only a single participant was analyzed.
Part 2: Belantamab Mafodotin 2.5 mg/kg End Stage Renal Disease (Not on Dialysis)
-5.0
NA
Not reported
Not reported
Standard Deviation is not evaluable as only a single participant was analyzed.
Part 2: Belantamab Mafodotin 2.5 mg/kg ESRD (On Dialysis)
-2.0
NA
Not reported
Not reported
Standard Deviation is not evaluable as only a single participant was analyzed.
CFB to Cycle 15 Day 1, PRE-INFUSION
Analysis denominator · Participants
Group
Source count
Part 1: Belantamab Mafodotin 2.5 mg/kg (Normal/Mildly Impaired Renal Function)
1
Part 1: Belantamab Mafodotin 2.5 mg/kg (Severely Impaired Renal Function)
1
Part 1: Belantamab Mafodotin 2.5 mg/kg (Other Renal Function)
1
Part 2: Belantamab Mafodotin 2.5 mg/kg End Stage Renal Disease (Not on Dialysis)
1
Part 2: Belantamab Mafodotin 2.5 mg/kg ESRD (On Dialysis)
1
Values in Beats per minute · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Part 1: Belantamab Mafodotin 2.5 mg/kg (Normal/Mildly Impaired Renal Function)
-24.0
NA
Not reported
Not reported
Standard Deviation is not evaluable as only a single participant was analyzed.
Part 1: Belantamab Mafodotin 2.5 mg/kg (Severely Impaired Renal Function)
10.0
NA
Not reported
Not reported
Standard Deviation is not evaluable as only a single participant was analyzed.
Part 1: Belantamab Mafodotin 2.5 mg/kg (Other Renal Function)
0.0
NA
Not reported
Not reported
Standard Deviation is not evaluable as only a single participant was analyzed.
Part 2: Belantamab Mafodotin 2.5 mg/kg End Stage Renal Disease (Not on Dialysis)
-15.0
NA
Not reported
Not reported
Standard Deviation is not evaluable as only a single participant was analyzed.
Part 2: Belantamab Mafodotin 2.5 mg/kg ESRD (On Dialysis)
0.0
NA
Not reported
Not reported
Standard Deviation is not evaluable as only a single participant was analyzed.
CFB to Cycle 15 Day 1, WITHIN 15 MINS AFTER EOI
Analysis denominator · Participants
Group
Source count
Part 1: Belantamab Mafodotin 2.5 mg/kg (Normal/Mildly Impaired Renal Function)
1
Part 1: Belantamab Mafodotin 2.5 mg/kg (Severely Impaired Renal Function)
1
Part 1: Belantamab Mafodotin 2.5 mg/kg (Other Renal Function)
1
Part 2: Belantamab Mafodotin 2.5 mg/kg End Stage Renal Disease (Not on Dialysis)
1
Part 2: Belantamab Mafodotin 2.5 mg/kg ESRD (On Dialysis)
1
Values in Beats per minute · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Part 1: Belantamab Mafodotin 2.5 mg/kg (Normal/Mildly Impaired Renal Function)
-24.0
NA
Not reported
Not reported
Standard Deviation is not evaluable as only a single participant was analyzed.
Part 1: Belantamab Mafodotin 2.5 mg/kg (Severely Impaired Renal Function)
8.0
NA
Not reported
Not reported
Standard Deviation is not evaluable as only a single participant was analyzed.
Part 1: Belantamab Mafodotin 2.5 mg/kg (Other Renal Function)
-1.0
NA
Not reported
Not reported
Standard Deviation is not evaluable as only a single participant was analyzed.
Part 2: Belantamab Mafodotin 2.5 mg/kg End Stage Renal Disease (Not on Dialysis)
-14.0
NA
Not reported
Not reported
Standard Deviation is not evaluable as only a single participant was analyzed.
Part 2: Belantamab Mafodotin 2.5 mg/kg ESRD (On Dialysis)
-1.0
NA
Not reported
Not reported
Standard Deviation is not evaluable as only a single participant was analyzed.
CFB to Cycle 16 Day 1, PRE-INFUSION
Analysis denominator · Participants
Group
Source count
Part 1: Belantamab Mafodotin 2.5 mg/kg (Normal/Mildly Impaired Renal Function)
1
Part 1: Belantamab Mafodotin 2.5 mg/kg (Severely Impaired Renal Function)
1
Part 1: Belantamab Mafodotin 2.5 mg/kg (Other Renal Function)
1
Part 2: Belantamab Mafodotin 2.5 mg/kg End Stage Renal Disease (Not on Dialysis)
1
Part 2: Belantamab Mafodotin 2.5 mg/kg ESRD (On Dialysis)
1
Values in Beats per minute · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Part 1: Belantamab Mafodotin 2.5 mg/kg (Normal/Mildly Impaired Renal Function)
-30.0
NA
Not reported
Not reported
Standard Deviation is not evaluable as only a single participant was analyzed.
Part 1: Belantamab Mafodotin 2.5 mg/kg (Severely Impaired Renal Function)
6.0
NA
Not reported
Not reported
Standard Deviation is not evaluable as only a single participant was analyzed.
Part 1: Belantamab Mafodotin 2.5 mg/kg (Other Renal Function)
-5.0
NA
Not reported
Not reported
Standard Deviation is not evaluable as only a single participant was analyzed.
Part 2: Belantamab Mafodotin 2.5 mg/kg End Stage Renal Disease (Not on Dialysis)
-17.0
NA
Not reported
Not reported
Standard Deviation is not evaluable as only a single participant was analyzed.
Part 2: Belantamab Mafodotin 2.5 mg/kg ESRD (On Dialysis)
-2.0
NA
Not reported
Not reported
Standard Deviation is not evaluable as only a single participant was analyzed.
CFB to Cycle 16 Day 1, WITHIN 15 MINS AFTER EOI
Analysis denominator · Participants
Group
Source count
Part 1: Belantamab Mafodotin 2.5 mg/kg (Normal/Mildly Impaired Renal Function)
1
Part 1: Belantamab Mafodotin 2.5 mg/kg (Severely Impaired Renal Function)
1
Part 1: Belantamab Mafodotin 2.5 mg/kg (Other Renal Function)
1
Part 2: Belantamab Mafodotin 2.5 mg/kg End Stage Renal Disease (Not on Dialysis)
1
Part 2: Belantamab Mafodotin 2.5 mg/kg ESRD (On Dialysis)
1
Values in Beats per minute · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Part 1: Belantamab Mafodotin 2.5 mg/kg (Normal/Mildly Impaired Renal Function)
-28.0
NA
Not reported
Not reported
Standard Deviation is not evaluable as only a single participant was analyzed.
Part 1: Belantamab Mafodotin 2.5 mg/kg (Severely Impaired Renal Function)
2.0
NA
Not reported
Not reported
Standard Deviation is not evaluable as only a single participant was analyzed.
Part 1: Belantamab Mafodotin 2.5 mg/kg (Other Renal Function)
-3.0
NA
Not reported
Not reported
Standard Deviation is not evaluable as only a single participant was analyzed.
Part 2: Belantamab Mafodotin 2.5 mg/kg End Stage Renal Disease (Not on Dialysis)
-11.0
NA
Not reported
Not reported
Standard Deviation is not evaluable as only a single participant was analyzed.
Part 2: Belantamab Mafodotin 2.5 mg/kg ESRD (On Dialysis)
2.0
NA
Not reported
Not reported
Standard Deviation is not evaluable as only a single participant was analyzed.
CFB to Cycle 17 Day 1, PRE-INFUSION
Analysis denominator · Participants
Group
Source count
Part 1: Belantamab Mafodotin 2.5 mg/kg (Normal/Mildly Impaired Renal Function)
1
Part 1: Belantamab Mafodotin 2.5 mg/kg (Severely Impaired Renal Function)
1
Part 1: Belantamab Mafodotin 2.5 mg/kg (Other Renal Function)
1
Part 2: Belantamab Mafodotin 2.5 mg/kg End Stage Renal Disease (Not on Dialysis)
1
Part 2: Belantamab Mafodotin 2.5 mg/kg ESRD (On Dialysis)
1
Values in Beats per minute · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Part 1: Belantamab Mafodotin 2.5 mg/kg (Normal/Mildly Impaired Renal Function)
-30.0
NA
Not reported
Not reported
Standard Deviation is not evaluable as only a single participant was analyzed.
Part 1: Belantamab Mafodotin 2.5 mg/kg (Severely Impaired Renal Function)
3.0
NA
Not reported
Not reported
Standard Deviation is not evaluable as only a single participant was analyzed.
Part 1: Belantamab Mafodotin 2.5 mg/kg (Other Renal Function)
-2.0
NA
Not reported
Not reported
Standard Deviation is not evaluable as only a single participant was analyzed.
Part 2: Belantamab Mafodotin 2.5 mg/kg End Stage Renal Disease (Not on Dialysis)
-3.0
NA
Not reported
Not reported
Standard Deviation is not evaluable as only a single participant was analyzed.
Part 2: Belantamab Mafodotin 2.5 mg/kg ESRD (On Dialysis)
0.0
NA
Not reported
Not reported
Standard Deviation is not evaluable as only a single participant was analyzed.
CFB to Cycle 17 Day 1, WITHIN 15 MINS AFTER EOI
Analysis denominator · Participants
Group
Source count
Part 1: Belantamab Mafodotin 2.5 mg/kg (Normal/Mildly Impaired Renal Function)
1
Part 1: Belantamab Mafodotin 2.5 mg/kg (Severely Impaired Renal Function)
1
Part 1: Belantamab Mafodotin 2.5 mg/kg (Other Renal Function)
1
Part 2: Belantamab Mafodotin 2.5 mg/kg End Stage Renal Disease (Not on Dialysis)
1
Part 2: Belantamab Mafodotin 2.5 mg/kg ESRD (On Dialysis)
1
Values in Beats per minute · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Part 1: Belantamab Mafodotin 2.5 mg/kg (Normal/Mildly Impaired Renal Function)
-28.0
NA
Not reported
Not reported
Standard Deviation is not evaluable as only a single participant was analyzed.
Part 1: Belantamab Mafodotin 2.5 mg/kg (Severely Impaired Renal Function)
2.0
NA
Not reported
Not reported
Standard Deviation is not evaluable as only a single participant was analyzed.
Part 1: Belantamab Mafodotin 2.5 mg/kg (Other Renal Function)
0.0
NA
Not reported
Not reported
Standard Deviation is not evaluable as only a single participant was analyzed.
Part 2: Belantamab Mafodotin 2.5 mg/kg End Stage Renal Disease (Not on Dialysis)
-3.0
NA
Not reported
Not reported
Standard Deviation is not evaluable as only a single participant was analyzed.
Part 2: Belantamab Mafodotin 2.5 mg/kg ESRD (On Dialysis)
7.0
NA
Not reported
Not reported
Standard Deviation is not evaluable as only a single participant was analyzed.
CFB to Cycle 18 Day 1, PRE-INFUSION
Analysis denominator · Participants
Group
Source count
Part 1: Belantamab Mafodotin 2.5 mg/kg (Normal/Mildly Impaired Renal Function)
1
Part 1: Belantamab Mafodotin 2.5 mg/kg (Severely Impaired Renal Function)
1
Part 1: Belantamab Mafodotin 2.5 mg/kg (Other Renal Function)
1
Part 2: Belantamab Mafodotin 2.5 mg/kg End Stage Renal Disease (Not on Dialysis)
1
Part 2: Belantamab Mafodotin 2.5 mg/kg ESRD (On Dialysis)
1
Values in Beats per minute · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Part 1: Belantamab Mafodotin 2.5 mg/kg (Normal/Mildly Impaired Renal Function)
-40.0
NA
Not reported
Not reported
Standard Deviation is not evaluable as only a single participant was analyzed.
Part 1: Belantamab Mafodotin 2.5 mg/kg (Severely Impaired Renal Function)
5.0
NA
Not reported
Not reported
Standard Deviation is not evaluable as only a single participant was analyzed.
Part 1: Belantamab Mafodotin 2.5 mg/kg (Other Renal Function)
-1.0
NA
Not reported
Not reported
Standard Deviation is not evaluable as only a single participant was analyzed.
Part 2: Belantamab Mafodotin 2.5 mg/kg End Stage Renal Disease (Not on Dialysis)
-9.0
NA
Not reported
Not reported
Standard Deviation is not evaluable as only a single participant was analyzed.
Part 2: Belantamab Mafodotin 2.5 mg/kg ESRD (On Dialysis)
-4.0
NA
Not reported
Not reported
Standard Deviation is not evaluable as only a single participant was analyzed.
CFB to Cycle 18 Day 1, WITHIN 15 MINS AFTER EOI
Analysis denominator · Participants
Group
Source count
Part 1: Belantamab Mafodotin 2.5 mg/kg (Normal/Mildly Impaired Renal Function)
1
Part 1: Belantamab Mafodotin 2.5 mg/kg (Severely Impaired Renal Function)
1
Part 1: Belantamab Mafodotin 2.5 mg/kg (Other Renal Function)
1
Part 2: Belantamab Mafodotin 2.5 mg/kg End Stage Renal Disease (Not on Dialysis)
1
Part 2: Belantamab Mafodotin 2.5 mg/kg ESRD (On Dialysis)
1
Values in Beats per minute · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Part 1: Belantamab Mafodotin 2.5 mg/kg (Normal/Mildly Impaired Renal Function)
-38.0
NA
Not reported
Not reported
Standard Deviation is not evaluable as only a single participant was analyzed.
Part 1: Belantamab Mafodotin 2.5 mg/kg (Severely Impaired Renal Function)
6.0
NA
Not reported
Not reported
Standard Deviation is not evaluable as only a single participant was analyzed.
Part 1: Belantamab Mafodotin 2.5 mg/kg (Other Renal Function)
-2.0
NA
Not reported
Not reported
Standard Deviation is not evaluable as only a single participant was analyzed.
Part 2: Belantamab Mafodotin 2.5 mg/kg End Stage Renal Disease (Not on Dialysis)
-1.0
NA
Not reported
Not reported
Standard Deviation is not evaluable as only a single participant was analyzed.
Part 2: Belantamab Mafodotin 2.5 mg/kg ESRD (On Dialysis)
11.0
NA
Not reported
Not reported
Standard Deviation is not evaluable as only a single participant was analyzed.
CFB to Cycle 19 Day 1, PRE-INFUSION
Analysis denominator · Participants
Group
Source count
Part 1: Belantamab Mafodotin 2.5 mg/kg (Normal/Mildly Impaired Renal Function)
1
Part 1: Belantamab Mafodotin 2.5 mg/kg (Severely Impaired Renal Function)
1
Part 1: Belantamab Mafodotin 2.5 mg/kg (Other Renal Function)
1
Part 2: Belantamab Mafodotin 2.5 mg/kg End Stage Renal Disease (Not on Dialysis)
1
Part 2: Belantamab Mafodotin 2.5 mg/kg ESRD (On Dialysis)
0
Values in Beats per minute · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Part 1: Belantamab Mafodotin 2.5 mg/kg (Normal/Mildly Impaired Renal Function)
-38.0
NA
Not reported
Not reported
Standard Deviation is not evaluable as only a single participant was analyzed.
Part 1: Belantamab Mafodotin 2.5 mg/kg (Severely Impaired Renal Function)
6.0
NA
Not reported
Not reported
Standard Deviation is not evaluable as only a single participant was analyzed.
Part 1: Belantamab Mafodotin 2.5 mg/kg (Other Renal Function)
3.0
NA
Not reported
Not reported
Standard Deviation is not evaluable as only a single participant was analyzed.
Part 2: Belantamab Mafodotin 2.5 mg/kg End Stage Renal Disease (Not on Dialysis)
-8.0
NA
Not reported
Not reported
Standard Deviation is not evaluable as only a single participant was analyzed.
CFB to Cycle 19 Day 1, WITHIN 15 MINS AFTER EOI
Analysis denominator · Participants
Group
Source count
Part 1: Belantamab Mafodotin 2.5 mg/kg (Normal/Mildly Impaired Renal Function)
1
Part 1: Belantamab Mafodotin 2.5 mg/kg (Severely Impaired Renal Function)
1
Part 1: Belantamab Mafodotin 2.5 mg/kg (Other Renal Function)
1
Part 2: Belantamab Mafodotin 2.5 mg/kg End Stage Renal Disease (Not on Dialysis)
1
Part 2: Belantamab Mafodotin 2.5 mg/kg ESRD (On Dialysis)
0
Values in Beats per minute · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Part 1: Belantamab Mafodotin 2.5 mg/kg (Normal/Mildly Impaired Renal Function)
-40.0
NA
Not reported
Not reported
Standard Deviation is not evaluable as only a single participant was analyzed.
Part 1: Belantamab Mafodotin 2.5 mg/kg (Severely Impaired Renal Function)
9.0
NA
Not reported
Not reported
Standard Deviation is not evaluable as only a single participant was analyzed.
Part 1: Belantamab Mafodotin 2.5 mg/kg (Other Renal Function)
2.0
NA
Not reported
Not reported
Standard Deviation is not evaluable as only a single participant was analyzed.
Part 2: Belantamab Mafodotin 2.5 mg/kg End Stage Renal Disease (Not on Dialysis)
-2.0
NA
Not reported
Not reported
Standard Deviation is not evaluable as only a single participant was analyzed.
CFB to Cycle 20 Day 1, PRE-INFUSION
Analysis denominator · Participants
Group
Source count
Part 1: Belantamab Mafodotin 2.5 mg/kg (Normal/Mildly Impaired Renal Function)
1
Part 1: Belantamab Mafodotin 2.5 mg/kg (Severely Impaired Renal Function)
0
Part 1: Belantamab Mafodotin 2.5 mg/kg (Other Renal Function)
0
Part 2: Belantamab Mafodotin 2.5 mg/kg End Stage Renal Disease (Not on Dialysis)
1
Part 2: Belantamab Mafodotin 2.5 mg/kg ESRD (On Dialysis)
0
Values in Beats per minute · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Part 1: Belantamab Mafodotin 2.5 mg/kg (Normal/Mildly Impaired Renal Function)
-20.0
NA
Not reported
Not reported
Standard Deviation is not evaluable as only a single participant was analyzed.
Part 2: Belantamab Mafodotin 2.5 mg/kg End Stage Renal Disease (Not on Dialysis)
1.0
NA
Not reported
Not reported
Standard Deviation is not evaluable as only a single participant was analyzed.
CFB to Cycle 20 Day 1, WITHIN 15 MINS AFTER EOI
Analysis denominator · Participants
Group
Source count
Part 1: Belantamab Mafodotin 2.5 mg/kg (Normal/Mildly Impaired Renal Function)
1
Part 1: Belantamab Mafodotin 2.5 mg/kg (Severely Impaired Renal Function)
0
Part 1: Belantamab Mafodotin 2.5 mg/kg (Other Renal Function)
0
Part 2: Belantamab Mafodotin 2.5 mg/kg End Stage Renal Disease (Not on Dialysis)
1
Part 2: Belantamab Mafodotin 2.5 mg/kg ESRD (On Dialysis)
0
Values in Beats per minute · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Part 1: Belantamab Mafodotin 2.5 mg/kg (Normal/Mildly Impaired Renal Function)
-17.0
NA
Not reported
Not reported
Standard Deviation is not evaluable as only a single participant was analyzed.
Part 2: Belantamab Mafodotin 2.5 mg/kg End Stage Renal Disease (Not on Dialysis)
-2.0
NA
Not reported
Not reported
Standard Deviation is not evaluable as only a single participant was analyzed.
CFB to Cycle 21 Day 1, PRE-INFUSION
Analysis denominator · Participants
Group
Source count
Part 1: Belantamab Mafodotin 2.5 mg/kg (Normal/Mildly Impaired Renal Function)
1
Part 1: Belantamab Mafodotin 2.5 mg/kg (Severely Impaired Renal Function)
0
Part 1: Belantamab Mafodotin 2.5 mg/kg (Other Renal Function)
0
Part 2: Belantamab Mafodotin 2.5 mg/kg End Stage Renal Disease (Not on Dialysis)
0
Part 2: Belantamab Mafodotin 2.5 mg/kg ESRD (On Dialysis)
0
Values in Beats per minute · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Part 1: Belantamab Mafodotin 2.5 mg/kg (Normal/Mildly Impaired Renal Function)
-16.0
NA
Not reported
Not reported
Standard Deviation is not evaluable as only a single participant was analyzed.
CFB to Cycle 21 Day 1, WITHIN 15 MINS AFTER EOI
Analysis denominator · Participants
Group
Source count
Part 1: Belantamab Mafodotin 2.5 mg/kg (Normal/Mildly Impaired Renal Function)
1
Part 1: Belantamab Mafodotin 2.5 mg/kg (Severely Impaired Renal Function)
0
Part 1: Belantamab Mafodotin 2.5 mg/kg (Other Renal Function)
0
Part 2: Belantamab Mafodotin 2.5 mg/kg End Stage Renal Disease (Not on Dialysis)
0
Part 2: Belantamab Mafodotin 2.5 mg/kg ESRD (On Dialysis)
0
Values in Beats per minute · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Part 1: Belantamab Mafodotin 2.5 mg/kg (Normal/Mildly Impaired Renal Function)
-34.0
NA
Not reported
Not reported
Standard Deviation is not evaluable as only a single participant was analyzed.
CFB to Cycle 22 Day 1, PRE-INFUSION
Analysis denominator · Participants
Group
Source count
Part 1: Belantamab Mafodotin 2.5 mg/kg (Normal/Mildly Impaired Renal Function)
1
Part 1: Belantamab Mafodotin 2.5 mg/kg (Severely Impaired Renal Function)
0
Part 1: Belantamab Mafodotin 2.5 mg/kg (Other Renal Function)
0
Part 2: Belantamab Mafodotin 2.5 mg/kg End Stage Renal Disease (Not on Dialysis)
0
Part 2: Belantamab Mafodotin 2.5 mg/kg ESRD (On Dialysis)
0
Values in Beats per minute · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Part 1: Belantamab Mafodotin 2.5 mg/kg (Normal/Mildly Impaired Renal Function)
-23.0
NA
Not reported
Not reported
Standard Deviation is not evaluable as only a single participant was analyzed.
CFB to Cycle 22 Day 1, WITHIN 15 MINS AFTER EOI
Analysis denominator · Participants
Group
Source count
Part 1: Belantamab Mafodotin 2.5 mg/kg (Normal/Mildly Impaired Renal Function)
1
Part 1: Belantamab Mafodotin 2.5 mg/kg (Severely Impaired Renal Function)
0
Part 1: Belantamab Mafodotin 2.5 mg/kg (Other Renal Function)
0
Part 2: Belantamab Mafodotin 2.5 mg/kg End Stage Renal Disease (Not on Dialysis)
0
Part 2: Belantamab Mafodotin 2.5 mg/kg ESRD (On Dialysis)
0
Values in Beats per minute · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Part 1: Belantamab Mafodotin 2.5 mg/kg (Normal/Mildly Impaired Renal Function)
-18.0
NA
Not reported
Not reported
Standard Deviation is not evaluable as only a single participant was analyzed.
CFB to Cycle 23 Day 1, PRE-INFUSION
Analysis denominator · Participants
Group
Source count
Part 1: Belantamab Mafodotin 2.5 mg/kg (Normal/Mildly Impaired Renal Function)
1
Part 1: Belantamab Mafodotin 2.5 mg/kg (Severely Impaired Renal Function)
0
Part 1: Belantamab Mafodotin 2.5 mg/kg (Other Renal Function)
0
Part 2: Belantamab Mafodotin 2.5 mg/kg End Stage Renal Disease (Not on Dialysis)
0
Part 2: Belantamab Mafodotin 2.5 mg/kg ESRD (On Dialysis)
0
Values in Beats per minute · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Part 1: Belantamab Mafodotin 2.5 mg/kg (Normal/Mildly Impaired Renal Function)
-19.0
NA
Not reported
Not reported
Standard Deviation is not evaluable as only a single participant was analyzed.
CFB to Cycle 23 Day 1, WITHIN 15 MINS AFTER EOI
Analysis denominator · Participants
Group
Source count
Part 1: Belantamab Mafodotin 2.5 mg/kg (Normal/Mildly Impaired Renal Function)
1
Part 1: Belantamab Mafodotin 2.5 mg/kg (Severely Impaired Renal Function)
0
Part 1: Belantamab Mafodotin 2.5 mg/kg (Other Renal Function)
0
Part 2: Belantamab Mafodotin 2.5 mg/kg End Stage Renal Disease (Not on Dialysis)
0
Part 2: Belantamab Mafodotin 2.5 mg/kg ESRD (On Dialysis)
0
Values in Beats per minute · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Part 1: Belantamab Mafodotin 2.5 mg/kg (Normal/Mildly Impaired Renal Function)
-29.0
NA
Not reported
Not reported
Standard Deviation is not evaluable as only a single participant was analyzed.
CFB to End of Treatment (Up to 236 weeks)
Analysis denominator · Participants
Group
Source count
Part 1: Belantamab Mafodotin 2.5 mg/kg (Normal/Mildly Impaired Renal Function)
4
Part 1: Belantamab Mafodotin 2.5 mg/kg (Severely Impaired Renal Function)
7
Part 1: Belantamab Mafodotin 2.5 mg/kg (Other Renal Function)
1
Part 2: Belantamab Mafodotin 2.5 mg/kg End Stage Renal Disease (Not on Dialysis)
2
Part 2: Belantamab Mafodotin 2.5 mg/kg ESRD (On Dialysis)
0
Values in Beats per minute · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Part 1: Belantamab Mafodotin 2.5 mg/kg (Normal/Mildly Impaired Renal Function)
8.8
26.08
Not reported
Not reported
Not reported
Part 1: Belantamab Mafodotin 2.5 mg/kg (Severely Impaired Renal Function)
14.1
10.61
Not reported
Not reported
Not reported
Part 1: Belantamab Mafodotin 2.5 mg/kg (Other Renal Function)
3.0
NA
Not reported
Not reported
Standard Deviation is not evaluable as only a single participant was analyzed.
Part 2: Belantamab Mafodotin 2.5 mg/kg End Stage Renal Disease (Not on Dialysis)
8.0
22.63
Not reported
Not reported
Not reported
Complete source fields
classes
categories
measurements
group Id
OG000
spread
14.67
value
77.2
group Id
OG001
spread
15.34
value
74.9
group Id
OG002
spread
4.57
value
71.8
group Id
OG003
spread
11.05
value
69.0
group Id
OG004
spread
6.78
value
67.4
denoms
counts
group Id
OG000
value
10
group Id
OG001
value
9
group Id
OG002
value
4
group Id
OG003
value
5
group Id
OG004
value
8
units
Participants
title
Baseline (Day 1)
categories
measurements
group Id
OG000
spread
3.65
value
-1.3
group Id
OG001
spread
6.22
value
-4.0
group Id
OG002
spread
2.94
value
2.0
group Id
OG003
spread
5.45
value
1.2
group Id
OG004
spread
2.87
value
2.3
denoms
counts
group Id
OG000
value
10
group Id
OG001
value
9
group Id
OG002
value
4
group Id
OG003
value
5
group Id
OG004
value
7
units
Participants
title
CFB to Cycle 1 Day 1, 15 MINS AFTER SOI
categories
measurements
group Id
OG000
spread
6.03
value
-1.1
group Id
OG001
spread
4.04
value
-0.9
group Id
OG002
spread
7.41
value
4.3
group Id
OG003
spread
7.19
value
1.8
group Id
OG004
spread
2.27
value
2.1
denoms
counts
group Id
OG000
value
10
group Id
OG001
value
9
group Id
OG002
value
4
group Id
OG003
value
5
group Id
OG004
value
7
units
Participants
title
CFB to Cycle 1 Day 1, WITHIN 15 MINS AFTER EOI
categories
measurements
group Id
OG000
spread
5.72
value
3.0
group Id
OG001
spread
4.30
value
-1.0
group Id
OG002
spread
10.37
value
4.8
group Id
OG003
spread
6.91
value
-1.2
group Id
OG004
spread
3.56
value
0.9
denoms
counts
group Id
OG000
value
10
group Id
OG001
value
9
group Id
OG002
value
4
group Id
OG003
value
5
group Id
OG004
value
8
units
Participants
title
CFB to Cycle 1 Day 1, 1 HOUR AFTER EOI
categories
measurements
group Id
OG000
spread
10.03
value
1.2
group Id
OG001
spread
5.50
value
-5.0
group Id
OG002
spread
9.29
value
1.3
group Id
OG003
spread
9.15
value
-0.2
group Id
OG004
spread
7.96
value
1.2
denoms
counts
group Id
OG000
value
9
group Id
OG001
value
8
group Id
OG002
value
3
group Id
OG003
value
5
group Id
OG004
value
6
units
Participants
title
CFB to Cycle 2 Day 1, PRE-INFUSION
categories
measurements
group Id
OG000
spread
13.34
value
-2.2
group Id
OG001
spread
7.67
value
-3.8
group Id
OG002
spread
7.37
value
-0.3
group Id
OG003
spread
10.49
value
-1.0
group Id
OG004
spread
8.53
value
6.4
denoms
counts
group Id
OG000
value
9
group Id
OG001
value
8
group Id
OG002
value
3
group Id
OG003
value
5
group Id
OG004
value
5
units
Participants
title
CFB to Cycle 2 Day 1, WITHIN 15 MINS AFTER EOI
categories
measurements
group Id
OG000
spread
7.85
value
-12.3
group Id
OG001
spread
11.48
value
-2.4
group Id
OG002
spread
9.19
value
7.5
group Id
OG003
spread
19.05
value
5.3
group Id
OG004
spread
9.12
value
2.9
denoms
counts
group Id
OG000
value
4
group Id
OG001
value
5
group Id
OG002
value
2
group Id
OG003
value
4
group Id
OG004
value
7
units
Participants
title
CFB to Cycle 3 Day 1, PRE-INFUSION
categories
measurements
group Id
OG000
spread
9.45
value
-9.0
group Id
OG001
spread
13.50
value
0.6
group Id
OG002
spread
6.36
value
4.5
group Id
OG003
spread
7.79
value
-5.0
group Id
OG004
spread
10.23
value
5.8
denoms
counts
group Id
OG000
value
4
group Id
OG001
value
5
group Id
OG002
value
2
group Id
OG003
value
4
group Id
OG004
value
5
units
Participants
title
CFB to Cycle 3 Day 1, WITHIN 15 MINS AFTER EOI
categories
measurements
group Id
OG000
spread
6.00
value
0.0
group Id
OG001
spread
25.74
value
-12.3
group Id
OG002
spread
14.85
value
5.5
group Id
OG003
spread
11.47
value
-6.5
group Id
OG004
spread
5.37
value
4.0
denoms
counts
group Id
OG000
value
3
group Id
OG001
value
3
group Id
OG002
value
2
group Id
OG003
value
4
group Id
OG004
value
6
units
Participants
title
CFB to Cycle 4 Day 1, PRE-INFUSION
categories
measurements
group Id
OG000
spread
9.07
value
-1.3
group Id
OG001
spread
22.94
value
-15.7
group Id
OG002
spread
11.31
value
1.0
group Id
OG003
spread
12.87
value
-8.5
group Id
OG004
spread
5.52
value
6.0
denoms
counts
group Id
OG000
value
3
group Id
OG001
value
3
group Id
OG002
value
2
group Id
OG003
value
4
group Id
OG004
value
5
units
Participants
title
CFB to Cycle 4 Day 1, WITHIN 15 MINS AFTER EOI
categories
measurements
group Id
OG000
spread
19.14
value
-3.7
group Id
OG001
spread
9.29
value
-3.3
comment
Standard Deviation is not evaluable as only a single participant was analyzed.
group Id
OG002
spread
NA
value
0.0
group Id
OG003
spread
8.96
value
-5.8
group Id
OG004
spread
10.65
value
5.7
denoms
counts
group Id
OG000
value
3
group Id
OG001
value
3
group Id
OG002
value
1
group Id
OG003
value
4
group Id
OG004
value
6
units
Participants
title
CFB to Cycle 5 Day 1, PRE-INFUSION
categories
measurements
group Id
OG000
spread
11.14
value
-6.0
group Id
OG001
spread
9.07
value
-5.7
comment
Standard Deviation is not evaluable as only a single participant was analyzed.
group Id
OG002
spread
NA
value
-2.0
group Id
OG003
spread
9.24
value
-5.0
group Id
OG004
spread
3.83
value
4.2
denoms
counts
group Id
OG000
value
3
group Id
OG001
value
3
group Id
OG002
value
1
group Id
OG003
value
4
group Id
OG004
value
5
units
Participants
title
CFB to Cycle 5 Day 1, WITHIN 15 MINS AFTER EOI
denoms
counts
group Id
OG000
value
10
group Id
OG001
value
9
group Id
OG002
value
4
group Id
OG003
value
5
group Id
OG004
value
8
units
Participants
description
Heart rate was measured after resting for at least 5 minutes in a supine or semi-recumbent position. Baseline (Day 1) was defined as latest pre-dose assessment with a non-missing value, including unscheduled visits. Change from Baseline was calculated as post-dose visit value minus Baseline value.
dispersion Type
Standard Deviation
groups
description
Participants with Relapsed/Refractory Multiple Myeloma (RRMM) who have had at least 3 lines of prior treatment (or at least 2 lines of prior treatment if ineligible for autologous stem cell transplantation) and normal/mildly impaired renal function received intravenous (IV) infusion of 2.5 milligram (mg)/kilogram (kg) belantamab mafodotin for 30 minutes on Day 1 of every 21-day Cycle until disease progression, withdrawal of consent, withdrawal due to adverse event (AE), lost to follow-up, death, whichever occurs first.
id
OG000
title
Part 1: Belantamab Mafodotin 2.5 mg/kg (Normal/Mildly Impaired Renal Function)
description
Participants with RRMM who have had at least 3 lines of prior treatment (or at least 2 lines of prior treatment if ineligible for autologous stem cell transplantation) and severe renal impairment renal function received IV infusion of 2.5 mg/kg belantamab mafodotin for 30 minutes on Day 1 of every 21-day Cycle until disease progression, withdrawal of consent, withdrawal due to AE, lost to follow-up, death, whichever occurs first.
id
OG001
title
Part 1: Belantamab Mafodotin 2.5 mg/kg (Severely Impaired Renal Function)
description
Participants with RRMM who have had at least 3 lines of prior treatment (or at least 2 lines of prior treatment if ineligible for autologous stem cell transplantation) and other renal impairment renal function received IV infusion of 2.5 mg/kg belantamab mafodotin for 30 minutes on Day 1 of every 21-day Cycle until disease progression, withdrawal of consent, withdrawal due to AE, lost to follow-up, death, whichever occurs first.
id
OG002
title
Part 1: Belantamab Mafodotin 2.5 mg/kg (Other Renal Function)
description
Participants with RRMM who have had at least 3 lines of prior treatment (or at least 2 lines of prior treatment if ineligible for autologous stem cell transplantation) and end stage renal disease (ESRD) (not on hemodialysis) received IV infusion of 2.5 mg/kg belantamab mafodotin for 30 minutes on Day 1 of every 21-day Cycle until disease progression, withdrawal of consent, withdrawal due to AE, lost to follow-up, death, whichever occurs first.
id
OG003
title
Part 2: Belantamab Mafodotin 2.5 mg/kg End Stage Renal Disease (Not on Dialysis)
description
Participants with RRMM who have had at least 3 lines of prior treatment (or at least 2 lines of prior treatment if ineligible for autologous stem cell transplantation) and ESRD (on hemodialysis) received IV infusion of 2.5 mg/kg belantamab mafodotin for 30 minutes on Day 1 of every 21-day Cycle until disease progression, withdrawal of consent, withdrawal due to AE, lost to follow-up, death, whichever occurs first.
id
OG004
title
Part 2: Belantamab Mafodotin 2.5 mg/kg ESRD (On Dialysis)
param Type
MEAN
population Description
Safety population. Only those participants who were measured and analyzed (i.e., contributed to 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
Baseline (Day 1) and up to approx. 236 weeks
title
Part 1 and Part 2: Change From Baseline (CFB) in Vital Signs: Heart Rate
Triangle