NCT07217184 · ADVERSE EVENTS

Adverse events

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.

Adverse events occurred during the study; they are not necessarily caused by treatment. Serious events are not interchangeable with severe/grade 3–4 events. These safety populations may differ from efficacy populations.

Collection time frame: All cause mortality, Non- Serious Adverse Events (non-SAEs) and Serious Adverse Events (SAEs) were collected up to approximately 194 weeks.
Other-event reporting threshold: 5%

Safety population included all participants who received at least one dose of any component of the combination therapy. The results presented are based on data cut-off date 17 Apr 2025. Safety data collection is still ongoing and will be provided within a year of study completion.

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
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 / 10	10 / 10	6 / 10
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.	3 / 10	9 / 10	3 / 10
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.	3 / 10	10 / 10	3 / 10

Group identifiers: EG000: 1.9 Milligram (mg)/Kilogram (kg) Belantamab Mafodotin (Q4W) + Isatuximab · EG001: 1.4 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab · EG002: 1.9 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab

Serious adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA v 28.0
stats
group Id
EG000
num Affected
0
num At Risk
10
num Events
0
group Id
EG001
num Affected
0
num At Risk
10
num Events
0
group Id
EG002
num Affected
1
num At Risk
10
num Events
2
term
Atrial fibrillation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA v 28.0
stats
group Id
EG000
num Affected
0
num At Risk
10
num Events
0
group Id
EG001
num Affected
0
num At Risk
10
num Events
0
group Id
EG002
num Affected
1
num At Risk
10
num Events
1
term
Myocardial ischaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA v 28.0
stats
group Id
EG000
num Affected
0
num At Risk
10
num Events
0
group Id
EG001
num Affected
0
num At Risk
10
num Events
0
group Id
EG002
num Affected
1
num At Risk
10
num Events
1
term
Sinus bradycardia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA v 28.0
stats
group Id
EG000
num Affected
0
num At Risk
10
num Events
0
group Id
EG001
num Affected
0
num At Risk
10
num Events
0
group Id
EG002
num Affected
1
num At Risk
10
num Events
1
term
Bacteroides bacteraemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA v 28.0
stats
group Id
EG000
num Affected
0
num At Risk
10
num Events
0
group Id
EG001
num Affected
0
num At Risk
10
num Events
0
group Id
EG002
num Affected
1
num At Risk
10
num Events
1
term
Bronchitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA v 28.0
stats
group Id
EG000
num Affected
0
num At Risk
10
num Events
0
group Id
EG001
num Affected
0
num At Risk
10
num Events
0
group Id
EG002
num Affected
1
num At Risk
10
num Events
1
term
COVID-19
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA v 28.0
stats
group Id
EG000
num Affected
0
num At Risk
10
num Events
0
group Id
EG001
num Affected
0
num At Risk
10
num Events
0
group Id
EG002
num Affected
1
num At Risk
10
num Events
1
term
Device related infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA v 28.0
stats
group Id
EG000
num Affected
0
num At Risk
10
num Events
0
group Id
EG001
num Affected
1
num At Risk
10
num Events
1
group Id
EG002
num Affected
0
num At Risk
10
num Events
0
term
Gastroenteritis salmonella
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA v 28.0
stats
group Id
EG000
num Affected
0
num At Risk
10
num Events
0
group Id
EG001
num Affected
1
num At Risk
10
num Events
1
group Id
EG002
num Affected
1
num At Risk
10
num Events
1
term
Pneumonia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA v 28.0
stats
group Id
EG000
num Affected
0
num At Risk
10
num Events
0
group Id
EG001
num Affected
0
num At Risk
10
num Events
0
group Id
EG002
num Affected
1
num At Risk
10
num Events
1
term
Pneumonia bacterial
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA v 28.0
stats
group Id
EG000
num Affected
0
num At Risk
10
num Events
0
group Id
EG001
num Affected
1
num At Risk
10
num Events
2
group Id
EG002
num Affected
0
num At Risk
10
num Events
0
term
Sepsis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA v 28.0
stats
group Id
EG000
num Affected
0
num At Risk
10
num Events
0
group Id
EG001
num Affected
0
num At Risk
10
num Events
0
group Id
EG002
num Affected
1
num At Risk
10
num Events
1
term
Subarachnoid abscess

Other reported adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA v 28.0
stats
group Id
EG000
num Affected
4
num At Risk
10
num Events
4
group Id
EG001
num Affected
2
num At Risk
10
num Events
2
group Id
EG002
num Affected
3
num At Risk
10
num Events
4
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA v 28.0
stats
group Id
EG000
num Affected
0
num At Risk
10
num Events
0
group Id
EG001
num Affected
1
num At Risk
10
num Events
1
group Id
EG002
num Affected
0
num At Risk
10
num Events
0
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA v 28.0
stats
group Id
EG000
num Affected
3
num At Risk
10
num Events
3
group Id
EG001
num Affected
1
num At Risk
10
num Events
1
group Id
EG002
num Affected
4
num At Risk
10
num Events
8
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Ear and labyrinth disorders
source Vocabulary
MedDRA v 28.0
stats
group Id
EG000
num Affected
1
num At Risk
10
num Events
1
group Id
EG001
num Affected
0
num At Risk
10
num Events
0
group Id
EG002
num Affected
0
num At Risk
10
num Events
0
term
Vertigo
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Endocrine disorders
source Vocabulary
MedDRA v 28.0
stats
group Id
EG000
num Affected
0
num At Risk
10
num Events
0
group Id
EG001
num Affected
0
num At Risk
10
num Events
0
group Id
EG002
num Affected
1
num At Risk
10
num Events
1
term
Hypothyroidism
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Endocrine disorders
source Vocabulary
MedDRA v 28.0
stats
group Id
EG000
num Affected
0
num At Risk
10
num Events
0
group Id
EG001
num Affected
2
num At Risk
10
num Events
3
group Id
EG002
num Affected
1
num At Risk
10
num Events
1
term
Steroid withdrawal syndrome
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA v 28.0
stats
group Id
EG000
num Affected
0
num At Risk
10
num Events
0
group Id
EG001
num Affected
0
num At Risk
10
num Events
0
group Id
EG002
num Affected
1
num At Risk
10
num Events
1
term
Cataract cortical
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA v 28.0
stats
group Id
EG000
num Affected
0
num At Risk
10
num Events
0
group Id
EG001
num Affected
1
num At Risk
10
num Events
1
group Id
EG002
num Affected
0
num At Risk
10
num Events
0
term
Conjunctival haemorrhage
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA v 28.0
stats
group Id
EG000
num Affected
0
num At Risk
10
num Events
0
group Id
EG001
num Affected
0
num At Risk
10
num Events
0
group Id
EG002
num Affected
1
num At Risk
10
num Events
1
term
Diplopia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA v 28.0
stats
group Id
EG000
num Affected
3
num At Risk
10
num Events
5
group Id
EG001
num Affected
4
num At Risk
10
num Events
5
group Id
EG002
num Affected
3
num At Risk
10
num Events
6
term
Dry eye
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA v 28.0
stats
group Id
EG000
num Affected
1
num At Risk
10
num Events
3
group Id
EG001
num Affected
0
num At Risk
10
num Events
0
group Id
EG002
num Affected
2
num At Risk
10
num Events
3
term
Eye irritation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA v 28.0
stats
group Id
EG000
num Affected
0
num At Risk
10
num Events
0
group Id
EG001
num Affected
0
num At Risk
10
num Events
0
group Id
EG002
num Affected
1
num At Risk
10
num Events
1
term
Eye pruritus

Complete source fields

description

event Groups

deaths Num Affected
6
deaths Num At Risk
10
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
EG000
other Num Affected
10
other Num At Risk
10
serious Num Affected
1
serious Num At Risk
10
title
1.9 Milligram (mg)/Kilogram (kg) Belantamab Mafodotin (Q4W) + Isatuximab
deaths Num Affected
3
deaths Num At Risk
10
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
EG001
other Num Affected
9
other Num At Risk
10
serious Num Affected
3
serious Num At Risk
10
title
1.4 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab
deaths Num Affected
3
deaths Num At Risk
10
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
EG002
other Num Affected
10
other Num At Risk
10
serious Num Affected
3
serious Num At Risk
10
title
1.9 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA v 28.0
stats
group Id
EG000
num Affected
4
num At Risk
10
num Events
4
group Id
EG001
num Affected
2
num At Risk
10
num Events
2
group Id
EG002
num Affected
3
num At Risk
10
num Events
4
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA v 28.0
stats
group Id
EG000
num Affected
0
num At Risk
10
num Events
0
group Id
EG001
num Affected
1
num At Risk
10
num Events
1
group Id
EG002
num Affected
0
num At Risk
10
num Events
0
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA v 28.0
stats
group Id
EG000
num Affected
3
num At Risk
10
num Events
3
group Id
EG001
num Affected
1
num At Risk
10
num Events
1
group Id
EG002
num Affected
4
num At Risk
10
num Events
8
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Ear and labyrinth disorders
source Vocabulary
MedDRA v 28.0
stats
group Id
EG000
num Affected
1
num At Risk
10
num Events
1
group Id
EG001
num Affected
0
num At Risk
10
num Events
0
group Id
EG002
num Affected
0
num At Risk
10
num Events
0
term
Vertigo
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Endocrine disorders
source Vocabulary
MedDRA v 28.0
stats
group Id
EG000
num Affected
0
num At Risk
10
num Events
0
group Id
EG001
num Affected
0
num At Risk
10
num Events
0
group Id
EG002
num Affected
1
num At Risk
10
num Events
1
term
Hypothyroidism
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Endocrine disorders
source Vocabulary
MedDRA v 28.0
stats
group Id
EG000
num Affected
0
num At Risk
10
num Events
0
group Id
EG001
num Affected
2
num At Risk
10
num Events
3
group Id
EG002
num Affected
1
num At Risk
10
num Events
1
term
Steroid withdrawal syndrome
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA v 28.0
stats
group Id
EG000
num Affected
0
num At Risk
10
num Events
0
group Id
EG001
num Affected
0
num At Risk
10
num Events
0
group Id
EG002
num Affected
1
num At Risk
10
num Events
1
term
Cataract cortical
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA v 28.0
stats
group Id
EG000
num Affected
0
num At Risk
10
num Events
0
group Id
EG001
num Affected
1
num At Risk
10
num Events
1
group Id
EG002
num Affected
0
num At Risk
10
num Events
0
term
Conjunctival haemorrhage
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA v 28.0
stats
group Id
EG000
num Affected
0
num At Risk
10
num Events
0
group Id
EG001
num Affected
0
num At Risk
10
num Events
0
group Id
EG002
num Affected
1
num At Risk
10
num Events
1
term
Diplopia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA v 28.0
stats
group Id
EG000
num Affected
3
num At Risk
10
num Events
5
group Id
EG001
num Affected
4
num At Risk
10
num Events
5
group Id
EG002
num Affected
3
num At Risk
10
num Events
6
term
Dry eye
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA v 28.0
stats
group Id
EG000
num Affected
1
num At Risk
10
num Events
3
group Id
EG001
num Affected
0
num At Risk
10
num Events
0
group Id
EG002
num Affected
2
num At Risk
10
num Events
3
term
Eye irritation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA v 28.0
stats
group Id
EG000
num Affected
0
num At Risk
10
num Events
0
group Id
EG001
num Affected
0
num At Risk
10
num Events
0
group Id
EG002
num Affected
1
num At Risk
10
num Events
1
term
Eye pruritus

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA v 28.0
stats
group Id
EG000
num Affected
0
num At Risk
10
num Events
0
group Id
EG001
num Affected
0
num At Risk
10
num Events
0
group Id
EG002
num Affected
1
num At Risk
10
num Events
2
term
Atrial fibrillation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA v 28.0
stats
group Id
EG000
num Affected
0
num At Risk
10
num Events
0
group Id
EG001
num Affected
0
num At Risk
10
num Events
0
group Id
EG002
num Affected
1
num At Risk
10
num Events
1
term
Myocardial ischaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA v 28.0
stats
group Id
EG000
num Affected
0
num At Risk
10
num Events
0
group Id
EG001
num Affected
0
num At Risk
10
num Events
0
group Id
EG002
num Affected
1
num At Risk
10
num Events
1
term
Sinus bradycardia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA v 28.0
stats
group Id
EG000
num Affected
0
num At Risk
10
num Events
0
group Id
EG001
num Affected
0
num At Risk
10
num Events
0
group Id
EG002
num Affected
1
num At Risk
10
num Events
1
term
Bacteroides bacteraemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA v 28.0
stats
group Id
EG000
num Affected
0
num At Risk
10
num Events
0
group Id
EG001
num Affected
0
num At Risk
10
num Events
0
group Id
EG002
num Affected
1
num At Risk
10
num Events
1
term
Bronchitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA v 28.0
stats
group Id
EG000
num Affected
0
num At Risk
10
num Events
0
group Id
EG001
num Affected
0
num At Risk
10
num Events
0
group Id
EG002
num Affected
1
num At Risk
10
num Events
1
term
COVID-19
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA v 28.0
stats
group Id
EG000
num Affected
0
num At Risk
10
num Events
0
group Id
EG001
num Affected
0
num At Risk
10
num Events
0
group Id
EG002
num Affected
1
num At Risk
10
num Events
1
term
Device related infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA v 28.0
stats
group Id
EG000
num Affected
0
num At Risk
10
num Events
0
group Id
EG001
num Affected
1
num At Risk
10
num Events
1
group Id
EG002
num Affected
0
num At Risk
10
num Events
0
term
Gastroenteritis salmonella
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA v 28.0
stats
group Id
EG000
num Affected
0
num At Risk
10
num Events
0
group Id
EG001
num Affected
1
num At Risk
10
num Events
1
group Id
EG002
num Affected
1
num At Risk
10
num Events
1
term
Pneumonia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA v 28.0
stats
group Id
EG000
num Affected
0
num At Risk
10
num Events
0
group Id
EG001
num Affected
0
num At Risk
10
num Events
0
group Id
EG002
num Affected
1
num At Risk
10
num Events
1
term
Pneumonia bacterial
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA v 28.0
stats
group Id
EG000
num Affected
0
num At Risk
10
num Events
0
group Id
EG001
num Affected
1
num At Risk
10
num Events
2
group Id
EG002
num Affected
0
num At Risk
10
num Events
0
term
Sepsis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA v 28.0
stats
group Id
EG000
num Affected
0
num At Risk
10
num Events
0
group Id
EG001
num Affected
0
num At Risk
10
num Events
0
group Id
EG002
num Affected
1
num At Risk
10
num Events
1
term
Subarachnoid abscess

time Frame

All cause mortality, Non- Serious Adverse Events (non-SAEs) and Serious Adverse Events (SAEs) were collected up to approximately 194 weeks.

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice