NCT07150104 · ADVERSE EVENTS

Adverse events

Sub-study of Belantamab Mafodotin (GSK2857916) as Monotherapy and in Combination With Nirogacestat, Pomalidomide, and Dexamethasone 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 upto approximately 137 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
0.5 Milligram/Kilogram (mg/kg) Belantamab Mafodotin + Nirogacestat + Pomalidomide + Dexamethasone Participants with Relapsed/Refractory Multiple Myeloma (RRMM) received 0.5 mg/kg belantamab mafodotin intravenous (IV) infusion as powder for solution once every 4 weeks (Q4W) infused over 30- 60 minutes on day 1 of each 28-day cycle in combination with 100 mg Nirogacestat administered orally twice a day (BID) up to Day 28. Along with 4 mg Pomalidomide orally per day (QD) on Days 1-21 of each 28-day cycle and Dexamethasone 40mg (20 mg for participants \>75 years old or BMI \<18.5 kg/m\^2) administered orally on days 1, 8, 15 and 22 of each 28-day cycle.	12 / 14	14 / 14	3 / 14

Group identifiers: EG000: 0.5 Milligram/Kilogram (mg/kg) Belantamab Mafodotin + Nirogacestat + Pomalidomide + Dexamethasone

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
Blood and lymphatic system disorders
source Vocabulary
MedDRA v28.0
stats
group Id
EG000
num Affected
1
num At Risk
14
num Events
1
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA v28.0
stats
group Id
EG000
num Affected
1
num At Risk
14
num Events
1
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA v28.0
stats
group Id
EG000
num Affected
2
num At Risk
14
num Events
2
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA v28.0
stats
group Id
EG000
num Affected
1
num At Risk
14
num Events
1
term
Atrial fibrillation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA v28.0
stats
group Id
EG000
num Affected
1
num At Risk
14
num Events
1
term
Myocardial infarction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA v28.0
stats
group Id
EG000
num Affected
1
num At Risk
14
num Events
1
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Hepatobiliary disorders
source Vocabulary
MedDRA v28.0
stats
group Id
EG000
num Affected
1
num At Risk
14
num Events
1
term
Liver injury
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA v28.0
stats
group Id
EG000
num Affected
1
num At Risk
14
num Events
1
term
Atypical pneumonia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA v28.0
stats
group Id
EG000
num Affected
1
num At Risk
14
num Events
1
term
Device related infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA v28.0
stats
group Id
EG000
num Affected
1
num At Risk
14
num Events
1
term
Enterocolitis infectious
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA v28.0
stats
group Id
EG000
num Affected
1
num At Risk
14
num Events
2
term
Folliculitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA v28.0
stats
group Id
EG000
num Affected
1
num At Risk
14
num Events
1
term
Gastroenteritis

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 v28.0
stats
group Id
EG000
num Affected
6
num At Risk
14
num Events
10
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA v28.0
stats
group Id
EG000
num Affected
1
num At Risk
14
num Events
2
term
Leukopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA v28.0
stats
group Id
EG000
num Affected
6
num At Risk
14
num Events
20
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA v28.0
stats
group Id
EG000
num Affected
5
num At Risk
14
num Events
7
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA v28.0
stats
group Id
EG000
num Affected
2
num At Risk
14
num Events
3
term
Cataract
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA v28.0
stats
group Id
EG000
num Affected
1
num At Risk
14
num Events
1
term
Conjunctival hyperaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA v28.0
stats
group Id
EG000
num Affected
1
num At Risk
14
num Events
1
term
Corneal neovascularisation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA v28.0
stats
group Id
EG000
num Affected
5
num At Risk
14
num Events
8
term
Dry eye
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA v28.0
stats
group Id
EG000
num Affected
1
num At Risk
14
num Events
1
term
Ectropion
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA v28.0
stats
group Id
EG000
num Affected
1
num At Risk
14
num Events
1
term
Epiretinal membrane
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA v28.0
stats
group Id
EG000
num Affected
1
num At Risk
14
num Events
1
term
Eye allergy
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA v28.0
stats
group Id
EG000
num Affected
3
num At Risk
14
num Events
8
term
Eye irritation

Complete source fields

description

event Groups

deaths Num Affected
3
deaths Num At Risk
14
description
Participants with Relapsed/Refractory Multiple Myeloma (RRMM) received 0.5 mg/kg belantamab mafodotin intravenous (IV) infusion as powder for solution once every 4 weeks (Q4W) infused over 30- 60 minutes on day 1 of each 28-day cycle in combination with 100 mg Nirogacestat administered orally twice a day (BID) up to Day 28. Along with 4 mg Pomalidomide orally per day (QD) on Days 1-21 of each 28-day cycle and Dexamethasone 40mg (20 mg for participants \>75 years old or BMI \<18.5 kg/m\^2) administered orally on days 1, 8, 15 and 22 of each 28-day cycle.
id
EG000
other Num Affected
14
other Num At Risk
14
serious Num Affected
12
serious Num At Risk
14
title
0.5 Milligram/Kilogram (mg/kg) Belantamab Mafodotin + Nirogacestat + Pomalidomide + Dexamethasone

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA v28.0
stats
group Id
EG000
num Affected
6
num At Risk
14
num Events
10
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA v28.0
stats
group Id
EG000
num Affected
1
num At Risk
14
num Events
2
term
Leukopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA v28.0
stats
group Id
EG000
num Affected
6
num At Risk
14
num Events
20
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA v28.0
stats
group Id
EG000
num Affected
5
num At Risk
14
num Events
7
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA v28.0
stats
group Id
EG000
num Affected
2
num At Risk
14
num Events
3
term
Cataract
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA v28.0
stats
group Id
EG000
num Affected
1
num At Risk
14
num Events
1
term
Conjunctival hyperaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA v28.0
stats
group Id
EG000
num Affected
1
num At Risk
14
num Events
1
term
Corneal neovascularisation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA v28.0
stats
group Id
EG000
num Affected
5
num At Risk
14
num Events
8
term
Dry eye
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA v28.0
stats
group Id
EG000
num Affected
1
num At Risk
14
num Events
1
term
Ectropion
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA v28.0
stats
group Id
EG000
num Affected
1
num At Risk
14
num Events
1
term
Epiretinal membrane
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA v28.0
stats
group Id
EG000
num Affected
1
num At Risk
14
num Events
1
term
Eye allergy
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA v28.0
stats
group Id
EG000
num Affected
3
num At Risk
14
num Events
8
term
Eye irritation

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA v28.0
stats
group Id
EG000
num Affected
1
num At Risk
14
num Events
1
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA v28.0
stats
group Id
EG000
num Affected
1
num At Risk
14
num Events
1
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA v28.0
stats
group Id
EG000
num Affected
2
num At Risk
14
num Events
2
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA v28.0
stats
group Id
EG000
num Affected
1
num At Risk
14
num Events
1
term
Atrial fibrillation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA v28.0
stats
group Id
EG000
num Affected
1
num At Risk
14
num Events
1
term
Myocardial infarction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA v28.0
stats
group Id
EG000
num Affected
1
num At Risk
14
num Events
1
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Hepatobiliary disorders
source Vocabulary
MedDRA v28.0
stats
group Id
EG000
num Affected
1
num At Risk
14
num Events
1
term
Liver injury
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA v28.0
stats
group Id
EG000
num Affected
1
num At Risk
14
num Events
1
term
Atypical pneumonia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA v28.0
stats
group Id
EG000
num Affected
1
num At Risk
14
num Events
1
term
Device related infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA v28.0
stats
group Id
EG000
num Affected
1
num At Risk
14
num Events
1
term
Enterocolitis infectious
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA v28.0
stats
group Id
EG000
num Affected
1
num At Risk
14
num Events
2
term
Folliculitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA v28.0
stats
group Id
EG000
num Affected
1
num At Risk
14
num Events
1
term
Gastroenteritis

time Frame

All cause mortality, Non- Serious Adverse Events (non-SAEs) and Serious Adverse Events (SAEs) were collected upto approximately 137 weeks.

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