NCT07150091 · ADVERSE EVENTS

Adverse events

Sub-study of Belantamab Mafodotin (GSK2857916) in Combination With Nirogacestat, Lenalidomide, and Dexamethasone in Participants With RRMM · Source last updated 2026-06-16

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 143 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 + Lenalidomide + 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; with Lenalidomide 25 mg (10 mg if Estimated Glomerular Filtration (eGFR) is 40-60 milliLitre (mL)/minute/1.73 square meter (m)\^2) administered orally once daily (QD) from Day 1 to Day 21; and Dexamethasone 40 mg (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.	5 / 10	8 / 10	4 / 10
1.0 mg/kg Belantamab Mafodotin + Nirogacestat + Lenalidomide + Dexamethasone Participants with Relapsed/Refractory Multiple Myeloma (RRMM) received 1.0 mg/kg belantamab mafodotin intravenous (IV) infusion as powder for solution infused over 30- 60 minutes Q4W for cycle 1 and then Q8W for cycle 2 onwards on day 1 of 28-day cycle in Q4W and 56-day cycle in Q8W in combination with 100 mg Nirogacestat administered orally twice a day (BID) up to Day 28; with Lenalidomide 25 mg (10 mg if Estimated Glomerular Filtration (eGFR) is 40-60 milliLitre (mL)/minute/1.73 square meter (m)\^2) administered orally once daily (QD) from Day 1 to Day 21; and Dexamethasone 40 mg (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.	8 / 10	10 / 10	3 / 10

Group identifiers: EG000: 0.5 Milligram/Kilogram (mg/kg) Belantamab Mafodotin + Nirogacestat + Lenalidomide + Dexamethasone · EG001: 1.0 mg/kg Belantamab Mafodotin + Nirogacestat + Lenalidomide + 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 v28.1
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
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA v28.1
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
term
Cardiac amyloidosis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA v28.1
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
term
Cardiac failure
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA v28.1
stats
group Id
EG000
num Affected
2
num At Risk
10
num Events
2
group Id
EG001
num Affected
2
num At Risk
10
num Events
2
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA v28.1
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
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA v28.1
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
term
Stomatitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA v28.1
stats
group Id
EG000
num Affected
1
num At Risk
10
num Events
1
group Id
EG001
num Affected
1
num At Risk
10
num Events
1
term
Vomiting
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA v28.1
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
2
term
Asthenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Hepatobiliary disorders
source Vocabulary
MedDRA v28.1
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
term
Drug-induced liver injury
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA v28.1
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
term
Dengue fever
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA v28.1
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
term
Febrile infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA v28.1
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
term
Pneumonia

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 v28.1
stats
group Id
EG000
num Affected
3
num At Risk
10
num Events
8
group Id
EG001
num Affected
3
num At Risk
10
num Events
5
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA v28.1
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
term
Eosinophilia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA v28.1
stats
group Id
EG000
num Affected
1
num At Risk
10
num Events
11
group Id
EG001
num Affected
0
num At Risk
10
num Events
0
term
Leukopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA v28.1
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
term
Lymphopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA v28.1
stats
group Id
EG000
num Affected
4
num At Risk
10
num Events
18
group Id
EG001
num Affected
1
num At Risk
10
num Events
1
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA v28.1
stats
group Id
EG000
num Affected
4
num At Risk
10
num Events
17
group Id
EG001
num Affected
3
num At Risk
10
num Events
3
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA v28.1
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
term
Pericardial effusion
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA v28.1
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
3
term
Sinus bradycardia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA v28.1
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
term
Sinus tachycardia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA v28.1
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
term
Cataract
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA v28.1
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
term
Cataract subcapsular
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA v28.1
stats
group Id
EG000
num Affected
1
num At Risk
10
num Events
2
group Id
EG001
num Affected
0
num At Risk
10
num Events
0
term
Diplopia

Complete source fields

description

event Groups

deaths Num Affected
4
deaths Num At Risk
10
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; with Lenalidomide 25 mg (10 mg if Estimated Glomerular Filtration (eGFR) is 40-60 milliLitre (mL)/minute/1.73 square meter (m)\^2) administered orally once daily (QD) from Day 1 to Day 21; and Dexamethasone 40 mg (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
8
other Num At Risk
10
serious Num Affected
5
serious Num At Risk
10
title
0.5 Milligram/Kilogram (mg/kg) Belantamab Mafodotin + Nirogacestat + Lenalidomide + Dexamethasone
deaths Num Affected
3
deaths Num At Risk
10
description
Participants with Relapsed/Refractory Multiple Myeloma (RRMM) received 1.0 mg/kg belantamab mafodotin intravenous (IV) infusion as powder for solution infused over 30- 60 minutes Q4W for cycle 1 and then Q8W for cycle 2 onwards on day 1 of 28-day cycle in Q4W and 56-day cycle in Q8W in combination with 100 mg Nirogacestat administered orally twice a day (BID) up to Day 28; with Lenalidomide 25 mg (10 mg if Estimated Glomerular Filtration (eGFR) is 40-60 milliLitre (mL)/minute/1.73 square meter (m)\^2) administered orally once daily (QD) from Day 1 to Day 21; and Dexamethasone 40 mg (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
EG001
other Num Affected
10
other Num At Risk
10
serious Num Affected
8
serious Num At Risk
10
title
1.0 mg/kg Belantamab Mafodotin + Nirogacestat + Lenalidomide + Dexamethasone

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA v28.1
stats
group Id
EG000
num Affected
3
num At Risk
10
num Events
8
group Id
EG001
num Affected
3
num At Risk
10
num Events
5
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA v28.1
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
term
Eosinophilia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA v28.1
stats
group Id
EG000
num Affected
1
num At Risk
10
num Events
11
group Id
EG001
num Affected
0
num At Risk
10
num Events
0
term
Leukopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA v28.1
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
term
Lymphopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA v28.1
stats
group Id
EG000
num Affected
4
num At Risk
10
num Events
18
group Id
EG001
num Affected
1
num At Risk
10
num Events
1
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA v28.1
stats
group Id
EG000
num Affected
4
num At Risk
10
num Events
17
group Id
EG001
num Affected
3
num At Risk
10
num Events
3
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA v28.1
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
term
Pericardial effusion
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA v28.1
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
3
term
Sinus bradycardia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA v28.1
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
term
Sinus tachycardia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA v28.1
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
term
Cataract
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA v28.1
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
term
Cataract subcapsular
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA v28.1
stats
group Id
EG000
num Affected
1
num At Risk
10
num Events
2
group Id
EG001
num Affected
0
num At Risk
10
num Events
0
term
Diplopia

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA v28.1
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
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA v28.1
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
term
Cardiac amyloidosis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA v28.1
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
term
Cardiac failure
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA v28.1
stats
group Id
EG000
num Affected
2
num At Risk
10
num Events
2
group Id
EG001
num Affected
2
num At Risk
10
num Events
2
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA v28.1
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
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA v28.1
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
term
Stomatitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA v28.1
stats
group Id
EG000
num Affected
1
num At Risk
10
num Events
1
group Id
EG001
num Affected
1
num At Risk
10
num Events
1
term
Vomiting
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA v28.1
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
2
term
Asthenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Hepatobiliary disorders
source Vocabulary
MedDRA v28.1
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
term
Drug-induced liver injury
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA v28.1
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
term
Dengue fever
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA v28.1
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
term
Febrile infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA v28.1
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
term
Pneumonia

time Frame

All cause mortality, Non- Serious Adverse Events (non-SAEs) and Serious Adverse Events (SAEs) were collected upto approximately 143 weeks.

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

Preserved source evidence · Not medical advice