NCT06956170 · ADVERSE EVENTS

Adverse events

All Japanese Population: Belantamab Mafodotin Plus Pomalidomide and Dexamethasone (Pd) Versus Bortezomib Plus Pd in Relapsed/Refractory Multiple Myeloma · Source last updated 2026-06-12

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 120 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Other-event reporting threshold: 5%

Safety population included all randomized participants who received at least 1 dose of study intervention (any component).

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Belantamab Mafodotin+Pomalidomide+Dexamethasone Japanese participants with Relapsed/Refractory Multiple Myeloma (RRMM) received intravenous (IV) infusion of 2.5 milligram (mg)/kilogram (kg) belantamab mafodotin on Day 1 of Cycle 1 and 1.9 mg/kg on Day 1 of Cycle 2 onwards in each 28-day cycle, in combination with oral 4 mg per day Pomalidomide capsule on Days 1 to 21 of each 28-day cycle; and oral 40 mg per day Dexamethasone tablet on Days 1, 8, 15, and 22 of each 28-day cycle until disease progression, death, unacceptable toxicity, withdrawal of consent, initiation of another anti-myeloma therapy or end of study, whichever occurs first.	5 / 10	10 / 10	2 / 10
Bortezomib + Pomalidomide + Dexamethasone Japanese participants with RRMM received subcutaneous (SC) injection of 1.3 mg/meter\^2(m\^2) Bortezomib on Days 1, 4, 8, 11, of each 21-day cycle for Cycles 1 through 8, and on Days 1, 8, of each 21-day cycle for Cycles 9+ in combination with oral 4 mg per day Pomalidomide capsule on Days 1 to 14 of each 21-day cycle, and oral 20 mg Dexamethasone tablet on Days 1, 2, 4, 5, 8, 9, 11, 12, of each 21-day cycle for Cycles 1 through 8 and then on Days 1, 2, 8, 9, every 3 Weeks (Q3W) from Cycles 9 onwards until disease progression, death, unacceptable toxicity, withdrawal of consent, initiation of another anti-myeloma therapy or end of study, whichever occurs first.	4 / 11	11 / 11	1 / 11

Group identifiers: EG000: Belantamab Mafodotin+Pomalidomide+Dexamethasone · EG001: Bortezomib + 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
Cardiac disorders
source Vocabulary
MedDRA v26.1
stats
group Id
EG000
num Affected
0
num At Risk
10
num Events
0
group Id
EG001
num Affected
1
num At Risk
11
num Events
1
term
Sinus node dysfunction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA v26.1
stats
group Id
EG000
num Affected
0
num At Risk
10
num Events
0
group Id
EG001
num Affected
1
num At Risk
11
num Events
2
term
Cataract
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA v26.1
stats
group Id
EG000
num Affected
1
num At Risk
10
num Events
1
group Id
EG001
num Affected
0
num At Risk
11
num Events
0
term
Oedema
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Hepatobiliary disorders
source Vocabulary
MedDRA v26.1
stats
group Id
EG000
num Affected
1
num At Risk
10
num Events
1
group Id
EG001
num Affected
0
num At Risk
11
num Events
0
term
Cholelithiasis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA v26.1
stats
group Id
EG000
num Affected
1
num At Risk
10
num Events
1
group Id
EG001
num Affected
0
num At Risk
11
num Events
0
term
Cytomegalovirus chorioretinitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA v26.1
stats
group Id
EG000
num Affected
0
num At Risk
10
num Events
0
group Id
EG001
num Affected
1
num At Risk
11
num Events
1
term
Influenza
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA v26.1
stats
group Id
EG000
num Affected
1
num At Risk
10
num Events
1
group Id
EG001
num Affected
0
num At Risk
11
num Events
0
term
Morganella infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA v26.1
stats
group Id
EG000
num Affected
1
num At Risk
10
num Events
1
group Id
EG001
num Affected
0
num At Risk
11
num Events
0
term
Pneumocystis jirovecii pneumonia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA v26.1
stats
group Id
EG000
num Affected
1
num At Risk
10
num Events
3
group Id
EG001
num Affected
1
num At Risk
11
num Events
1
term
Pneumonia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
MedDRA v26.1
stats
group Id
EG000
num Affected
1
num At Risk
10
num Events
1
group Id
EG001
num Affected
0
num At Risk
11
num Events
0
term
Diabetic ketoacidosis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
source Vocabulary
MedDRA v26.1
stats
group Id
EG000
num Affected
0
num At Risk
10
num Events
0
group Id
EG001
num Affected
1
num At Risk
11
num Events
1
term
Colon cancer metastatic
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
MedDRA v26.1
stats
group Id
EG000
num Affected
1
num At Risk
10
num Events
1
group Id
EG001
num Affected
0
num At Risk
11
num Events
0
term
Normal pressure hydrocephalus

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 v26.1
stats
group Id
EG000
num Affected
2
num At Risk
10
num Events
2
group Id
EG001
num Affected
2
num At Risk
11
num Events
5
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA v26.1
stats
group Id
EG000
num Affected
0
num At Risk
10
num Events
0
group Id
EG001
num Affected
1
num At Risk
11
num Events
2
term
Eosinophilia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA v26.1
stats
group Id
EG000
num Affected
0
num At Risk
10
num Events
0
group Id
EG001
num Affected
1
num At Risk
11
num Events
3
term
Leukocytosis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA v26.1
stats
group Id
EG000
num Affected
0
num At Risk
10
num Events
0
group Id
EG001
num Affected
2
num At Risk
11
num Events
2
term
Leukopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA v26.1
stats
group Id
EG000
num Affected
0
num At Risk
10
num Events
0
group Id
EG001
num Affected
1
num At Risk
11
num Events
1
term
Lymphopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA v26.1
stats
group Id
EG000
num Affected
1
num At Risk
10
num Events
2
group Id
EG001
num Affected
1
num At Risk
11
num Events
1
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA v26.1
stats
group Id
EG000
num Affected
3
num At Risk
10
num Events
5
group Id
EG001
num Affected
4
num At Risk
11
num Events
11
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA v26.1
stats
group Id
EG000
num Affected
0
num At Risk
10
num Events
0
group Id
EG001
num Affected
1
num At Risk
11
num Events
1
term
Atrial fibrillation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA v26.1
stats
group Id
EG000
num Affected
3
num At Risk
10
num Events
3
group Id
EG001
num Affected
1
num At Risk
11
num Events
1
term
Cataract
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA v26.1
stats
group Id
EG000
num Affected
2
num At Risk
10
num Events
3
group Id
EG001
num Affected
1
num At Risk
11
num Events
2
term
Dry eye
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA v26.1
stats
group Id
EG000
num Affected
0
num At Risk
10
num Events
0
group Id
EG001
num Affected
1
num At Risk
11
num Events
1
term
Eye discharge
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA v26.1
stats
group Id
EG000
num Affected
2
num At Risk
10
num Events
4
group Id
EG001
num Affected
0
num At Risk
11
num Events
0
term
Eye irritation

Complete source fields

description

Safety population included all randomized participants who received at least 1 dose of study intervention (any component).

event Groups

deaths Num Affected
2
deaths Num At Risk
10
description
Japanese participants with Relapsed/Refractory Multiple Myeloma (RRMM) received intravenous (IV) infusion of 2.5 milligram (mg)/kilogram (kg) belantamab mafodotin on Day 1 of Cycle 1 and 1.9 mg/kg on Day 1 of Cycle 2 onwards in each 28-day cycle, in combination with oral 4 mg per day Pomalidomide capsule on Days 1 to 21 of each 28-day cycle; and oral 40 mg per day Dexamethasone tablet on Days 1, 8, 15, and 22 of each 28-day cycle until disease progression, death, unacceptable toxicity, withdrawal of consent, initiation of another anti-myeloma therapy or end of study, whichever occurs first.
id
EG000
other Num Affected
10
other Num At Risk
10
serious Num Affected
5
serious Num At Risk
10
title
Belantamab Mafodotin+Pomalidomide+Dexamethasone
deaths Num Affected
1
deaths Num At Risk
11
description
Japanese participants with RRMM received subcutaneous (SC) injection of 1.3 mg/meter\^2(m\^2) Bortezomib on Days 1, 4, 8, 11, of each 21-day cycle for Cycles 1 through 8, and on Days 1, 8, of each 21-day cycle for Cycles 9+ in combination with oral 4 mg per day Pomalidomide capsule on Days 1 to 14 of each 21-day cycle, and oral 20 mg Dexamethasone tablet on Days 1, 2, 4, 5, 8, 9, 11, 12, of each 21-day cycle for Cycles 1 through 8 and then on Days 1, 2, 8, 9, every 3 Weeks (Q3W) from Cycles 9 onwards until disease progression, death, unacceptable toxicity, withdrawal of consent, initiation of another anti-myeloma therapy or end of study, whichever occurs first.
id
EG001
other Num Affected
11
other Num At Risk
11
serious Num Affected
4
serious Num At Risk
11
title
Bortezomib + Pomalidomide + Dexamethasone

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA v26.1
stats
group Id
EG000
num Affected
2
num At Risk
10
num Events
2
group Id
EG001
num Affected
2
num At Risk
11
num Events
5
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA v26.1
stats
group Id
EG000
num Affected
0
num At Risk
10
num Events
0
group Id
EG001
num Affected
1
num At Risk
11
num Events
2
term
Eosinophilia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA v26.1
stats
group Id
EG000
num Affected
0
num At Risk
10
num Events
0
group Id
EG001
num Affected
1
num At Risk
11
num Events
3
term
Leukocytosis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA v26.1
stats
group Id
EG000
num Affected
0
num At Risk
10
num Events
0
group Id
EG001
num Affected
2
num At Risk
11
num Events
2
term
Leukopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA v26.1
stats
group Id
EG000
num Affected
0
num At Risk
10
num Events
0
group Id
EG001
num Affected
1
num At Risk
11
num Events
1
term
Lymphopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA v26.1
stats
group Id
EG000
num Affected
1
num At Risk
10
num Events
2
group Id
EG001
num Affected
1
num At Risk
11
num Events
1
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA v26.1
stats
group Id
EG000
num Affected
3
num At Risk
10
num Events
5
group Id
EG001
num Affected
4
num At Risk
11
num Events
11
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA v26.1
stats
group Id
EG000
num Affected
0
num At Risk
10
num Events
0
group Id
EG001
num Affected
1
num At Risk
11
num Events
1
term
Atrial fibrillation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA v26.1
stats
group Id
EG000
num Affected
3
num At Risk
10
num Events
3
group Id
EG001
num Affected
1
num At Risk
11
num Events
1
term
Cataract
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA v26.1
stats
group Id
EG000
num Affected
2
num At Risk
10
num Events
3
group Id
EG001
num Affected
1
num At Risk
11
num Events
2
term
Dry eye
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA v26.1
stats
group Id
EG000
num Affected
0
num At Risk
10
num Events
0
group Id
EG001
num Affected
1
num At Risk
11
num Events
1
term
Eye discharge
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA v26.1
stats
group Id
EG000
num Affected
2
num At Risk
10
num Events
4
group Id
EG001
num Affected
0
num At Risk
11
num Events
0
term
Eye irritation

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA v26.1
stats
group Id
EG000
num Affected
0
num At Risk
10
num Events
0
group Id
EG001
num Affected
1
num At Risk
11
num Events
1
term
Sinus node dysfunction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA v26.1
stats
group Id
EG000
num Affected
0
num At Risk
10
num Events
0
group Id
EG001
num Affected
1
num At Risk
11
num Events
2
term
Cataract
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA v26.1
stats
group Id
EG000
num Affected
1
num At Risk
10
num Events
1
group Id
EG001
num Affected
0
num At Risk
11
num Events
0
term
Oedema
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Hepatobiliary disorders
source Vocabulary
MedDRA v26.1
stats
group Id
EG000
num Affected
1
num At Risk
10
num Events
1
group Id
EG001
num Affected
0
num At Risk
11
num Events
0
term
Cholelithiasis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA v26.1
stats
group Id
EG000
num Affected
1
num At Risk
10
num Events
1
group Id
EG001
num Affected
0
num At Risk
11
num Events
0
term
Cytomegalovirus chorioretinitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA v26.1
stats
group Id
EG000
num Affected
0
num At Risk
10
num Events
0
group Id
EG001
num Affected
1
num At Risk
11
num Events
1
term
Influenza
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA v26.1
stats
group Id
EG000
num Affected
1
num At Risk
10
num Events
1
group Id
EG001
num Affected
0
num At Risk
11
num Events
0
term
Morganella infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA v26.1
stats
group Id
EG000
num Affected
1
num At Risk
10
num Events
1
group Id
EG001
num Affected
0
num At Risk
11
num Events
0
term
Pneumocystis jirovecii pneumonia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA v26.1
stats
group Id
EG000
num Affected
1
num At Risk
10
num Events
3
group Id
EG001
num Affected
1
num At Risk
11
num Events
1
term
Pneumonia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
MedDRA v26.1
stats
group Id
EG000
num Affected
1
num At Risk
10
num Events
1
group Id
EG001
num Affected
0
num At Risk
11
num Events
0
term
Diabetic ketoacidosis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
source Vocabulary
MedDRA v26.1
stats
group Id
EG000
num Affected
0
num At Risk
10
num Events
0
group Id
EG001
num Affected
1
num At Risk
11
num Events
1
term
Colon cancer metastatic
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
MedDRA v26.1
stats
group Id
EG000
num Affected
1
num At Risk
10
num Events
1
group Id
EG001
num Affected
0
num At Risk
11
num Events
0
term
Normal pressure hydrocephalus

time Frame

All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 120 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.

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