NCT05405166 · ADVERSE EVENTS

Adverse events

SC Versus IV Isatuximab in Combination With Pomalidomide and Dexamethasone in RRMM · Source last updated 2026-09-02

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: Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 38 months. Partial results are presented up to DCO date of 29-Aug-2025.
Other-event reporting threshold: 5%

Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Isa-IV + Pd Participants received isatuximab 10 mg/kg IV infusion QW (i.e. on Days 1, 8, 15 and 22) in Cycle 1 (28 days) and then 10 mg/kg Q2W (i.e. on Days 1 and 15) of each subsequent 28-day cycle along with pomalidomide 4 mg orally on Days 1 to 21 of each 28-day cycle and dexamethasone 40 mg (or 20 mg for participant \>=75 years) orally on Days 1, 8, 15, and 22 of each cycle until disease progression, unacceptable AEs, participant request to discontinue treatment, or any other reason, whichever came first.	152 / 264	248 / 264	73 / 268
Isa-SC + Pd Participants received isatuximab 1400 mg SC injection administered via an OBDS which is an investigational device injector QW (i.e on Days 1, 8, 15 and 22) in Cycle 1 (28 days) and then 1400 mg Q2W (i.e. on Days 1 and 15) of each subsequent 28-day cycle along with pomalidomide 4 mg orally on Days 1 to 21 of each 28-day cycle and dexamethasone 40 mg (or 20 mg for participant \>=75 years) orally on Days 1, 8, 15, and 22 of each cycle until disease progression, unacceptable AEs, participant request to discontinue treatment, or any other reason, whichever came first.	160 / 263	242 / 263	77 / 263

Group identifiers: EG000: Isa-IV + Pd · EG001: Isa-SC + Pd

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
Infections and infestations
source Vocabulary
MedDra 28.0
stats
group Id
EG000
num Affected
2
num At Risk
264
num Events
2
group Id
EG001
num Affected
0
num At Risk
263
num Events
0
term
Bacteraemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDra 28.0
stats
group Id
EG000
num Affected
0
num At Risk
264
num Events
0
group Id
EG001
num Affected
1
num At Risk
263
num Events
1
term
Bronchiolitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDra 28.0
stats
group Id
EG000
num Affected
1
num At Risk
264
num Events
1
group Id
EG001
num Affected
2
num At Risk
263
num Events
2
term
Bronchitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDra 28.0
stats
group Id
EG000
num Affected
0
num At Risk
264
num Events
0
group Id
EG001
num Affected
1
num At Risk
263
num Events
1
term
Bronchopulmonary Aspergillosis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDra 28.0
stats
group Id
EG000
num Affected
1
num At Risk
264
num Events
1
group Id
EG001
num Affected
0
num At Risk
263
num Events
0
term
Bullous Erysipelas
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDra 28.0
stats
group Id
EG000
num Affected
7
num At Risk
264
num Events
7
group Id
EG001
num Affected
11
num At Risk
263
num Events
11
term
Covid-19
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDra 28.0
stats
group Id
EG000
num Affected
6
num At Risk
264
num Events
6
group Id
EG001
num Affected
7
num At Risk
263
num Events
7
term
Covid-19 Pneumonia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDra 28.0
stats
group Id
EG000
num Affected
0
num At Risk
264
num Events
0
group Id
EG001
num Affected
1
num At Risk
263
num Events
1
term
Campylobacter Bacteraemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDra 28.0
stats
group Id
EG000
num Affected
0
num At Risk
264
num Events
0
group Id
EG001
num Affected
1
num At Risk
263
num Events
1
term
Campylobacter Gastroenteritis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDra 28.0
stats
group Id
EG000
num Affected
2
num At Risk
264
num Events
2
group Id
EG001
num Affected
1
num At Risk
263
num Events
1
term
Cellulitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDra 28.0
stats
group Id
EG000
num Affected
0
num At Risk
264
num Events
0
group Id
EG001
num Affected
2
num At Risk
263
num Events
2
term
Clostridium Difficile Colitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDra 28.0
stats
group Id
EG000
num Affected
0
num At Risk
264
num Events
0
group Id
EG001
num Affected
1
num At Risk
263
num Events
1
term
Coronavirus 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
Infections and infestations
source Vocabulary
MedDra 28.0
stats
group Id
EG000
num Affected
21
num At Risk
264
num Events
37
group Id
EG001
num Affected
26
num At Risk
263
num Events
34
term
Bronchitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDra 28.0
stats
group Id
EG000
num Affected
36
num At Risk
264
num Events
38
group Id
EG001
num Affected
32
num At Risk
263
num Events
34
term
Covid-19
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDra 28.0
stats
group Id
EG000
num Affected
11
num At Risk
264
num Events
12
group Id
EG001
num Affected
23
num At Risk
263
num Events
23
term
Influenza
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDra 28.0
stats
group Id
EG000
num Affected
25
num At Risk
264
num Events
36
group Id
EG001
num Affected
21
num At Risk
263
num Events
28
term
Nasopharyngitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDra 28.0
stats
group Id
EG000
num Affected
35
num At Risk
264
num Events
43
group Id
EG001
num Affected
19
num At Risk
263
num Events
21
term
Pneumonia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDra 28.0
stats
group Id
EG000
num Affected
14
num At Risk
264
num Events
15
group Id
EG001
num Affected
12
num At Risk
263
num Events
14
term
Respiratory Tract Infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDra 28.0
stats
group Id
EG000
num Affected
76
num At Risk
264
num Events
145
group Id
EG001
num Affected
74
num At Risk
263
num Events
165
term
Upper Respiratory Tract Infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDra 28.0
stats
group Id
EG000
num Affected
20
num At Risk
264
num Events
25
group Id
EG001
num Affected
15
num At Risk
263
num Events
16
term
Urinary Tract Infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDra 28.0
stats
group Id
EG000
num Affected
8
num At Risk
264
num Events
8
group Id
EG001
num Affected
14
num At Risk
263
num Events
16
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDra 28.0
stats
group Id
EG000
num Affected
88
num At Risk
264
num Events
204
group Id
EG001
num Affected
93
num At Risk
263
num Events
218
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDra 28.0
stats
group Id
EG000
num Affected
18
num At Risk
264
num Events
25
group Id
EG001
num Affected
17
num At Risk
263
num Events
19
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Immune system disorders
source Vocabulary
MedDra 28.0
stats
group Id
EG000
num Affected
8
num At Risk
264
num Events
9
group Id
EG001
num Affected
15
num At Risk
263
num Events
19
term
Hypogammaglobulinaemia

Complete source fields

description

Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.

event Groups

deaths Num Affected
73
deaths Num At Risk
268
description
Participants received isatuximab 10 mg/kg IV infusion QW (i.e. on Days 1, 8, 15 and 22) in Cycle 1 (28 days) and then 10 mg/kg Q2W (i.e. on Days 1 and 15) of each subsequent 28-day cycle along with pomalidomide 4 mg orally on Days 1 to 21 of each 28-day cycle and dexamethasone 40 mg (or 20 mg for participant \>=75 years) orally on Days 1, 8, 15, and 22 of each cycle until disease progression, unacceptable AEs, participant request to discontinue treatment, or any other reason, whichever came first.
id
EG000
other Num Affected
248
other Num At Risk
264
serious Num Affected
152
serious Num At Risk
264
title
Isa-IV + Pd
deaths Num Affected
77
deaths Num At Risk
263
description
Participants received isatuximab 1400 mg SC injection administered via an OBDS which is an investigational device injector QW (i.e on Days 1, 8, 15 and 22) in Cycle 1 (28 days) and then 1400 mg Q2W (i.e. on Days 1 and 15) of each subsequent 28-day cycle along with pomalidomide 4 mg orally on Days 1 to 21 of each 28-day cycle and dexamethasone 40 mg (or 20 mg for participant \>=75 years) orally on Days 1, 8, 15, and 22 of each cycle until disease progression, unacceptable AEs, participant request to discontinue treatment, or any other reason, whichever came first.
id
EG001
other Num Affected
242
other Num At Risk
263
serious Num Affected
160
serious Num At Risk
263
title
Isa-SC + Pd

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDra 28.0
stats
group Id
EG000
num Affected
21
num At Risk
264
num Events
37
group Id
EG001
num Affected
26
num At Risk
263
num Events
34
term
Bronchitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDra 28.0
stats
group Id
EG000
num Affected
36
num At Risk
264
num Events
38
group Id
EG001
num Affected
32
num At Risk
263
num Events
34
term
Covid-19
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDra 28.0
stats
group Id
EG000
num Affected
11
num At Risk
264
num Events
12
group Id
EG001
num Affected
23
num At Risk
263
num Events
23
term
Influenza
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDra 28.0
stats
group Id
EG000
num Affected
25
num At Risk
264
num Events
36
group Id
EG001
num Affected
21
num At Risk
263
num Events
28
term
Nasopharyngitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDra 28.0
stats
group Id
EG000
num Affected
35
num At Risk
264
num Events
43
group Id
EG001
num Affected
19
num At Risk
263
num Events
21
term
Pneumonia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDra 28.0
stats
group Id
EG000
num Affected
14
num At Risk
264
num Events
15
group Id
EG001
num Affected
12
num At Risk
263
num Events
14
term
Respiratory Tract Infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDra 28.0
stats
group Id
EG000
num Affected
76
num At Risk
264
num Events
145
group Id
EG001
num Affected
74
num At Risk
263
num Events
165
term
Upper Respiratory Tract Infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDra 28.0
stats
group Id
EG000
num Affected
20
num At Risk
264
num Events
25
group Id
EG001
num Affected
15
num At Risk
263
num Events
16
term
Urinary Tract Infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDra 28.0
stats
group Id
EG000
num Affected
8
num At Risk
264
num Events
8
group Id
EG001
num Affected
14
num At Risk
263
num Events
16
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDra 28.0
stats
group Id
EG000
num Affected
88
num At Risk
264
num Events
204
group Id
EG001
num Affected
93
num At Risk
263
num Events
218
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDra 28.0
stats
group Id
EG000
num Affected
18
num At Risk
264
num Events
25
group Id
EG001
num Affected
17
num At Risk
263
num Events
19
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Immune system disorders
source Vocabulary
MedDra 28.0
stats
group Id
EG000
num Affected
8
num At Risk
264
num Events
9
group Id
EG001
num Affected
15
num At Risk
263
num Events
19
term
Hypogammaglobulinaemia

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDra 28.0
stats
group Id
EG000
num Affected
2
num At Risk
264
num Events
2
group Id
EG001
num Affected
0
num At Risk
263
num Events
0
term
Bacteraemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDra 28.0
stats
group Id
EG000
num Affected
0
num At Risk
264
num Events
0
group Id
EG001
num Affected
1
num At Risk
263
num Events
1
term
Bronchiolitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDra 28.0
stats
group Id
EG000
num Affected
1
num At Risk
264
num Events
1
group Id
EG001
num Affected
2
num At Risk
263
num Events
2
term
Bronchitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDra 28.0
stats
group Id
EG000
num Affected
0
num At Risk
264
num Events
0
group Id
EG001
num Affected
1
num At Risk
263
num Events
1
term
Bronchopulmonary Aspergillosis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDra 28.0
stats
group Id
EG000
num Affected
1
num At Risk
264
num Events
1
group Id
EG001
num Affected
0
num At Risk
263
num Events
0
term
Bullous Erysipelas
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDra 28.0
stats
group Id
EG000
num Affected
7
num At Risk
264
num Events
7
group Id
EG001
num Affected
11
num At Risk
263
num Events
11
term
Covid-19
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDra 28.0
stats
group Id
EG000
num Affected
6
num At Risk
264
num Events
6
group Id
EG001
num Affected
7
num At Risk
263
num Events
7
term
Covid-19 Pneumonia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDra 28.0
stats
group Id
EG000
num Affected
0
num At Risk
264
num Events
0
group Id
EG001
num Affected
1
num At Risk
263
num Events
1
term
Campylobacter Bacteraemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDra 28.0
stats
group Id
EG000
num Affected
0
num At Risk
264
num Events
0
group Id
EG001
num Affected
1
num At Risk
263
num Events
1
term
Campylobacter Gastroenteritis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDra 28.0
stats
group Id
EG000
num Affected
2
num At Risk
264
num Events
2
group Id
EG001
num Affected
1
num At Risk
263
num Events
1
term
Cellulitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDra 28.0
stats
group Id
EG000
num Affected
0
num At Risk
264
num Events
0
group Id
EG001
num Affected
2
num At Risk
263
num Events
2
term
Clostridium Difficile Colitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDra 28.0
stats
group Id
EG000
num Affected
0
num At Risk
264
num Events
0
group Id
EG001
num Affected
1
num At Risk
263
num Events
1
term
Coronavirus Pneumonia

time Frame

Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 38 months. Partial results are presented up to DCO date of 29-Aug-2025.

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