NCT06055075 · ADVERSE EVENTS

Adverse events

A Study Evaluating Safety, Tolerability, and Clinical Activity of Forimtamig-Based Treatment Combinations in Participants With Relapsed or Refractory Multiple Myeloma · Source last updated 2026-09-29

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: From initiation of study treatment up to approximately 15.7 months
Other-event reporting threshold: 5%

Safety population included all participants enrolled in the study who received any amount of any study treatment.

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Cohort 1: Arm B1: Forimtamig 0.3 mg + Carfilzomib Participants received step-up doses of forimtamig 0.03 mg on Cycle 1 Day 1, 0.15 mg on Cycle 1 Day 8, and the target dose of 0.3 mg on Cycle 1 Day 15 and on Days 1 and 15 of each subsequent cycle, administered as a SC injection. Participants also received carfilzomib, 20 mg/m\^2 on Cycle 2 Day 1 and 56 mg/m\^2 on Cycle 2 Days 8 and 15, and from Cycle 3 onwards on Days 1, 8, and 15, administered as an IV infusion (1 cycle = 28 days).	5 / 7	7 / 7	0 / 7
Cohort 1: Arm B2: Forimtamig 0.75 mg + Carfilzomib Participants received step-up doses of forimtamig, 0.03 mg on Cycle 1 Day 1, 0.15 mg on Cycle 1 Day 8, and the target dose of 0.75 mg on Cycle 1 Day 15 and on Days 1 and 15 of each subsequent cycle, administered as a SC injection. Participants also received carfilzomib 20 mg/m\^2 on Cycle 2 Day 1 and 56 mg/m\^2 on Cycle 2 Days 8 and 15, and from Cycle 3 onwards on Days 1, 8, and 15, administered as an IV infusion (1 cycle = 28 days).	3 / 6	6 / 6	1 / 6
Cohort 1: Arm B3: Forimtamig 1.5 mg + Carfilzomib Participants received step-up doses of forimtamig, 0.03 mg on Cycle 1 Day 1, 0.15 mg on Cycle 1 Day 8, and the target dose of 1.5 mg on Cycle 1 Day 15 and on Days 1 and 15 of each subsequent cycle, administered as a SC injection. Participants also received carfilzomib, 20 mg/m\^2 on Cycle 2 Day 1 and 56 mg/m\^2 on Cycle 2 Days 8 and 15, and from Cycle 3 onwards on Days 1, 8, and 15, administered as an IV infusion (1 cycle = 28 days).	4 / 6	6 / 6	1 / 6

Group identifiers: EG000: Cohort 1: Arm B1: Forimtamig 0.3 mg + Carfilzomib · EG001: Cohort 1: Arm B2: Forimtamig 0.75 mg + Carfilzomib · EG002: Cohort 1: Arm B3: Forimtamig 1.5 mg + Carfilzomib

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
General disorders
source Vocabulary
MedDRA version: 28.0
stats
group Id
EG000
num Affected
2
num At Risk
7
num Events
2
group Id
EG001
num Affected
1
num At Risk
6
num Events
1
group Id
EG002
num Affected
2
num At Risk
6
num Events
3
term
Pyrexia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Immune system disorders
source Vocabulary
MedDRA version: 28.0
stats
group Id
EG000
num Affected
1
num At Risk
7
num Events
1
group Id
EG001
num Affected
0
num At Risk
6
num Events
0
group Id
EG002
num Affected
0
num At Risk
6
num Events
0
term
Anaphylactic reaction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Immune system disorders
source Vocabulary
MedDRA version: 28.0
stats
group Id
EG000
num Affected
1
num At Risk
7
num Events
2
group Id
EG001
num Affected
2
num At Risk
6
num Events
4
group Id
EG002
num Affected
3
num At Risk
6
num Events
4
term
Cytokine release syndrome
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA version: 28.0
stats
group Id
EG000
num Affected
0
num At Risk
7
num Events
0
group Id
EG001
num Affected
0
num At Risk
6
num Events
0
group Id
EG002
num Affected
1
num At Risk
6
num Events
1
term
Pneumonia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA version: 28.0
stats
group Id
EG000
num Affected
1
num At Risk
7
num Events
1
group Id
EG001
num Affected
0
num At Risk
6
num Events
0
group Id
EG002
num Affected
1
num At Risk
6
num Events
1
term
Sepsis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
MedDRA version: 28.0
stats
group Id
EG000
num Affected
0
num At Risk
7
num Events
0
group Id
EG001
num Affected
1
num At Risk
6
num Events
1
group Id
EG002
num Affected
0
num At Risk
6
num Events
0
term
Bone pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
source Vocabulary
MedDRA version: 28.0
stats
group Id
EG000
num Affected
1
num At Risk
7
num Events
1
group Id
EG001
num Affected
0
num At Risk
6
num Events
0
group Id
EG002
num Affected
0
num At Risk
6
num Events
0
term
Squamous cell carcinoma
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
MedDRA version: 28.0
stats
group Id
EG000
num Affected
0
num At Risk
7
num Events
0
group Id
EG001
num Affected
1
num At Risk
6
num Events
1
group Id
EG002
num Affected
0
num At Risk
6
num Events
0
term
Cauda equina syndrome
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
MedDRA version: 28.0
stats
group Id
EG000
num Affected
0
num At Risk
7
num Events
0
group Id
EG001
num Affected
0
num At Risk
6
num Events
0
group Id
EG002
num Affected
1
num At Risk
6
num Events
1
term
Pleural effusion
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Vascular disorders
source Vocabulary
MedDRA version: 28.0
stats
group Id
EG000
num Affected
0
num At Risk
7
num Events
0
group Id
EG001
num Affected
1
num At Risk
6
num Events
1
group Id
EG002
num Affected
0
num At Risk
6
num Events
0
term
Deep vein thrombosis

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 version: 28.0
stats
group Id
EG000
num Affected
1
num At Risk
7
num Events
1
group Id
EG001
num Affected
4
num At Risk
6
num Events
6
group Id
EG002
num Affected
4
num At Risk
6
num Events
5
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA version: 28.0
stats
group Id
EG000
num Affected
1
num At Risk
7
num Events
1
group Id
EG001
num Affected
0
num At Risk
6
num Events
0
group Id
EG002
num Affected
0
num At Risk
6
num Events
0
term
Increased tendency to bruise
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA version: 28.0
stats
group Id
EG000
num Affected
0
num At Risk
7
num Events
0
group Id
EG001
num Affected
2
num At Risk
6
num Events
5
group Id
EG002
num Affected
1
num At Risk
6
num Events
2
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA version: 28.0
stats
group Id
EG000
num Affected
0
num At Risk
7
num Events
0
group Id
EG001
num Affected
1
num At Risk
6
num Events
1
group Id
EG002
num Affected
1
num At Risk
6
num Events
1
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Ear and labyrinth disorders
source Vocabulary
MedDRA version: 28.0
stats
group Id
EG000
num Affected
0
num At Risk
7
num Events
0
group Id
EG001
num Affected
0
num At Risk
6
num Events
0
group Id
EG002
num Affected
1
num At Risk
6
num Events
1
term
Ear pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA version: 28.0
stats
group Id
EG000
num Affected
1
num At Risk
7
num Events
1
group Id
EG001
num Affected
0
num At Risk
6
num Events
0
group Id
EG002
num Affected
0
num At Risk
6
num Events
0
term
Cataract
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA version: 28.0
stats
group Id
EG000
num Affected
0
num At Risk
7
num Events
0
group Id
EG001
num Affected
0
num At Risk
6
num Events
0
group Id
EG002
num Affected
1
num At Risk
6
num Events
1
term
Chalazion
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA version: 28.0
stats
group Id
EG000
num Affected
1
num At Risk
7
num Events
1
group Id
EG001
num Affected
0
num At Risk
6
num Events
0
group Id
EG002
num Affected
0
num At Risk
6
num Events
0
term
Dry eye
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA version: 28.0
stats
group Id
EG000
num Affected
1
num At Risk
7
num Events
1
group Id
EG001
num Affected
0
num At Risk
6
num Events
0
group Id
EG002
num Affected
0
num At Risk
6
num Events
0
term
Eyelid skin dryness
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA version: 28.0
stats
group Id
EG000
num Affected
0
num At Risk
7
num Events
0
group Id
EG001
num Affected
0
num At Risk
6
num Events
0
group Id
EG002
num Affected
1
num At Risk
6
num Events
1
term
Punctate keratitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA version: 28.0
stats
group Id
EG000
num Affected
0
num At Risk
7
num Events
0
group Id
EG001
num Affected
0
num At Risk
6
num Events
0
group Id
EG002
num Affected
1
num At Risk
6
num Events
1
term
Xerophthalmia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA version: 28.0
stats
group Id
EG000
num Affected
0
num At Risk
7
num Events
0
group Id
EG001
num Affected
1
num At Risk
6
num Events
1
group Id
EG002
num Affected
0
num At Risk
6
num Events
0
term
Abdominal distension

Complete source fields

description

Safety population included all participants enrolled in the study who received any amount of any study treatment.

event Groups

deaths Num Affected
0
deaths Num At Risk
7
description
Participants received step-up doses of forimtamig 0.03 mg on Cycle 1 Day 1, 0.15 mg on Cycle 1 Day 8, and the target dose of 0.3 mg on Cycle 1 Day 15 and on Days 1 and 15 of each subsequent cycle, administered as a SC injection. Participants also received carfilzomib, 20 mg/m\^2 on Cycle 2 Day 1 and 56 mg/m\^2 on Cycle 2 Days 8 and 15, and from Cycle 3 onwards on Days 1, 8, and 15, administered as an IV infusion (1 cycle = 28 days).
id
EG000
other Num Affected
7
other Num At Risk
7
serious Num Affected
5
serious Num At Risk
7
title
Cohort 1: Arm B1: Forimtamig 0.3 mg + Carfilzomib
deaths Num Affected
1
deaths Num At Risk
6
description
Participants received step-up doses of forimtamig, 0.03 mg on Cycle 1 Day 1, 0.15 mg on Cycle 1 Day 8, and the target dose of 0.75 mg on Cycle 1 Day 15 and on Days 1 and 15 of each subsequent cycle, administered as a SC injection. Participants also received carfilzomib 20 mg/m\^2 on Cycle 2 Day 1 and 56 mg/m\^2 on Cycle 2 Days 8 and 15, and from Cycle 3 onwards on Days 1, 8, and 15, administered as an IV infusion (1 cycle = 28 days).
id
EG001
other Num Affected
6
other Num At Risk
6
serious Num Affected
3
serious Num At Risk
6
title
Cohort 1: Arm B2: Forimtamig 0.75 mg + Carfilzomib
deaths Num Affected
1
deaths Num At Risk
6
description
Participants received step-up doses of forimtamig, 0.03 mg on Cycle 1 Day 1, 0.15 mg on Cycle 1 Day 8, and the target dose of 1.5 mg on Cycle 1 Day 15 and on Days 1 and 15 of each subsequent cycle, administered as a SC injection. Participants also received carfilzomib, 20 mg/m\^2 on Cycle 2 Day 1 and 56 mg/m\^2 on Cycle 2 Days 8 and 15, and from Cycle 3 onwards on Days 1, 8, and 15, administered as an IV infusion (1 cycle = 28 days).
id
EG002
other Num Affected
6
other Num At Risk
6
serious Num Affected
4
serious Num At Risk
6
title
Cohort 1: Arm B3: Forimtamig 1.5 mg + Carfilzomib

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA version: 28.0
stats
group Id
EG000
num Affected
1
num At Risk
7
num Events
1
group Id
EG001
num Affected
4
num At Risk
6
num Events
6
group Id
EG002
num Affected
4
num At Risk
6
num Events
5
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA version: 28.0
stats
group Id
EG000
num Affected
1
num At Risk
7
num Events
1
group Id
EG001
num Affected
0
num At Risk
6
num Events
0
group Id
EG002
num Affected
0
num At Risk
6
num Events
0
term
Increased tendency to bruise
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA version: 28.0
stats
group Id
EG000
num Affected
0
num At Risk
7
num Events
0
group Id
EG001
num Affected
2
num At Risk
6
num Events
5
group Id
EG002
num Affected
1
num At Risk
6
num Events
2
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA version: 28.0
stats
group Id
EG000
num Affected
0
num At Risk
7
num Events
0
group Id
EG001
num Affected
1
num At Risk
6
num Events
1
group Id
EG002
num Affected
1
num At Risk
6
num Events
1
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Ear and labyrinth disorders
source Vocabulary
MedDRA version: 28.0
stats
group Id
EG000
num Affected
0
num At Risk
7
num Events
0
group Id
EG001
num Affected
0
num At Risk
6
num Events
0
group Id
EG002
num Affected
1
num At Risk
6
num Events
1
term
Ear pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA version: 28.0
stats
group Id
EG000
num Affected
1
num At Risk
7
num Events
1
group Id
EG001
num Affected
0
num At Risk
6
num Events
0
group Id
EG002
num Affected
0
num At Risk
6
num Events
0
term
Cataract
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA version: 28.0
stats
group Id
EG000
num Affected
0
num At Risk
7
num Events
0
group Id
EG001
num Affected
0
num At Risk
6
num Events
0
group Id
EG002
num Affected
1
num At Risk
6
num Events
1
term
Chalazion
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA version: 28.0
stats
group Id
EG000
num Affected
1
num At Risk
7
num Events
1
group Id
EG001
num Affected
0
num At Risk
6
num Events
0
group Id
EG002
num Affected
0
num At Risk
6
num Events
0
term
Dry eye
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA version: 28.0
stats
group Id
EG000
num Affected
1
num At Risk
7
num Events
1
group Id
EG001
num Affected
0
num At Risk
6
num Events
0
group Id
EG002
num Affected
0
num At Risk
6
num Events
0
term
Eyelid skin dryness
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA version: 28.0
stats
group Id
EG000
num Affected
0
num At Risk
7
num Events
0
group Id
EG001
num Affected
0
num At Risk
6
num Events
0
group Id
EG002
num Affected
1
num At Risk
6
num Events
1
term
Punctate keratitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA version: 28.0
stats
group Id
EG000
num Affected
0
num At Risk
7
num Events
0
group Id
EG001
num Affected
0
num At Risk
6
num Events
0
group Id
EG002
num Affected
1
num At Risk
6
num Events
1
term
Xerophthalmia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA version: 28.0
stats
group Id
EG000
num Affected
0
num At Risk
7
num Events
0
group Id
EG001
num Affected
1
num At Risk
6
num Events
1
group Id
EG002
num Affected
0
num At Risk
6
num Events
0
term
Abdominal distension

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA version: 28.0
stats
group Id
EG000
num Affected
2
num At Risk
7
num Events
2
group Id
EG001
num Affected
1
num At Risk
6
num Events
1
group Id
EG002
num Affected
2
num At Risk
6
num Events
3
term
Pyrexia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Immune system disorders
source Vocabulary
MedDRA version: 28.0
stats
group Id
EG000
num Affected
1
num At Risk
7
num Events
1
group Id
EG001
num Affected
0
num At Risk
6
num Events
0
group Id
EG002
num Affected
0
num At Risk
6
num Events
0
term
Anaphylactic reaction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Immune system disorders
source Vocabulary
MedDRA version: 28.0
stats
group Id
EG000
num Affected
1
num At Risk
7
num Events
2
group Id
EG001
num Affected
2
num At Risk
6
num Events
4
group Id
EG002
num Affected
3
num At Risk
6
num Events
4
term
Cytokine release syndrome
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA version: 28.0
stats
group Id
EG000
num Affected
0
num At Risk
7
num Events
0
group Id
EG001
num Affected
0
num At Risk
6
num Events
0
group Id
EG002
num Affected
1
num At Risk
6
num Events
1
term
Pneumonia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA version: 28.0
stats
group Id
EG000
num Affected
1
num At Risk
7
num Events
1
group Id
EG001
num Affected
0
num At Risk
6
num Events
0
group Id
EG002
num Affected
1
num At Risk
6
num Events
1
term
Sepsis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
MedDRA version: 28.0
stats
group Id
EG000
num Affected
0
num At Risk
7
num Events
0
group Id
EG001
num Affected
1
num At Risk
6
num Events
1
group Id
EG002
num Affected
0
num At Risk
6
num Events
0
term
Bone pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
source Vocabulary
MedDRA version: 28.0
stats
group Id
EG000
num Affected
1
num At Risk
7
num Events
1
group Id
EG001
num Affected
0
num At Risk
6
num Events
0
group Id
EG002
num Affected
0
num At Risk
6
num Events
0
term
Squamous cell carcinoma
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
MedDRA version: 28.0
stats
group Id
EG000
num Affected
0
num At Risk
7
num Events
0
group Id
EG001
num Affected
1
num At Risk
6
num Events
1
group Id
EG002
num Affected
0
num At Risk
6
num Events
0
term
Cauda equina syndrome
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
MedDRA version: 28.0
stats
group Id
EG000
num Affected
0
num At Risk
7
num Events
0
group Id
EG001
num Affected
0
num At Risk
6
num Events
0
group Id
EG002
num Affected
1
num At Risk
6
num Events
1
term
Pleural effusion
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Vascular disorders
source Vocabulary
MedDRA version: 28.0
stats
group Id
EG000
num Affected
0
num At Risk
7
num Events
0
group Id
EG001
num Affected
1
num At Risk
6
num Events
1
group Id
EG002
num Affected
0
num At Risk
6
num Events
0
term
Deep vein thrombosis

time Frame

From initiation of study treatment up to approximately 15.7 months

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Preserved source evidence · Not medical advice