NCT03151811 · ADVERSE EVENTS

Adverse events

A Study of Melphalan Flufenamide (Melflufen)-Dex or Pomalidomide-dex for RRMM Patients Refractory to Lenalidomide · Source last updated 2024-01-30

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: Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
Other-event reporting threshold: 5%

All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Arm A: Melflufen+Dexamethasone Melflufen 40 mg i.v. on Day 1 and dexamethasone 40 mg (20 mg for patients ≥ 75 years of age) on Days 1, 8, 15 and 22 of each 28-day cycle. Patients were to be treated until confirmed progression, unacceptable toxicity, or the patient or investigator decided it was not in the patient's best interest to continue. Melflufen: Intravenous infusion Dexamethasone: Oral tablets	99 / 228	227 / 228	180 / 246
Arm B: Pomalidomide+Dexamethasone Pomalidomide 4 mg orally daily on Days 1 to 21 and dexamethasone 40 mg (20 mg for patients ≥ 75 years of age) on Days 1, 8, 15 and 22 of each 28-day cycle. Patients were to be treated until confirmed progression, unacceptable toxicity, or the patient or investigator decided it was not in the patient's best interest to continue. Pomalidomide: Oral capsules Dexamethasone: Oral tablets	124 / 246	243 / 246	169 / 249

Group identifiers: EG000: Arm A: Melflufen+Dexamethasone · EG001: Arm B: 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
Infections and infestations
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
14
num At Risk
228
num Events
17
group Id
EG001
num Affected
23
num At Risk
246
num Events
26
term
Pneumonia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
12
num At Risk
228
num Events
13
group Id
EG001
num Affected
14
num At Risk
246
num Events
14
term
COVID-19 pneumonia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
2
num At Risk
228
num Events
2
group Id
EG001
num Affected
6
num At Risk
246
num Events
11
term
Urinary tract infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
1
num At Risk
228
num Events
1
group Id
EG001
num Affected
6
num At Risk
246
num Events
6
term
Sepsis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
3
num At Risk
228
num Events
4
group Id
EG001
num Affected
4
num At Risk
246
num Events
5
term
Bronchitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
0
num At Risk
228
num Events
0
group Id
EG001
num Affected
5
num At Risk
246
num Events
5
term
Influenzae
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
3
num At Risk
228
num Events
3
group Id
EG001
num Affected
1
num At Risk
246
num Events
1
term
Upper respiratory tract infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
1
num At Risk
228
num Events
3
group Id
EG001
num Affected
3
num At Risk
246
num Events
3
term
Viral Infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
0
num At Risk
228
num Events
0
group Id
EG001
num Affected
3
num At Risk
246
num Events
4
term
Lower respiratory tract infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
1
num At Risk
228
num Events
1
group Id
EG001
num Affected
2
num At Risk
246
num Events
2
term
Respiratory tract infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
0
num At Risk
228
num Events
0
group Id
EG001
num Affected
3
num At Risk
246
num Events
3
term
Septic shock
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
1
num At Risk
228
num Events
1
group Id
EG001
num Affected
1
num At Risk
246
num Events
1
term
Escherichia sepsis

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 23.0
stats
group Id
EG000
num Affected
137
num At Risk
228
num Events
795
group Id
EG001
num Affected
115
num At Risk
246
num Events
421
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
154
num At Risk
228
num Events
487
group Id
EG001
num Affected
97
num At Risk
246
num Events
238
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
161
num At Risk
228
num Events
918
group Id
EG001
num Affected
50
num At Risk
246
num Events
149
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
24
num At Risk
228
num Events
89
group Id
EG001
num Affected
11
num At Risk
246
num Events
18
term
Leukopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
32
num At Risk
228
num Events
46
group Id
EG001
num Affected
24
num At Risk
246
num Events
32
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
31
num At Risk
228
num Events
44
group Id
EG001
num Affected
18
num At Risk
246
num Events
20
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
17
num At Risk
228
num Events
19
group Id
EG001
num Affected
29
num At Risk
246
num Events
33
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
33
num At Risk
228
num Events
52
group Id
EG001
num Affected
44
num At Risk
246
num Events
57
term
Fatigue
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
33
num At Risk
228
num Events
50
group Id
EG001
num Affected
32
num At Risk
246
num Events
47
term
Asthenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
33
num At Risk
228
num Events
43
group Id
EG001
num Affected
18
num At Risk
246
num Events
25
term
Pyrexia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
12
num At Risk
228
num Events
17
group Id
EG001
num Affected
24
num At Risk
246
num Events
24
term
Oedema peripheral
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
29
num At Risk
228
num Events
33
group Id
EG001
num Affected
27
num At Risk
246
num Events
43
term
Upper respiratory tract infection

Complete source fields

description

event Groups

deaths Num Affected
180
deaths Num At Risk
246
description
Melflufen 40 mg i.v. on Day 1 and dexamethasone 40 mg (20 mg for patients ≥ 75 years of age) on Days 1, 8, 15 and 22 of each 28-day cycle. Patients were to be treated until confirmed progression, unacceptable toxicity, or the patient or investigator decided it was not in the patient's best interest to continue. Melflufen: Intravenous infusion Dexamethasone: Oral tablets
id
EG000
other Num Affected
227
other Num At Risk
228
serious Num Affected
99
serious Num At Risk
228
title
Arm A: Melflufen+Dexamethasone
deaths Num Affected
169
deaths Num At Risk
249
description
Pomalidomide 4 mg orally daily on Days 1 to 21 and dexamethasone 40 mg (20 mg for patients ≥ 75 years of age) on Days 1, 8, 15 and 22 of each 28-day cycle. Patients were to be treated until confirmed progression, unacceptable toxicity, or the patient or investigator decided it was not in the patient's best interest to continue. Pomalidomide: Oral capsules Dexamethasone: Oral tablets
id
EG001
other Num Affected
243
other Num At Risk
246
serious Num Affected
124
serious Num At Risk
246
title
Arm B: Pomalidomide+Dexamethasone

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
137
num At Risk
228
num Events
795
group Id
EG001
num Affected
115
num At Risk
246
num Events
421
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
154
num At Risk
228
num Events
487
group Id
EG001
num Affected
97
num At Risk
246
num Events
238
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
161
num At Risk
228
num Events
918
group Id
EG001
num Affected
50
num At Risk
246
num Events
149
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
24
num At Risk
228
num Events
89
group Id
EG001
num Affected
11
num At Risk
246
num Events
18
term
Leukopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
32
num At Risk
228
num Events
46
group Id
EG001
num Affected
24
num At Risk
246
num Events
32
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
31
num At Risk
228
num Events
44
group Id
EG001
num Affected
18
num At Risk
246
num Events
20
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
17
num At Risk
228
num Events
19
group Id
EG001
num Affected
29
num At Risk
246
num Events
33
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
33
num At Risk
228
num Events
52
group Id
EG001
num Affected
44
num At Risk
246
num Events
57
term
Fatigue
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
33
num At Risk
228
num Events
50
group Id
EG001
num Affected
32
num At Risk
246
num Events
47
term
Asthenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
33
num At Risk
228
num Events
43
group Id
EG001
num Affected
18
num At Risk
246
num Events
25
term
Pyrexia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
12
num At Risk
228
num Events
17
group Id
EG001
num Affected
24
num At Risk
246
num Events
24
term
Oedema peripheral
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
29
num At Risk
228
num Events
33
group Id
EG001
num Affected
27
num At Risk
246
num Events
43
term
Upper respiratory tract infection

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
14
num At Risk
228
num Events
17
group Id
EG001
num Affected
23
num At Risk
246
num Events
26
term
Pneumonia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
12
num At Risk
228
num Events
13
group Id
EG001
num Affected
14
num At Risk
246
num Events
14
term
COVID-19 pneumonia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
2
num At Risk
228
num Events
2
group Id
EG001
num Affected
6
num At Risk
246
num Events
11
term
Urinary tract infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
1
num At Risk
228
num Events
1
group Id
EG001
num Affected
6
num At Risk
246
num Events
6
term
Sepsis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
3
num At Risk
228
num Events
4
group Id
EG001
num Affected
4
num At Risk
246
num Events
5
term
Bronchitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
0
num At Risk
228
num Events
0
group Id
EG001
num Affected
5
num At Risk
246
num Events
5
term
Influenzae
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
3
num At Risk
228
num Events
3
group Id
EG001
num Affected
1
num At Risk
246
num Events
1
term
Upper respiratory tract infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
1
num At Risk
228
num Events
3
group Id
EG001
num Affected
3
num At Risk
246
num Events
3
term
Viral Infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
0
num At Risk
228
num Events
0
group Id
EG001
num Affected
3
num At Risk
246
num Events
4
term
Lower respiratory tract infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
1
num At Risk
228
num Events
1
group Id
EG001
num Affected
2
num At Risk
246
num Events
2
term
Respiratory tract infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
0
num At Risk
228
num Events
0
group Id
EG001
num Affected
3
num At Risk
246
num Events
3
term
Septic shock
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
1
num At Risk
228
num Events
1
group Id
EG001
num Affected
1
num At Risk
246
num Events
1
term
Escherichia sepsis

time Frame

Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.

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