NCT05288062 · ADVERSE EVENTS

Adverse events

Immunomodulatory Drugs (Lenalidomide With or Without Pomalidomide) in Combination With a Corticosteroid Drug (Dexamethasone) for the Treatment of Multiple Myeloma · Source last updated 2025-08-20

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: 1 year
Other-event reporting threshold: 0%

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Cohort B (Lenalidomide, Dexamethasone) Patients with newly diagnosed multiple myeloma receive treatment as in Cohort A. Bone Marrow Biopsy: Undergo bone marrow aspirate/biopsy Dexamethasone: Given orally Lenalidomide: Given orally	0 / 5	3 / 5	0 / 5
Cohort C (Lenalidomide, Dexamethasone, Pomalidomide) Patients with relapsed or refractory multiple myeloma receive lenalidomide PO QD on days 1-14 in combination with dexamethasone PO QD on days 1, 8 and 15 OR pomalidomide PO QD on days 1-21 in combination with dexamethasone PO QD on days 1, 8 and 15. Treatment for cycle 1 continues for 21 days in the absence of disease progression or unacceptable toxicity. Patients then receive lenalidomide PO QD on days 1-21 in combination with dexamethasone PO QD on days 1, 8, 15, and 22 OR pomalidomide PO QD on days 1-21 in combination with dexamethasone PO QD on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 5 cycles in the absence of disease progression or unacceptable toxicity. Bone Marrow Biopsy: Undergo bone marrow aspirate/biopsy Dexamethasone: Given orally Lenalidomide: Given orally Pomalidomide: Given orally	2 / 11	10 / 11	0 / 11

Group identifiers: EG000: Cohort B (Lenalidomide, Dexamethasone) · EG001: Cohort C (Lenalidomide, Dexamethasone, Pomalidomide)

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 12.1
stats
group Id
EG000
num Affected
0
num At Risk
5
num Events
0
group Id
EG001
num Affected
1
num At Risk
11
num Events
1
term
Anemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 12.1
stats
group Id
EG000
num Affected
0
num At Risk
5
num Events
0
group Id
EG001
num Affected
1
num At Risk
11
num Events
1
term
Non-cardiac chest pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
MedDRA 12.1
stats
group Id
EG000
num Affected
0
num At Risk
5
num Events
0
group Id
EG001
num Affected
1
num At Risk
11
num Events
1
term
Pulmonary edema
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Vascular disorders
source Vocabulary
MedDRA 12.1
stats
group Id
EG000
num Affected
0
num At Risk
5
num Events
0
group Id
EG001
num Affected
1
num At Risk
11
num Events
1
term
Thromboembolic event

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 12.1
stats
group Id
EG000
num Affected
2
num At Risk
5
num Events
2
group Id
EG001
num Affected
2
num At Risk
11
num Events
2
term
Anemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 12.1
stats
group Id
EG000
num Affected
1
num At Risk
5
num Events
1
group Id
EG001
num Affected
0
num At Risk
11
num Events
0
term
Sinus tachycardia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA 12.1
stats
group Id
EG000
num Affected
1
num At Risk
5
num Events
1
group Id
EG001
num Affected
0
num At Risk
11
num Events
0
term
Eye pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 12.1
stats
group Id
EG000
num Affected
0
num At Risk
5
num Events
0
group Id
EG001
num Affected
1
num At Risk
11
num Events
1
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 12.1
stats
group Id
EG000
num Affected
2
num At Risk
5
num Events
2
group Id
EG001
num Affected
1
num At Risk
11
num Events
1
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 12.1
stats
group Id
EG000
num Affected
0
num At Risk
5
num Events
0
group Id
EG001
num Affected
2
num At Risk
11
num Events
3
term
Diarrhea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 12.1
stats
group Id
EG000
num Affected
1
num At Risk
5
num Events
1
group Id
EG001
num Affected
0
num At Risk
11
num Events
0
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 12.1
stats
group Id
EG000
num Affected
3
num At Risk
5
num Events
3
group Id
EG001
num Affected
4
num At Risk
11
num Events
4
term
Fatigue
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 12.1
stats
group Id
EG000
num Affected
0
num At Risk
5
num Events
0
group Id
EG001
num Affected
1
num At Risk
11
num Events
1
term
Gait disturbance
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Immune system disorders
source Vocabulary
MedDRA 12.1
stats
group Id
EG000
num Affected
1
num At Risk
5
num Events
1
group Id
EG001
num Affected
1
num At Risk
11
num Events
2
term
Allergic reaction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 12.1
stats
group Id
EG000
num Affected
1
num At Risk
5
num Events
1
group Id
EG001
num Affected
0
num At Risk
11
num Events
0
term
Upper respiratory infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 12.1
stats
group Id
EG000
num Affected
0
num At Risk
5
num Events
0
group Id
EG001
num Affected
1
num At Risk
11
num Events
1
term
Urinary tract infection

Complete source fields

event Groups

deaths Num Affected
0
deaths Num At Risk
5
description
Patients with newly diagnosed multiple myeloma receive treatment as in Cohort A. Bone Marrow Biopsy: Undergo bone marrow aspirate/biopsy Dexamethasone: Given orally Lenalidomide: Given orally
id
EG000
other Num Affected
3
other Num At Risk
5
serious Num Affected
0
serious Num At Risk
5
title
Cohort B (Lenalidomide, Dexamethasone)
deaths Num Affected
0
deaths Num At Risk
11
description
Patients with relapsed or refractory multiple myeloma receive lenalidomide PO QD on days 1-14 in combination with dexamethasone PO QD on days 1, 8 and 15 OR pomalidomide PO QD on days 1-21 in combination with dexamethasone PO QD on days 1, 8 and 15. Treatment for cycle 1 continues for 21 days in the absence of disease progression or unacceptable toxicity. Patients then receive lenalidomide PO QD on days 1-21 in combination with dexamethasone PO QD on days 1, 8, 15, and 22 OR pomalidomide PO QD on days 1-21 in combination with dexamethasone PO QD on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 5 cycles in the absence of disease progression or unacceptable toxicity. Bone Marrow Biopsy: Undergo bone marrow aspirate/biopsy Dexamethasone: Given orally Lenalidomide: Given orally Pomalidomide: Given orally
id
EG001
other Num Affected
10
other Num At Risk
11
serious Num Affected
2
serious Num At Risk
11
title
Cohort C (Lenalidomide, Dexamethasone, Pomalidomide)

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 12.1
stats
group Id
EG000
num Affected
2
num At Risk
5
num Events
2
group Id
EG001
num Affected
2
num At Risk
11
num Events
2
term
Anemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 12.1
stats
group Id
EG000
num Affected
1
num At Risk
5
num Events
1
group Id
EG001
num Affected
0
num At Risk
11
num Events
0
term
Sinus tachycardia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA 12.1
stats
group Id
EG000
num Affected
1
num At Risk
5
num Events
1
group Id
EG001
num Affected
0
num At Risk
11
num Events
0
term
Eye pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 12.1
stats
group Id
EG000
num Affected
0
num At Risk
5
num Events
0
group Id
EG001
num Affected
1
num At Risk
11
num Events
1
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 12.1
stats
group Id
EG000
num Affected
2
num At Risk
5
num Events
2
group Id
EG001
num Affected
1
num At Risk
11
num Events
1
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 12.1
stats
group Id
EG000
num Affected
0
num At Risk
5
num Events
0
group Id
EG001
num Affected
2
num At Risk
11
num Events
3
term
Diarrhea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 12.1
stats
group Id
EG000
num Affected
1
num At Risk
5
num Events
1
group Id
EG001
num Affected
0
num At Risk
11
num Events
0
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 12.1
stats
group Id
EG000
num Affected
3
num At Risk
5
num Events
3
group Id
EG001
num Affected
4
num At Risk
11
num Events
4
term
Fatigue
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 12.1
stats
group Id
EG000
num Affected
0
num At Risk
5
num Events
0
group Id
EG001
num Affected
1
num At Risk
11
num Events
1
term
Gait disturbance
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Immune system disorders
source Vocabulary
MedDRA 12.1
stats
group Id
EG000
num Affected
1
num At Risk
5
num Events
1
group Id
EG001
num Affected
1
num At Risk
11
num Events
2
term
Allergic reaction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 12.1
stats
group Id
EG000
num Affected
1
num At Risk
5
num Events
1
group Id
EG001
num Affected
0
num At Risk
11
num Events
0
term
Upper respiratory infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 12.1
stats
group Id
EG000
num Affected
0
num At Risk
5
num Events
0
group Id
EG001
num Affected
1
num At Risk
11
num Events
1
term
Urinary tract infection

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 12.1
stats
group Id
EG000
num Affected
0
num At Risk
5
num Events
0
group Id
EG001
num Affected
1
num At Risk
11
num Events
1
term
Anemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 12.1
stats
group Id
EG000
num Affected
0
num At Risk
5
num Events
0
group Id
EG001
num Affected
1
num At Risk
11
num Events
1
term
Non-cardiac chest pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
MedDRA 12.1
stats
group Id
EG000
num Affected
0
num At Risk
5
num Events
0
group Id
EG001
num Affected
1
num At Risk
11
num Events
1
term
Pulmonary edema
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Vascular disorders
source Vocabulary
MedDRA 12.1
stats
group Id
EG000
num Affected
0
num At Risk
5
num Events
0
group Id
EG001
num Affected
1
num At Risk
11
num Events
1
term
Thromboembolic event

time Frame

1 year

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Preserved source evidence · Not medical advice