NCT02906332 · ADVERSE EVENTS

Adverse events

Pembrolizumab + Lenalidomide Post Autologous Stem Cell Transplant (ASCT) in High-risk Multiple Myeloma (MM) · Source last updated 2023-08-22

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: Study Enrollment to Study Completion, up to 3 years
Other-event reporting threshold: 0%

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Pembrolizumab + Lenalidomide This is an open label study. * Pembrolizumab 200 mg IV every 3 weeks and lenalidomide 25 mg po daily x 14 days and dexamethasone 40 mg po once weekly for a 21-day cycle x 2 cycles. * This is followed by pembrolizumab 200 mg every 3 weeks and lenalidomide 25 mg po daily x 14 days for a 21-day cycle x 2 cycles for a total of 4 cycles. Pembrolizumab: Pembrolizumab 200 mg IV every 3 weeks x 2 cycles. This is followed by followed by pembrolizumab 200 mg IV every 3 weeks for 2 additional cycles. Lenalidomide: Lenalidomide 25 mg po daily x 14 days once weekly for a 21-day cycle x 2 cycles. This is followed by lenalidomide 25 mg po daily x 14 days for a 21-day cycle x 2 cycles for 2 additional cycles. Dexamethasone: Dexamethasone 40 mg po once weekly for a 21-day cycle x 2 cycles only.	1 / 12	12 / 12	0 / 12

Group identifiers: EG000: Pembrolizumab + Lenalidomide

Serious adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
stats
group Id
EG000
num Affected
1
num At Risk
12
num Events
1
term
H. Influenza 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
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
stats
group Id
EG000
num Affected
5
num At Risk
12
term
Neutropenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
2
num At Risk
12
term
Constipation
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
2
num At Risk
12
term
Diarrhea
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Psychiatric disorders
stats
group Id
EG000
num Affected
1
num At Risk
12
term
Fatigue
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
stats
group Id
EG000
num Affected
1
num At Risk
12
term
Increased ALT
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
stats
group Id
EG000
num Affected
1
num At Risk
12
term
Hypoxia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Skin and subcutaneous tissue disorders
stats
group Id
EG000
num Affected
1
num At Risk
12
term
Maculopapular Rash

Complete source fields

event Groups

deaths Num Affected
0
deaths Num At Risk
12
description
This is an open label study. * Pembrolizumab 200 mg IV every 3 weeks and lenalidomide 25 mg po daily x 14 days and dexamethasone 40 mg po once weekly for a 21-day cycle x 2 cycles. * This is followed by pembrolizumab 200 mg every 3 weeks and lenalidomide 25 mg po daily x 14 days for a 21-day cycle x 2 cycles for a total of 4 cycles. Pembrolizumab: Pembrolizumab 200 mg IV every 3 weeks x 2 cycles. This is followed by followed by pembrolizumab 200 mg IV every 3 weeks for 2 additional cycles. Lenalidomide: Lenalidomide 25 mg po daily x 14 days once weekly for a 21-day cycle x 2 cycles. This is followed by lenalidomide 25 mg po daily x 14 days for a 21-day cycle x 2 cycles for 2 additional cycles. Dexamethasone: Dexamethasone 40 mg po once weekly for a 21-day cycle x 2 cycles only.
id
EG000
other Num Affected
12
other Num At Risk
12
serious Num Affected
1
serious Num At Risk
12
title
Pembrolizumab + Lenalidomide

frequency Threshold

other Events

assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
stats
group Id
EG000
num Affected
5
num At Risk
12
term
Neutropenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
2
num At Risk
12
term
Constipation
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
2
num At Risk
12
term
Diarrhea
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Psychiatric disorders
stats
group Id
EG000
num Affected
1
num At Risk
12
term
Fatigue
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
stats
group Id
EG000
num Affected
1
num At Risk
12
term
Increased ALT
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
stats
group Id
EG000
num Affected
1
num At Risk
12
term
Hypoxia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Skin and subcutaneous tissue disorders
stats
group Id
EG000
num Affected
1
num At Risk
12
term
Maculopapular Rash

serious Events

assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
stats
group Id
EG000
num Affected
1
num At Risk
12
num Events
1
term
H. Influenza Pneumonia

time Frame

Study Enrollment to Study Completion, up to 3 years

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Preserved source evidence · Not medical advice