NCT02685826 · OUTCOME

Participants With Treatment Emergent Adverse Events (TEAE)

A Study of Durvalumab in Combination With Lenalidomide With and Without Dexamethasone in Adults With Newly Diagnosed Multiple Myeloma · Source last updated 2023-10-06

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure: COUNT_OF_PARTICIPANTS
Unit: Participants
Interval / dispersion: Not reported
Time frame: Day 1 up to Week 84 (the longer of 90 days after discontinuing treatment with DURVA, or 28 days after the last dose of LEN or dex)

What was measured

An AE is any noxious, unintended, or untoward medical occurrence that may appear or worsen during the course of a study. A TEAE includes AEs between the first dose date of either study drug and 90 days after the last dose of study drug. A serious AE is any AE occurring at any dose that: • Results in death; • Is life-threatening; • Requires or prolongs existing inpatient hospitalization; • Results in persistent or significant disability/incapacity; • Is a congenital anomaly/birth defect; • Constitutes an important medical event. The Investigator assessed the relationship of each AE to study drug and graded the severity according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE, Version 4.03): - Grade 1 = Mild - Grade 2 = Moderate (some limitation in activity; no/minimal medical intervention required) - Grade 3 = Severe (limitation in activity; medical intervention required) - Grade 4 = Life-threatening - Grade 5 = Death

Analysis population: Safety population. The Safety Population is defined as all enrolled subjects who receive at least 1 dose of the study medications.

Groups in this outcome

Cohort A: High Risk, TNE

High risk, transplant non-eligible \[TNE\], newly diagnosed multiple myeloma (NDMM) participants who were administered • Intravenous (IV) durvalumab at 1500 mg on Day 1 of each 28-day cycle • Oral lenalidomide (LEN) 25 mg/day (adjust per the creatinine clearance \[CrCl\] value) on Days 1 to 21 of each 28-day treatment cycle • Oral dexamethasone (dex) 40 mg/day (≤ 75 years old) or 20 mg/day (\> 75 years old) on Days 1, 8, 15, and 22 of each 28-day cycle.

Cohort B: >=65 Years Old, TNE

\>= 65 years old, transplant non-eligible \[TNE\], newly diagnosed multiple myeloma (NDMM) participants who were not high risk were administered • Intravenous (IV) durvalumab at 1500 mg on Day 1 of each 28-day cycle • Oral lenalidomide (LEN) 25 mg/day (adjust per the creatinine clearance \[CrCl\] value) on Days 1 to 21 of each 28-day treatment cycle • Oral dexamethasone (dex) 40 mg/day (≤ 75 years old) or 20 mg/day (\> 75 years old) on Days 1, 8, 15, and 22 of each 28-day cycle, up to 12 cycles.

Cohort C: High Risk, Post-transplant

High risk, post-transplant NDMM participants were administered the following as maintenance therapy: • Intravenous (IV) durvalumab at 1500 mg on Day 1 of each 28-day cycle • Oral lenalidomide (LEN) 10 mg/day on Days 1 to 21 of each 28-day treatment cycle.

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

Group	Source count
Cohort A: High Risk, TNE	25
Cohort B: >=65 Years Old, TNE	10
Cohort C: High Risk, Post-transplant	21

Reported measurements

>= 1 TEAE

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Cohort A: High Risk, TNE	24	Not reported	Not reported	Not reported	Not reported
Cohort B: >=65 Years Old, TNE	9	Not reported	Not reported	Not reported	Not reported
Cohort C: High Risk, Post-transplant	18	Not reported	Not reported	Not reported	Not reported

>=1 treatment-related TEAE

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Cohort A: High Risk, TNE	22	Not reported	Not reported	Not reported	Not reported
Cohort B: >=65 Years Old, TNE	8	Not reported	Not reported	Not reported	Not reported
Cohort C: High Risk, Post-transplant	17	Not reported	Not reported	Not reported	Not reported

>=1 related to DURVA

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Cohort A: High Risk, TNE	16	Not reported	Not reported	Not reported	Not reported
Cohort B: >=65 Years Old, TNE	4	Not reported	Not reported	Not reported	Not reported
Cohort C: High Risk, Post-transplant	15	Not reported	Not reported	Not reported	Not reported

>=1 related to LEN

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Cohort A: High Risk, TNE	22	Not reported	Not reported	Not reported	Not reported
Cohort B: >=65 Years Old, TNE	8	Not reported	Not reported	Not reported	Not reported
Cohort C: High Risk, Post-transplant	15	Not reported	Not reported	Not reported	Not reported

>=1 related to dex

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Cohort A: High Risk, TNE	16	Not reported	Not reported	Not reported	Not reported
Cohort B: >=65 Years Old, TNE	6	Not reported	Not reported	Not reported	Not reported
Cohort C: High Risk, Post-transplant	NA	Not reported	Not reported	Not reported	Dexamethasone not administered to Cohort C

>=1 TEAE of severity grade 3 or 4

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Cohort A: High Risk, TNE	19	Not reported	Not reported	Not reported	Not reported
Cohort B: >=65 Years Old, TNE	8	Not reported	Not reported	Not reported	Not reported
Cohort C: High Risk, Post-transplant	7	Not reported	Not reported	Not reported	Not reported

>=1 severity 3/4, related to study drug

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Cohort A: High Risk, TNE	13	Not reported	Not reported	Not reported	Not reported
Cohort B: >=65 Years Old, TNE	8	Not reported	Not reported	Not reported	Not reported
Cohort C: High Risk, Post-transplant	6	Not reported	Not reported	Not reported	Not reported

>=1 severity 3/4, related to DURVA

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Cohort A: High Risk, TNE	7	Not reported	Not reported	Not reported	Not reported
Cohort B: >=65 Years Old, TNE	4	Not reported	Not reported	Not reported	Not reported
Cohort C: High Risk, Post-transplant	4	Not reported	Not reported	Not reported	Not reported

>=1 severity 3/4, related to LEN

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Cohort A: High Risk, TNE	11	Not reported	Not reported	Not reported	Not reported
Cohort B: >=65 Years Old, TNE	8	Not reported	Not reported	Not reported	Not reported
Cohort C: High Risk, Post-transplant	4	Not reported	Not reported	Not reported	Not reported

>=1 severity 3/4, related to dex

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Cohort A: High Risk, TNE	5	Not reported	Not reported	Not reported	Not reported
Cohort B: >=65 Years Old, TNE	2	Not reported	Not reported	Not reported	Not reported
Cohort C: High Risk, Post-transplant	NA	Not reported	Not reported	Not reported	Dexamethasone not administered to Cohort C

>=1 Grade 5 TEAE (Death)

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Cohort A: High Risk, TNE	1	Not reported	Not reported	Not reported	Not reported
Cohort B: >=65 Years Old, TNE	0	Not reported	Not reported	Not reported	Not reported
Cohort C: High Risk, Post-transplant	1	Not reported	Not reported	Not reported	Not reported

>=1 Grade 5 TEAE related to study drug

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Cohort A: High Risk, TNE	0	Not reported	Not reported	Not reported	Not reported
Cohort B: >=65 Years Old, TNE	0	Not reported	Not reported	Not reported	Not reported
Cohort C: High Risk, Post-transplant	1	Not reported	Not reported	Not reported	Not reported

>=1 Grade 5 TEAE related to DURVA

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Cohort A: High Risk, TNE	0	Not reported	Not reported	Not reported	Not reported
Cohort B: >=65 Years Old, TNE	0	Not reported	Not reported	Not reported	Not reported
Cohort C: High Risk, Post-transplant	1	Not reported	Not reported	Not reported	Not reported

>=1 Grade 5 TEAE related to LEN

Values in Participants · Interval/dispersion: Not reported
Group	Spread	Lower	Upper	Comment
Cohort A: High Risk, TNE	Not reported	Not reported	Not reported	Not reported
Cohort B: >=65 Years Old, TNE	Not reported	Not reported	Not reported	Not reported
Cohort C: High Risk, Post-transplant	Not reported	Not reported	Not reported	Not reported

>=1 Grade 5 TEAE related to dex

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Cohort A: High Risk, TNE	0	Not reported	Not reported	Not reported	Not reported
Cohort B: >=65 Years Old, TNE	0	Not reported	Not reported	Not reported	Not reported
Cohort C: High Risk, Post-transplant	NA	Not reported	Not reported	Not reported	Dexamethasone not administered to Cohort C

>=1 Serious TEAE

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Cohort A: High Risk, TNE	12	Not reported	Not reported	Not reported	Not reported
Cohort B: >=65 Years Old, TNE	6	Not reported	Not reported	Not reported	Not reported
Cohort C: High Risk, Post-transplant	4	Not reported	Not reported	Not reported	Not reported

>=1 Serious TEAE related to study drug

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Cohort A: High Risk, TNE	8	Not reported	Not reported	Not reported	Not reported
Cohort B: >=65 Years Old, TNE	4	Not reported	Not reported	Not reported	Not reported
Cohort C: High Risk, Post-transplant	4	Not reported	Not reported	Not reported	Not reported

>=1 Serious TEAE related to DURVA

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Cohort A: High Risk, TNE	5	Not reported	Not reported	Not reported	Not reported
Cohort B: >=65 Years Old, TNE	1	Not reported	Not reported	Not reported	Not reported
Cohort C: High Risk, Post-transplant	4	Not reported	Not reported	Not reported	Not reported

>=1 Serious TEAE related to LEN

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Cohort A: High Risk, TNE	6	Not reported	Not reported	Not reported	Not reported
Cohort B: >=65 Years Old, TNE	3	Not reported	Not reported	Not reported	Not reported
Cohort C: High Risk, Post-transplant	2	Not reported	Not reported	Not reported	Not reported

>=1 Serious TEAE related to dex

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Cohort A: High Risk, TNE	5	Not reported	Not reported	Not reported	Not reported
Cohort B: >=65 Years Old, TNE	1	Not reported	Not reported	Not reported	Not reported
Cohort C: High Risk, Post-transplant	NA	Not reported	Not reported	Not reported	Dexamethasone not administered to Cohort C

>=1 TEAE leading to discontinuation of study drug

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Cohort A: High Risk, TNE	3	Not reported	Not reported	Not reported	Not reported
Cohort B: >=65 Years Old, TNE	0	Not reported	Not reported	Not reported	Not reported
Cohort C: High Risk, Post-transplant	1	Not reported	Not reported	Not reported	Not reported

>= TEAE leading to discontinuation of DURVA

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Cohort A: High Risk, TNE	2	Not reported	Not reported	Not reported	Not reported
Cohort B: >=65 Years Old, TNE	0	Not reported	Not reported	Not reported	Not reported
Cohort C: High Risk, Post-transplant	1	Not reported	Not reported	Not reported	Not reported

>= TEAE leading to discontinuation of LEN

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Cohort A: High Risk, TNE	3	Not reported	Not reported	Not reported	Not reported
Cohort B: >=65 Years Old, TNE	0	Not reported	Not reported	Not reported	Not reported
Cohort C: High Risk, Post-transplant	0	Not reported	Not reported	Not reported	Not reported

>= TEAE leading to discontinuation of dex

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Cohort A: High Risk, TNE	2	Not reported	Not reported	Not reported	Not reported
Cohort B: >=65 Years Old, TNE	0	Not reported	Not reported	Not reported	Not reported
Cohort C: High Risk, Post-transplant	NA	Not reported	Not reported	Not reported	Dexamethasone not administered to Cohort C

>=1 leading to delay/reduction/interruption drug

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Cohort A: High Risk, TNE	14	Not reported	Not reported	Not reported	Not reported
Cohort B: >=65 Years Old, TNE	7	Not reported	Not reported	Not reported	Not reported
Cohort C: High Risk, Post-transplant	6	Not reported	Not reported	Not reported	Not reported

>=1 leading to dose delay of DURVA

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Cohort A: High Risk, TNE	10	Not reported	Not reported	Not reported	Not reported
Cohort B: >=65 Years Old, TNE	3	Not reported	Not reported	Not reported	Not reported
Cohort C: High Risk, Post-transplant	4	Not reported	Not reported	Not reported	Not reported

>=1 leading to infusion interruption of DURVA

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Cohort A: High Risk, TNE	0	Not reported	Not reported	Not reported	Not reported
Cohort B: >=65 Years Old, TNE	0	Not reported	Not reported	Not reported	Not reported
Cohort C: High Risk, Post-transplant	1	Not reported	Not reported	Not reported	Not reported

>=1 leading to dose reduction of LEN

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Cohort A: High Risk, TNE	2	Not reported	Not reported	Not reported	Not reported
Cohort B: >=65 Years Old, TNE	2	Not reported	Not reported	Not reported	Not reported
Cohort C: High Risk, Post-transplant	3	Not reported	Not reported	Not reported	Not reported

>=1 leading to interruption of LEN

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Cohort A: High Risk, TNE	13	Not reported	Not reported	Not reported	Not reported
Cohort B: >=65 Years Old, TNE	5	Not reported	Not reported	Not reported	Not reported
Cohort C: High Risk, Post-transplant	5	Not reported	Not reported	Not reported	Not reported

>=1 leading to dose reduction of dex

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Cohort A: High Risk, TNE	1	Not reported	Not reported	Not reported	Not reported
Cohort B: >=65 Years Old, TNE	3	Not reported	Not reported	Not reported	Not reported
Cohort C: High Risk, Post-transplant	NA	Not reported	Not reported	Not reported	Dexamethasone not administered to Cohort C

>=1 leading to interruption of dex

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Cohort A: High Risk, TNE	9	Not reported	Not reported	Not reported	Not reported
Cohort B: >=65 Years Old, TNE	3	Not reported	Not reported	Not reported	Not reported
Cohort C: High Risk, Post-transplant	NA	Not reported	Not reported	Not reported	Dexamethasone not administered to Cohort C

Complete source fields

classes

categories
measurements
group Id
OG000
value
24
group Id
OG001
value
9
group Id
OG002
value
18
title
>= 1 TEAE
categories
measurements
group Id
OG000
value
22
group Id
OG001
value
8
group Id
OG002
value
17
title
>=1 treatment-related TEAE
categories
measurements
group Id
OG000
value
16
group Id
OG001
value
4
group Id
OG002
value
15
title
>=1 related to DURVA
categories
measurements
group Id
OG000
value
22
group Id
OG001
value
8
group Id
OG002
value
15
title
>=1 related to LEN
categories
measurements
group Id
OG000
value
16
group Id
OG001
value
6
comment
Dexamethasone not administered to Cohort C
group Id
OG002
value
NA
title
>=1 related to dex
categories
measurements
group Id
OG000
value
19
group Id
OG001
value
8
group Id
OG002
value
7
title
>=1 TEAE of severity grade 3 or 4
categories
measurements
group Id
OG000
value
13
group Id
OG001
value
8
group Id
OG002
value
6
title
>=1 severity 3/4, related to study drug
categories
measurements
group Id
OG000
value
7
group Id
OG001
value
4
group Id
OG002
value
4
title
>=1 severity 3/4, related to DURVA
categories
measurements
group Id
OG000
value
11
group Id
OG001
value
8
group Id
OG002
value
4
title
>=1 severity 3/4, related to LEN
categories
measurements
group Id
OG000
value
5
group Id
OG001
value
2
comment
Dexamethasone not administered to Cohort C
group Id
OG002
value
NA
title
>=1 severity 3/4, related to dex
categories
measurements
group Id
OG000
value
1
group Id
OG001
value
0
group Id
OG002
value
1
title
>=1 Grade 5 TEAE (Death)
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
0
group Id
OG002
value
1
title
>=1 Grade 5 TEAE related to study drug

denoms

counts
group Id
OG000
value
25
group Id
OG001
value
10
group Id
OG002
value
21
units
Participants

description

groups

description
High risk, transplant non-eligible \[TNE\], newly diagnosed multiple myeloma (NDMM) participants who were administered • Intravenous (IV) durvalumab at 1500 mg on Day 1 of each 28-day cycle • Oral lenalidomide (LEN) 25 mg/day (adjust per the creatinine clearance \[CrCl\] value) on Days 1 to 21 of each 28-day treatment cycle • Oral dexamethasone (dex) 40 mg/day (≤ 75 years old) or 20 mg/day (\> 75 years old) on Days 1, 8, 15, and 22 of each 28-day cycle.
id
OG000
title
Cohort A: High Risk, TNE
description
\>= 65 years old, transplant non-eligible \[TNE\], newly diagnosed multiple myeloma (NDMM) participants who were not high risk were administered • Intravenous (IV) durvalumab at 1500 mg on Day 1 of each 28-day cycle • Oral lenalidomide (LEN) 25 mg/day (adjust per the creatinine clearance \[CrCl\] value) on Days 1 to 21 of each 28-day treatment cycle • Oral dexamethasone (dex) 40 mg/day (≤ 75 years old) or 20 mg/day (\> 75 years old) on Days 1, 8, 15, and 22 of each 28-day cycle, up to 12 cycles.
id
OG001
title
Cohort B: >=65 Years Old, TNE
description
High risk, post-transplant NDMM participants were administered the following as maintenance therapy: • Intravenous (IV) durvalumab at 1500 mg on Day 1 of each 28-day cycle • Oral lenalidomide (LEN) 10 mg/day on Days 1 to 21 of each 28-day treatment cycle.
id
OG002
title
Cohort C: High Risk, Post-transplant

param Type

COUNT_OF_PARTICIPANTS

population Description

Safety population. The Safety Population is defined as all enrolled subjects who receive at least 1 dose of the study medications.

reporting Status

POSTED

time Frame

Day 1 up to Week 84 (the longer of 90 days after discontinuing treatment with DURVA, or 28 days after the last dose of LEN or dex)

title

Participants With Treatment Emergent Adverse Events (TEAE)

type

SECONDARY

unit Of Measure

Participants

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice