A Phase 3, Multicenter, Randomized, Open-Label Study to Compare the Efficacy and Safety of Pomalidomide in Combination With Low-Dose Dexamethasone Versus High-Dose Dexamethasone in Subjects With Refractory Multiple Myeloma or Relapsed and Refractory Multiple Myeloma and Companion Study · Source last updated 2018-10-24
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
From first dose of study drug through to 30 days after the last dose as of the end of the study (29 August 2017); maximum time on treatment was 297, 269, and 239 weeks in the Pomalidomide + LD-Dex, HD-Dex, and cross-over groups respectively.
What was measured
An adverse event is any noxious, unintended, or untoward medical occurrence that may appear or worsen in a participant during the course of a study. 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 4.0): Grade 1 = Mild (no limitation in activity or intervention required); Grade 2 = Moderate (some limitation in activity; no/minimal medical intervention required); Grade 3 = Severe (marked limitation in activity; medical intervention required, hospitalization possible); Grade 4 = Life-threatening; Grade 5 = Death.
Analysis population: Safety population (all randomized participants who received at least one dose of study drug (either pomalidomide or dexamethasone)).
Groups in this outcome
Pomalidomide Plus Low-Dose Dexamethasone
Participants received 4 mg pomalidomide administered by mouth on Days 1-21 of each 28-day treatment cycle and 40 mg dexamethasone (participants \> 75 years of age received 20 mg dexamethasone) administered by mouth once per day on Days 1, 8, 15, and 22 of a 28-day cycle until disease progression.
High-Dose Dexamethasone
Participants received 40 mg dexamethasone (participants \> 75 years of age received 20 mg dexamethasone) administered by mouth once per day on Days 1 through 4, 9 through 12, and 17 through 20 of a 28-day cycle until disease progression, or until cross-over to pomalidomide. Data are up to the time of cross-over.
HD-Dex / Pomalidomide
Participants initially randomized to high-dose dexamethasone (HD-Dex) crossed over to receive 4 mg pomalidomide administered by mouth on Days 1-21 of each 28-day treatment cycle, with or without low-dose dexamethasone (40 mg for participants ≤ 75 years or 20 mg for participants \> 75 years of age, administered orally once per day on Days 1, 8, 15, and 22 of each 28-day cycle) at the discretion of the investigator. Data include AEs that occurred after cross-over to pomalidomide.
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
Pomalidomide Plus Low-Dose Dexamethasone
300
High-Dose Dexamethasone
150
HD-Dex / Pomalidomide
11
Reported measurements
Any adverse event
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Pomalidomide Plus Low-Dose Dexamethasone
298
Not reported
Not reported
Not reported
Not reported
High-Dose Dexamethasone
149
Not reported
Not reported
Not reported
Not reported
HD-Dex / Pomalidomide
11
Not reported
Not reported
Not reported
Not reported
Grade 3-4 adverse events
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Pomalidomide Plus Low-Dose Dexamethasone
266
Not reported
Not reported
Not reported
Not reported
High-Dose Dexamethasone
127
Not reported
Not reported
Not reported
Not reported
HD-Dex / Pomalidomide
8
Not reported
Not reported
Not reported
Not reported
AE related to pomalidomide
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Pomalidomide Plus Low-Dose Dexamethasone
251
Not reported
Not reported
Not reported
Not reported
High-Dose Dexamethasone
0
Not reported
Not reported
Not reported
Not reported
HD-Dex / Pomalidomide
11
Not reported
Not reported
Not reported
Not reported
AE related to dexamethasone
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Pomalidomide Plus Low-Dose Dexamethasone
205
Not reported
Not reported
Not reported
Not reported
High-Dose Dexamethasone
115
Not reported
Not reported
Not reported
Not reported
HD-Dex / Pomalidomide
5
Not reported
Not reported
Not reported
Not reported
AE related to either study drug
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Pomalidomide Plus Low-Dose Dexamethasone
271
Not reported
Not reported
Not reported
Not reported
High-Dose Dexamethasone
115
Not reported
Not reported
Not reported
Not reported
HD-Dex / Pomalidomide
11
Not reported
Not reported
Not reported
Not reported
Grade 3-4 AE related to pomalidomide
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Pomalidomide Plus Low-Dose Dexamethasone
199
Not reported
Not reported
Not reported
Not reported
High-Dose Dexamethasone
0
Not reported
Not reported
Not reported
Not reported
HD-Dex / Pomalidomide
6
Not reported
Not reported
Not reported
Not reported
Grade 3-4 AE related to dexamethasone
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Pomalidomide Plus Low-Dose Dexamethasone
114
Not reported
Not reported
Not reported
Not reported
High-Dose Dexamethasone
70
Not reported
Not reported
Not reported
Not reported
HD-Dex / Pomalidomide
2
Not reported
Not reported
Not reported
Not reported
Grade 3-4 AE related to either study drug
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Pomalidomide Plus Low-Dose Dexamethasone
212
Not reported
Not reported
Not reported
Not reported
High-Dose Dexamethasone
70
Not reported
Not reported
Not reported
Not reported
HD-Dex / Pomalidomide
6
Not reported
Not reported
Not reported
Not reported
Grade 5 adverse events
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Pomalidomide Plus Low-Dose Dexamethasone
46
Not reported
Not reported
Not reported
Not reported
High-Dose Dexamethasone
21
Not reported
Not reported
Not reported
Not reported
HD-Dex / Pomalidomide
1
Not reported
Not reported
Not reported
Not reported
Serious adverse events (SAEs)
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Pomalidomide Plus Low-Dose Dexamethasone
195
Not reported
Not reported
Not reported
Not reported
High-Dose Dexamethasone
80
Not reported
Not reported
Not reported
Not reported
HD-Dex / Pomalidomide
4
Not reported
Not reported
Not reported
Not reported
SAE related to pomalidomide
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Pomalidomide Plus Low-Dose Dexamethasone
89
Not reported
Not reported
Not reported
Not reported
High-Dose Dexamethasone
0
Not reported
Not reported
Not reported
Not reported
HD-Dex / Pomalidomide
1
Not reported
Not reported
Not reported
Not reported
SAE related to dexamethasone
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Pomalidomide Plus Low-Dose Dexamethasone
73
Not reported
Not reported
Not reported
Not reported
High-Dose Dexamethasone
36
Not reported
Not reported
Not reported
Not reported
HD-Dex / Pomalidomide
0
Not reported
Not reported
Not reported
Not reported
SAE related to either study drug
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Pomalidomide Plus Low-Dose Dexamethasone
98
Not reported
Not reported
Not reported
Not reported
High-Dose Dexamethasone
36
Not reported
Not reported
Not reported
Not reported
HD-Dex / Pomalidomide
1
Not reported
Not reported
Not reported
Not reported
SAE leading to discontinuation of pomalidomide
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Pomalidomide Plus Low-Dose Dexamethasone
20
Not reported
Not reported
Not reported
Not reported
High-Dose Dexamethasone
0
Not reported
Not reported
Not reported
Not reported
HD-Dex / Pomalidomide
1
Not reported
Not reported
Not reported
Not reported
SAE leading to discontinuation of dexamethasone
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Pomalidomide Plus Low-Dose Dexamethasone
20
Not reported
Not reported
Not reported
Not reported
High-Dose Dexamethasone
14
Not reported
Not reported
Not reported
Not reported
HD-Dex / Pomalidomide
1
Not reported
Not reported
Not reported
Not reported
SAE leading to discontinuation of either study dru
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Pomalidomide Plus Low-Dose Dexamethasone
23
Not reported
Not reported
Not reported
Not reported
High-Dose Dexamethasone
14
Not reported
Not reported
Not reported
Not reported
HD-Dex / Pomalidomide
1
Not reported
Not reported
Not reported
Not reported
AE leading to discontinuation of pomalidomide
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Pomalidomide Plus Low-Dose Dexamethasone
30
Not reported
Not reported
Not reported
Not reported
High-Dose Dexamethasone
0
Not reported
Not reported
Not reported
Not reported
HD-Dex / Pomalidomide
1
Not reported
Not reported
Not reported
Not reported
AE leading to discontinuation of dexamethasone
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Pomalidomide Plus Low-Dose Dexamethasone
34
Not reported
Not reported
Not reported
Not reported
High-Dose Dexamethasone
16
Not reported
Not reported
Not reported
Not reported
HD-Dex / Pomalidomide
1
Not reported
Not reported
Not reported
Not reported
AE leading to discontinuation of either study drug
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Pomalidomide Plus Low-Dose Dexamethasone
38
Not reported
Not reported
Not reported
Not reported
High-Dose Dexamethasone
16
Not reported
Not reported
Not reported
Not reported
HD-Dex / Pomalidomide
1
Not reported
Not reported
Not reported
Not reported
Complete source fields
classes
categories
measurements
group Id
OG000
value
298
group Id
OG001
value
149
group Id
OG002
value
11
title
Any adverse event
categories
measurements
group Id
OG000
value
266
group Id
OG001
value
127
group Id
OG002
value
8
title
Grade 3-4 adverse events
categories
measurements
group Id
OG000
value
251
group Id
OG001
value
0
group Id
OG002
value
11
title
AE related to pomalidomide
categories
measurements
group Id
OG000
value
205
group Id
OG001
value
115
group Id
OG002
value
5
title
AE related to dexamethasone
categories
measurements
group Id
OG000
value
271
group Id
OG001
value
115
group Id
OG002
value
11
title
AE related to either study drug
categories
measurements
group Id
OG000
value
199
group Id
OG001
value
0
group Id
OG002
value
6
title
Grade 3-4 AE related to pomalidomide
categories
measurements
group Id
OG000
value
114
group Id
OG001
value
70
group Id
OG002
value
2
title
Grade 3-4 AE related to dexamethasone
categories
measurements
group Id
OG000
value
212
group Id
OG001
value
70
group Id
OG002
value
6
title
Grade 3-4 AE related to either study drug
categories
measurements
group Id
OG000
value
46
group Id
OG001
value
21
group Id
OG002
value
1
title
Grade 5 adverse events
categories
measurements
group Id
OG000
value
195
group Id
OG001
value
80
group Id
OG002
value
4
title
Serious adverse events (SAEs)
categories
measurements
group Id
OG000
value
89
group Id
OG001
value
0
group Id
OG002
value
1
title
SAE related to pomalidomide
categories
measurements
group Id
OG000
value
73
group Id
OG001
value
36
group Id
OG002
value
0
title
SAE related to dexamethasone
denoms
counts
group Id
OG000
value
300
group Id
OG001
value
150
group Id
OG002
value
11
units
Participants
description
An adverse event is any noxious, unintended, or untoward medical occurrence that may appear or worsen in a participant during the course of a study. 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 4.0): Grade 1 = Mild (no limitation in activity or intervention required); Grade 2 = Moderate (some limitation in activity; no/minimal medical intervention required); Grade 3 = Severe (marked limitation in activity; medical intervention required, hospitalization possible); Grade 4 = Life-threatening; Grade 5 = Death.
groups
description
Participants received 4 mg pomalidomide administered by mouth on Days 1-21 of each 28-day treatment cycle and 40 mg dexamethasone (participants \> 75 years of age received 20 mg dexamethasone) administered by mouth once per day on Days 1, 8, 15, and 22 of a 28-day cycle until disease progression.
id
OG000
title
Pomalidomide Plus Low-Dose Dexamethasone
description
Participants received 40 mg dexamethasone (participants \> 75 years of age received 20 mg dexamethasone) administered by mouth once per day on Days 1 through 4, 9 through 12, and 17 through 20 of a 28-day cycle until disease progression, or until cross-over to pomalidomide. Data are up to the time of cross-over.
id
OG001
title
High-Dose Dexamethasone
description
Participants initially randomized to high-dose dexamethasone (HD-Dex) crossed over to receive 4 mg pomalidomide administered by mouth on Days 1-21 of each 28-day treatment cycle, with or without low-dose dexamethasone (40 mg for participants ≤ 75 years or 20 mg for participants \> 75 years of age, administered orally once per day on Days 1, 8, 15, and 22 of each 28-day cycle) at the discretion of the investigator. Data include AEs that occurred after cross-over to pomalidomide.
id
OG002
title
HD-Dex / Pomalidomide
param Type
COUNT_OF_PARTICIPANTS
population Description
Safety population (all randomized participants who received at least one dose of study drug (either pomalidomide or dexamethasone)).
reporting Status
POSTED
time Frame
From first dose of study drug through to 30 days after the last dose as of the end of the study (29 August 2017); maximum time on treatment was 297, 269, and 239 weeks in the Pomalidomide + LD-Dex, HD-Dex, and cross-over groups respectively.
Triangle