NCT03170882 · OUTCOME

Overall Survival (OS)

A Study of Ixazomib, Given With Dexamethasone in Adults With Multiple Myeloma · Source last updated 2022-12-20

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

Measure: MEDIAN
Unit: months
Interval / dispersion: 95% Confidence Interval
Time frame: From date of randomization to death due to any cause (Up to approximately 3 years)

What was measured

OS was defined as the time from randomization to death from any cause, up to 3 years are reported.

Analysis population: ITT Population included all participants who were randomized. Participants without documented death at the time of analysis were censored at the date last known to be alive.

Groups in this outcome

Pomalidomide 4 mg + Dexamethasone 40 mg

Pomalidomide 4 mg, capsules, orally, once daily on Days 1 to 21 of each 28-day cycle, plus dexamethasone 40 mg, (or 20 mg if participant is aged \>=75 years), tablets, orally, once daily on Days 1, 8, 15, and 22 of each 28-day cycle until disease progression, unacceptable toxicity, withdrawal of consent, or sponsor termination of study up to 2 years.

Ixazomib 4 mg + Dexamethasone 20 mg

Ixazomib 4 mg as starting dose, capsules, orally, once daily on Days 1, 8, and 15 of each 28-day cycle, with escalation to 5.5 mg at the start of Cycle 2 for participants who tolerated the 4 mg dose in Cycle 1, plus dexamethasone 20 mg (or 10 mg if participant is aged \>=75 years), tablets, orally, once daily on Days 1, 2, 8, 9, 15, 16, 22, and 23 of every 28-day cycle until disease progression, unacceptable toxicity, withdrawal of consent, or sponsor termination of study up to 2 years.

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 4 mg + Dexamethasone 40 mg	49
Ixazomib 4 mg + Dexamethasone 20 mg	73

Reported measurements

Source class 1

Values in months · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Pomalidomide 4 mg + Dexamethasone 40 mg	NA	Not reported	13.963	NA	Median and upper limit of 95% confidence interval (CI) were not estimable due to low number of participants with events.
Ixazomib 4 mg + Dexamethasone 20 mg	18.8	Not reported	10.973	NA	Upper limit of 95% CI was not estimable due to low number of participants with events.

Source statistical analyses

Group order, estimate direction, methods and comments are retained. No treatment ranking is inferred.

ci Lower Limit
0.761
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
2.677
estimate Comment
HR obtained by unadjusted Cox's proportional hazard regression model stratified by age, ISS and prior lines of therapy. HR \<1 was deemed to indicate longer survival time in Ixazomib + Dexamethasone arm as compared to Pomalidomide + Dexamethasone arm.
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY
p Value
=0.265
param Type
Hazard Ratio (HR)
param Value
1.427
statistical Method
Log Rank

Complete source fields

analyses

ci Lower Limit
0.761
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
2.677
estimate Comment
HR obtained by unadjusted Cox's proportional hazard regression model stratified by age, ISS and prior lines of therapy. HR \<1 was deemed to indicate longer survival time in Ixazomib + Dexamethasone arm as compared to Pomalidomide + Dexamethasone arm.
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY
p Value
=0.265
param Type
Hazard Ratio (HR)
param Value
1.427
statistical Method
Log Rank

classes

categories
measurements
comment
Median and upper limit of 95% confidence interval (CI) were not estimable due to low number of participants with events.
group Id
OG000
lower Limit
13.963
upper Limit
NA
value
NA
comment
Upper limit of 95% CI was not estimable due to low number of participants with events.
group Id
OG001
lower Limit
10.973
upper Limit
NA
value
18.8

denoms

counts
group Id
OG000
value
49
group Id
OG001
value
73
units
Participants

description

OS was defined as the time from randomization to death from any cause, up to 3 years are reported.

dispersion Type

95% Confidence Interval

groups

description
Pomalidomide 4 mg, capsules, orally, once daily on Days 1 to 21 of each 28-day cycle, plus dexamethasone 40 mg, (or 20 mg if participant is aged \>=75 years), tablets, orally, once daily on Days 1, 8, 15, and 22 of each 28-day cycle until disease progression, unacceptable toxicity, withdrawal of consent, or sponsor termination of study up to 2 years.
id
OG000
title
Pomalidomide 4 mg + Dexamethasone 40 mg
description
Ixazomib 4 mg as starting dose, capsules, orally, once daily on Days 1, 8, and 15 of each 28-day cycle, with escalation to 5.5 mg at the start of Cycle 2 for participants who tolerated the 4 mg dose in Cycle 1, plus dexamethasone 20 mg (or 10 mg if participant is aged \>=75 years), tablets, orally, once daily on Days 1, 2, 8, 9, 15, 16, 22, and 23 of every 28-day cycle until disease progression, unacceptable toxicity, withdrawal of consent, or sponsor termination of study up to 2 years.
id
OG001
title
Ixazomib 4 mg + Dexamethasone 20 mg

param Type

MEDIAN

population Description

ITT Population included all participants who were randomized. Participants without documented death at the time of analysis were censored at the date last known to be alive.

reporting Status

POSTED

time Frame

From date of randomization to death due to any cause (Up to approximately 3 years)

title

Overall Survival (OS)

type

SECONDARY

unit Of Measure

months

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Preserved source evidence · Not medical advice