NCT02181413 · OUTCOME

Correlation Between MRD Status and Overall Survival (OS)

A Study of Oral Ixazomib Citrate (MLN9708) Maintenance Therapy in Participants With Multiple Myeloma Following Autologous Stem Cell Transplant · Source last updated 2024-11-19

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 randomization up to 107 months

What was measured

OS was measured as the time from the date of randomization to the date of death, assessed for up to 107 months in this outcome measure.

Analysis population: ITT population was defined as all participants who were randomized and had post randomization data. Overall number analyzed is the number of participants with data available for analyses. Number analyzed indicates the number of participants available for analysis in the specified category.

Groups in this outcome

Placebo

Ixazomib citrate placebo-matching capsules, orally, once on Days 1, 8 and 15 in a 28-day cycle for Cycles 1 through 26 until progressive disease (PD), unacceptable toxicity, or discontinuation for alternate reasons.

Ixazomib Citrate

Ixazomib citrate 3 mg, capsules, orally, once, on Days 1, 8 and 15 in a 28-day cycle for Cycles 1 through 4. Ixazomib citrate 4 mg, capsules, orally, once, on Days 1, 8 and 15 in a 28-day cycle for Cycles 5 through 26 until PD, unacceptable toxicity, or discontinuation for alternate reasons. Participants who had any dose reductions due to AEs were not dose escalated.

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
Placebo	214
Ixazomib Citrate	342

Reported measurements

MRD- at Study Entry

Analysis denominator · Participants

Group	Source count
Placebo	75
Ixazomib Citrate	117

Values in months · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Placebo	NA	Not reported	84.90	NA	Median and upper limit of 95% CI were not estimable due to censoring.
Ixazomib Citrate	NA	Not reported	NA	NA	Median, lower limit, and upper limit of 95% CI were not estimable due to censoring.

MRD+ at Study Entry

Analysis denominator · Participants

Group	Source count
Placebo	139
Ixazomib Citrate	225

Values in months · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Placebo	NA	Not reported	90.74	NA	Median and upper limit of 95% CI were not estimable due to censoring.
Ixazomib Citrate	105.0	Not reported	91.47	NA	Upper limit of 95% CI was not estimable due to censoring.

Source statistical analyses

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

ci Lower Limit
0.414
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
1.184
estimate Comment
Hazard ratio is based on an unadjusted Cox's proportional hazard regression model stratified by induction regimen, pre-induction ISS, and response after transplantation, comparing the hazard rate of Ixazomib arm over the hazard rate of Placebo arm.
group Description
MRD- at Study Entry
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY
p Value
0.182
p Value Comment
P-value was based on log-rank test stratified by pre-induction regimen, ISS stage and response after transplantation.
param Type
Hazard Ratio (HR)
param Value
0.7
statistical Method
Log Rank
ci Lower Limit
0.682
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
1.368
estimate Comment
Hazard ratio is based on an unadjusted Cox's proportional hazard regression model stratified by induction regimen, pre-induction ISS, and response after transplantation, comparing the hazard rate of Ixazomib arm over the hazard rate of Placebo arm.
group Description
MRD+ at Study Entry
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY
p Value
0.847
p Value Comment
P-value was based on log-rank test stratified by pre-induction regimen, ISS stage and response after transplantation.
param Type
Hazard Ratio (HR)
param Value
0.966
statistical Method
Log Rank

Complete source fields

analyses

ci Lower Limit
0.414
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
1.184
estimate Comment
Hazard ratio is based on an unadjusted Cox's proportional hazard regression model stratified by induction regimen, pre-induction ISS, and response after transplantation, comparing the hazard rate of Ixazomib arm over the hazard rate of Placebo arm.
group Description
MRD- at Study Entry
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY
p Value
0.182
p Value Comment
P-value was based on log-rank test stratified by pre-induction regimen, ISS stage and response after transplantation.
param Type
Hazard Ratio (HR)
param Value
0.7
statistical Method
Log Rank
ci Lower Limit
0.682
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
1.368
estimate Comment
Hazard ratio is based on an unadjusted Cox's proportional hazard regression model stratified by induction regimen, pre-induction ISS, and response after transplantation, comparing the hazard rate of Ixazomib arm over the hazard rate of Placebo arm.
group Description
MRD+ at Study Entry
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY
p Value
0.847
p Value Comment
P-value was based on log-rank test stratified by pre-induction regimen, ISS stage and response after transplantation.
param Type
Hazard Ratio (HR)
param Value
0.966
statistical Method
Log Rank

classes

categories
measurements
comment
Median and upper limit of 95% CI were not estimable due to censoring.
group Id
OG000
lower Limit
84.90
upper Limit
NA
value
NA
comment
Median, lower limit, and upper limit of 95% CI were not estimable due to censoring.
group Id
OG001
lower Limit
NA
upper Limit
NA
value
NA
denoms
counts
group Id
OG000
value
75
group Id
OG001
value
117
units
Participants
title
MRD- at Study Entry
categories
measurements
comment
Median and upper limit of 95% CI were not estimable due to censoring.
group Id
OG000
lower Limit
90.74
upper Limit
NA
value
NA
comment
Upper limit of 95% CI was not estimable due to censoring.
group Id
OG001
lower Limit
91.47
upper Limit
NA
value
105.0
denoms
counts
group Id
OG000
value
139
group Id
OG001
value
225
units
Participants
title
MRD+ at Study Entry

denoms

counts
group Id
OG000
value
214
group Id
OG001
value
342
units
Participants

description

OS was measured as the time from the date of randomization to the date of death, assessed for up to 107 months in this outcome measure.

dispersion Type

95% Confidence Interval

groups

description
Ixazomib citrate placebo-matching capsules, orally, once on Days 1, 8 and 15 in a 28-day cycle for Cycles 1 through 26 until progressive disease (PD), unacceptable toxicity, or discontinuation for alternate reasons.
id
OG000
title
Placebo
description
Ixazomib citrate 3 mg, capsules, orally, once, on Days 1, 8 and 15 in a 28-day cycle for Cycles 1 through 4. Ixazomib citrate 4 mg, capsules, orally, once, on Days 1, 8 and 15 in a 28-day cycle for Cycles 5 through 26 until PD, unacceptable toxicity, or discontinuation for alternate reasons. Participants who had any dose reductions due to AEs were not dose escalated.
id
OG001
title
Ixazomib Citrate

param Type

MEDIAN

population Description

ITT population was defined as all participants who were randomized and had post randomization data. Overall number analyzed is the number of participants with data available for analyses. Number analyzed indicates the number of participants available for analysis in the specified category.

reporting Status

POSTED

time Frame

From randomization up to 107 months

title

Correlation Between MRD Status and Overall Survival (OS)

type

SECONDARY

unit Of Measure

months

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Preserved source evidence · Not medical advice