NCT01850524 · OUTCOME

Overall Survival (OS)

IXAZOMIB Plus Lenalidomide and Dexamethasone Versus Placebo Plus Lenalidomide and Dexamethasone in Adult Patients With Newly Diagnosed Multiple Myeloma · Source last updated 2023-07-21

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 the date of randomization to death due to any cause (Up to approximately 9 years)

What was measured

OS was defined as the time from the date of randomization to the date of death. Participants without documented death at the time of analysis are censored at the date last known to be alive.

Analysis population: ITT population included all participants who were randomized.

Groups in this outcome

Placebo + LenDex

Participants who were randomly assigned to receive placebo matching capsule single oral dose on Days 1, 8 and 15 along with standard regimen of LenDex (lenalidomide 25 mg capsules orally on Days 1-21 and dexamethasone 40 mg tablets orally on Days 1, 8, 15 and 22) for the first 18 cycles (each cycle was of 28 days). Following Cycle 18, participants received 3.0 mg ixazomib matching placebo capsule as single oral dose on Days 1, 8 and 15 along with lenalidomide 10 mg capsules orally on Days 1-21 in each 28-day cycle until progressive disease or unacceptable toxicity, whichever comes first up to end of study (up to approximately 109 months).

Ixazomib + LenDex

Participants who were randomly assigned to receive Ixazomib 4.0 mg capsule single oral dose on Days 1, 8 and 15 along with standard regimen of LenDex (lenalidomide 25 mg capsules orally on Days 1-21 and dexamethasone 40 mg tablets orally on Days 1, 8, 15 and 22) for the first 18 cycles (each cycle was of 28 days). Following Cycle 18, participants received 3.0 mg ixazomib capsule as single oral dose on Days 1, 8 and 15 along with lenalidomide 10 mg capsules orally on Days 1-21 in each 28-day cycle until progressive disease or unacceptable toxicity, whichever comes first up to end of study (up to approximately 109 months).

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 + LenDex	354
Ixazomib + LenDex	351

Reported measurements

Source class 1

Values in months · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Placebo + LenDex	NA	Not reported	58.71	NA	Median and Upper limit of Confidence Interval (CI) was not estimable due to censoring of participants as most participants were still alive during last contact.
Ixazomib + LenDex	NA	Not reported	63.18	NA	Median and Upper limit of CI was not estimable due to censoring of participants as most participants were still alive during last contact.

Source statistical analyses

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

ci Lower Limit
0.790
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
1.261
estimate Comment
Hazard ratio is based on an Unadjusted Cox's proportional hazard regression model is stratified by age (\<75 years vs \>=75), ISS (stage I or II vs stage III), and BPI-SF worst pain score (\<4 vs \>=4) at screening.
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY
p Value
0.988
param Type
Hazard Ratio (HR)
param Value
0.998
statistical Comment
Log-rank test is stratified by age (\<75 years vs \>=75), ISS (stage I or II vs stage III), and BPI-SF worst pain score (\<4 vs \>=4) at screening.
statistical Method
Log Rank

Complete source fields

analyses

ci Lower Limit
0.790
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
1.261
estimate Comment
Hazard ratio is based on an Unadjusted Cox's proportional hazard regression model is stratified by age (\<75 years vs \>=75), ISS (stage I or II vs stage III), and BPI-SF worst pain score (\<4 vs \>=4) at screening.
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY
p Value
0.988
param Type
Hazard Ratio (HR)
param Value
0.998
statistical Comment
Log-rank test is stratified by age (\<75 years vs \>=75), ISS (stage I or II vs stage III), and BPI-SF worst pain score (\<4 vs \>=4) at screening.
statistical Method
Log Rank

classes

categories
measurements
comment
Median and Upper limit of Confidence Interval (CI) was not estimable due to censoring of participants as most participants were still alive during last contact.
group Id
OG000
lower Limit
58.71
upper Limit
NA
value
NA
comment
Median and Upper limit of CI was not estimable due to censoring of participants as most participants were still alive during last contact.
group Id
OG001
lower Limit
63.18
upper Limit
NA
value
NA

denoms

counts
group Id
OG000
value
354
group Id
OG001
value
351
units
Participants

description

OS was defined as the time from the date of randomization to the date of death. Participants without documented death at the time of analysis are censored at the date last known to be alive.

dispersion Type

95% Confidence Interval

groups

description
Participants who were randomly assigned to receive placebo matching capsule single oral dose on Days 1, 8 and 15 along with standard regimen of LenDex (lenalidomide 25 mg capsules orally on Days 1-21 and dexamethasone 40 mg tablets orally on Days 1, 8, 15 and 22) for the first 18 cycles (each cycle was of 28 days). Following Cycle 18, participants received 3.0 mg ixazomib matching placebo capsule as single oral dose on Days 1, 8 and 15 along with lenalidomide 10 mg capsules orally on Days 1-21 in each 28-day cycle until progressive disease or unacceptable toxicity, whichever comes first up to end of study (up to approximately 109 months).
id
OG000
title
Placebo + LenDex
description
Participants who were randomly assigned to receive Ixazomib 4.0 mg capsule single oral dose on Days 1, 8 and 15 along with standard regimen of LenDex (lenalidomide 25 mg capsules orally on Days 1-21 and dexamethasone 40 mg tablets orally on Days 1, 8, 15 and 22) for the first 18 cycles (each cycle was of 28 days). Following Cycle 18, participants received 3.0 mg ixazomib capsule as single oral dose on Days 1, 8 and 15 along with lenalidomide 10 mg capsules orally on Days 1-21 in each 28-day cycle until progressive disease or unacceptable toxicity, whichever comes first up to end of study (up to approximately 109 months).
id
OG001
title
Ixazomib + LenDex

param Type

MEDIAN

population Description

ITT population included all participants who were randomized.

reporting Status

POSTED

time Frame

From the date of randomization to death due to any cause (Up to approximately 9 years)

title

Overall Survival (OS)

type

SECONDARY

unit Of Measure

months

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Preserved source evidence · Not medical advice