NCT02181413 · OUTCOME

Second Progression Free Survival (PFS2)

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: Randomization up to EOT (24 months); thereafter followed up every 4 weeks until initiation of next-line therapy and then every 12 weeks until second progressive disease (PD2) or death (up to 107 months)

What was measured

PFS2 is defined as the time from the date of randomization to the date of objective disease progression on next line treatment or death from any cause (whichever occurs first). PD is defined as ≥25% increase from lowest value in: serum/urine M-component; participants without measurable serum and urine M-protein levels, the difference between involved and uninvolved FLC levels must be \>10 mg/dL; participants without measurable serum, urine M-protein levels and FLC levels, bone marrow plasma cell percent must be ≥10%; new bone lesions/soft tissue plasmacytomas development/existing bone lesions/soft tissue plasmacytomas size rise; hypercalcaemia development.

Analysis population: ITT population was defined as all participants who were randomized and had post randomization data.

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	261
Ixazomib Citrate	395

Reported measurements

Source class 1

Values in months · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Placebo	80.4	Not reported	68.7	NA	Upper limit of 95% CI was not estimable due to low number of participants with events.
Ixazomib Citrate	84.0	Not reported	67.22	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
0.795
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
1.298
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 Ids
OG000
OG001
non Inferiority Type
SUPERIORITY
p Value
0.902
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
1.015
statistical Method
Log Rank

Complete source fields

analyses

ci Lower Limit
0.795
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
1.298
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 Ids
OG000
OG001
non Inferiority Type
SUPERIORITY
p Value
0.902
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
1.015
statistical Method
Log Rank

classes

categories
measurements
comment
Upper limit of 95% CI was not estimable due to low number of participants with events.
group Id
OG000
lower Limit
68.7
upper Limit
NA
value
80.4
comment
Upper limit of 95% CI was not estimable due to low number of participants with events.
group Id
OG001
lower Limit
67.22
upper Limit
NA
value
84.0

denoms

counts
group Id
OG000
value
261
group Id
OG001
value
395
units
Participants

description

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.

reporting Status

POSTED

time Frame

Randomization up to EOT (24 months); thereafter followed up every 4 weeks until initiation of next-line therapy and then every 12 weeks until second progressive disease (PD2) or death (up to 107 months)

title

Second Progression Free Survival (PFS2)

type

SECONDARY

unit Of Measure

months

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Preserved source evidence · Not medical advice