NCT01734928 · OUTCOME

Overall Survival (OS)

Safety and Efficacy of Pomalidomide, Bortezomib and Low-dose Dexamethasone in Subjects With Relapsed or Refractory Multiple Myeloma · Source last updated 2023-06-06

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 to date of death, up to approximately 65 months

What was measured

Overall survival (OS) is calculated as the time from randomization to death from any cause.

Analysis population: All randomized participants

Groups in this outcome

Treatment 1: POM+BTZ+LD-DEX

POM (Pomalidomide) * 4 mg/day on Days 1 to 14 of each 21-day treatment cycle BTZ (Bortezomib) * For Cycles 1 - 8: 1.3 mg/m2/dose on Days 1, 4, 8, and 11 of a 21-day cycle * For Cycles 9 onwards: 1.3 mg/m2/dose on Days 1 and 8 of a 21-day cycle DEX (Dexamethasone) * For Cycles 1 to 8, 20 mg/day (≤ 75 years old) or 10 mg/day (\> 75 years old) on Days 1, 2, 4, 5, 8, 9, 11 and 12 of a 21-day cycle. * For Cycles 9 and onward, 20 mg/day (≤ 75 years old) or 10 mg/day (\> 75 years old) on Days 1, 2, 8, and 9 of a 21-day cycle.

Treatment 2: BTZ+LD-DEX

BTZ ((Bortezomib) * For Cycles 1 - 8: 1.3 mg/m2/dose on Days 1, 4, 8, and 11 of a 21-day cycle * For Cycles 9 onwards: 1.3 mg/m2/dose on Days 1 and 8 of a 21-day cycle DEX (Dexamethasone) * For Cycles 1 to 8, 20 mg/day (≤ 75 years old) or 10 mg/day (\> 75 years old) on Days 1, 2, 4, 5, 8, 9, 11 and 12 of a 21-day cycle. * For Cycles 9 and onward, 20 mg/day (≤ 75 years old) or 10 mg/day (\> 75 years old) on Days 1, 2, 8, and 9 of a 21-day cycle.

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
Treatment 1: POM+BTZ+LD-DEX	281
Treatment 2: BTZ+LD-DEX	278

Reported measurements

Source class 1

Values in Months · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Treatment 1: POM+BTZ+LD-DEX	35.58	Not reported	28.55	41.20	Not reported
Treatment 2: BTZ+LD-DEX	31.61	Not reported	26.05	37.16	Not reported

Source statistical analyses

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

ci Lower Limit
0.77
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
1.15
estimate Comment
Based on Cox proportional hazards model, comparing the hazard functions associated with treatment groups, stratified by age, prior number of anti-myeloma regimens, and beta-2 macroglobulin at Screening.
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY
p Value
0.571
param Type
Hazard Ratio (HR)
param Value
0.94
statistical Comment
The p-value is based on a stratified log-rank test with stratification factors as above Cox model.
statistical Method
Log Rank

Complete source fields

analyses

ci Lower Limit
0.77
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
1.15
estimate Comment
Based on Cox proportional hazards model, comparing the hazard functions associated with treatment groups, stratified by age, prior number of anti-myeloma regimens, and beta-2 macroglobulin at Screening.
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY
p Value
0.571
param Type
Hazard Ratio (HR)
param Value
0.94
statistical Comment
The p-value is based on a stratified log-rank test with stratification factors as above Cox model.
statistical Method
Log Rank

classes

categories
measurements
group Id
OG000
lower Limit
28.55
upper Limit
41.20
value
35.58
group Id
OG001
lower Limit
26.05
upper Limit
37.16
value
31.61

denoms

counts
group Id
OG000
value
281
group Id
OG001
value
278
units
Participants

description

Overall survival (OS) is calculated as the time from randomization to death from any cause.

dispersion Type

95% Confidence Interval

groups

description
POM (Pomalidomide) * 4 mg/day on Days 1 to 14 of each 21-day treatment cycle BTZ (Bortezomib) * For Cycles 1 - 8: 1.3 mg/m2/dose on Days 1, 4, 8, and 11 of a 21-day cycle * For Cycles 9 onwards: 1.3 mg/m2/dose on Days 1 and 8 of a 21-day cycle DEX (Dexamethasone) * For Cycles 1 to 8, 20 mg/day (≤ 75 years old) or 10 mg/day (\> 75 years old) on Days 1, 2, 4, 5, 8, 9, 11 and 12 of a 21-day cycle. * For Cycles 9 and onward, 20 mg/day (≤ 75 years old) or 10 mg/day (\> 75 years old) on Days 1, 2, 8, and 9 of a 21-day cycle.
id
OG000
title
Treatment 1: POM+BTZ+LD-DEX
description
BTZ ((Bortezomib) * For Cycles 1 - 8: 1.3 mg/m2/dose on Days 1, 4, 8, and 11 of a 21-day cycle * For Cycles 9 onwards: 1.3 mg/m2/dose on Days 1 and 8 of a 21-day cycle DEX (Dexamethasone) * For Cycles 1 to 8, 20 mg/day (≤ 75 years old) or 10 mg/day (\> 75 years old) on Days 1, 2, 4, 5, 8, 9, 11 and 12 of a 21-day cycle. * For Cycles 9 and onward, 20 mg/day (≤ 75 years old) or 10 mg/day (\> 75 years old) on Days 1, 2, 8, and 9 of a 21-day cycle.
id
OG001
title
Treatment 2: BTZ+LD-DEX

param Type

MEDIAN

population Description

All randomized participants

reporting Status

POSTED

time Frame

From randomization to date of death, up to approximately 65 months

title

Overall Survival (OS)

type

SECONDARY

unit Of Measure

Months

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Preserved source evidence · Not medical advice