NCT01734928 · OUTCOME

Progression Free Survival by Independent Response Adjudication Committee (IRAC)

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 progressive disease or death during the IRAC assessment period, up to approximately 42 months

What was measured

Progression free survival (PFS) will be calculated as the time between the randomization and progressive disease (PD) or death. Progressive Disease is defined as an Increase of ≥ 25% from nadir in: * Serum M-component and/or (the absolute increase must be ≥ 0.5 g/dL)g * Urine M-component and/or (the absolute increase must be ≥ 200 mg/24 hours) * In patients without measurable serum and urine M-protein levels the difference between involved and uninvolved FLC levels, the absolute increase must be \> 100 mg/dL. * Bone marrow plasma cell percentage, the absolute % must be ≥ 10%h * Definite development of new bone lesions or soft tissue plasmacytomas increase in the size of existing bone lesions or soft tissue plasmacytomas. -Development of hypercalcemia (corrected serum calcium \> 11.5 mg/dL or 2.65 mmol/L) that can be attributed solely to the plasma cell proliferative disorder.

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	11.20	Not reported	9.66	13.73	Not reported
Treatment 2: BTZ+LD-DEX	7.10	Not reported	5.88	8.48	Not reported

Source statistical analyses

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

ci Lower Limit
0.49
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
0.77
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY
p Value
0.001
param Type
Hazard Ratio (HR)
param Value
0.61
statistical Method
Based on Cox proportional hazards model

Complete source fields

analyses

ci Lower Limit
0.49
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
0.77
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY
p Value
0.001
param Type
Hazard Ratio (HR)
param Value
0.61
statistical Method
Based on Cox proportional hazards model

classes

categories
measurements
group Id
OG000
lower Limit
9.66
upper Limit
13.73
value
11.20
group Id
OG001
lower Limit
5.88
upper Limit
8.48
value
7.10

denoms

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

description

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 progressive disease or death during the IRAC assessment period, up to approximately 42 months

title

Progression Free Survival by Independent Response Adjudication Committee (IRAC)

type

PRIMARY

unit Of Measure

Months

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Preserved source evidence · Not medical advice