NCT00689936 · OUTCOME

Kaplan Meier Estimates of Time to Treatment Failure (TTF) at the Time of Final Analysis

Study to Determine Efficacy and Safety of Lenalidomide Plus Low-dose Dexamethasone Versus Melphalan, Prednisone, Thalidomide in Patients With Previously Untreated Multiple Myeloma · Source last updated 2019-11-20

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 date of randomization until the data cut-off date of 21 January 2016; median follow up for all participants was 16.1 months.

What was measured

TTF is defined as the time between the randomization and discontinuation of study treatment for any reason, including disease progression (determined by the investigators assessment based on the IMWG response criteria), treatment toxicity, start of another anti-myeloma therapy (AMT) or death.

Analysis population: ITT population includes participants who were randomized, independent of whether they received study treatment or not

Groups in this outcome

Lenalidomide and Low-Dose Dexamethasone (Rd)

Participants ≤ 75 years old received 25 mg lenalidomide (R) administered by mouth (PO) on days 1 to 21 of each 28-day cycle plus 40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle until disease progression or intolerable toxicity. Participants \> 75 years old received lenalidomide 25 mg PO on the same schedule and frequency plus 20 mg dexamethasone at the same schedule. Participants with moderate renal insufficiency received 10-15 mg lenalidomide (R) PO on days 1-21 of each 28-day treatment cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle until disease progression or intolerable toxicity. Participants with severe renal insufficiency received 15 mg lenalidomide (R) PO every other day on days 1-21 of each 28-day treatment cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle until disease progression or intolerable toxicity.

Lenalidomide and Dexamethasone Rd18

Participants ≤ 75 years old received 25 mg lenalidomide (R) PO on days 1 to 21 of each 28-day treatment cycle 40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless progressive disease (PD) or intolerable toxicity occurred. Those \> 75 years old received lenalidomide 25 mg PO on the same schedule and frequency plus 20 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity. Those with moderate renal insufficiency received 10-15 mg lenalidomide (R) PO on days 1-21 of each 28-day cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity. Participants with severe renal insufficiency received 15 mg lenalidomide (R) PO every other day (QOD) on days 1-21 of each 28-day cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity.

Melphalan + Prednisone + Thalidomide (MPT)

Participants received melphalan (M) 0.25 mg/kg PO daily (QD) on days 1 to 4 of each 42-day cycle plus prednisone (P) at 2 mg/kg PO on days 1 to 4 of each 42-day cycle and thalidomide 200 mg PO QD on days 1 to 41 of each 42-day cycle. MPT therapy was given for up to 12 cycles unless PD or intolerable toxicity occurred. Participants with moderate to severe renal insufficiency received melphalan (M) 0.10-0.125 mg/kg PO daily (QD) on days 1 to 4 of each 42-day cycle plus prednisone (P) at 2 mg/kg PO on days 1 to 4 of each 42-day cycle and thalidomide 100-200 mg PO QD on days 1 to 41 of each 42-day cycle. MPT therapy was given for up to 12 cycles unless PD or intolerable toxicity occurred.

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
Lenalidomide and Low-Dose Dexamethasone (Rd)	535
Lenalidomide and Dexamethasone Rd18	541
Melphalan + Prednisone + Thalidomide (MPT)	547

Reported measurements

Source class 1

Values in months · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Lenalidomide and Low-Dose Dexamethasone (Rd)	16.9	Not reported	14.1	18.4	Not reported
Lenalidomide and Dexamethasone Rd18	17.2	Not reported	14.6	18.2	Not reported
Melphalan + Prednisone + Thalidomide (MPT)	14.1	Not reported	12.0	16.1	Not reported

Source statistical analyses

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

ci Lower Limit
0.67
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
0.86
estimate Comment
Based on a stratified Cox proportional hazards model
group Ids
OG000
OG002
non Inferiority Type
SUPERIORITY_OR_OTHER_LEGACY
p Value
0.00002
p Value Comment
The p-value is based on the unstratified log-rank test.
param Type
Hazard Ratio (HR)
param Value
0.76
statistical Method
Log Rank
ci Lower Limit
0.72
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
0.92
estimate Comment
Based on a stratified Cox proportional hazards model
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY_OR_OTHER_LEGACY
p Value
0.00126
p Value Comment
The p-value is based on the unstratified log-rank test.
param Type
Hazard Ratio (HR)
param Value
0.81
statistical Method
Log Rank
ci Lower Limit
0.83
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
1.06
estimate Comment
Based on a stratified Cox proportional hazards model
group Ids
OG001
OG002
non Inferiority Type
SUPERIORITY_OR_OTHER_LEGACY
p Value
0.27704
p Value Comment
The p-value is based on the unstratified log-rank test.
param Type
Hazard Ratio (HR)
param Value
0.93
statistical Method
Log Rank

Complete source fields

analyses

ci Lower Limit
0.67
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
0.86
estimate Comment
Based on a stratified Cox proportional hazards model
group Ids
OG000
OG002
non Inferiority Type
SUPERIORITY_OR_OTHER_LEGACY
p Value
0.00002
p Value Comment
The p-value is based on the unstratified log-rank test.
param Type
Hazard Ratio (HR)
param Value
0.76
statistical Method
Log Rank
ci Lower Limit
0.72
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
0.92
estimate Comment
Based on a stratified Cox proportional hazards model
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY_OR_OTHER_LEGACY
p Value
0.00126
p Value Comment
The p-value is based on the unstratified log-rank test.
param Type
Hazard Ratio (HR)
param Value
0.81
statistical Method
Log Rank
ci Lower Limit
0.83
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
1.06
estimate Comment
Based on a stratified Cox proportional hazards model
group Ids
OG001
OG002
non Inferiority Type
SUPERIORITY_OR_OTHER_LEGACY
p Value
0.27704
p Value Comment
The p-value is based on the unstratified log-rank test.
param Type
Hazard Ratio (HR)
param Value
0.93
statistical Method
Log Rank

classes

categories
measurements
group Id
OG000
lower Limit
14.1
upper Limit
18.4
value
16.9
group Id
OG001
lower Limit
14.6
upper Limit
18.2
value
17.2
group Id
OG002
lower Limit
12.0
upper Limit
16.1
value
14.1

denoms

counts
group Id
OG000
value
535
group Id
OG001
value
541
group Id
OG002
value
547
units
Participants

description

dispersion Type

95% Confidence Interval

groups

description
Participants ≤ 75 years old received 25 mg lenalidomide (R) administered by mouth (PO) on days 1 to 21 of each 28-day cycle plus 40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle until disease progression or intolerable toxicity. Participants \> 75 years old received lenalidomide 25 mg PO on the same schedule and frequency plus 20 mg dexamethasone at the same schedule. Participants with moderate renal insufficiency received 10-15 mg lenalidomide (R) PO on days 1-21 of each 28-day treatment cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle until disease progression or intolerable toxicity. Participants with severe renal insufficiency received 15 mg lenalidomide (R) PO every other day on days 1-21 of each 28-day treatment cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle until disease progression or intolerable toxicity.
id
OG000
title
Lenalidomide and Low-Dose Dexamethasone (Rd)
description
Participants ≤ 75 years old received 25 mg lenalidomide (R) PO on days 1 to 21 of each 28-day treatment cycle 40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless progressive disease (PD) or intolerable toxicity occurred. Those \> 75 years old received lenalidomide 25 mg PO on the same schedule and frequency plus 20 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity. Those with moderate renal insufficiency received 10-15 mg lenalidomide (R) PO on days 1-21 of each 28-day cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity. Participants with severe renal insufficiency received 15 mg lenalidomide (R) PO every other day (QOD) on days 1-21 of each 28-day cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity.
id
OG001
title
Lenalidomide and Dexamethasone Rd18
description
Participants received melphalan (M) 0.25 mg/kg PO daily (QD) on days 1 to 4 of each 42-day cycle plus prednisone (P) at 2 mg/kg PO on days 1 to 4 of each 42-day cycle and thalidomide 200 mg PO QD on days 1 to 41 of each 42-day cycle. MPT therapy was given for up to 12 cycles unless PD or intolerable toxicity occurred. Participants with moderate to severe renal insufficiency received melphalan (M) 0.10-0.125 mg/kg PO daily (QD) on days 1 to 4 of each 42-day cycle plus prednisone (P) at 2 mg/kg PO on days 1 to 4 of each 42-day cycle and thalidomide 100-200 mg PO QD on days 1 to 41 of each 42-day cycle. MPT therapy was given for up to 12 cycles unless PD or intolerable toxicity occurred.
id
OG002
title
Melphalan + Prednisone + Thalidomide (MPT)

param Type

MEDIAN

population Description

ITT population includes participants who were randomized, independent of whether they received study treatment or not

reporting Status

POSTED

time Frame

From date of randomization until the data cut-off date of 21 January 2016; median follow up for all participants was 16.1 months.

title

Kaplan Meier Estimates of Time to Treatment Failure (TTF) at the Time of Final Analysis

type

SECONDARY

unit Of Measure

months

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Preserved source evidence · Not medical advice