NCT00689936 · OUTCOME

Percentage of Participants With an Objective Response Based on Investigator Assessment at 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: NUMBER
Unit: percentage of participants
Interval / dispersion: Not reported
Time frame: Disease response was assessed every 28 days until end of treatment or the data cut-off date of 21 January 2016; median duration of treatment was 80.2 weeks in the Rd arm; 72 weeks in the Rd18 arm and 67.1 weeks in the MPT arm

What was measured

Objective response according to IMWG Uniform Response Criteria was defined as a best overall response including a complete response (CR), very good partial response (VGPR) or partial response (PR) based on the IRAC Review. A CR is defined s: negative serum and urine on immunofixation, disappearance of any soft tissue plasmacytomas and ≤5% plasma cells in BM; A VGPR is serum and urine M-protein detectable by immunofixation but not on electrophoresis or ≥90% reduction in serum M-protein and urine M-protein level \<100 mg/24 hours; A PR is: ≥50% reduction of serum M-Protein and reduction in urinary M-protein by ≥90% or to \<200 mg/24 hours. If present at baseline a ≥50% reduction in size of soft tissue plasmacytomas.

Analysis population: ITT population includes all 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 percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Lenalidomide and Low-Dose Dexamethasone (Rd)	80.7	Not reported	Not reported	Not reported	Not reported
Lenalidomide and Dexamethasone Rd18	78.6	Not reported	Not reported	Not reported	Not reported
Melphalan + Prednisone + Thalidomide (MPT)	67.5	Not reported	Not reported	Not reported	Not reported

Source statistical analyses

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

ci Lower Limit
1.53
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
2.68
group Ids
OG000
OG002
non Inferiority Type
SUPERIORITY_OR_OTHER_LEGACY
p Value
<0.00001
param Type
Odds Ratio (OR)
param Value
2.02
statistical Method
Fisher Exact
ci Lower Limit
0.85
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
1.54
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY_OR_OTHER_LEGACY
p Value
0.40500
param Type
Odds Ratio (OR)
param Value
1.14
statistical Method
Fisher Exact
ci Lower Limit
1.35
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
2.32
group Ids
OG001
OG002
non Inferiority Type
SUPERIORITY_OR_OTHER_LEGACY
p Value
0.00004
param Type
Odds Ratio (OR)
param Value
1.77
statistical Method
Fisher Exact

Complete source fields

analyses

ci Lower Limit
1.53
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
2.68
group Ids
OG000
OG002
non Inferiority Type
SUPERIORITY_OR_OTHER_LEGACY
p Value
<0.00001
param Type
Odds Ratio (OR)
param Value
2.02
statistical Method
Fisher Exact
ci Lower Limit
0.85
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
1.54
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY_OR_OTHER_LEGACY
p Value
0.40500
param Type
Odds Ratio (OR)
param Value
1.14
statistical Method
Fisher Exact
ci Lower Limit
1.35
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
2.32
group Ids
OG001
OG002
non Inferiority Type
SUPERIORITY_OR_OTHER_LEGACY
p Value
0.00004
param Type
Odds Ratio (OR)
param Value
1.77
statistical Method
Fisher Exact

classes

categories
measurements
group Id
OG000
value
80.7
group Id
OG001
value
78.6
group Id
OG002
value
67.5

denoms

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

description

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

NUMBER

population Description

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

reporting Status

POSTED

time Frame

Disease response was assessed every 28 days until end of treatment or the data cut-off date of 21 January 2016; median duration of treatment was 80.2 weeks in the Rd arm; 72 weeks in the Rd18 arm and 67.1 weeks in the MPT arm

title

Percentage of Participants With an Objective Response Based on Investigator Assessment at Time of Final Analysis

type

SECONDARY

unit Of Measure

percentage of participants

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Preserved source evidence · Not medical advice