Shift From Baseline to Most Extreme Postbaseline Value in Platelet Count During the Active Treatment Phase.
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
participants
Interval / dispersion
Not reported
Time frame
Randomization to end of treatment or the data cut off of 24 May 2013; 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
Improvement in platelets was assessed for participants from baseline grade to most extreme severity grade using the NCI CTCAE v 3.0 grading scale.
Analysis population: Safety population; Includes participants with baseline and postbaseline platelet laboratory test grade information
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)
527
Lenalidomide and Dexamethasone Rd18
535
Melphalan + Prednisone + Thalidomide (MPT)
526
Reported measurements
Normal Baseline Grade to Normal Postbaseline Grade
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Lenalidomide and Low-Dose Dexamethasone (Rd)
197
Not reported
Not reported
Not reported
Not reported
Lenalidomide and Dexamethasone Rd18
197
Not reported
Not reported
Not reported
Not reported
Melphalan + Prednisone + Thalidomide (MPT)
165
Not reported
Not reported
Not reported
Not reported
Normal Baseline Grade to Grade 1 postbaseline
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Lenalidomide and Low-Dose Dexamethasone (Rd)
216
Not reported
Not reported
Not reported
Not reported
Lenalidomide and Dexamethasone Rd18
211
Not reported
Not reported
Not reported
Not reported
Melphalan + Prednisone + Thalidomide (MPT)
208
Not reported
Not reported
Not reported
Not reported
Normal Baseline Grade to Grade 2 postbaseline
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Lenalidomide and Low-Dose Dexamethasone (Rd)
24
Not reported
Not reported
Not reported
Not reported
Lenalidomide and Dexamethasone Rd18
30
Not reported
Not reported
Not reported
Not reported
Melphalan + Prednisone + Thalidomide (MPT)
27
Not reported
Not reported
Not reported
Not reported
Normal Baseline Grade to Grade 3 postbaseline
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Lenalidomide and Low-Dose Dexamethasone (Rd)
15
Not reported
Not reported
Not reported
Not reported
Lenalidomide and Dexamethasone Rd18
12
Not reported
Not reported
Not reported
Not reported
Melphalan + Prednisone + Thalidomide (MPT)
31
Not reported
Not reported
Not reported
Not reported
Normal Baseline Grade to Grade 4 postbaseline
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Lenalidomide and Low-Dose Dexamethasone (Rd)
4
Not reported
Not reported
Not reported
Not reported
Lenalidomide and Dexamethasone Rd18
5
Not reported
Not reported
Not reported
Not reported
Melphalan + Prednisone + Thalidomide (MPT)
11
Not reported
Not reported
Not reported
Not reported
Grade1 Baseline to Normal postbaseline Grade
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Lenalidomide and Low-Dose Dexamethasone (Rd)
1
Not reported
Not reported
Not reported
Not reported
Lenalidomide and Dexamethasone Rd18
3
Not reported
Not reported
Not reported
Not reported
Melphalan + Prednisone + Thalidomide (MPT)
6
Not reported
Not reported
Not reported
Not reported
Grade 1 Baseline to Grade 1 postbaseline
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Lenalidomide and Low-Dose Dexamethasone (Rd)
34
Not reported
Not reported
Not reported
Not reported
Lenalidomide and Dexamethasone Rd18
38
Not reported
Not reported
Not reported
Not reported
Melphalan + Prednisone + Thalidomide (MPT)
51
Not reported
Not reported
Not reported
Not reported
Grade 1 Baseline to Grade 2 postbaseline
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Lenalidomide and Low-Dose Dexamethasone (Rd)
15
Not reported
Not reported
Not reported
Not reported
Lenalidomide and Dexamethasone Rd18
19
Not reported
Not reported
Not reported
Not reported
Melphalan + Prednisone + Thalidomide (MPT)
7
Not reported
Not reported
Not reported
Not reported
Grade 1 Baseline to Grade 3 postbaseline
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Lenalidomide and Low-Dose Dexamethasone (Rd)
10
Not reported
Not reported
Not reported
Not reported
Lenalidomide and Dexamethasone Rd18
12
Not reported
Not reported
Not reported
Not reported
Melphalan + Prednisone + Thalidomide (MPT)
10
Not reported
Not reported
Not reported
Not reported
Grade 1 Baseline to Grade 4 postbaseline
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Lenalidomide and Low-Dose Dexamethasone (Rd)
2
Not reported
Not reported
Not reported
Not reported
Lenalidomide and Dexamethasone Rd18
1
Not reported
Not reported
Not reported
Not reported
Melphalan + Prednisone + Thalidomide (MPT)
1
Not reported
Not reported
Not reported
Not reported
Grade 2 Baseline to normal postbaseline Grade
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Lenalidomide and Low-Dose Dexamethasone (Rd)
0
Not reported
Not reported
Not reported
Not reported
Lenalidomide and Dexamethasone Rd18
0
Not reported
Not reported
Not reported
Not reported
Melphalan + Prednisone + Thalidomide (MPT)
0
Not reported
Not reported
Not reported
Not reported
Grade 2 Baseline to Grade 1 postbaseline
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Lenalidomide and Low-Dose Dexamethasone (Rd)
0
Not reported
Not reported
Not reported
Not reported
Lenalidomide and Dexamethasone Rd18
1
Not reported
Not reported
Not reported
Not reported
Melphalan + Prednisone + Thalidomide (MPT)
2
Not reported
Not reported
Not reported
Not reported
Grade 2 Baseline to Grade 2 postbaseline
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Lenalidomide and Low-Dose Dexamethasone (Rd)
3
Not reported
Not reported
Not reported
Not reported
Lenalidomide and Dexamethasone Rd18
3
Not reported
Not reported
Not reported
Not reported
Melphalan + Prednisone + Thalidomide (MPT)
1
Not reported
Not reported
Not reported
Not reported
Grade 2 Baseline to Grade 3 postbaseline
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Lenalidomide and Low-Dose Dexamethasone (Rd)
3
Not reported
Not reported
Not reported
Not reported
Lenalidomide and Dexamethasone Rd18
2
Not reported
Not reported
Not reported
Not reported
Melphalan + Prednisone + Thalidomide (MPT)
2
Not reported
Not reported
Not reported
Not reported
Grade 2 Baseline to Grade 4 postbaseline
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Lenalidomide and Low-Dose Dexamethasone (Rd)
1
Not reported
Not reported
Not reported
Not reported
Lenalidomide and Dexamethasone Rd18
0
Not reported
Not reported
Not reported
Not reported
Melphalan + Prednisone + Thalidomide (MPT)
2
Not reported
Not reported
Not reported
Not reported
Grade 3 Baseline to Normal postbaseline Grade
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Lenalidomide and Low-Dose Dexamethasone (Rd)
0
Not reported
Not reported
Not reported
Not reported
Lenalidomide and Dexamethasone Rd18
0
Not reported
Not reported
Not reported
Not reported
Melphalan + Prednisone + Thalidomide (MPT)
0
Not reported
Not reported
Not reported
Not reported
Grade 3 Baseline to Grade 1 postbaseline
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Lenalidomide and Low-Dose Dexamethasone (Rd)
0
Not reported
Not reported
Not reported
Not reported
Lenalidomide and Dexamethasone Rd18
0
Not reported
Not reported
Not reported
Not reported
Melphalan + Prednisone + Thalidomide (MPT)
0
Not reported
Not reported
Not reported
Not reported
Grade 3 Baseline to Grade 2 postbaseline
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Lenalidomide and Low-Dose Dexamethasone (Rd)
0
Not reported
Not reported
Not reported
Not reported
Lenalidomide and Dexamethasone Rd18
0
Not reported
Not reported
Not reported
Not reported
Melphalan + Prednisone + Thalidomide (MPT)
1
Not reported
Not reported
Not reported
Not reported
Grade 3 Baseline to Grade 3 postbaseline
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Lenalidomide and Low-Dose Dexamethasone (Rd)
0
Not reported
Not reported
Not reported
Not reported
Lenalidomide and Dexamethasone Rd18
0
Not reported
Not reported
Not reported
Not reported
Melphalan + Prednisone + Thalidomide (MPT)
1
Not reported
Not reported
Not reported
Not reported
Grade 3 Baseline to Grade 4 postbaseline
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Lenalidomide and Low-Dose Dexamethasone (Rd)
2
Not reported
Not reported
Not reported
Not reported
Lenalidomide and Dexamethasone Rd18
1
Not reported
Not reported
Not reported
Not reported
Melphalan + Prednisone + Thalidomide (MPT)
0
Not reported
Not reported
Not reported
Not reported
Complete source fields
classes
categories
measurements
group Id
OG000
value
197
group Id
OG001
value
197
group Id
OG002
value
165
title
Normal Baseline Grade to Normal Postbaseline Grade
categories
measurements
group Id
OG000
value
216
group Id
OG001
value
211
group Id
OG002
value
208
title
Normal Baseline Grade to Grade 1 postbaseline
categories
measurements
group Id
OG000
value
24
group Id
OG001
value
30
group Id
OG002
value
27
title
Normal Baseline Grade to Grade 2 postbaseline
categories
measurements
group Id
OG000
value
15
group Id
OG001
value
12
group Id
OG002
value
31
title
Normal Baseline Grade to Grade 3 postbaseline
categories
measurements
group Id
OG000
value
4
group Id
OG001
value
5
group Id
OG002
value
11
title
Normal Baseline Grade to Grade 4 postbaseline
categories
measurements
group Id
OG000
value
1
group Id
OG001
value
3
group Id
OG002
value
6
title
Grade1 Baseline to Normal postbaseline Grade
categories
measurements
group Id
OG000
value
34
group Id
OG001
value
38
group Id
OG002
value
51
title
Grade 1 Baseline to Grade 1 postbaseline
categories
measurements
group Id
OG000
value
15
group Id
OG001
value
19
group Id
OG002
value
7
title
Grade 1 Baseline to Grade 2 postbaseline
categories
measurements
group Id
OG000
value
10
group Id
OG001
value
12
group Id
OG002
value
10
title
Grade 1 Baseline to Grade 3 postbaseline
categories
measurements
group Id
OG000
value
2
group Id
OG001
value
1
group Id
OG002
value
1
title
Grade 1 Baseline to Grade 4 postbaseline
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
0
group Id
OG002
value
0
title
Grade 2 Baseline to normal postbaseline Grade
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
1
group Id
OG002
value
2
title
Grade 2 Baseline to Grade 1 postbaseline
denoms
counts
group Id
OG000
value
527
group Id
OG001
value
535
group Id
OG002
value
526
units
Participants
description
Improvement in platelets was assessed for participants from baseline grade to most extreme severity grade using the NCI CTCAE v 3.0 grading scale.
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
Safety population; Includes participants with baseline and postbaseline platelet laboratory test grade information
reporting Status
POSTED
time Frame
Randomization to end of treatment or the data cut off of 24 May 2013; 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
Shift From Baseline to Most Extreme Postbaseline Value in Platelet Count During the Active Treatment Phase.