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NCT00689936 · OUTCOME

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

GroupSource count
Lenalidomide and Low-Dose Dexamethasone (Rd)527
Lenalidomide and Dexamethasone Rd18535
Melphalan + Prednisone + Thalidomide (MPT)526

Reported measurements

Normal Baseline Grade to Normal Postbaseline Grade
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Lenalidomide and Low-Dose Dexamethasone (Rd)197Not reportedNot reportedNot reportedNot reported
Lenalidomide and Dexamethasone Rd18197Not reportedNot reportedNot reportedNot reported
Melphalan + Prednisone + Thalidomide (MPT)165Not reportedNot reportedNot reportedNot reported
Normal Baseline Grade to Grade 1 postbaseline
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Lenalidomide and Low-Dose Dexamethasone (Rd)216Not reportedNot reportedNot reportedNot reported
Lenalidomide and Dexamethasone Rd18211Not reportedNot reportedNot reportedNot reported
Melphalan + Prednisone + Thalidomide (MPT)208Not reportedNot reportedNot reportedNot reported
Normal Baseline Grade to Grade 2 postbaseline
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Lenalidomide and Low-Dose Dexamethasone (Rd)24Not reportedNot reportedNot reportedNot reported
Lenalidomide and Dexamethasone Rd1830Not reportedNot reportedNot reportedNot reported
Melphalan + Prednisone + Thalidomide (MPT)27Not reportedNot reportedNot reportedNot reported
Normal Baseline Grade to Grade 3 postbaseline
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Lenalidomide and Low-Dose Dexamethasone (Rd)15Not reportedNot reportedNot reportedNot reported
Lenalidomide and Dexamethasone Rd1812Not reportedNot reportedNot reportedNot reported
Melphalan + Prednisone + Thalidomide (MPT)31Not reportedNot reportedNot reportedNot reported
Normal Baseline Grade to Grade 4 postbaseline
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Lenalidomide and Low-Dose Dexamethasone (Rd)4Not reportedNot reportedNot reportedNot reported
Lenalidomide and Dexamethasone Rd185Not reportedNot reportedNot reportedNot reported
Melphalan + Prednisone + Thalidomide (MPT)11Not reportedNot reportedNot reportedNot reported
Grade1 Baseline to Normal postbaseline Grade
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Lenalidomide and Low-Dose Dexamethasone (Rd)1Not reportedNot reportedNot reportedNot reported
Lenalidomide and Dexamethasone Rd183Not reportedNot reportedNot reportedNot reported
Melphalan + Prednisone + Thalidomide (MPT)6Not reportedNot reportedNot reportedNot reported
Grade 1 Baseline to Grade 1 postbaseline
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Lenalidomide and Low-Dose Dexamethasone (Rd)34Not reportedNot reportedNot reportedNot reported
Lenalidomide and Dexamethasone Rd1838Not reportedNot reportedNot reportedNot reported
Melphalan + Prednisone + Thalidomide (MPT)51Not reportedNot reportedNot reportedNot reported
Grade 1 Baseline to Grade 2 postbaseline
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Lenalidomide and Low-Dose Dexamethasone (Rd)15Not reportedNot reportedNot reportedNot reported
Lenalidomide and Dexamethasone Rd1819Not reportedNot reportedNot reportedNot reported
Melphalan + Prednisone + Thalidomide (MPT)7Not reportedNot reportedNot reportedNot reported
Grade 1 Baseline to Grade 3 postbaseline
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Lenalidomide and Low-Dose Dexamethasone (Rd)10Not reportedNot reportedNot reportedNot reported
Lenalidomide and Dexamethasone Rd1812Not reportedNot reportedNot reportedNot reported
Melphalan + Prednisone + Thalidomide (MPT)10Not reportedNot reportedNot reportedNot reported
Grade 1 Baseline to Grade 4 postbaseline
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Lenalidomide and Low-Dose Dexamethasone (Rd)2Not reportedNot reportedNot reportedNot reported
Lenalidomide and Dexamethasone Rd181Not reportedNot reportedNot reportedNot reported
Melphalan + Prednisone + Thalidomide (MPT)1Not reportedNot reportedNot reportedNot reported
Grade 2 Baseline to normal postbaseline Grade
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Lenalidomide and Low-Dose Dexamethasone (Rd)0Not reportedNot reportedNot reportedNot reported
Lenalidomide and Dexamethasone Rd180Not reportedNot reportedNot reportedNot reported
Melphalan + Prednisone + Thalidomide (MPT)0Not reportedNot reportedNot reportedNot reported
Grade 2 Baseline to Grade 1 postbaseline
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Lenalidomide and Low-Dose Dexamethasone (Rd)0Not reportedNot reportedNot reportedNot reported
Lenalidomide and Dexamethasone Rd181Not reportedNot reportedNot reportedNot reported
Melphalan + Prednisone + Thalidomide (MPT)2Not reportedNot reportedNot reportedNot reported
Grade 2 Baseline to Grade 2 postbaseline
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Lenalidomide and Low-Dose Dexamethasone (Rd)3Not reportedNot reportedNot reportedNot reported
Lenalidomide and Dexamethasone Rd183Not reportedNot reportedNot reportedNot reported
Melphalan + Prednisone + Thalidomide (MPT)1Not reportedNot reportedNot reportedNot reported
Grade 2 Baseline to Grade 3 postbaseline
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Lenalidomide and Low-Dose Dexamethasone (Rd)3Not reportedNot reportedNot reportedNot reported
Lenalidomide and Dexamethasone Rd182Not reportedNot reportedNot reportedNot reported
Melphalan + Prednisone + Thalidomide (MPT)2Not reportedNot reportedNot reportedNot reported
Grade 2 Baseline to Grade 4 postbaseline
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Lenalidomide and Low-Dose Dexamethasone (Rd)1Not reportedNot reportedNot reportedNot reported
Lenalidomide and Dexamethasone Rd180Not reportedNot reportedNot reportedNot reported
Melphalan + Prednisone + Thalidomide (MPT)2Not reportedNot reportedNot reportedNot reported
Grade 3 Baseline to Normal postbaseline Grade
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Lenalidomide and Low-Dose Dexamethasone (Rd)0Not reportedNot reportedNot reportedNot reported
Lenalidomide and Dexamethasone Rd180Not reportedNot reportedNot reportedNot reported
Melphalan + Prednisone + Thalidomide (MPT)0Not reportedNot reportedNot reportedNot reported
Grade 3 Baseline to Grade 1 postbaseline
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Lenalidomide and Low-Dose Dexamethasone (Rd)0Not reportedNot reportedNot reportedNot reported
Lenalidomide and Dexamethasone Rd180Not reportedNot reportedNot reportedNot reported
Melphalan + Prednisone + Thalidomide (MPT)0Not reportedNot reportedNot reportedNot reported
Grade 3 Baseline to Grade 2 postbaseline
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Lenalidomide and Low-Dose Dexamethasone (Rd)0Not reportedNot reportedNot reportedNot reported
Lenalidomide and Dexamethasone Rd180Not reportedNot reportedNot reportedNot reported
Melphalan + Prednisone + Thalidomide (MPT)1Not reportedNot reportedNot reportedNot reported
Grade 3 Baseline to Grade 3 postbaseline
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Lenalidomide and Low-Dose Dexamethasone (Rd)0Not reportedNot reportedNot reportedNot reported
Lenalidomide and Dexamethasone Rd180Not reportedNot reportedNot reportedNot reported
Melphalan + Prednisone + Thalidomide (MPT)1Not reportedNot reportedNot reportedNot reported
Grade 3 Baseline to Grade 4 postbaseline
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Lenalidomide and Low-Dose Dexamethasone (Rd)2Not reportedNot reportedNot reportedNot reported
Lenalidomide and Dexamethasone Rd181Not reportedNot reportedNot reportedNot reported
Melphalan + Prednisone + Thalidomide (MPT)0Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        197
      2. group Id
        OG001
        value
        197
      3. group Id
        OG002
        value
        165
    title
    Normal Baseline Grade to Normal Postbaseline Grade
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        216
      2. group Id
        OG001
        value
        211
      3. group Id
        OG002
        value
        208
    title
    Normal Baseline Grade to Grade 1 postbaseline
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        24
      2. group Id
        OG001
        value
        30
      3. group Id
        OG002
        value
        27
    title
    Normal Baseline Grade to Grade 2 postbaseline
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        15
      2. group Id
        OG001
        value
        12
      3. group Id
        OG002
        value
        31
    title
    Normal Baseline Grade to Grade 3 postbaseline
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        4
      2. group Id
        OG001
        value
        5
      3. group Id
        OG002
        value
        11
    title
    Normal Baseline Grade to Grade 4 postbaseline
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        3
      3. group Id
        OG002
        value
        6
    title
    Grade1 Baseline to Normal postbaseline Grade
  7. categories
    1. measurements
      1. group Id
        OG000
        value
        34
      2. group Id
        OG001
        value
        38
      3. group Id
        OG002
        value
        51
    title
    Grade 1 Baseline to Grade 1 postbaseline
  8. categories
    1. measurements
      1. group Id
        OG000
        value
        15
      2. group Id
        OG001
        value
        19
      3. group Id
        OG002
        value
        7
    title
    Grade 1 Baseline to Grade 2 postbaseline
  9. categories
    1. measurements
      1. group Id
        OG000
        value
        10
      2. group Id
        OG001
        value
        12
      3. group Id
        OG002
        value
        10
    title
    Grade 1 Baseline to Grade 3 postbaseline
  10. categories
    1. measurements
      1. group Id
        OG000
        value
        2
      2. group Id
        OG001
        value
        1
      3. group Id
        OG002
        value
        1
    title
    Grade 1 Baseline to Grade 4 postbaseline
  11. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
    title
    Grade 2 Baseline to normal postbaseline Grade
  12. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        1
      3. group Id
        OG002
        value
        2
    title
    Grade 2 Baseline to Grade 1 postbaseline
denoms
  1. counts
    1. group Id
      OG000
      value
      527
    2. group Id
      OG001
      value
      535
    3. 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
  1. 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)
  2. 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
  3. 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.
type
SECONDARY
unit Of Measure
participants

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Preserved source evidence · Not medical advice