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NCT00405756 · OUTCOME

Number of Participants in Disease Response Categories Representing Their Best Response During the Double-blind Treatment Period

A Study to Compare MPR With MP in Newly Diagnosed Multiple Myeloma Subjects 65 Years Old or Older. · Source last updated 2017-01-11

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
Up to 165 weeks

What was measured

Data as of 11 May 2010 cutoff. Best response was determined by the Central Assessment Committee (CAC) based on the European Group for Blood and Marrow Transplantation (EBMT) criteria: Complete Response (CR)-absence of serum and urine monoclonal paraprotein for 6 weeks, plus no increase in size or number of bone lesions, plus other factors); Partial Response (PR)-not all CR criteria, plus \>=50% reduction in serum monoclonal paraprotein plus others; Stable Disease (SD)- not PR or PD; Progressive Disease (PD)- reappearance of monoclonal paraprotein, bone lesions, other; Not Evaluable (NE).

Analysis population: Intent to treat population

Groups in this outcome

MPR+R

Double-blind induction therapy with melphalan/prednisone and lenalidomide 10 mg (MPR) for up to 9 cycles, followed by maintenance therapy with single-agent lenalidomide (R) 10mg from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.

MPR+p

Double-blind induction therapy with melphalan/prednisone and lenalidomide 10mg (MPR) for up to 9 cycles, followed by maintenance therapy with placebo (p) from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.

MPp+p

Double-blind induction therapy with melphalan/prednisone and placebo (MPp) for up to 9 cycles, followed by maintenance therapy with placebo (p) from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
MPR+R152
MPR+p153
MPp+p154

Reported measurements

Complete response (CR)
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
MPR+R15Not reportedNot reportedNot reportedNot reported
MPR+p5Not reportedNot reportedNot reportedNot reported
MPp+p5Not reportedNot reportedNot reportedNot reported
Partial response (PR)
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
MPR+R102Not reportedNot reportedNot reportedNot reported
MPR+p99Not reportedNot reportedNot reportedNot reported
MPp+p72Not reportedNot reportedNot reportedNot reported
Stable disease (SD)
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
MPR+R28Not reportedNot reportedNot reportedNot reported
MPR+p40Not reportedNot reportedNot reportedNot reported
MPp+p70Not reportedNot reportedNot reportedNot reported
Progressive disease (PD)
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
MPR+R0Not reportedNot reportedNot reportedNot reported
MPR+p2Not reportedNot reportedNot reportedNot reported
MPp+p0Not reportedNot reportedNot reportedNot reported
Response not evaluable (NE)
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
MPR+R7Not reportedNot reportedNot reportedNot reported
MPR+p7Not reportedNot reportedNot reportedNot reported
MPp+p7Not reportedNot reportedNot reportedNot reported

Source statistical analyses

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

  1. ci Pct Value
    95
    group Ids
    1. OG000
    2. OG002
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    <0.001
    p Value Comment
    P-value calculation excludes the category - Response not evaluable (NE)
    statistical Method
    Wilcoxon (Mann-Whitney)
    tested Non Inferiority
    false
  2. ci Pct Value
    95
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.009
    p Value Comment
    P-value calculation excludes the category - Response not evaluable (NE)
    statistical Method
    Wilcoxon (Mann-Whitney)
    tested Non Inferiority
    false
  3. ci Pct Value
    95
    group Ids
    1. OG001
    2. OG002
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.003
    p Value Comment
    P-value calculation excludes the category - Response not evaluable (NE)
    statistical Method
    Wilcoxon (Mann-Whitney)
    tested Non Inferiority
    false
  4. ci Lower Limit
    2.04
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    5.47
    group Description
    Based on dichotomized response: 1) CR or PR 2) SD or PD or NE
    group Ids
    1. OG000
    2. OG002
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    <0.001
    param Type
    Odds Ratio (OR)
    param Value
    3.34
    statistical Method
    Fisher Exact
    tested Non Inferiority
    false
  5. ci Lower Limit
    0.95
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    2.62
    group Description
    Based on dichotomized response: 1) CR or PR 2) SD or PD or NE
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.096
    param Type
    Odds Ratio (OR)
    param Value
    1.58
    statistical Method
    Fisher Exact
    tested Non Inferiority
    false
  6. ci Lower Limit
    1.33
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    3.37
    group Description
    Based on dichotomized response: 1) CR or PR 2) SD or PD or NE
    group Ids
    1. OG001
    2. OG002
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.002
    param Type
    Odds Ratio (OR)
    param Value
    2.12
    statistical Method
    Fisher Exact
    tested Non Inferiority
    false
Complete source fields
analyses
  1. ci Pct Value
    95
    group Ids
    1. OG000
    2. OG002
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    <0.001
    p Value Comment
    P-value calculation excludes the category - Response not evaluable (NE)
    statistical Method
    Wilcoxon (Mann-Whitney)
    tested Non Inferiority
    false
  2. ci Pct Value
    95
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.009
    p Value Comment
    P-value calculation excludes the category - Response not evaluable (NE)
    statistical Method
    Wilcoxon (Mann-Whitney)
    tested Non Inferiority
    false
  3. ci Pct Value
    95
    group Ids
    1. OG001
    2. OG002
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.003
    p Value Comment
    P-value calculation excludes the category - Response not evaluable (NE)
    statistical Method
    Wilcoxon (Mann-Whitney)
    tested Non Inferiority
    false
  4. ci Lower Limit
    2.04
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    5.47
    group Description
    Based on dichotomized response: 1) CR or PR 2) SD or PD or NE
    group Ids
    1. OG000
    2. OG002
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    <0.001
    param Type
    Odds Ratio (OR)
    param Value
    3.34
    statistical Method
    Fisher Exact
    tested Non Inferiority
    false
  5. ci Lower Limit
    0.95
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    2.62
    group Description
    Based on dichotomized response: 1) CR or PR 2) SD or PD or NE
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.096
    param Type
    Odds Ratio (OR)
    param Value
    1.58
    statistical Method
    Fisher Exact
    tested Non Inferiority
    false
  6. ci Lower Limit
    1.33
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    3.37
    group Description
    Based on dichotomized response: 1) CR or PR 2) SD or PD or NE
    group Ids
    1. OG001
    2. OG002
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.002
    param Type
    Odds Ratio (OR)
    param Value
    2.12
    statistical Method
    Fisher Exact
    tested Non Inferiority
    false
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        15
      2. group Id
        OG001
        value
        5
      3. group Id
        OG002
        value
        5
    title
    Complete response (CR)
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        102
      2. group Id
        OG001
        value
        99
      3. group Id
        OG002
        value
        72
    title
    Partial response (PR)
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        28
      2. group Id
        OG001
        value
        40
      3. group Id
        OG002
        value
        70
    title
    Stable disease (SD)
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        2
      3. group Id
        OG002
        value
        0
    title
    Progressive disease (PD)
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        7
      2. group Id
        OG001
        value
        7
      3. group Id
        OG002
        value
        7
    title
    Response not evaluable (NE)
denoms
  1. counts
    1. group Id
      OG000
      value
      152
    2. group Id
      OG001
      value
      153
    3. group Id
      OG002
      value
      154
    units
    Participants
description
Data as of 11 May 2010 cutoff. Best response was determined by the Central Assessment Committee (CAC) based on the European Group for Blood and Marrow Transplantation (EBMT) criteria: Complete Response (CR)-absence of serum and urine monoclonal paraprotein for 6 weeks, plus no increase in size or number of bone lesions, plus other factors); Partial Response (PR)-not all CR criteria, plus \>=50% reduction in serum monoclonal paraprotein plus others; Stable Disease (SD)- not PR or PD; Progressive Disease (PD)- reappearance of monoclonal paraprotein, bone lesions, other; Not Evaluable (NE).
groups
  1. description
    Double-blind induction therapy with melphalan/prednisone and lenalidomide 10 mg (MPR) for up to 9 cycles, followed by maintenance therapy with single-agent lenalidomide (R) 10mg from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
    id
    OG000
    title
    MPR+R
  2. description
    Double-blind induction therapy with melphalan/prednisone and lenalidomide 10mg (MPR) for up to 9 cycles, followed by maintenance therapy with placebo (p) from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
    id
    OG001
    title
    MPR+p
  3. description
    Double-blind induction therapy with melphalan/prednisone and placebo (MPp) for up to 9 cycles, followed by maintenance therapy with placebo (p) from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
    id
    OG002
    title
    MPp+p
param Type
NUMBER
population Description
Intent to treat population
reporting Status
POSTED
time Frame
Up to 165 weeks
title
Number of Participants in Disease Response Categories Representing Their Best Response During the Double-blind Treatment Period
type
SECONDARY
unit Of Measure
participants

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Preserved source evidence · Not medical advice