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NCT00405756 · OUTCOME

Kaplan Meier Estimates for Time to Next Antimyeloma Therapy

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
MEDIAN
Unit
weeks
Interval / dispersion
95% Confidence Interval
Time frame
Up to 168 weeks

What was measured

Data as of 11 May 2010 cutoff. Time to the next antimyeloma therapy was defined as time from randomization to the start of another non-protocol antimyeloma therapy. Participants who do not receive another anti-myeloma therapy were censored at the last assessment or follow-up visit known to have received no new therapy.

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

Source class 1
Values in weeks · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
MPR+R128.9Not reported99.86NAUpper limit not estimable because of the number of participants who had not started a non-protocol anti-myeloma therapy at data cut-off.
MPR+p66.1Not reported60.1476.00Not reported
MPp+p66.3Not reported61.1472.43Not reported

Source statistical analyses

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

  1. ci Lower Limit
    0.296
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.553
    group Ids
    1. OG000
    2. OG002
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    <0.001
    p Value Comment
    The p-value is based on unstratified log rank test of Kaplan Meier curve differences between the treatment groups.
    param Type
    Hazard Ratio (HR)
    param Value
    0.404
    statistical Method
    Log Rank
    tested Non Inferiority
    false
  2. ci Lower Limit
    0.363
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.688
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    <0.001
    p Value Comment
    The p-value is based on unstratified log rank test of Kaplan Meier curve differences between the treatment groups.
    param Type
    Hazard Ratio (HR)
    param Value
    0.499
    statistical Method
    Log Rank
    tested Non Inferiority
    false
  3. ci Lower Limit
    0.630
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.085
    group Ids
    1. OG001
    2. OG002
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.169
    p Value Comment
    The p-value is based on unstratified log rank test of Kaplan Meier curve differences between the treatment groups.
    param Type
    Hazard Ratio (HR)
    param Value
    0.827
    statistical Method
    Log Rank
    tested Non Inferiority
    false
Complete source fields
analyses
  1. ci Lower Limit
    0.296
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.553
    group Ids
    1. OG000
    2. OG002
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    <0.001
    p Value Comment
    The p-value is based on unstratified log rank test of Kaplan Meier curve differences between the treatment groups.
    param Type
    Hazard Ratio (HR)
    param Value
    0.404
    statistical Method
    Log Rank
    tested Non Inferiority
    false
  2. ci Lower Limit
    0.363
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.688
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    <0.001
    p Value Comment
    The p-value is based on unstratified log rank test of Kaplan Meier curve differences between the treatment groups.
    param Type
    Hazard Ratio (HR)
    param Value
    0.499
    statistical Method
    Log Rank
    tested Non Inferiority
    false
  3. ci Lower Limit
    0.630
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.085
    group Ids
    1. OG001
    2. OG002
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.169
    p Value Comment
    The p-value is based on unstratified log rank test of Kaplan Meier curve differences between the treatment groups.
    param Type
    Hazard Ratio (HR)
    param Value
    0.827
    statistical Method
    Log Rank
    tested Non Inferiority
    false
classes
  1. categories
    1. measurements
      1. comment
        Upper limit not estimable because of the number of participants who had not started a non-protocol anti-myeloma therapy at data cut-off.
        group Id
        OG000
        lower Limit
        99.86
        upper Limit
        NA
        value
        128.9
      2. group Id
        OG001
        lower Limit
        60.14
        upper Limit
        76.00
        value
        66.1
      3. group Id
        OG002
        lower Limit
        61.14
        upper Limit
        72.43
        value
        66.3
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. Time to the next antimyeloma therapy was defined as time from randomization to the start of another non-protocol antimyeloma therapy. Participants who do not receive another anti-myeloma therapy were censored at the last assessment or follow-up visit known to have received no new therapy.
dispersion Type
95% Confidence Interval
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
MEDIAN
population Description
Intent to treat population
reporting Status
POSTED
time Frame
Up to 168 weeks
title
Kaplan Meier Estimates for Time to Next Antimyeloma Therapy
type
SECONDARY
unit Of Measure
weeks

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Preserved source evidence · Not medical advice