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NCT00872521 · OUTCOME

Overall Survival

A Study of Efficacy of Treatment With Bortezomib (in Combination With Doxorubicin and Dexamethasone) in Previously Untreated Patients With Multiple Myeloma · Source last updated 2014-05-16

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
2 years after Day 1 Cycle 1 of PAD

What was measured

Percentage of participants who had no event of death 2 years after Day 1 Cycle 1 of bortezomib, doxorubicin and dexamethasone (PAD).

Analysis population: Intent-to-treat (ITT) population - All participants who were screened and received at least one dose of PAD

Groups in this outcome

1q21 Not Amplified

Participants without 1q21 amplification. Four 21-day cycles of bortezomib 1.3 mg/m2 intravenous (IV) on Days 1, 4, 8 and 11; plus doxorubicin 20 mg/m2 IV on Days 1 and 4; and dexamethasone 20 mg oral on Days 1, 2, 4, 5, 8, 9, 11 and 12.

1q21 Amplified

Participants with 1q21 amplification. Four 21-day cycles of bortezomib 1.3 mg/m2 intravenous (IV) on Days 1, 4, 8 and 11; plus doxorubicin 20 mg/m2 IV on Days 1 and 4; and dexamethasone 20 mg oral on Days 1, 2, 4, 5, 8, 9, 11 and 12.

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

Analysis denominator · Participants

GroupSource count
1q21 Not Amplified58
1q21 Amplified20

Reported measurements

Source class 1
Values in Percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
1q21 Not Amplified93.8Not reportedNot reportedNot reportedNot reported
1q21 Amplified86.4Not reportedNot reportedNot reportedNot reported

Source statistical analyses

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

  1. group Description
    Null Hypothesis: There is no difference in response rate between 1q21 amplified and 1q21 NOT amplified
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.28
    statistical Method
    Log Rank
    tested Non Inferiority
    false
Complete source fields
analyses
  1. group Description
    Null Hypothesis: There is no difference in response rate between 1q21 amplified and 1q21 NOT amplified
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.28
    statistical Method
    Log Rank
    tested Non Inferiority
    false
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        93.8
      2. group Id
        OG001
        value
        86.4
denoms
  1. counts
    1. group Id
      OG000
      value
      58
    2. group Id
      OG001
      value
      20
    units
    Participants
description
Percentage of participants who had no event of death 2 years after Day 1 Cycle 1 of bortezomib, doxorubicin and dexamethasone (PAD).
groups
  1. description
    Participants without 1q21 amplification. Four 21-day cycles of bortezomib 1.3 mg/m2 intravenous (IV) on Days 1, 4, 8 and 11; plus doxorubicin 20 mg/m2 IV on Days 1 and 4; and dexamethasone 20 mg oral on Days 1, 2, 4, 5, 8, 9, 11 and 12.
    id
    OG000
    title
    1q21 Not Amplified
  2. description
    Participants with 1q21 amplification. Four 21-day cycles of bortezomib 1.3 mg/m2 intravenous (IV) on Days 1, 4, 8 and 11; plus doxorubicin 20 mg/m2 IV on Days 1 and 4; and dexamethasone 20 mg oral on Days 1, 2, 4, 5, 8, 9, 11 and 12.
    id
    OG001
    title
    1q21 Amplified
param Type
NUMBER
population Description
Intent-to-treat (ITT) population - All participants who were screened and received at least one dose of PAD
reporting Status
POSTED
time Frame
2 years after Day 1 Cycle 1 of PAD
title
Overall Survival
type
SECONDARY
unit Of Measure
Percentage of participants

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice