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NCT00872521 · OUTCOME

Disease Response 3-months After Autologous Stem Cell Transplant (ASCT)

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
Participants
Interval / dispersion
Not reported
Time frame
3-months after ASCT

What was measured

Number of participants who achieved stringent complete response (sCR), complete response (CR), very good partial response (VGPR), partial response (PR), stable disease (SD) and relapse as per IMWG criteria.

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.

Failed/Missing

Participants who failed 1q21 test/had missing results for 1q21 test. 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.

Total

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
Failed/Missing7
Total85

Reported measurements

stringent complete response (sCR)
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
1q21 Not Amplified6Not reportedNot reportedNot reportedNot reported
1q21 Amplified5Not reportedNot reportedNot reportedNot reported
Failed/Missing3Not reportedNot reportedNot reportedNot reported
Total14Not reportedNot reportedNot reportedNot reported
complete response (CR)
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
1q21 Not Amplified8Not reportedNot reportedNot reportedNot reported
1q21 Amplified3Not reportedNot reportedNot reportedNot reported
Failed/Missing0Not reportedNot reportedNot reportedNot reported
Total11Not reportedNot reportedNot reportedNot reported
Very Good Partial Response (VGPR)
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
1q21 Not Amplified21Not reportedNot reportedNot reportedNot reported
1q21 Amplified7Not reportedNot reportedNot reportedNot reported
Failed/Missing1Not reportedNot reportedNot reportedNot reported
Total29Not reportedNot reportedNot reportedNot reported
Partial Response (PR)
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
1q21 Not Amplified19Not reportedNot reportedNot reportedNot reported
1q21 Amplified5Not reportedNot reportedNot reportedNot reported
Failed/Missing3Not reportedNot reportedNot reportedNot reported
Total27Not reportedNot reportedNot reportedNot reported
Stable Disease (SD)
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
1q21 Not Amplified3Not reportedNot reportedNot reportedNot reported
1q21 Amplified0Not reportedNot reportedNot reportedNot reported
Failed/Missing0Not reportedNot reportedNot reportedNot reported
Total3Not reportedNot reportedNot reportedNot reported
Relapse
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
1q21 Not Amplified1Not reportedNot reportedNot reportedNot reported
1q21 Amplified0Not reportedNot reportedNot reportedNot reported
Failed/Missing0Not reportedNot reportedNot reportedNot reported
Total1Not reportedNot reportedNot reportedNot reported
Total
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
1q21 Not Amplified58Not reportedNot reportedNot reportedNot reported
1q21 Amplified20Not reportedNot reportedNot reportedNot reported
Failed/Missing7Not reportedNot reportedNot reportedNot reported
Total85Not 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
    0.56
    statistical Method
    Chi-squared
    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
    0.56
    statistical Method
    Chi-squared
    tested Non Inferiority
    false
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        6
      2. group Id
        OG001
        value
        5
      3. group Id
        OG002
        value
        3
      4. group Id
        OG003
        value
        14
    title
    stringent complete response (sCR)
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        8
      2. group Id
        OG001
        value
        3
      3. group Id
        OG002
        value
        0
      4. group Id
        OG003
        value
        11
    title
    complete response (CR)
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        21
      2. group Id
        OG001
        value
        7
      3. group Id
        OG002
        value
        1
      4. group Id
        OG003
        value
        29
    title
    Very Good Partial Response (VGPR)
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        19
      2. group Id
        OG001
        value
        5
      3. group Id
        OG002
        value
        3
      4. group Id
        OG003
        value
        27
    title
    Partial Response (PR)
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        3
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
      4. group Id
        OG003
        value
        3
    title
    Stable Disease (SD)
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
      4. group Id
        OG003
        value
        1
    title
    Relapse
  7. categories
    1. measurements
      1. group Id
        OG000
        value
        58
      2. group Id
        OG001
        value
        20
      3. group Id
        OG002
        value
        7
      4. group Id
        OG003
        value
        85
    title
    Total
denoms
  1. counts
    1. group Id
      OG000
      value
      58
    2. group Id
      OG001
      value
      20
    3. group Id
      OG002
      value
      7
    4. group Id
      OG003
      value
      85
    units
    Participants
description
Number of participants who achieved stringent complete response (sCR), complete response (CR), very good partial response (VGPR), partial response (PR), stable disease (SD) and relapse as per IMWG criteria.
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
  3. description
    Participants who failed 1q21 test/had missing results for 1q21 test. 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
    OG002
    title
    Failed/Missing
  4. description
    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
    OG003
    title
    Total
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
3-months after ASCT
title
Disease Response 3-months After Autologous Stem Cell Transplant (ASCT)
type
SECONDARY
unit Of Measure
Participants

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Preserved source evidence · Not medical advice