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NCT00872521 · OUTCOME

Overall Response Rate (ORR): Number of Participants Who Are Responders (Had Stringent Complete Response [sCR], CR, Very Good Partial Response [VGPR] or Partial Response [PR]) After 4 Cycles of Bortezomib, Doxorubicin and Dexamethasone (PAD) Induction

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
84 days

What was measured

International Myeloma Working Group (IMWG) criteria - CR: negative immunofixation on the serum and urine, no soft tissue plasmacytomas and \<5% plasma cells in the bone marrow; sCR: CR+normal free light chain ratio, no clonal cells in bone marrow by immunohistochemistry or immunofluorescence; VGPR: serum and urine M-protein detected by immunofixation but not electrophoresis, \>90% in serum M-protein+urine, M-protein level \<100 mg/24hour; PR: ≥50% decrease of serum and M-protein, 24 hour urinary M-protein decrease by ≥90% or \<200 mg/24hour

Analysis population: Intent-to-treat (ITT) population- All enrolled participants who proceeded to receive Day 1 of Cycle 1 of PAD induction.

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 Test

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 Amplified63
1q21 Amplified20
Failed/Missing Test8
Total91

Reported measurements

Non Responder
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
1q21 Not Amplified8Not reportedNot reportedNot reportedNot reported
1q21 Amplified0Not reportedNot reportedNot reportedNot reported
Failed/Missing Test1Not reportedNot reportedNot reportedNot reported
Total9Not reportedNot reportedNot reportedNot reported
Responder
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
1q21 Not Amplified55Not reportedNot reportedNot reportedNot reported
1q21 Amplified20Not reportedNot reportedNot reportedNot reported
Failed/Missing Test7Not reportedNot reportedNot reportedNot reported
Total82Not reportedNot reportedNot reportedNot reported
Total
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
1q21 Not Amplified63Not reportedNot reportedNot reportedNot reported
1q21 Amplified20Not reportedNot reportedNot reportedNot reported
Failed/Missing Test8Not reportedNot reportedNot reportedNot reported
Total91Not reportedNot reportedNot reportedNot reported

Source statistical analyses

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

  1. ci Num Sides
    TWO_SIDED
    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
    0.09
    statistical Method
    Chi-squared
    tested Non Inferiority
    false
Complete source fields
analyses
  1. ci Num Sides
    TWO_SIDED
    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
    0.09
    statistical Method
    Chi-squared
    tested Non Inferiority
    false
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        8
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        1
      4. group Id
        OG003
        value
        9
    title
    Non Responder
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        55
      2. group Id
        OG001
        value
        20
      3. group Id
        OG002
        value
        7
      4. group Id
        OG003
        value
        82
    title
    Responder
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        63
      2. group Id
        OG001
        value
        20
      3. group Id
        OG002
        value
        8
      4. group Id
        OG003
        value
        91
    title
    Total
denoms
  1. counts
    1. group Id
      OG000
      value
      63
    2. group Id
      OG001
      value
      20
    3. group Id
      OG002
      value
      8
    4. group Id
      OG003
      value
      91
    units
    Participants
description
International Myeloma Working Group (IMWG) criteria - CR: negative immunofixation on the serum and urine, no soft tissue plasmacytomas and \<5% plasma cells in the bone marrow; sCR: CR+normal free light chain ratio, no clonal cells in bone marrow by immunohistochemistry or immunofluorescence; VGPR: serum and urine M-protein detected by immunofixation but not electrophoresis, \>90% in serum M-protein+urine, M-protein level \<100 mg/24hour; PR: ≥50% decrease of serum and M-protein, 24 hour urinary M-protein decrease by ≥90% or \<200 mg/24hour
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 Test
  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 enrolled participants who proceeded to receive Day 1 of Cycle 1 of PAD induction.
reporting Status
POSTED
time Frame
84 days
title
Overall Response Rate (ORR): Number of Participants Who Are Responders (Had Stringent Complete Response [sCR], CR, Very Good Partial Response [VGPR] or Partial Response [PR]) After 4 Cycles of Bortezomib, Doxorubicin and Dexamethasone (PAD) Induction
type
PRIMARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice