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NCT00473590 · OUTCOME

Duration of Response

A Study of Bevacizumab in Combination With Bortezomib in Patients With Relapsed or Refractory Multiple Myeloma (AMBER) · Source last updated 2017-06-14

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
MEDIAN
Unit
Months
Interval / dispersion
95% Confidence Interval
Time frame
From randomization to the end of study (clinical cut-off; up to 116 weeks).

What was measured

Duration of response was defined as the time from the initial response to disease progression or death on study. Disease progression was determined by the investigator using the IMWG's uniform response criteria and defined as an increase of ≥25% from best response in: Serum M-protein and/or Urine M-protein and/or Marrow plasma cells; or new or increased plasmacytomas or bone lesions; or hypercalcemia due to myeloma. Duration of response was estimated using Kaplan-Meier. For patients who had not progressed or died, duration of response was censored at the date of the last response assessment.

Analysis population: Randomized Patients with an overall response

Groups in this outcome

BORT + P

Participants received bortezomib 1.3 mg/m\^2 administered as a 3- to 5-second bolus intravenous injection on Days 1, 4, 8, and 11 of a 21-day cycle for a maximum of eight cycles and placebo intravenous infusion on the first day of each 21-day cycle during the blinded treatment phase. At the completion of the 8-cycle treatment phase, participants entered the observation phase until disease progression.

BORT + BV

Participants received bortezomib 1.3 mg/m\^2 administered as a 3- to 5-second bolus intravenous injection on Days 1, 4, 8, and 11 of a 21-day cycle for a maximum of eight cycles and bevacizumab 15 mg/kg administered by intravenous infusion on the first day of each 21-day cycle during the blinded treatment phase. After completion of 8 cycles, participants could continue to receive bevacizumab as monotherapy until disease progression.

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

Analysis denominator · Participants

GroupSource count
BORT + P23
BORT + BV25

Reported measurements

Source class 1
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
BORT + P6.0Not reported4.868.31Not reported
BORT + BV6.9Not reported4.7311.83Not reported

Source statistical analyses

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

  1. ci Lower Limit
    0.404
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    2.261
    estimate Comment
    The hazard ratios were estimated using Cox regression.
    group Description
    Stratified analysis
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.9179
    param Type
    Hazard Ratio (HR)
    param Value
    0.956
    statistical Comment
    The strata were number of prior cancer treatments (1, \> 1) and β2-microglobulin level (\< 3.5, ≥ 3.5 mg/L).
    statistical Method
    Log Rank
  2. ci Lower Limit
    0.369
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.893
    estimate Comment
    The hazard ratios were estimated using Cox regression.
    group Description
    Unstratified analysis.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.6665
    p Value Comment
    The tests were exploratory because patients were not randomized to the two arms with respect to response status.
    param Type
    Hazard Ratio (HR)
    param Value
    0.836
    statistical Method
    Log Rank
Complete source fields
analyses
  1. ci Lower Limit
    0.404
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    2.261
    estimate Comment
    The hazard ratios were estimated using Cox regression.
    group Description
    Stratified analysis
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.9179
    param Type
    Hazard Ratio (HR)
    param Value
    0.956
    statistical Comment
    The strata were number of prior cancer treatments (1, \> 1) and β2-microglobulin level (\< 3.5, ≥ 3.5 mg/L).
    statistical Method
    Log Rank
  2. ci Lower Limit
    0.369
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.893
    estimate Comment
    The hazard ratios were estimated using Cox regression.
    group Description
    Unstratified analysis.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.6665
    p Value Comment
    The tests were exploratory because patients were not randomized to the two arms with respect to response status.
    param Type
    Hazard Ratio (HR)
    param Value
    0.836
    statistical Method
    Log Rank
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        4.86
        upper Limit
        8.31
        value
        6.0
      2. group Id
        OG001
        lower Limit
        4.73
        upper Limit
        11.83
        value
        6.9
denoms
  1. counts
    1. group Id
      OG000
      value
      23
    2. group Id
      OG001
      value
      25
    units
    Participants
description
Duration of response was defined as the time from the initial response to disease progression or death on study. Disease progression was determined by the investigator using the IMWG's uniform response criteria and defined as an increase of ≥25% from best response in: Serum M-protein and/or Urine M-protein and/or Marrow plasma cells; or new or increased plasmacytomas or bone lesions; or hypercalcemia due to myeloma. Duration of response was estimated using Kaplan-Meier. For patients who had not progressed or died, duration of response was censored at the date of the last response assessment.
dispersion Type
95% Confidence Interval
groups
  1. description
    Participants received bortezomib 1.3 mg/m\^2 administered as a 3- to 5-second bolus intravenous injection on Days 1, 4, 8, and 11 of a 21-day cycle for a maximum of eight cycles and placebo intravenous infusion on the first day of each 21-day cycle during the blinded treatment phase. At the completion of the 8-cycle treatment phase, participants entered the observation phase until disease progression.
    id
    OG000
    title
    BORT + P
  2. description
    Participants received bortezomib 1.3 mg/m\^2 administered as a 3- to 5-second bolus intravenous injection on Days 1, 4, 8, and 11 of a 21-day cycle for a maximum of eight cycles and bevacizumab 15 mg/kg administered by intravenous infusion on the first day of each 21-day cycle during the blinded treatment phase. After completion of 8 cycles, participants could continue to receive bevacizumab as monotherapy until disease progression.
    id
    OG001
    title
    BORT + BV
param Type
MEDIAN
population Description
Randomized Patients with an overall response
reporting Status
POSTED
time Frame
From randomization to the end of study (clinical cut-off; up to 116 weeks).
title
Duration of Response
type
SECONDARY
unit Of Measure
Months

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Preserved source evidence · Not medical advice