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NCT00473590 · OUTCOME

Progression-free Survival (PFS)

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 disease progression or death on study (up to 116 weeks).

What was measured

Progression-free survival (PFS) was defined as the time from randomization to disease progression or death on study from any cause within 30 days of the last response assessment. Disease progression was determined by the investigator using the International Myeloma Working Group's (IMWG) uniform response criteria. Median PFS was estimated using Kaplan-Meier methodology. For patients who were alive at the time of the analysis and whose disease had not yet progressed, PFS was censored at the time of the last response assessment.

Analysis population: Randomized Patients

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 + P53
BORT + BV49

Reported measurements

Source class 1
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
BORT + P5.1Not reported4.177.20Not reported
BORT + BV6.2Not reported4.408.54Not reported

Source statistical analyses

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

  1. ci Lower Limit
    0.432
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.276
    estimate Comment
    The hazard ratio was estimated using Cox regression. The hazard ratio is relative to BORT + P.
    group Description
    The null hypothesis was that there was no difference between the 2 treatment groups. The alternative hypothesis was that progression-free survival was longer in the BORT + BV group. Stratified Analysis.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.2804
    param Type
    Hazard Ratio (HR)
    param Value
    0.743
    statistical Comment
    The analysis was stratified for 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
    0.424
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.200
    estimate Comment
    Hazard ratio relative to BORT + P was estimated using Cox regression.
    group Description
    Unstratified Analysis.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.2009
    param Type
    Hazard Ratio (HR)
    param Value
    0.713
    statistical Method
    Log Rank
Complete source fields
analyses
  1. ci Lower Limit
    0.432
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.276
    estimate Comment
    The hazard ratio was estimated using Cox regression. The hazard ratio is relative to BORT + P.
    group Description
    The null hypothesis was that there was no difference between the 2 treatment groups. The alternative hypothesis was that progression-free survival was longer in the BORT + BV group. Stratified Analysis.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.2804
    param Type
    Hazard Ratio (HR)
    param Value
    0.743
    statistical Comment
    The analysis was stratified for 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
    0.424
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.200
    estimate Comment
    Hazard ratio relative to BORT + P was estimated using Cox regression.
    group Description
    Unstratified Analysis.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.2009
    param Type
    Hazard Ratio (HR)
    param Value
    0.713
    statistical Method
    Log Rank
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        4.17
        upper Limit
        7.20
        value
        5.1
      2. group Id
        OG001
        lower Limit
        4.40
        upper Limit
        8.54
        value
        6.2
denoms
  1. counts
    1. group Id
      OG000
      value
      53
    2. group Id
      OG001
      value
      49
    units
    Participants
description
Progression-free survival (PFS) was defined as the time from randomization to disease progression or death on study from any cause within 30 days of the last response assessment. Disease progression was determined by the investigator using the International Myeloma Working Group's (IMWG) uniform response criteria. Median PFS was estimated using Kaplan-Meier methodology. For patients who were alive at the time of the analysis and whose disease had not yet progressed, PFS was censored at the time 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
reporting Status
POSTED
time Frame
From randomization to disease progression or death on study (up to 116 weeks).
title
Progression-free Survival (PFS)
type
PRIMARY
unit Of Measure
months

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Preserved source evidence · Not medical advice