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NCT00473590 · OUTCOME

Overall Survival (OS)

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 until death from any cause, up until the end of study (clinical cut-off; up to 116 weeks).

What was measured

Overall survival was defined as the duration of time from randomization until death from any cause. All deaths were included, whether they occurred on study treatment or following treatment discontinuation. Overall survival was estimated using Kaplan-Meier. For patients who had not died, overall survival was censored at the date that the patient was last known to be alive.

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 + P24.0Not reported15.24NAUpper limit of 95% CI not estimable due to too few events at the time of analysis.
BORT + BVNANot reportedNANAThe median duration of overall survival in the BORT + BV arm was not estimable, as too few events had been observed

Source statistical analyses

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

  1. ci Lower Limit
    0.258
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.552
    estimate Comment
    The hazard ratios were estimated using Cox regression. The strata were number of prior cancer treatments (1, \> 1) and β2-microglobulin level (\< 3.5, ≥ 3.5 mg/L).
    group Description
    Stratified analysis
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.3134
    param Type
    Hazard Ratio (HR)
    param Value
    0.633
    statistical Method
    Log Rank
  2. ci Lower Limit
    0.251
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.468
    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
    0.2634
    param Type
    Hazard Ratio (HR)
    param Value
    0.608
    statistical Method
    Log Rank
Complete source fields
analyses
  1. ci Lower Limit
    0.258
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.552
    estimate Comment
    The hazard ratios were estimated using Cox regression. The strata were number of prior cancer treatments (1, \> 1) and β2-microglobulin level (\< 3.5, ≥ 3.5 mg/L).
    group Description
    Stratified analysis
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.3134
    param Type
    Hazard Ratio (HR)
    param Value
    0.633
    statistical Method
    Log Rank
  2. ci Lower Limit
    0.251
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.468
    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
    0.2634
    param Type
    Hazard Ratio (HR)
    param Value
    0.608
    statistical Method
    Log Rank
classes
  1. categories
    1. measurements
      1. comment
        Upper limit of 95% CI not estimable due to too few events at the time of analysis.
        group Id
        OG000
        lower Limit
        15.24
        upper Limit
        NA
        value
        24.0
      2. comment
        The median duration of overall survival in the BORT + BV arm was not estimable, as too few events had been observed
        group Id
        OG001
        lower Limit
        NA
        upper Limit
        NA
        value
        NA
denoms
  1. counts
    1. group Id
      OG000
      value
      53
    2. group Id
      OG001
      value
      49
    units
    Participants
description
Overall survival was defined as the duration of time from randomization until death from any cause. All deaths were included, whether they occurred on study treatment or following treatment discontinuation. Overall survival was estimated using Kaplan-Meier. For patients who had not died, overall survival was censored at the date that the patient was last known to be alive.
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 until death from any cause, up until the end of study (clinical cut-off; up to 116 weeks).
title
Overall Survival (OS)
type
SECONDARY
unit Of Measure
Months

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Preserved source evidence · Not medical advice