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NCT00813150 · OUTCOME

Overall Survival (OS)

Study of Bortezomib and Dexamethasone With or Without Cyclophosphamide in Patients With Relapsed or Not Controllable Multiple Myeloma · Source last updated 2014-08-15

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 the date of randomization until Month 49

What was measured

Time interval in months time from randomisation to death from any cause.

Analysis population: Intent-to-treat (ITT): Participants received at least 1 dose of study medication were included in the ITT analysis set. Participants still alive at the end of the study or dropped out will be censored with the last available date.

Groups in this outcome

Vd (Bortezomib + Dexamethasone)

Participants received bortezomib at a dose of 1.3 mg/m² body surface area (BSA) for eight 3-week cycles. Within each cycle it was administered twice weekly (on Days 1, 4, 8, and 11) followed by a 10-day rest period (Days 12 through 21). They received single oral doses of 20 mg dexamethasone on Days 1 and 2, 4 and 5, 8 and 9, and 11 and 12 of each cycle.

Vcd (Bortezomib + Low-dose Dexamethasone + Cyclophosphamide)

Participants received bortezomib at a dose of 1.3 mg/m² body surface area (BSA) for eight 3-week cycles. Within each cycle it was administered twice weekly (on Days 1, 4, 8, and 11) followed by a 10-day rest period (Days 12 through 21). They received single oral doses of 20 mg dexamethasone on Days 1 and 2, 4 and 5, 8 and 9, and 11 and 12 of each cycle and single oral doses of 50 mg cyclophosphamide on a once daily basis from Day 1, Cycle 1 continuously until Day 21, Cycle 8.

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

Analysis denominator · Participants

GroupSource count
Vd (Bortezomib + Dexamethasone)43
Vcd (Bortezomib + Low-dose Dexamethasone + Cyclophosphamide)47

Reported measurements

Source class 1
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Vd (Bortezomib + Dexamethasone)NANot reportedNANAThe values could not be estimated
Vcd (Bortezomib + Low-dose Dexamethasone + Cyclophosphamide)41.50Not reported24.87NAThe upper limit value could not be estimated

Source statistical analyses

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

  1. ci Lower Limit
    0.41
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.73
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.645
    param Type
    Hazard Ratio (HR)
    param Value
    0.85
    statistical Method
    Regression, Cox
    tested Non Inferiority
    false
Complete source fields
analyses
  1. ci Lower Limit
    0.41
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.73
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.645
    param Type
    Hazard Ratio (HR)
    param Value
    0.85
    statistical Method
    Regression, Cox
    tested Non Inferiority
    false
classes
  1. categories
    1. measurements
      1. comment
        The values could not be estimated
        group Id
        OG000
        lower Limit
        NA
        upper Limit
        NA
        value
        NA
      2. comment
        The upper limit value could not be estimated
        group Id
        OG001
        lower Limit
        24.87
        upper Limit
        NA
        value
        41.50
denoms
  1. counts
    1. group Id
      OG000
      value
      43
    2. group Id
      OG001
      value
      47
    units
    Participants
description
Time interval in months time from randomisation to death from any cause.
dispersion Type
95% Confidence Interval
groups
  1. description
    Participants received bortezomib at a dose of 1.3 mg/m² body surface area (BSA) for eight 3-week cycles. Within each cycle it was administered twice weekly (on Days 1, 4, 8, and 11) followed by a 10-day rest period (Days 12 through 21). They received single oral doses of 20 mg dexamethasone on Days 1 and 2, 4 and 5, 8 and 9, and 11 and 12 of each cycle.
    id
    OG000
    title
    Vd (Bortezomib + Dexamethasone)
  2. description
    Participants received bortezomib at a dose of 1.3 mg/m² body surface area (BSA) for eight 3-week cycles. Within each cycle it was administered twice weekly (on Days 1, 4, 8, and 11) followed by a 10-day rest period (Days 12 through 21). They received single oral doses of 20 mg dexamethasone on Days 1 and 2, 4 and 5, 8 and 9, and 11 and 12 of each cycle and single oral doses of 50 mg cyclophosphamide on a once daily basis from Day 1, Cycle 1 continuously until Day 21, Cycle 8.
    id
    OG001
    title
    Vcd (Bortezomib + Low-dose Dexamethasone + Cyclophosphamide)
param Type
MEDIAN
population Description
Intent-to-treat (ITT): Participants received at least 1 dose of study medication were included in the ITT analysis set. Participants still alive at the end of the study or dropped out will be censored with the last available date.
reporting Status
POSTED
time Frame
From the date of randomization until Month 49
title
Overall Survival (OS)
type
SECONDARY
unit Of Measure
Months

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

Preserved source evidence · Not medical advice