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NCT00507416 · OUTCOME

Overall Survival

Velcade,Thalidomide, and Dexamethasone Versus Velcade and Dexamethasone Versus Velcade, Melphalan, and Prednisone · Source last updated 2014-05-01

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. Median follow-up time was 43 months.

What was measured

Overall survival is defined as the time between randomization and death. Participants still alive at the cutoff date or lost to follow-up were censored at the date of last contact.

Analysis population: Intent to treat

Groups in this outcome

Bortezomib and Dexamethasone

Participants received bortezomib (Velcade) 1.3 mg/m\^2 administered as a bolus intravenous (IV) injection on Days 1, 4, 8, and 11, and dexamethasone 20 mg orally on Days 1, 2, 4, 5, 8, 9, 11 and 12 for eight 21-day treatment cycles (Induction). Participants then received bortezomib 1.6 mg/\^2 IV on Days 1, 8, 15 and 22 for five 35-day cycles (Maintenance).

Bortezomib, Thalidomide, and Dexamethasone

Participants received bortezomib 1.3 mg/m\^2 administered as a bolus IV injection on Days 1, 4, 8, and 11, and dexamethasone 20 mg orally on Days 1, 2, 4, 5, 8, 9, 11 and 12, and thalidomide 100 mg orally on Days 1-21 for eight 21-day treatment cycles (Induction). Participants then received bortezomib 1.6 mg/\^2 IV on Days 1, 8, 15 and 22 for five 35-day cycles (Maintenance).

Bortezomib, Melphalan and Prednisone

Participants received bortezomib 1.3 mg/m\^2 administered as a bolus IV injection on Days 1, 4, 8, and 11, and melphalan 9 mg/m\^2 orally on Days 1-4 every other cycle and prednisone 60 mg/m\^2 orally on Days 1-4 every other cycle for eight 21-day treatment cycles (Induction). Participants then received bortezomib 1.6 mg/\^2 IV on Days 1, 8, 15 and 22 for five 35-day cycles (Maintenance).

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

Analysis denominator · Participants

GroupSource count
Bortezomib and Dexamethasone168
Bortezomib, Thalidomide, and Dexamethasone167
Bortezomib, Melphalan and Prednisone167

Reported measurements

Source class 1
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Bortezomib and Dexamethasone49.8Not reported35.7NAUpper limit was not estimable due to low number of events
Bortezomib, Thalidomide, and Dexamethasone51.5Not reported38.5NAUpper limit was not estimable due to low number of events
Bortezomib, Melphalan and Prednisone53.1Not reported41.1NAUpper limit was not estimable due to low number of events
Complete source fields
classes
  1. categories
    1. measurements
      1. comment
        Upper limit was not estimable due to low number of events
        group Id
        OG000
        lower Limit
        35.7
        upper Limit
        NA
        value
        49.8
      2. comment
        Upper limit was not estimable due to low number of events
        group Id
        OG001
        lower Limit
        38.5
        upper Limit
        NA
        value
        51.5
      3. comment
        Upper limit was not estimable due to low number of events
        group Id
        OG002
        lower Limit
        41.1
        upper Limit
        NA
        value
        53.1
denoms
  1. counts
    1. group Id
      OG000
      value
      168
    2. group Id
      OG001
      value
      167
    3. group Id
      OG002
      value
      167
    units
    Participants
description
Overall survival is defined as the time between randomization and death. Participants still alive at the cutoff date or lost to follow-up were censored at the date of last contact.
dispersion Type
95% Confidence Interval
groups
  1. description
    Participants received bortezomib (Velcade) 1.3 mg/m\^2 administered as a bolus intravenous (IV) injection on Days 1, 4, 8, and 11, and dexamethasone 20 mg orally on Days 1, 2, 4, 5, 8, 9, 11 and 12 for eight 21-day treatment cycles (Induction). Participants then received bortezomib 1.6 mg/\^2 IV on Days 1, 8, 15 and 22 for five 35-day cycles (Maintenance).
    id
    OG000
    title
    Bortezomib and Dexamethasone
  2. description
    Participants received bortezomib 1.3 mg/m\^2 administered as a bolus IV injection on Days 1, 4, 8, and 11, and dexamethasone 20 mg orally on Days 1, 2, 4, 5, 8, 9, 11 and 12, and thalidomide 100 mg orally on Days 1-21 for eight 21-day treatment cycles (Induction). Participants then received bortezomib 1.6 mg/\^2 IV on Days 1, 8, 15 and 22 for five 35-day cycles (Maintenance).
    id
    OG001
    title
    Bortezomib, Thalidomide, and Dexamethasone
  3. description
    Participants received bortezomib 1.3 mg/m\^2 administered as a bolus IV injection on Days 1, 4, 8, and 11, and melphalan 9 mg/m\^2 orally on Days 1-4 every other cycle and prednisone 60 mg/m\^2 orally on Days 1-4 every other cycle for eight 21-day treatment cycles (Induction). Participants then received bortezomib 1.6 mg/\^2 IV on Days 1, 8, 15 and 22 for five 35-day cycles (Maintenance).
    id
    OG002
    title
    Bortezomib, Melphalan and Prednisone
param Type
MEDIAN
population Description
Intent to treat
reporting Status
POSTED
time Frame
From randomization until death. Median follow-up time was 43 months.
title
Overall Survival
type
SECONDARY
unit Of Measure
months

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

Preserved source evidence · Not medical advice