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NCT00734149 · OUTCOME

Median Duration of Response

Bortezomib With Melphalan and Prednisone for Multiple Myeloma · Source last updated 2023-11-07

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
up to 4 years

What was measured

Duration of response is measured from date of first confirmed response until date of disease progression.

Groups in this outcome

Bortezomib+Melphalan+Prednisone: Non-ASCT

Bortezomib 1.3 mg/m2 is administered intravenously in a 3-5 second bolus on days 1, 4, 8, and 11 of a 28 day cycle. Six cycles are planned. On days when both melphalan and bortezomib are given, melphalan is given at least one hour prior to bortezomib. Melphalan 6 mg/m2 is administered orally on an empty stomach daily on days 1-7 of each cycle. Prednisone 60 mg/m2 is administered orally daily on days 1-7 of each cycle. Patients did not proceed to autologous stem cell transplant (ASCT).

Bortezomib+Melphalan+Prednisone: ASCT

Bortezomib 1.3 mg/m2 is administered intravenously in a 3-5 second bolus on days 1, 4, 8, and 11 of a 28 day cycle. Six cycles are planned. On days when both melphalan and bortezomib are given, melphalan is given at least one hour prior to bortezomib. Melphalan 6 mg/m2 is administered orally on an empty stomach daily on days 1-7 of each cycle. Prednisone 60 mg/m2 is administered orally daily on days 1-7 of each cycle. Patients proceeded to autologous stem cell transplant (ASCT).

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+Melphalan+Prednisone: Non-ASCT24
Bortezomib+Melphalan+Prednisone: ASCT20

Reported measurements

Source class 1
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Bortezomib+Melphalan+Prednisone: Non-ASCT19.8Not reported14.3NANA = many patients were censored at the time of last assessment, and therefore upper bound was not estimable- confidence intervals are extremely wide.
Bortezomib+Melphalan+Prednisone: ASCT27.9Not reported14.6NANA = many patients were censored at the time of last assessment, and therefore upper bound was not estimable- confidence intervals are extremely wide.
Complete source fields
classes
  1. categories
    1. measurements
      1. comment
        NA = many patients were censored at the time of last assessment, and therefore upper bound was not estimable- confidence intervals are extremely wide.
        group Id
        OG000
        lower Limit
        14.3
        upper Limit
        NA
        value
        19.8
      2. comment
        NA = many patients were censored at the time of last assessment, and therefore upper bound was not estimable- confidence intervals are extremely wide.
        group Id
        OG001
        lower Limit
        14.6
        upper Limit
        NA
        value
        27.9
denoms
  1. counts
    1. group Id
      OG000
      value
      24
    2. group Id
      OG001
      value
      20
    units
    Participants
description
Duration of response is measured from date of first confirmed response until date of disease progression.
dispersion Type
95% Confidence Interval
groups
  1. description
    Bortezomib 1.3 mg/m2 is administered intravenously in a 3-5 second bolus on days 1, 4, 8, and 11 of a 28 day cycle. Six cycles are planned. On days when both melphalan and bortezomib are given, melphalan is given at least one hour prior to bortezomib. Melphalan 6 mg/m2 is administered orally on an empty stomach daily on days 1-7 of each cycle. Prednisone 60 mg/m2 is administered orally daily on days 1-7 of each cycle. Patients did not proceed to autologous stem cell transplant (ASCT).
    id
    OG000
    title
    Bortezomib+Melphalan+Prednisone: Non-ASCT
  2. description
    Bortezomib 1.3 mg/m2 is administered intravenously in a 3-5 second bolus on days 1, 4, 8, and 11 of a 28 day cycle. Six cycles are planned. On days when both melphalan and bortezomib are given, melphalan is given at least one hour prior to bortezomib. Melphalan 6 mg/m2 is administered orally on an empty stomach daily on days 1-7 of each cycle. Prednisone 60 mg/m2 is administered orally daily on days 1-7 of each cycle. Patients proceeded to autologous stem cell transplant (ASCT).
    id
    OG001
    title
    Bortezomib+Melphalan+Prednisone: ASCT
param Type
MEDIAN
reporting Status
POSTED
time Frame
up to 4 years
title
Median Duration of Response
type
SECONDARY
unit Of Measure
months

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

Preserved source evidence · Not medical advice