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NCT01177683 · OUTCOME

Phase II: Duration of Survival

Bendamustine in Combination With Bortezomib and Pegylated Liposomal Doxorubicin for Multiple Myeloma · Source last updated 2023-10-06

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 C1D1 up to a maximum of 52 months

What was measured

Duration of MM patients treated with bendamustine, bortezomib and pegylated liposomal doxorubicin. from first date of at least partial response to the time of progression or death due to disease progression as events, with disease progression and death due to disease progression as events and deaths due to causes other than progression as censored. Censoring date will be the last disease evaluation date or date of death due to other causes as appropriate.

Analysis population: Two subjects never received treatment. Therefore, they were not included in any assessment of objectives.

Groups in this outcome

Phase II : Bendamustine in Combination With Bortezomib and Pegylated Liposomal Doxorubicin.

Bendamustine: At phase II, Bendamustine will be administered at 90mg/m\^2 by IV over 1 hour at days 1 and 4 of the 28 day treatment cycle. Doxorubicin: Pegylated liposomal doxorubicin at phase II will be administered at 30 mg/m2 by IV over 1 hour,at day 4 of the 28 day treatment cycle. Bortezomib: Bortezomib at Phase II will be administered at 1.3 mg/m2 by IV bolus or SQ injection on days 1, 4, 8, and 11 of the 28 day cycle.

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

Analysis denominator · Participants

GroupSource count
Phase II : Bendamustine in Combination With Bortezomib and Pegylated Liposomal Doxorubicin.24

Reported measurements

Source class 1
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Phase II : Bendamustine in Combination With Bortezomib and Pegylated Liposomal Doxorubicin.13.80Not reported7.85NAThe upper limit could not be determined within 95% confidence interval due to low enrollment.The limited sample size is not enough to accurately estimate the upper limit of the confidence interval. A larger sample size would be needed to get a more reliable estimate.
Complete source fields
classes
  1. categories
    1. measurements
      1. comment
        The upper limit could not be determined within 95% confidence interval due to low enrollment.The limited sample size is not enough to accurately estimate the upper limit of the confidence interval. A larger sample size would be needed to get a more reliable estimate.
        group Id
        OG000
        lower Limit
        7.85
        upper Limit
        NA
        value
        13.80
denoms
  1. counts
    1. group Id
      OG000
      value
      24
    units
    Participants
description
Duration of MM patients treated with bendamustine, bortezomib and pegylated liposomal doxorubicin. from first date of at least partial response to the time of progression or death due to disease progression as events, with disease progression and death due to disease progression as events and deaths due to causes other than progression as censored. Censoring date will be the last disease evaluation date or date of death due to other causes as appropriate.
dispersion Type
95% Confidence Interval
groups
  1. description
    Bendamustine: At phase II, Bendamustine will be administered at 90mg/m\^2 by IV over 1 hour at days 1 and 4 of the 28 day treatment cycle. Doxorubicin: Pegylated liposomal doxorubicin at phase II will be administered at 30 mg/m2 by IV over 1 hour,at day 4 of the 28 day treatment cycle. Bortezomib: Bortezomib at Phase II will be administered at 1.3 mg/m2 by IV bolus or SQ injection on days 1, 4, 8, and 11 of the 28 day cycle.
    id
    OG000
    title
    Phase II : Bendamustine in Combination With Bortezomib and Pegylated Liposomal Doxorubicin.
param Type
MEDIAN
population Description
Two subjects never received treatment. Therefore, they were not included in any assessment of objectives.
reporting Status
POSTED
time Frame
From C1D1 up to a maximum of 52 months
title
Phase II: Duration of Survival
type
SECONDARY
unit Of Measure
months

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

Preserved source evidence · Not medical advice