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NCT00916058 · OUTCOME

Overall Survival at 2 Years (Phase 1)

Conditioning Regimen of Bendamustine and Melphalan Followed by Transplant in Patients With Multiple Myeloma · Source last updated 2019-06-04

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
MEDIAN
Unit
Percentage of participants alive
Interval / dispersion
95% Confidence Interval
Time frame
From Day 0 until time of death, assessed up to 2 years.

What was measured

Time elapsed between Day 0 and death from any cause, whichever came first, assessed up to 2 years.

Analysis population: Phase 1 includes all patients treated on Phase 1 of the study (Dose Levels 1-6). All cohorts were evaluated as one group for assessment of overall survival, as overall survival is a secondary endpoint and there was no intent to stratify by cohort for the analysis. The number of patients per cohort is also too small for to evaluate by cohort.

Groups in this outcome

Phase 1

Patients treated on Dose Level 1 through Dose Level 6. All patients received Melphalan 200 mg/m\^2 total (140 mg/m\^2 total for patients with Creatinine Clearance \<70 ml/min). Dose Level 1; Bendamustine 30 mg/m\^2 total Dose Level 2; Bendamustine 60 mg/m\^2 total Dose Level 3; Bendamustine 90 mg/m\^2 total Dose Level 4; Bendamustine 120 mg/m\^2 total Dose Level 5; Bendamustine 150 mg/m\^2 total Dose Level 6; Bendamustine 225 mg/m\^2 total

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 125

Reported measurements

Source class 1
Values in Percentage of participants alive · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Phase 170Not reported43.985.7Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        43.9
        upper Limit
        85.7
        value
        70
denoms
  1. counts
    1. group Id
      OG000
      value
      25
    units
    Participants
description
Time elapsed between Day 0 and death from any cause, whichever came first, assessed up to 2 years.
dispersion Type
95% Confidence Interval
groups
  1. description
    Patients treated on Dose Level 1 through Dose Level 6. All patients received Melphalan 200 mg/m\^2 total (140 mg/m\^2 total for patients with Creatinine Clearance \<70 ml/min). Dose Level 1; Bendamustine 30 mg/m\^2 total Dose Level 2; Bendamustine 60 mg/m\^2 total Dose Level 3; Bendamustine 90 mg/m\^2 total Dose Level 4; Bendamustine 120 mg/m\^2 total Dose Level 5; Bendamustine 150 mg/m\^2 total Dose Level 6; Bendamustine 225 mg/m\^2 total
    id
    OG000
    title
    Phase 1
param Type
MEDIAN
population Description
Phase 1 includes all patients treated on Phase 1 of the study (Dose Levels 1-6). All cohorts were evaluated as one group for assessment of overall survival, as overall survival is a secondary endpoint and there was no intent to stratify by cohort for the analysis. The number of patients per cohort is also too small for to evaluate by cohort.
reporting Status
POSTED
time Frame
From Day 0 until time of death, assessed up to 2 years.
title
Overall Survival at 2 Years (Phase 1)
type
SECONDARY
unit Of Measure
Percentage of participants alive

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

Preserved source evidence · Not medical advice