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NCT00520767 · OUTCOME

Time to Treatment Failure (TTF)

Bortezomib, Melphalan, and Dexamethasone in Treating Patients With Primary Amyloidosis or Light Chain Deposition Disease · Source last updated 2023-12-22

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

Measure
MEDIAN
Unit
month
Interval / dispersion
95% Confidence Interval
Time frame
start of treatment until 72 months

What was measured

Time from start of treatment until date of documented disease progression, removal from protocol due to toxicity, or death from any cause.

Groups in this outcome

Melphalan, Dexamethasone, Bortezomib,

Bortezomib 1.3 mg/m2 days 1, 8, 15, 22; Dexamethasone 40 mg/d days 1, 2, 8, 9, 15, 16, 22, 23; Melphalan 9 mg/m2/day days 1-4 bortezomib: Bortezomib 1.3 mg/m2 days 1, 8, 15, 22 dexamethasone: Dexamethasone 40 mg/d days 1, 2, 8, 9, 15, 16, 22, 23 melphalan: Melphalan 9 mg/m2/day days 1-4 microarray analysis: ≤28 days prior to enrollment flow cytometry: Day 1 of cycles 6, 12, 18 and at end of study. laboratory biomarker analysis: ≤28 days prior to enrollment quality-of-life assessment: Start of each 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
Melphalan, Dexamethasone, Bortezomib,35

Reported measurements

Source class 1
Values in month · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Melphalan, Dexamethasone, Bortezomib,18.1Not reported10.834.4Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        10.8
        upper Limit
        34.4
        value
        18.1
denoms
  1. counts
    1. group Id
      OG000
      value
      35
    units
    Participants
description
Time from start of treatment until date of documented disease progression, removal from protocol due to toxicity, or death from any cause.
dispersion Type
95% Confidence Interval
groups
  1. description
    Bortezomib 1.3 mg/m2 days 1, 8, 15, 22; Dexamethasone 40 mg/d days 1, 2, 8, 9, 15, 16, 22, 23; Melphalan 9 mg/m2/day days 1-4 bortezomib: Bortezomib 1.3 mg/m2 days 1, 8, 15, 22 dexamethasone: Dexamethasone 40 mg/d days 1, 2, 8, 9, 15, 16, 22, 23 melphalan: Melphalan 9 mg/m2/day days 1-4 microarray analysis: ≤28 days prior to enrollment flow cytometry: Day 1 of cycles 6, 12, 18 and at end of study. laboratory biomarker analysis: ≤28 days prior to enrollment quality-of-life assessment: Start of each cycle
    id
    OG000
    title
    Melphalan, Dexamethasone, Bortezomib,
param Type
MEDIAN
reporting Status
POSTED
time Frame
start of treatment until 72 months
title
Time to Treatment Failure (TTF)
type
SECONDARY
unit Of Measure
month

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

Preserved source evidence · Not medical advice