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NCT00477971 · OUTCOME

3 Year Overall Survival

Low-Dose Melphalan and Dexamethasone Compared With High-Dose Melphalan Followed By Autologous Stem Cell Transplant in Treating Patients With Primary Systemic Amyloidosis · Source last updated 2016-05-17

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

Measure
NUMBER
Unit
percentage of participants
Interval / dispersion
95% Confidence Interval
Time frame
3 years

What was measured

Percentage of patients who were alive at 3 years. The 3-year survival rate was estimated using the Kaplan Meier method.

Groups in this outcome

Low-Dose Melphalan

Patients receive low-dose melphalan 20 mg/m\^2 IV over 15-30 minutes on day 1 or 0.12 mg/kg tablet orally once daily on days 1-7 and dexamethasone 40 mg orally on days 1-4 and 22-25. Treatment repeats every 6 weeks for 10 courses. (Study treatment beyond one year is not allowed.)

High-Dose Melphalan + Autologous HSC

Patients receive filgrastim (G-CSF) 10 mg/kg/day on days -7 to -3 and undergo autologous hematopoietic stem cell (HSC) collection. Patients receive high-dose melphalan 140 mg/m\^2 IV for low risk or 200 mg/m\^2 IV for high risk patients over 1 hour on days -2 and -1 and undergo autologous HSC transplantation on day 0.

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

Analysis denominator · Participants

GroupSource count
Low-Dose Melphalan34
High-Dose Melphalan + Autologous HSC55

Reported measurements

Source class 1
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Low-Dose Melphalan58.8Not reported44.477.9Not reported
High-Dose Melphalan + Autologous HSC83.6Not reported74.794Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        44.4
        upper Limit
        77.9
        value
        58.8
      2. group Id
        OG001
        lower Limit
        74.7
        upper Limit
        94
        value
        83.6
denoms
  1. counts
    1. group Id
      OG000
      value
      34
    2. group Id
      OG001
      value
      55
    units
    Participants
description
Percentage of patients who were alive at 3 years. The 3-year survival rate was estimated using the Kaplan Meier method.
dispersion Type
95% Confidence Interval
groups
  1. description
    Patients receive low-dose melphalan 20 mg/m\^2 IV over 15-30 minutes on day 1 or 0.12 mg/kg tablet orally once daily on days 1-7 and dexamethasone 40 mg orally on days 1-4 and 22-25. Treatment repeats every 6 weeks for 10 courses. (Study treatment beyond one year is not allowed.)
    id
    OG000
    title
    Low-Dose Melphalan
  2. description
    Patients receive filgrastim (G-CSF) 10 mg/kg/day on days -7 to -3 and undergo autologous hematopoietic stem cell (HSC) collection. Patients receive high-dose melphalan 140 mg/m\^2 IV for low risk or 200 mg/m\^2 IV for high risk patients over 1 hour on days -2 and -1 and undergo autologous HSC transplantation on day 0.
    id
    OG001
    title
    High-Dose Melphalan + Autologous HSC
param Type
NUMBER
reporting Status
POSTED
time Frame
3 years
title
3 Year Overall Survival
type
SECONDARY
unit Of Measure
percentage of participants

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

Preserved source evidence · Not medical advice