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NCT00064337 · OUTCOME

Overall Survival

S0115, High-Dose Melphalan and Autologous Peripheral Stem Cell Transplantation in Treating Patients With Multiple Myeloma or Primary Systemic Amyloidosis · Source last updated 2018-08-09

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
5 years from initial registration, or until death, whichever occurred earlier, on average, about 4.5 years

What was measured

Time from initial registration until death or date of last contact, whichever occurs first, for up to 5 years from the date of the last patient registration.

Analysis population: Eligible and analyzable patients only.

Groups in this outcome

Treatment

MM Induction: dexamethasone 20mg/d PO Days 1-4, 9-12 and 17-20 every 35 days for 2 cycles and thalidomide 200 mg/d PO Days 1-70. Mobilization and SC Collection: MM, MM+AL, MM+LCD: cyclophosphamide 2.5 gm/m2 IV Day 1; mesna 800 mg/m2 IV Day 1 x 3 doses; G-CSF 10 mcg/kg/d SQ Day 2 through day prior to last leukapheresis. Amyloid or LCDD-Only: G-CSF 16 mcg/kg/d SQ Days 1-3 (continued daily until the day prior to the last day of stem cell collection). Conditioning/Transplant - Modified HighDose Melphalan (given for both transplants): melphalan 100 mg/m2/d IV over 20 mins Day -2; PBSC infusion \>/= 3.5 x 10\^6 CD34+ cells/kg IV Day 0. Maintenance (MM only): dexamethasone 40 mg/d PO Days 1-4 every 28 days and thalidomide 100 mg/d PO daily - given for one year, followed by dexamethasone 40 mg/d PO Days 1-4 every 28 days and thalidomide 100 mg/d PO daily - given for one year. filgrastim cyclophosphamide dexamethasone melphalan thalidomide peripheral blood

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

Analysis denominator · Participants

GroupSource count
Treatment93

Reported measurements

Source class 1
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Treatment68Not reported42NAThe upper limit of the 95% CI for the median had not yet been reached at time of analysis.
Complete source fields
classes
  1. categories
    1. measurements
      1. comment
        The upper limit of the 95% CI for the median had not yet been reached at time of analysis.
        group Id
        OG000
        lower Limit
        42
        upper Limit
        NA
        value
        68
denoms
  1. counts
    1. group Id
      OG000
      value
      93
    units
    Participants
description
Time from initial registration until death or date of last contact, whichever occurs first, for up to 5 years from the date of the last patient registration.
dispersion Type
95% Confidence Interval
groups
  1. description
    MM Induction: dexamethasone 20mg/d PO Days 1-4, 9-12 and 17-20 every 35 days for 2 cycles and thalidomide 200 mg/d PO Days 1-70. Mobilization and SC Collection: MM, MM+AL, MM+LCD: cyclophosphamide 2.5 gm/m2 IV Day 1; mesna 800 mg/m2 IV Day 1 x 3 doses; G-CSF 10 mcg/kg/d SQ Day 2 through day prior to last leukapheresis. Amyloid or LCDD-Only: G-CSF 16 mcg/kg/d SQ Days 1-3 (continued daily until the day prior to the last day of stem cell collection). Conditioning/Transplant - Modified HighDose Melphalan (given for both transplants): melphalan 100 mg/m2/d IV over 20 mins Day -2; PBSC infusion \>/= 3.5 x 10\^6 CD34+ cells/kg IV Day 0. Maintenance (MM only): dexamethasone 40 mg/d PO Days 1-4 every 28 days and thalidomide 100 mg/d PO daily - given for one year, followed by dexamethasone 40 mg/d PO Days 1-4 every 28 days and thalidomide 100 mg/d PO daily - given for one year. filgrastim cyclophosphamide dexamethasone melphalan thalidomide peripheral blood
    id
    OG000
    title
    Treatment
param Type
MEDIAN
population Description
Eligible and analyzable patients only.
reporting Status
POSTED
time Frame
5 years from initial registration, or until death, whichever occurred earlier, on average, about 4.5 years
title
Overall Survival
type
PRIMARY
unit Of Measure
Months

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

Preserved source evidence · Not medical advice