NCT00615589 · OUTCOME

Non Relapse Mortality (NRM) at 1 Year and 3 yearsThe Percentage of Deaths Not Attributable to Disease Relapse or Progression

Stem Cell Transplantation To Treat High Risk Multiple Myeloma With Reduced Toxicity Myeloablative Conditioning Regimen · Source last updated 2016-04-04

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

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

What was measured

Non relapse mortality, defined as the percentage of deaths not attributable to disease relapse or progression at 1 year and at 3 years.

Groups in this outcome

Flu-Bu4

Fludarabine Busulfan chemotherapy regimen (Flu-Bu4), followed by allogeneic stem cell transplant from best available, matched donor. Fludarabine/Busulfan x 4 days: Fludarabine: 40 mg/m2/day, administered IV over 30 minutes on days -5, -4, -3, and -2 pre-transplant. Busulfan: 3.2 mg/kg IV daily over 4 hours on days -5, -4, -3, and -2. The Fludarabine shall be administered prior to the Busulfan each day.

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

Analysis denominator · Participants

Group	Source count
Flu-Bu4	22

Reported measurements

NRM at 1 Year

Values in percentage of deaths · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Flu-Bu4	19	Not reported	7	44	Not reported

NRM at 3 Years

Values in percentage of deaths · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Flu-Bu4	29	Not reported	13	55	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
lower Limit
7
upper Limit
44
value
19
title
NRM at 1 Year
categories
measurements
group Id
OG000
lower Limit
13
upper Limit
55
value
29
title
NRM at 3 Years

denoms

counts
group Id
OG000
value
22
units
Participants

description

Non relapse mortality, defined as the percentage of deaths not attributable to disease relapse or progression at 1 year and at 3 years.

dispersion Type

95% Confidence Interval

groups

description
Fludarabine Busulfan chemotherapy regimen (Flu-Bu4), followed by allogeneic stem cell transplant from best available, matched donor. Fludarabine/Busulfan x 4 days: Fludarabine: 40 mg/m2/day, administered IV over 30 minutes on days -5, -4, -3, and -2 pre-transplant. Busulfan: 3.2 mg/kg IV daily over 4 hours on days -5, -4, -3, and -2. The Fludarabine shall be administered prior to the Busulfan each day.
id
OG000
title
Flu-Bu4

param Type

NUMBER

reporting Status

POSTED

time Frame

3 years

title

Non Relapse Mortality (NRM) at 1 Year and 3 yearsThe Percentage of Deaths Not Attributable to Disease Relapse or Progression

type

SECONDARY

unit Of Measure

percentage of deaths

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

Preserved source evidence · Not medical advice