NCT00615589 · OUTCOME

Percentage of Patients With Acute and Chronic Graft Versus Host Disease (GVHD)

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 participants
Interval / dispersion: 95% Confidence Interval
Time frame: 100 days, 2 years

What was measured

Incidence of acute (Stage II-IV and Stage III-IV) and chronic GVHD (any stage) were analyzed. Acute GVHD Grading: Stage II - Skin, 25-50% BSA (Body Surface Area); Liver, 3.1-6mg/dl bilirubin; Gut, 1000-1500ml/day diarrhea Stage III - Skin, generalized erythroderma; Liver, 6.1-15mg/dl bilirubin; Gut, \>1500ml/day diarrhea Stage IV - Skin, bullae; Liver, \>15mg/dl bilirubin; Gut, pain +/- ileus

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 in NS, administered IV over 30 minutes on days -5, -4, -3, and -2 pre-transplant. Busulfan: 3.2 mg/kg IV daily in NS 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

Grade II-IV Acute GVHD

Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Flu-Bu4	48	Not reported	29	72	Not reported

Grade III-IV Acute GVHD

Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Flu-Bu4	23	Not reported	10	47	Not reported

Chronic GVHD

Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Flu-Bu4	55	Not reported	34	78	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
lower Limit
29
upper Limit
72
value
48
title
Grade II-IV Acute GVHD
categories
measurements
group Id
OG000
lower Limit
10
upper Limit
47
value
23
title
Grade III-IV Acute GVHD
categories
measurements
group Id
OG000
lower Limit
34
upper Limit
78
value
55
title
Chronic GVHD

denoms

counts
group Id
OG000
value
22
units
Participants

description

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 in NS, administered IV over 30 minutes on days -5, -4, -3, and -2 pre-transplant. Busulfan: 3.2 mg/kg IV daily in NS 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

100 days, 2 years

title

Percentage of Patients With Acute and Chronic Graft Versus Host Disease (GVHD)

type

SECONDARY

unit Of Measure

percentage of participants

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

Preserved source evidence · Not medical advice