NCT00505895 · OUTCOME

Acute Grade II-IV Graft Versus Host Disease (GVHD)

FM 140 vs FM100 Study in Patients With Multiple Myeloma · Source last updated 2014-10-17

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: Not reported
Time frame: GVHD grading weekly during first 100 days; Annual examinations for nine year study period

What was measured

Effects of Rituximab as measured by percentage of participants with Acute and Chronic Graft Versus Host Disease (GVHD) incidences after allogeneic transplantation. GVHD occurring anytime after day 90 post transplant was considered chronic GVHD; otherwise it was considered acute GVHD. Acute GVHD status defined as GVHD with maximum grade ≥2. Clinical grading of Acute GVHD (Thomas et al., New England Journal of Medicine (NEJM), 229:895, 1975): Grade 1 to 4.

Analysis population: For the acute GVHD analysis, only 48 patients' data were available.

Groups in this outcome

Fludarabine + Melphalan + Stem Cell Infusion

Fludarabine 30 mg/m\^2 intravenous (IV) daily over 30 minutes for 4 Days (Beginning Day -4). Melphalan 140 mg/m\^2 IV over 20 minutes on Day -1. Stem Cell Infusion on Day 0. Rituximab 375 mg/m\^2 IV infused starting on day -5.

Fludarabine + Lower-Dose Melphalan + Stem Cell Infusion

Fludarabine 30 mg/m\^2 IV daily over 30 minutes for 4 Days (Beginning Day -4). Lower-Dose Melphalan 100 mg/m\^2 IV over 20 minutes on Day -1. Stem Cell Infusion on Day 0. Rituximab 375 mg/m\^2 IV infused starting on day -5.

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
Fludarabine + Melphalan + Stem Cell Infusion	27
Fludarabine + Lower-Dose Melphalan + Stem Cell Infusion	23

Reported measurements

Acute GVHD

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Fludarabine + Melphalan + Stem Cell Infusion	22	Not reported	Not reported	Not reported	Not reported
Fludarabine + Lower-Dose Melphalan + Stem Cell Infusion	21	Not reported	Not reported	Not reported	Not reported

Chronic GVHD

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Fludarabine + Melphalan + Stem Cell Infusion	29	Not reported	Not reported	Not reported	Not reported
Fludarabine + Lower-Dose Melphalan + Stem Cell Infusion	48	Not reported	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
value
22
group Id
OG001
value
21
title
Acute GVHD
categories
measurements
group Id
OG000
value
29
group Id
OG001
value
48
title
Chronic GVHD

denoms

counts
group Id
OG000
value
27
group Id
OG001
value
23
units
Participants

description

groups

description
Fludarabine 30 mg/m\^2 intravenous (IV) daily over 30 minutes for 4 Days (Beginning Day -4). Melphalan 140 mg/m\^2 IV over 20 minutes on Day -1. Stem Cell Infusion on Day 0. Rituximab 375 mg/m\^2 IV infused starting on day -5.
id
OG000
title
Fludarabine + Melphalan + Stem Cell Infusion
description
Fludarabine 30 mg/m\^2 IV daily over 30 minutes for 4 Days (Beginning Day -4). Lower-Dose Melphalan 100 mg/m\^2 IV over 20 minutes on Day -1. Stem Cell Infusion on Day 0. Rituximab 375 mg/m\^2 IV infused starting on day -5.
id
OG001
title
Fludarabine + Lower-Dose Melphalan + Stem Cell Infusion

param Type

NUMBER

population Description

For the acute GVHD analysis, only 48 patients' data were available.

time Frame

GVHD grading weekly during first 100 days; Annual examinations for nine year study period

title

Acute Grade II-IV 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