NCT01484275 · OUTCOME

Percentage of Participants With Serum M-protein Response

A Study of Siltuximab (Anti- IL 6 Monoclonal Antibody) in Patients With High-risk Smoldering Multiple Myeloma · Source last updated 2020-01-27

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: Up to 4.7 Years

What was measured

Serum M-protein response is defined as a decrease of greater than or equal to (\>=) 50% in serum M-protein compared with baseline at 2 consecutive assessments.

Analysis population: ITT population included participants who were randomly assigned to siltuximab or placebo treatment group based on an IVRS.

Groups in this outcome

Siltuximab

Participants received 15 milligram per kilogram (mg/kg) of siltuximab as a 1-hour intravenous (IV) infusion every 4 weeks until disease progression, unacceptable toxicity, withdrawal of consent, or the end of the study (up to 4 years after randomization of the last participant).

Placebo

Participants received placebo as a 1-hour IV infusion every 4 weeks until disease progression, unacceptable toxicity, withdrawal of consent, or the end of the study (up to 4 years after randomization of the last participant).

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
Siltuximab	43
Placebo	42

Reported measurements

Source class 1

Values in Percentage of participants · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Siltuximab	2.3	Not reported	0.1	12.3	Not reported
Placebo	0.0	Not reported	0.0	8.4	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
lower Limit
0.1
upper Limit
12.3
value
2.3
group Id
OG001
lower Limit
0.0
upper Limit
8.4
value
0.0

denoms

counts
group Id
OG000
value
43
group Id
OG001
value
42
units
Participants

description

Serum M-protein response is defined as a decrease of greater than or equal to (\>=) 50% in serum M-protein compared with baseline at 2 consecutive assessments.

dispersion Type

95% Confidence Interval

groups

description
Participants received 15 milligram per kilogram (mg/kg) of siltuximab as a 1-hour intravenous (IV) infusion every 4 weeks until disease progression, unacceptable toxicity, withdrawal of consent, or the end of the study (up to 4 years after randomization of the last participant).
id
OG000
title
Siltuximab
description
Participants received placebo as a 1-hour IV infusion every 4 weeks until disease progression, unacceptable toxicity, withdrawal of consent, or the end of the study (up to 4 years after randomization of the last participant).
id
OG001
title
Placebo

param Type

NUMBER

population Description

ITT population included participants who were randomly assigned to siltuximab or placebo treatment group based on an IVRS.

reporting Status

POSTED

time Frame

Up to 4.7 Years

title

Percentage of Participants With Serum M-protein Response

type

SECONDARY

unit Of Measure

Percentage of participants

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

Preserved source evidence · Not medical advice