NCT01441973 · OUTCOME

Progression Free Survival (PFS) Rate

Biomarker Study of Elotuzumab in High Risk Smoldering Myeloma · Source last updated 2018-01-23

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

Measure: NUMBER
Unit: Probability of Progression Free Survival
Interval / dispersion: 90% Confidence Interval
Time frame: Up to 2 years from the initiation of study therapy by dose cohort (approximately 24 months)

What was measured

The probability was estimated from the K-M curve of subjects being alive and without disease progression (modified IMWG criteria) at 2 years from the initiation of study therapy by dose cohort

Analysis population: All treated participants

Groups in this outcome

Elotuzumab, 20 mg/kg

Participants in 2 arms were enrolled sequentially. The first group of participants received elotuzumab intravenously at a dose of 20 mg/kg on Days 1 and 8 per 28-day cycle for Cycle 1 and then on Day 1 only in subsequent cycles.

Elotuzumab, 10 mg/kg

Participants in the second group received elotuzumab intravenously at a dose of 10 mg/kg weekly per 28-day cycle in Cycles 1 and 2, then on Days 1 and 15 in subsequent cycles.

Elotuzumab, All Dosages

All participants on Elotuzumab therapy. Comprised of both the 20mg/kg and 10mg/kg arms

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
Elotuzumab, 20 mg/kg	15
Elotuzumab, 10 mg/kg	16
Elotuzumab, All Dosages	31

Reported measurements

Source class 1

Values in Probability of Progression Free Survival · Interval/dispersion: 90% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Elotuzumab, 20 mg/kg	0.71	Not reported	0.45	0.86	Not reported
Elotuzumab, 10 mg/kg	0.54	Not reported	0.31	0.72	Not reported
Elotuzumab, All Dosages	0.62	Not reported	0.45	0.75	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
lower Limit
0.45
upper Limit
0.86
value
0.71
group Id
OG001
lower Limit
0.31
upper Limit
0.72
value
0.54
group Id
OG002
lower Limit
0.45
upper Limit
0.75
value
0.62

denoms

counts
group Id
OG000
value
15
group Id
OG001
value
16
group Id
OG002
value
31
units
Participants

description

The probability was estimated from the K-M curve of subjects being alive and without disease progression (modified IMWG criteria) at 2 years from the initiation of study therapy by dose cohort

dispersion Type

90% Confidence Interval

groups

description
Participants in 2 arms were enrolled sequentially. The first group of participants received elotuzumab intravenously at a dose of 20 mg/kg on Days 1 and 8 per 28-day cycle for Cycle 1 and then on Day 1 only in subsequent cycles.
id
OG000
title
Elotuzumab, 20 mg/kg
description
Participants in the second group received elotuzumab intravenously at a dose of 10 mg/kg weekly per 28-day cycle in Cycles 1 and 2, then on Days 1 and 15 in subsequent cycles.
id
OG001
title
Elotuzumab, 10 mg/kg
description
All participants on Elotuzumab therapy. Comprised of both the 20mg/kg and 10mg/kg arms
id
OG002
title
Elotuzumab, All Dosages

param Type

NUMBER

population Description

All treated participants

reporting Status

POSTED

time Frame

Up to 2 years from the initiation of study therapy by dose cohort (approximately 24 months)

title

Progression Free Survival (PFS) Rate

type

SECONDARY

unit Of Measure

Probability of Progression Free Survival

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

Preserved source evidence · Not medical advice