NCT01335399 · OUTCOME

Overall Survival (OS)

Phase III Study of Lenalidomide and Dexamethasone With or Without Elotuzumab to Treat Newly Diagnosed, Previously Untreated Multiple Myeloma · Source last updated 2022-09-30

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

Measure: MEDIAN
Unit: Months
Interval / dispersion: 95% Confidence Interval
Time frame: From randomization to the date of death (up to 8 years)

What was measured

Survival is defined as the time from randomization to the date of death. A participant who did not die had his or her survival duration censored at the date of last contact ('last known date alive").

Analysis population: All randomized participants

Groups in this outcome

E-Ld Cohort

Participants receiving a combination of Elotuzumab (E) Lenalidomide (L) Dexamethasone (d) in a 28 day cycle

Ld Cohort

Participants receiving a combination of Lenalidomide (L) Dexamethasone (d) in a 28 day cycle

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
E-Ld Cohort	374
Ld Cohort	374

Reported measurements

Source class 1

Values in Months · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
E-Ld Cohort	60.42	Not reported	52.76	67.35	Not reported
Ld Cohort	57.56	Not reported	48.95	66.56	Not reported

Source statistical analyses

Group order, estimate direction, methods and comments are retained. No treatment ranking is inferred.

ci Lower Limit
0.82
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
1.19
estimate Comment
Stratified by stage of disease (International Staging System 1 - 2 vs 3), age (\<75 years old vs \>= 75 years old) and ECOG performance status (0 vs 1 - 2) at randomization.
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY
p Value
0.8932
param Type
Hazard Ratio (HR)
param Value
0.99
statistical Method
Stratified log rank test

Complete source fields

analyses

ci Lower Limit
0.82
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
1.19
estimate Comment
Stratified by stage of disease (International Staging System 1 - 2 vs 3), age (\<75 years old vs \>= 75 years old) and ECOG performance status (0 vs 1 - 2) at randomization.
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY
p Value
0.8932
param Type
Hazard Ratio (HR)
param Value
0.99
statistical Method
Stratified log rank test

classes

categories
measurements
group Id
OG000
lower Limit
52.76
upper Limit
67.35
value
60.42
group Id
OG001
lower Limit
48.95
upper Limit
66.56
value
57.56

denoms

counts
group Id
OG000
value
374
group Id
OG001
value
374
units
Participants

description

Survival is defined as the time from randomization to the date of death. A participant who did not die had his or her survival duration censored at the date of last contact ('last known date alive").

dispersion Type

95% Confidence Interval

groups

description
Participants receiving a combination of Elotuzumab (E) Lenalidomide (L) Dexamethasone (d) in a 28 day cycle
id
OG000
title
E-Ld Cohort
description
Participants receiving a combination of Lenalidomide (L) Dexamethasone (d) in a 28 day cycle
id
OG001
title
Ld Cohort

param Type

MEDIAN

population Description

All randomized participants

reporting Status

POSTED

time Frame

From randomization to the date of death (up to 8 years)

title

Overall Survival (OS)

type

SECONDARY

unit Of Measure

Months

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

Preserved source evidence · Not medical advice