NCT05932290 · OUTCOME

Progression Free Survival (PFS): Study C1071003 Cohort A Versus RWD COTA Cohort- Using Unweighted Analysis

A Study to Learn About the Effectiveness of the Medicine Called Elranatamab in People With Relapsed Refractory Multiple Myeloma · Source last updated 2024-10-29

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: C1071003:First dose to confirmed PD/ death due to any cause or censoring whichever occurred first (maximum of 15 months);COTA:Initiation of first line post TCR MM to PD/ death due to any cause or censoring whichever occurred first (maximum of 64.3 months)

What was measured

PFS: a) C1071003 Cohort A: time from the date of the first dose until confirmed progressive disease (PD) per IMWG criteria or death due to any cause, whichever occurred first; b) RWD COTA: time from initiation of the first line after participant identified as having TCR MM to either the date of progression or death due to any cause, whichever occurred first. IMWG criteria for progression: an increase of \>=25% (Percent) from the lowest response value in any 1 or more of the criteria: serum protein electrophoresis (SPEP) with an absolute increase \>0.5 gram/deciliter (g/dL); 24-hour(h) urine protein electrophoresis (UPEP) with an absolute increase \>200 microgram (mg)/24 h; in participants without measurable serum and urine M-protein, the absolute increase of \>10 mg/dL in the difference between involved and uninvolved free light chain (FLC) levels; or an absolute bone marrow plasma cell \>10%. Retrospective data was retrieved and observed in the current study for approximately 1.5 months.

Analysis population: Eligible participants whose data was retrieved and was used in this retrospective cohort study. Kaplan Meier method was used for analysis. Participants without an event were censored at the date of last adequate disease assessment or the data cut-off.

Groups in this outcome

C1071003 Cohort A

Eligible participants with TCR MM, who were BCMA naïve, who were enrolled between 2 February 2021 to 07 January 2022 and who were treated with elranatamab in study C1071003 were included.

RWD: COTA

Eligible participants with TCR MM who were treated with SOC therapies in real world clinical practice setting, identified from COTA database were included. This arm served as external control arm.

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
C1071003 Cohort A	123
RWD: COTA	239

Reported measurements

Source class 1

Values in Months · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
C1071003 Cohort A	NA	Not reported	NA	NA	Median and 95% CI was not estimated because of insufficient number of participants with the event.
RWD: COTA	4.70	Not reported	3.09	5.98	Not reported

Source statistical analyses

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

ci Lower Limit
0.37
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
0.71
estimate Comment
Hazard ratios (HRs) were estimated using unadjusted Cox proportional hazard models.
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY
p Value
<.0001
param Type
Hazard Ratio (HR)
param Value
0.51
statistical Method
Regression, Cox

Complete source fields

analyses

ci Lower Limit
0.37
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
0.71
estimate Comment
Hazard ratios (HRs) were estimated using unadjusted Cox proportional hazard models.
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY
p Value
<.0001
param Type
Hazard Ratio (HR)
param Value
0.51
statistical Method
Regression, Cox

classes

categories
measurements
comment
Median and 95% CI was not estimated because of insufficient number of participants with the event.
group Id
OG000
lower Limit
NA
upper Limit
NA
value
NA
group Id
OG001
lower Limit
3.09
upper Limit
5.98
value
4.70

denoms

counts
group Id
OG000
value
123
group Id
OG001
value
239
units
Participants

description

dispersion Type

95% Confidence Interval

groups

description
Eligible participants with TCR MM, who were BCMA naïve, who were enrolled between 2 February 2021 to 07 January 2022 and who were treated with elranatamab in study C1071003 were included.
id
OG000
title
C1071003 Cohort A
description
Eligible participants with TCR MM who were treated with SOC therapies in real world clinical practice setting, identified from COTA database were included. This arm served as external control arm.
id
OG001
title
RWD: COTA

param Type

MEDIAN

population Description

Eligible participants whose data was retrieved and was used in this retrospective cohort study. Kaplan Meier method was used for analysis. Participants without an event were censored at the date of last adequate disease assessment or the data cut-off.

reporting Status

POSTED

time Frame

C1071003:First dose to confirmed PD/ death due to any cause or censoring whichever occurred first (maximum of 15 months);COTA:Initiation of first line post TCR MM to PD/ death due to any cause or censoring whichever occurred first (maximum of 64.3 months)

title

Progression Free Survival (PFS): Study C1071003 Cohort A Versus RWD COTA Cohort- Using Unweighted Analysis

type

PRIMARY

unit Of Measure

Months

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Preserved source evidence · Not medical advice