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NCT05932290 · OUTCOME

PFS: C1071003 Cohort A Versus COTA Cohort- Using Inverse Probability of Treatment Weights (IPTW)

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 PD per IMWG criteria or death due to any cause, whichever occurred first; b) 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% from the lowest response value in any 1 or more of the criteria: SPEP with an absolute increase \>0.5 g/dL; 24-hour UPEP with an absolute increase \>200 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 FLC levels; or an absolute bone marrow plasma cell percentage \>10%. Retrospective data was retrieved and observed in the current study for approximately 1.5 months. Participants without an event were censored at date of last adequate disease assessment or the data cut-off. Kaplan Meier method was used.

Analysis population: Eligible participants whose data was retrieved and was used in this retrospective cohort study. In this outcome measure, IPTW analysis was applied. IPTW eliminated the effect of confounding by observed baseline participant characteristics, improve covariate balance, and thereby obtained unbiased estimates of treatment effects. IPTW created pseudo-sets, hence "Number of Participants Analyzed" (N) are different from participant flow and baseline section.

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

GroupSource count
C1071003 Cohort A113
RWD: COTA235

Reported measurements

Source class 1
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
C1071003 Cohort ANANot reportedNANAMedian and 95% CI was not estimated because of insufficient number of participants with the event.
RWD: COTA5.26Not reported3.256.28Not reported

Source statistical analyses

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

  1. ci Lower Limit
    0.22
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.64
    estimate Comment
    IPTW HRs were estimated using weighted Cox proportional hazard models and confidence intervals were estimated using robust error variances.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    .0003
    param Type
    Hazard Ratio (HR)
    param Value
    0.37
    statistical Method
    Regression, Cox
Complete source fields
analyses
  1. ci Lower Limit
    0.22
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.64
    estimate Comment
    IPTW HRs were estimated using weighted Cox proportional hazard models and confidence intervals were estimated using robust error variances.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    .0003
    param Type
    Hazard Ratio (HR)
    param Value
    0.37
    statistical Method
    Regression, Cox
classes
  1. categories
    1. measurements
      1. 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
      2. group Id
        OG001
        lower Limit
        3.25
        upper Limit
        6.28
        value
        5.26
denoms
  1. counts
    1. group Id
      OG000
      value
      113
    2. group Id
      OG001
      value
      235
    units
    Participants
description
PFS: a) C1071003 Cohort A: time from the date of the first dose until confirmed PD per IMWG criteria or death due to any cause, whichever occurred first; b) 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% from the lowest response value in any 1 or more of the criteria: SPEP with an absolute increase \>0.5 g/dL; 24-hour UPEP with an absolute increase \>200 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 FLC levels; or an absolute bone marrow plasma cell percentage \>10%. Retrospective data was retrieved and observed in the current study for approximately 1.5 months. Participants without an event were censored at date of last adequate disease assessment or the data cut-off. Kaplan Meier method was used.
dispersion Type
95% Confidence Interval
groups
  1. 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
  2. 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. In this outcome measure, IPTW analysis was applied. IPTW eliminated the effect of confounding by observed baseline participant characteristics, improve covariate balance, and thereby obtained unbiased estimates of treatment effects. IPTW created pseudo-sets, hence "Number of Participants Analyzed" (N) are different from participant flow and baseline section.
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
PFS: C1071003 Cohort A Versus COTA Cohort- Using Inverse Probability of Treatment Weights (IPTW)
type
PRIMARY
unit Of Measure
Months

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Preserved source evidence · Not medical advice