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NCT05565391 · OUTCOME

Time to Response-Comparison Between Elranatamab in Study C1071003 Cohort A and Flatiron Health Cohort Using IPTW Analysis

A Study to Learn About the Medicine (Called Elranatamab) in People With Relapsed Refractory Multiple Myeloma · Source last updated 2024-05-21

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

Measure
MEDIAN
Unit
Months
Interval / dispersion
Inter-Quartile Range
Time frame
From index date to date of first documentation of OR (median follow-up of 10.4 months for study C1071003 cohort A, 8.8 months and 7.7 months for COTA and Flatiron Health cohorts)

What was measured

TTR was defined as the time from the index date to the first documentation of OR. OR is defined as having a best overall response (BOR) of confirmed sCR, CR, VGPR or PR per IMWG criteria. Analysis was performed using IPTW method to balance participant characteristics among reporting groups.

Analysis population: Eligible participants from study C1071003 (Cohort A) and RW participants identified from COTA and Flatiron Health databases were included. Here, "Overall Number of Participants Analyzed" is the number of participants after application of IPTW method to raw numbers.

Groups in this outcome

Study C1071003 Cohort A

Participants with TCR MM who initiated elranatamab (PF-06863135) following TCR eligibility in study C1071003 (NCT04649359) were included.

Flatiron Health Cohort

Participants with RW TCR MM who initiated standard of care treatment following TCR eligibility between 16-Nov-2015 and 31-Mar-2022 identified from Flatiron Health database were included.

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Study C1071003 Cohort A74
Flatiron Health Cohort43

Reported measurements

Source class 1
Values in Months · Interval/dispersion: Inter-Quartile Range
GroupValueSpreadLowerUpperComment
Study C1071003 Cohort A1.15Not reported0.992.00Not reported
Flatiron Health Cohort1.87Not reported0.952.10Not reported

Source statistical analyses

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

  1. group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    OTHER
    p Value
    0.0326
    statistical Method
    Quantile regression
Complete source fields
analyses
  1. group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    OTHER
    p Value
    0.0326
    statistical Method
    Quantile regression
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.99
        upper Limit
        2.00
        value
        1.15
      2. group Id
        OG001
        lower Limit
        0.95
        upper Limit
        2.10
        value
        1.87
denoms
  1. counts
    1. group Id
      OG000
      value
      74
    2. group Id
      OG001
      value
      43
    units
    Participants
description
TTR was defined as the time from the index date to the first documentation of OR. OR is defined as having a best overall response (BOR) of confirmed sCR, CR, VGPR or PR per IMWG criteria. Analysis was performed using IPTW method to balance participant characteristics among reporting groups.
dispersion Type
Inter-Quartile Range
groups
  1. description
    Participants with TCR MM who initiated elranatamab (PF-06863135) following TCR eligibility in study C1071003 (NCT04649359) were included.
    id
    OG000
    title
    Study C1071003 Cohort A
  2. description
    Participants with RW TCR MM who initiated standard of care treatment following TCR eligibility between 16-Nov-2015 and 31-Mar-2022 identified from Flatiron Health database were included.
    id
    OG001
    title
    Flatiron Health Cohort
param Type
MEDIAN
population Description
Eligible participants from study C1071003 (Cohort A) and RW participants identified from COTA and Flatiron Health databases were included. Here, "Overall Number of Participants Analyzed" is the number of participants after application of IPTW method to raw numbers.
reporting Status
POSTED
time Frame
From index date to date of first documentation of OR (median follow-up of 10.4 months for study C1071003 cohort A, 8.8 months and 7.7 months for COTA and Flatiron Health cohorts)
title
Time to Response-Comparison Between Elranatamab in Study C1071003 Cohort A and Flatiron Health Cohort Using IPTW Analysis
type
SECONDARY
unit Of Measure
Months

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

Preserved source evidence · Not medical advice