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NCT05565391 · OUTCOME

Time to Response (TTR)-Unweighted 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. No censoring was performed. OR is defined as having a best overall response (BOR) of confirmed sCR, CR, VGPR or PR per IMWG criteria.

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 evaluable for this outcome measure.

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.

COTA 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 COTA database 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 A75
COTA Cohort73
Flatiron Health Cohort46

Reported measurements

Source class 1
Values in Months · Interval/dispersion: Inter-Quartile Range
GroupValueSpreadLowerUpperComment
Study C1071003 Cohort A1.22Not reported0.992.00Not reported
COTA Cohort1.38Not reported0.822.79Not reported
Flatiron Health Cohort1.87Not reported0.952.69Not 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
    0.4241
    statistical Method
    Quantile regression
  2. group Ids
    1. OG000
    2. OG002
    non Inferiority Type
    OTHER
    p Value
    0.0281
    statistical Method
    Quantile regression
Complete source fields
analyses
  1. group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    OTHER
    p Value
    0.4241
    statistical Method
    Quantile regression
  2. group Ids
    1. OG000
    2. OG002
    non Inferiority Type
    OTHER
    p Value
    0.0281
    statistical Method
    Quantile regression
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.99
        upper Limit
        2.00
        value
        1.22
      2. group Id
        OG001
        lower Limit
        0.82
        upper Limit
        2.79
        value
        1.38
      3. group Id
        OG002
        lower Limit
        0.95
        upper Limit
        2.69
        value
        1.87
denoms
  1. counts
    1. group Id
      OG000
      value
      75
    2. group Id
      OG001
      value
      73
    3. group Id
      OG002
      value
      46
    units
    Participants
description
TTR was defined as the time from the index date to the first documentation of OR. No censoring was performed. OR is defined as having a best overall response (BOR) of confirmed sCR, CR, VGPR or PR per IMWG criteria.
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 COTA database were included.
    id
    OG001
    title
    COTA Cohort
  3. 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
    OG002
    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 evaluable for this outcome measure.
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 (TTR)-Unweighted Analysis
type
SECONDARY
unit Of Measure
Months

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

Preserved source evidence · Not medical advice