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NCT03430011 · OUTCOME

Overall Survival (OS) in Phase 2 and Phase 2a

Study Evaluating the Safety and Efficacy of JCARH125 in Subjects With Relapsed and/or Refractory Multiple Myeloma · Source last updated 2024-05-24

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
Form date of first infusion to the date of death due to any reason (Up to apprixamtely 61 months)

What was measured

OS is defined as the time from the JCARH125 infusion until death due to any cause.

Analysis population: All participants who received conforming JCARH125 cell product at the recommended phase 2 dose and have measurable disease at the last disease assessment prior to receiving JCARH125 infusion in phase 2 and in phase 2a

Groups in this outcome

Phase 2 600 x 10^6 Cells

JCARH125 IV at dose level 600 x 10\^6 consisting of CD3+CAR+T cells expansion

Phase 2a 600 x 10^6 Cells Anti-BCMA

JCARH125 IV at dose level 600 x 10\^6 consisting of CD3+CAR+T cells in participants previously treated with BCMA-directed anti-myeloma therapy

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

Analysis denominator · Participants

GroupSource count
Phase 2 600 x 10^6 Cells24
Phase 2a 600 x 10^6 Cells Anti-BCMA10

Reported measurements

Source class 1
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Phase 2 600 x 10^6 CellsNANot reported8.71NAinsufficient number of participants with events
Phase 2a 600 x 10^6 Cells Anti-BCMANANot reported7.62NAinsufficient number of participants with events
Complete source fields
classes
  1. categories
    1. measurements
      1. comment
        insufficient number of participants with events
        group Id
        OG000
        lower Limit
        8.71
        upper Limit
        NA
        value
        NA
      2. comment
        insufficient number of participants with events
        group Id
        OG001
        lower Limit
        7.62
        upper Limit
        NA
        value
        NA
denoms
  1. counts
    1. group Id
      OG000
      value
      24
    2. group Id
      OG001
      value
      10
    units
    Participants
description
OS is defined as the time from the JCARH125 infusion until death due to any cause.
dispersion Type
95% Confidence Interval
groups
  1. description
    JCARH125 IV at dose level 600 x 10\^6 consisting of CD3+CAR+T cells expansion
    id
    OG000
    title
    Phase 2 600 x 10^6 Cells
  2. description
    JCARH125 IV at dose level 600 x 10\^6 consisting of CD3+CAR+T cells in participants previously treated with BCMA-directed anti-myeloma therapy
    id
    OG001
    title
    Phase 2a 600 x 10^6 Cells Anti-BCMA
param Type
MEDIAN
population Description
All participants who received conforming JCARH125 cell product at the recommended phase 2 dose and have measurable disease at the last disease assessment prior to receiving JCARH125 infusion in phase 2 and in phase 2a
reporting Status
POSTED
time Frame
Form date of first infusion to the date of death due to any reason (Up to apprixamtely 61 months)
title
Overall Survival (OS) in Phase 2 and Phase 2a
type
SECONDARY
unit Of Measure
Months

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

Preserved source evidence · Not medical advice