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NCT03430011 · OUTCOME

Change From Baseline in the Total Score of European Organization for Research and Treatment of Cancer Quality-of-Life Questionnaire (QLQ-MY20) in Phase 2

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
MEAN
Unit
Score on a Scale
Interval / dispersion
Standard Deviation
Time frame
Baseline and visit 24 month

What was measured

QLQ-MY20 includes 20 questions across four scales: disease symptoms, treatment side-effects, future perspective, and body image. Questions used 4-point scale (1 'Not at All' to 4 'Very Much'). Scores are averaged, and transformed to 0-100 scale; higher score for the disease symptoms scale = higher level of symptomatology.

Analysis population: All participants who received at least one infusion of JCARH125 with baseline and post-baseline assessment at the respective visit in phase 2 only as prespecified in the protocol

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

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 Cells4

Reported measurements

Disease Symptoms
Values in Score on a Scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Phase 2 600 x 10^6 Cells0.000.00Not reportedNot reportedNot reported
Side Effects of Treatment
Values in Score on a Scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Phase 2 600 x 10^6 Cells6.113.98Not reportedNot reportedNot reported
Future Perspectives
Values in Score on a Scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Phase 2 600 x 10^6 Cells11.119.07Not reportedNot reportedNot reported
Body Image
Values in Score on a Scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Phase 2 600 x 10^6 Cells16.6733.33Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.00
        value
        0.00
    title
    Disease Symptoms
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        3.98
        value
        6.11
    title
    Side Effects of Treatment
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        9.07
        value
        11.11
    title
    Future Perspectives
  4. categories
    1. measurements
      1. group Id
        OG000
        spread
        33.33
        value
        16.67
    title
    Body Image
denoms
  1. counts
    1. group Id
      OG000
      value
      4
    units
    Participants
description
QLQ-MY20 includes 20 questions across four scales: disease symptoms, treatment side-effects, future perspective, and body image. Questions used 4-point scale (1 'Not at All' to 4 'Very Much'). Scores are averaged, and transformed to 0-100 scale; higher score for the disease symptoms scale = higher level of symptomatology.
dispersion Type
Standard Deviation
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
param Type
MEAN
population Description
All participants who received at least one infusion of JCARH125 with baseline and post-baseline assessment at the respective visit in phase 2 only as prespecified in the protocol
reporting Status
POSTED
time Frame
Baseline and visit 24 month
title
Change From Baseline in the Total Score of European Organization for Research and Treatment of Cancer Quality-of-Life Questionnaire (QLQ-MY20) in Phase 2
type
SECONDARY
unit Of Measure
Score on a Scale

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

Preserved source evidence · Not medical advice