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NCT03548207 · OUTCOME

Phase 2 (Japan Population): Change From Baseline in EuroQol Five Dimension Questionnaire (EQ-5D-5L) Utility Score at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324

A Study of JNJ-68284528, a Chimeric Antigen Receptor T Cell (CAR-T) Therapy Directed Against B-Cell Maturation Antigen (BCMA) in Participants With Relapsed or Refractory Multiple Myeloma · Source last updated 2025-07-30

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, Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324

What was measured

EQ-5D-5L was a 5-item questionnaire consisted of 2 components: a health state profile/a single utility index value and an optional VAS. EQ-5D health state profile/a single utility index value had 5 dimensions including mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension had 5 response levels: 1 =no problems, 2 =slight problems, 3 =moderate problems, 4 =severe problems and 5 =extreme problems. The scores for the 5 dimensions were used to compute a single utility score ranging from 0 to 1 representing the general health status of the individual. Higher score indicated better health status. EQ-5D VAS was used to record participant's rating for his/her "health today" and ranging from 0 to 100, where 0 = worst imaginable health state and 100 = best imaginable health state.

Analysis population: mITT analysis Set included all participants who received a JNJ-68284528 infusion at the targeted RP2D dose level. Here, N (number of participants analyzed) signifies participants who were evaluable for this outcome measure and "n" (number analyzed) signifies those participants who were evaluable for specified time points.

Groups in this outcome

Phase 2 (US Population)

Participants received a conditioning regimen of cyclophosphamide 300 mg/m\^2 IV infusion and fludarabine 30 mg/m\^2 IV infusion daily for 3 days from Day -5 to Day -3. On Day 1, participants received recommended phase 2 dose (RP2D) dose of JNJ-68284528 0.75\*10\^6 CAR positive viable T cells/kg as IV infusion.

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 (US Population)8

Reported measurements

Change at Day 7

Analysis denominator · Participants

GroupSource count
Phase 2 (US Population)8
Values in Score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Phase 2 (US Population)-0.050.149Not reportedNot reportedNot reported
Change at Day 28

Analysis denominator · Participants

GroupSource count
Phase 2 (US Population)8
Values in Score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Phase 2 (US Population)-0.060.185Not reportedNot reportedNot reported
Change at Day 56

Analysis denominator · Participants

GroupSource count
Phase 2 (US Population)8
Values in Score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Phase 2 (US Population)-0.030.057Not reportedNot reportedNot reported
Change at Day 78

Analysis denominator · Participants

GroupSource count
Phase 2 (US Population)8
Values in Score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Phase 2 (US Population)0.010.098Not reportedNot reportedNot reported
Change at Day 100

Analysis denominator · Participants

GroupSource count
Phase 2 (US Population)8
Values in Score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Phase 2 (US Population)-0.040.075Not reportedNot reportedNot reported
Change at Day 128

Analysis denominator · Participants

GroupSource count
Phase 2 (US Population)8
Values in Score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Phase 2 (US Population)0.000.063Not reportedNot reportedNot reported
Change at Day 156

Analysis denominator · Participants

GroupSource count
Phase 2 (US Population)8
Values in Score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Phase 2 (US Population)-0.020.053Not reportedNot reportedNot reported
Change at Day 184

Analysis denominator · Participants

GroupSource count
Phase 2 (US Population)8
Values in Score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Phase 2 (US Population)-0.010.079Not reportedNot reportedNot reported
Change at Day 212

Analysis denominator · Participants

GroupSource count
Phase 2 (US Population)6
Values in Score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Phase 2 (US Population)0.040.109Not reportedNot reportedNot reported
Change at Day 240

Analysis denominator · Participants

GroupSource count
Phase 2 (US Population)3
Values in Score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Phase 2 (US Population)0.050.079Not reportedNot reportedNot reported
Change at Day 268

Analysis denominator · Participants

GroupSource count
Phase 2 (US Population)2
Values in Score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Phase 2 (US Population)0.070.096Not reportedNot reportedNot reported
Change at Day 296

Analysis denominator · Participants

GroupSource count
Phase 2 (US Population)2
Values in Score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Phase 2 (US Population)0.040.061Not reportedNot reportedNot reported
Change at Day 324

Analysis denominator · Participants

GroupSource count
Phase 2 (US Population)1
Values in Score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Phase 2 (US Population)0.14NANot reportedNot reportedHere, 'NA' signifies that SD could not be calculated as only 1 participant was analyzed.
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.149
        value
        -0.05
    denoms
    1. counts
      1. group Id
        OG000
        value
        8
      units
      Participants
    title
    Change at Day 7
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.185
        value
        -0.06
    denoms
    1. counts
      1. group Id
        OG000
        value
        8
      units
      Participants
    title
    Change at Day 28
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.057
        value
        -0.03
    denoms
    1. counts
      1. group Id
        OG000
        value
        8
      units
      Participants
    title
    Change at Day 56
  4. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.098
        value
        0.01
    denoms
    1. counts
      1. group Id
        OG000
        value
        8
      units
      Participants
    title
    Change at Day 78
  5. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.075
        value
        -0.04
    denoms
    1. counts
      1. group Id
        OG000
        value
        8
      units
      Participants
    title
    Change at Day 100
  6. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.063
        value
        0.00
    denoms
    1. counts
      1. group Id
        OG000
        value
        8
      units
      Participants
    title
    Change at Day 128
  7. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.053
        value
        -0.02
    denoms
    1. counts
      1. group Id
        OG000
        value
        8
      units
      Participants
    title
    Change at Day 156
  8. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.079
        value
        -0.01
    denoms
    1. counts
      1. group Id
        OG000
        value
        8
      units
      Participants
    title
    Change at Day 184
  9. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.109
        value
        0.04
    denoms
    1. counts
      1. group Id
        OG000
        value
        6
      units
      Participants
    title
    Change at Day 212
  10. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.079
        value
        0.05
    denoms
    1. counts
      1. group Id
        OG000
        value
        3
      units
      Participants
    title
    Change at Day 240
  11. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.096
        value
        0.07
    denoms
    1. counts
      1. group Id
        OG000
        value
        2
      units
      Participants
    title
    Change at Day 268
  12. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.061
        value
        0.04
    denoms
    1. counts
      1. group Id
        OG000
        value
        2
      units
      Participants
    title
    Change at Day 296
denoms
  1. counts
    1. group Id
      OG000
      value
      8
    units
    Participants
description
EQ-5D-5L was a 5-item questionnaire consisted of 2 components: a health state profile/a single utility index value and an optional VAS. EQ-5D health state profile/a single utility index value had 5 dimensions including mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension had 5 response levels: 1 =no problems, 2 =slight problems, 3 =moderate problems, 4 =severe problems and 5 =extreme problems. The scores for the 5 dimensions were used to compute a single utility score ranging from 0 to 1 representing the general health status of the individual. Higher score indicated better health status. EQ-5D VAS was used to record participant's rating for his/her "health today" and ranging from 0 to 100, where 0 = worst imaginable health state and 100 = best imaginable health state.
dispersion Type
Standard Deviation
groups
  1. description
    Participants received a conditioning regimen of cyclophosphamide 300 mg/m\^2 IV infusion and fludarabine 30 mg/m\^2 IV infusion daily for 3 days from Day -5 to Day -3. On Day 1, participants received recommended phase 2 dose (RP2D) dose of JNJ-68284528 0.75\*10\^6 CAR positive viable T cells/kg as IV infusion.
    id
    OG000
    title
    Phase 2 (US Population)
param Type
MEAN
population Description
mITT analysis Set included all participants who received a JNJ-68284528 infusion at the targeted RP2D dose level. Here, N (number of participants analyzed) signifies participants who were evaluable for this outcome measure and "n" (number analyzed) signifies those participants who were evaluable for specified time points.
reporting Status
POSTED
time Frame
Baseline, Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324
title
Phase 2 (Japan Population): Change From Baseline in EuroQol Five Dimension Questionnaire (EQ-5D-5L) Utility Score at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324
type
SECONDARY
unit Of Measure
Score on a scale

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice