Phase 2 (US 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, 324, 352 and 380
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
LEAST_SQUARES_MEAN
Unit
Score on a scale
Interval / dispersion
95% Confidence Interval
Time frame
Baseline, Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380
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
Group
Source count
Phase 2 (US Population)
54
Reported measurements
Change at Day 7
Analysis denominator · Participants
Group
Source count
Phase 2 (US Population)
54
Values in Score on a scale · Interval/dispersion: 95% Confidence Interval
Group
Value
Spread
Lower
Upper
Comment
Phase 2 (US Population)
-0.1
Not reported
-0.1
0
Not reported
Change at Day 28
Analysis denominator · Participants
Group
Source count
Phase 2 (US Population)
53
Values in Score on a scale · Interval/dispersion: 95% Confidence Interval
Group
Value
Spread
Lower
Upper
Comment
Phase 2 (US Population)
0
Not reported
-0.1
0
Not reported
Change at Day 56
Analysis denominator · Participants
Group
Source count
Phase 2 (US Population)
52
Values in Score on a scale · Interval/dispersion: 95% Confidence Interval
Group
Value
Spread
Lower
Upper
Comment
Phase 2 (US Population)
0
Not reported
-0.1
0.1
Not reported
Change at Day 78
Analysis denominator · Participants
Group
Source count
Phase 2 (US Population)
46
Values in Score on a scale · Interval/dispersion: 95% Confidence Interval
Group
Value
Spread
Lower
Upper
Comment
Phase 2 (US Population)
0
Not reported
0
0.1
Not reported
Change at Day 100
Analysis denominator · Participants
Group
Source count
Phase 2 (US Population)
49
Values in Score on a scale · Interval/dispersion: 95% Confidence Interval
Group
Value
Spread
Lower
Upper
Comment
Phase 2 (US Population)
0
Not reported
0
0.1
Not reported
Change at Day 128
Analysis denominator · Participants
Group
Source count
Phase 2 (US Population)
40
Values in Score on a scale · Interval/dispersion: 95% Confidence Interval
Group
Value
Spread
Lower
Upper
Comment
Phase 2 (US Population)
0
Not reported
0
0.1
Not reported
Change at Day 156
Analysis denominator · Participants
Group
Source count
Phase 2 (US Population)
36
Values in Score on a scale · Interval/dispersion: 95% Confidence Interval
Group
Value
Spread
Lower
Upper
Comment
Phase 2 (US Population)
0
Not reported
0
0.1
Not reported
Change at Day 184
Analysis denominator · Participants
Group
Source count
Phase 2 (US Population)
40
Values in Score on a scale · Interval/dispersion: 95% Confidence Interval
Group
Value
Spread
Lower
Upper
Comment
Phase 2 (US Population)
0
Not reported
0
0.1
Not reported
Change at Day 212
Analysis denominator · Participants
Group
Source count
Phase 2 (US Population)
33
Values in Score on a scale · Interval/dispersion: 95% Confidence Interval
Group
Value
Spread
Lower
Upper
Comment
Phase 2 (US Population)
0.1
Not reported
0
0.1
Not reported
Change at Day 240
Analysis denominator · Participants
Group
Source count
Phase 2 (US Population)
32
Values in Score on a scale · Interval/dispersion: 95% Confidence Interval
Group
Value
Spread
Lower
Upper
Comment
Phase 2 (US Population)
0.1
Not reported
0
0.1
Not reported
Change at Day 268
Analysis denominator · Participants
Group
Source count
Phase 2 (US Population)
36
Values in Score on a scale · Interval/dispersion: 95% Confidence Interval
Group
Value
Spread
Lower
Upper
Comment
Phase 2 (US Population)
0.1
Not reported
0
0.1
Not reported
Change at Day 296
Analysis denominator · Participants
Group
Source count
Phase 2 (US Population)
33
Values in Score on a scale · Interval/dispersion: 95% Confidence Interval
Group
Value
Spread
Lower
Upper
Comment
Phase 2 (US Population)
0.1
Not reported
0
0.1
Not reported
Change at Day 324
Analysis denominator · Participants
Group
Source count
Phase 2 (US Population)
14
Values in Score on a scale · Interval/dispersion: 95% Confidence Interval
Group
Value
Spread
Lower
Upper
Comment
Phase 2 (US Population)
0
Not reported
0
0.1
Not reported
Change at Day 352
Analysis denominator · Participants
Group
Source count
Phase 2 (US Population)
7
Values in Score on a scale · Interval/dispersion: 95% Confidence Interval
Group
Value
Spread
Lower
Upper
Comment
Phase 2 (US Population)
0.1
Not reported
0
0.2
Not reported
Change at Day 380
Analysis denominator · Participants
Group
Source count
Phase 2 (US Population)
2
Values in Score on a scale · Interval/dispersion: 95% Confidence Interval
Group
Value
Spread
Lower
Upper
Comment
Phase 2 (US Population)
-0.1
Not reported
-0.3
0.2
Not reported
Complete source fields
classes
categories
measurements
group Id
OG000
lower Limit
-0.1
upper Limit
0
value
-0.1
denoms
counts
group Id
OG000
value
54
units
Participants
title
Change at Day 7
categories
measurements
group Id
OG000
lower Limit
-0.1
upper Limit
0
value
0
denoms
counts
group Id
OG000
value
53
units
Participants
title
Change at Day 28
categories
measurements
group Id
OG000
lower Limit
-0.1
upper Limit
0.1
value
0
denoms
counts
group Id
OG000
value
52
units
Participants
title
Change at Day 56
categories
measurements
group Id
OG000
lower Limit
0
upper Limit
0.1
value
0
denoms
counts
group Id
OG000
value
46
units
Participants
title
Change at Day 78
categories
measurements
group Id
OG000
lower Limit
0
upper Limit
0.1
value
0
denoms
counts
group Id
OG000
value
49
units
Participants
title
Change at Day 100
categories
measurements
group Id
OG000
lower Limit
0
upper Limit
0.1
value
0
denoms
counts
group Id
OG000
value
40
units
Participants
title
Change at Day 128
categories
measurements
group Id
OG000
lower Limit
0
upper Limit
0.1
value
0
denoms
counts
group Id
OG000
value
36
units
Participants
title
Change at Day 156
categories
measurements
group Id
OG000
lower Limit
0
upper Limit
0.1
value
0
denoms
counts
group Id
OG000
value
40
units
Participants
title
Change at Day 184
categories
measurements
group Id
OG000
lower Limit
0
upper Limit
0.1
value
0.1
denoms
counts
group Id
OG000
value
33
units
Participants
title
Change at Day 212
categories
measurements
group Id
OG000
lower Limit
0
upper Limit
0.1
value
0.1
denoms
counts
group Id
OG000
value
32
units
Participants
title
Change at Day 240
categories
measurements
group Id
OG000
lower Limit
0
upper Limit
0.1
value
0.1
denoms
counts
group Id
OG000
value
36
units
Participants
title
Change at Day 268
categories
measurements
group Id
OG000
lower Limit
0
upper Limit
0.1
value
0.1
denoms
counts
group Id
OG000
value
33
units
Participants
title
Change at Day 296
denoms
counts
group Id
OG000
value
54
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
95% Confidence Interval
groups
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
LEAST_SQUARES_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, 324, 352 and 380
title
Phase 2 (US 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, 324, 352 and 380
Triangle