Phase 2 (Japan Population): Change From Baseline in EORTC QLQ-MY20 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
EORTC QLQ-MY20 scale comprised of 20 questions that addressed four myeloma-specific HRQoL domains: disease symptoms (includes bone aches or pain, back pain, hip pain, arm or shoulder pain, chest pain, and pain increasing with activity), side effects of treatment (includes drowsiness, thirst, feeling ill, dry mouth, hair loss, upset by hair loss, tingling hands or feet, restlessness/agitation, acid indigestion/heartburn, and burning or sore eyes), future perspective (includes worry about death and health in the future, and thinking about illness) and body image. The scale was administered to assess 4 single items: feel restless or agitated, thinking about your illness, worried about dying, worried about health in the future. Scores were averaged and scales were transformed on a 0 to 100 scale. A high score for side effects of treatment represented a high level of symptomatology or problems, whereas a high score for future perspective represented better outcomes.
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)
8
Reported measurements
Restless or agitated: Change at Day 7
Analysis denominator · Participants
Group
Source count
Phase 2 (US Population)
8
Values in Score on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Phase 2 (US Population)
12.50
17.252
Not reported
Not reported
Not reported
Restless or agitated: Change at Day 28
Analysis denominator · Participants
Group
Source count
Phase 2 (US Population)
8
Values in Score on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Phase 2 (US Population)
8.33
15.430
Not reported
Not reported
Not reported
Restless or agitated: Change at Day 56
Analysis denominator · Participants
Group
Source count
Phase 2 (US Population)
8
Values in Score on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Phase 2 (US Population)
0.00
25.198
Not reported
Not reported
Not reported
Restless or agitated: Change at Day 78
Analysis denominator · Participants
Group
Source count
Phase 2 (US Population)
8
Values in Score on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Phase 2 (US Population)
0.00
17.817
Not reported
Not reported
Not reported
Restless or agitated: Change at Day 100
Analysis denominator · Participants
Group
Source count
Phase 2 (US Population)
8
Values in Score on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Phase 2 (US Population)
0.00
17.817
Not reported
Not reported
Not reported
Restless or agitated: Change at Day 128
Analysis denominator · Participants
Group
Source count
Phase 2 (US Population)
8
Values in Score on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Phase 2 (US Population)
0.00
25.198
Not reported
Not reported
Not reported
Restless or agitated: Change at Day 156
Analysis denominator · Participants
Group
Source count
Phase 2 (US Population)
8
Values in Score on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Phase 2 (US Population)
-8.33
15.430
Not reported
Not reported
Not reported
Restless or agitated: Change at Day 184
Analysis denominator · Participants
Group
Source count
Phase 2 (US Population)
8
Values in Score on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Phase 2 (US Population)
-4.17
21.362
Not reported
Not reported
Not reported
Restless or agitated: Change at Day 212
Analysis denominator · Participants
Group
Source count
Phase 2 (US Population)
6
Values in Score on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Phase 2 (US Population)
-5.56
13.608
Not reported
Not reported
Not reported
Restless or agitated: Change at Day 240
Analysis denominator · Participants
Group
Source count
Phase 2 (US Population)
3
Values in Score on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Phase 2 (US Population)
-11.11
19.245
Not reported
Not reported
Not reported
Restless or agitated: Change at Day 268
Analysis denominator · Participants
Group
Source count
Phase 2 (US Population)
2
Values in Score on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Phase 2 (US Population)
-16.67
23.570
Not reported
Not reported
Not reported
Restless or agitated: Change at Day 296
Analysis denominator · Participants
Group
Source count
Phase 2 (US Population)
2
Values in Score on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Phase 2 (US Population)
0.00
0.000
Not reported
Not reported
Not reported
Restless or agitated: Change at Day 324
Analysis denominator · Participants
Group
Source count
Phase 2 (US Population)
1
Values in Score on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Phase 2 (US Population)
-33.33
NA
Not reported
Not reported
SD could not be calculated as only 1 participant was analyzed.
Thinking about illness: Change at Day 7
Analysis denominator · Participants
Group
Source count
Phase 2 (US Population)
8
Values in Score on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Phase 2 (US Population)
4.17
33.034
Not reported
Not reported
Not reported
Thinking about illness: Change at Day 28
Analysis denominator · Participants
Group
Source count
Phase 2 (US Population)
8
Values in Score on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Phase 2 (US Population)
-4.17
11.785
Not reported
Not reported
Not reported
Thinking about illness: Change at Day 56
Analysis denominator · Participants
Group
Source count
Phase 2 (US Population)
8
Values in Score on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Phase 2 (US Population)
8.33
15.430
Not reported
Not reported
Not reported
Thinking about illness: Change at Day 78
Analysis denominator · Participants
Group
Source count
Phase 2 (US Population)
8
Values in Score on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Phase 2 (US Population)
4.17
11.785
Not reported
Not reported
Not reported
Thinking about illness: Change at Day 100
Analysis denominator · Participants
Group
Source count
Phase 2 (US Population)
8
Values in Score on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Phase 2 (US Population)
8.33
15.430
Not reported
Not reported
Not reported
Thinking about illness: Change at Day 128
Analysis denominator · Participants
Group
Source count
Phase 2 (US Population)
8
Values in Score on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Phase 2 (US Population)
8.33
15.430
Not reported
Not reported
Not reported
Thinking about illness: Change at Day 156
Analysis denominator · Participants
Group
Source count
Phase 2 (US Population)
8
Values in Score on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Phase 2 (US Population)
12.50
24.801
Not reported
Not reported
Not reported
Thinking about illness: Change at Day 184
Analysis denominator · Participants
Group
Source count
Phase 2 (US Population)
8
Values in Score on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Phase 2 (US Population)
12.50
17.252
Not reported
Not reported
Not reported
Thinking about illness: Change at Day 212
Analysis denominator · Participants
Group
Source count
Phase 2 (US Population)
6
Values in Score on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Phase 2 (US Population)
22.22
27.217
Not reported
Not reported
Not reported
Thinking about illness: Change at Day 240
Analysis denominator · Participants
Group
Source count
Phase 2 (US Population)
3
Values in Score on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Phase 2 (US Population)
0.00
0.000
Not reported
Not reported
Not reported
Thinking about illness: Change at Day 268
Analysis denominator · Participants
Group
Source count
Phase 2 (US Population)
2
Values in Score on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Phase 2 (US Population)
0.00
0.000
Not reported
Not reported
Not reported
Thinking about illness: Change at Day 296
Analysis denominator · Participants
Group
Source count
Phase 2 (US Population)
2
Values in Score on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Phase 2 (US Population)
0.00
0.000
Not reported
Not reported
Not reported
Thinking about illness: Change at Day 324
Analysis denominator · Participants
Group
Source count
Phase 2 (US Population)
1
Values in Score on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Phase 2 (US Population)
0.00
Not reported
Not reported
Not reported
Not reported
Worried about dying: Change at Day 7
Analysis denominator · Participants
Group
Source count
Phase 2 (US Population)
8
Values in Score on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Phase 2 (US Population)
16.67
17.817
Not reported
Not reported
Not reported
Worried about dying: Change at Day 28
Analysis denominator · Participants
Group
Source count
Phase 2 (US Population)
8
Values in Score on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Phase 2 (US Population)
8.33
15.430
Not reported
Not reported
Not reported
Worried about dying: Change at Day 56
Analysis denominator · Participants
Group
Source count
Phase 2 (US Population)
8
Values in Score on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Phase 2 (US Population)
16.67
25.198
Not reported
Not reported
Not reported
Worried about dying: Change at Day 78
Analysis denominator · Participants
Group
Source count
Phase 2 (US Population)
8
Values in Score on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Phase 2 (US Population)
25.00
23.570
Not reported
Not reported
Not reported
Worried about dying: Change at Day 100
Analysis denominator · Participants
Group
Source count
Phase 2 (US Population)
8
Values in Score on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Phase 2 (US Population)
25.00
23.570
Not reported
Not reported
Not reported
Worried about dying: Change at Day 128
Analysis denominator · Participants
Group
Source count
Phase 2 (US Population)
8
Values in Score on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Phase 2 (US Population)
25.00
23.570
Not reported
Not reported
Not reported
Worried about dying: Change at Day 156
Analysis denominator · Participants
Group
Source count
Phase 2 (US Population)
8
Values in Score on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Phase 2 (US Population)
20.83
24.801
Not reported
Not reported
Not reported
Worried about dying: Change at Day 184
Analysis denominator · Participants
Group
Source count
Phase 2 (US Population)
8
Values in Score on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Phase 2 (US Population)
29.17
21.362
Not reported
Not reported
Not reported
Worried about dying: Change at Day 212
Analysis denominator · Participants
Group
Source count
Phase 2 (US Population)
6
Values in Score on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Phase 2 (US Population)
27.78
25.092
Not reported
Not reported
Not reported
Worried about dying: Change at Day 240
Analysis denominator · Participants
Group
Source count
Phase 2 (US Population)
3
Values in Score on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Phase 2 (US Population)
11.11
19.245
Not reported
Not reported
Not reported
Worried about dying: Change at Day 268
Analysis denominator · Participants
Group
Source count
Phase 2 (US Population)
2
Values in Score on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Phase 2 (US Population)
16.67
23.570
Not reported
Not reported
Not reported
Worried about dying: Change at Day 296
Analysis denominator · Participants
Group
Source count
Phase 2 (US Population)
2
Values in Score on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Phase 2 (US Population)
16.67
23.570
Not reported
Not reported
Not reported
Worried about dying: Change at Day 324
Analysis denominator · Participants
Group
Source count
Phase 2 (US Population)
1
Values in Score on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Phase 2 (US Population)
0.00
Not reported
Not reported
Not reported
Not reported
Worried about health in future: Change at Day 7
Analysis denominator · Participants
Group
Source count
Phase 2 (US Population)
8
Values in Score on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Phase 2 (US Population)
0.00
17.817
Not reported
Not reported
Not reported
Worried about health in future: Change at Day 28
Analysis denominator · Participants
Group
Source count
Phase 2 (US Population)
8
Values in Score on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Phase 2 (US Population)
-4.17
11.785
Not reported
Not reported
Not reported
Worried about health in future: Change at Day 56
Analysis denominator · Participants
Group
Source count
Phase 2 (US Population)
8
Values in Score on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Phase 2 (US Population)
4.17
21.362
Not reported
Not reported
Not reported
Worried about health in future: Change at Day 78
Analysis denominator · Participants
Group
Source count
Phase 2 (US Population)
8
Values in Score on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Phase 2 (US Population)
4.17
11.785
Not reported
Not reported
Not reported
Worried about health in future: Change at Day 100
Analysis denominator · Participants
Group
Source count
Phase 2 (US Population)
8
Values in Score on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Phase 2 (US Population)
0.00
0.000
Not reported
Not reported
Not reported
Worried about health in future: Change at Day 128
Analysis denominator · Participants
Group
Source count
Phase 2 (US Population)
8
Values in Score on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Phase 2 (US Population)
0.00
0.000
Not reported
Not reported
Not reported
Worried about health in future: Change at Day 156
Analysis denominator · Participants
Group
Source count
Phase 2 (US Population)
8
Values in Score on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Phase 2 (US Population)
4.17
11.785
Not reported
Not reported
Not reported
Worried about health in future: Change at Day 184
Analysis denominator · Participants
Group
Source count
Phase 2 (US Population)
8
Values in Score on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Phase 2 (US Population)
8.33
15.430
Not reported
Not reported
Not reported
Worried about health in future: Change at Day 212
Analysis denominator · Participants
Group
Source count
Phase 2 (US Population)
6
Values in Score on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Phase 2 (US Population)
5.56
13.608
Not reported
Not reported
Not reported
Worried about health in future: Change at Day 240
Analysis denominator · Participants
Group
Source count
Phase 2 (US Population)
3
Values in Score on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Phase 2 (US Population)
22.22
19.245
Not reported
Not reported
Not reported
Worried about health in future: Change at Day 268
Analysis denominator · Participants
Group
Source count
Phase 2 (US Population)
2
Values in Score on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Phase 2 (US Population)
0.00
0.000
Not reported
Not reported
Not reported
Worried about health in future: Change at Day 296
Analysis denominator · Participants
Group
Source count
Phase 2 (US Population)
2
Values in Score on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Phase 2 (US Population)
0.00
0.000
Not reported
Not reported
Not reported
Worried about health in future: Change at Day 324
Analysis denominator · Participants
Group
Source count
Phase 2 (US Population)
1
Values in Score on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Phase 2 (US Population)
0.00
Not reported
Not reported
Not reported
Not reported
Complete source fields
classes
categories
measurements
group Id
OG000
spread
17.252
value
12.50
denoms
counts
group Id
OG000
value
8
units
Participants
title
Restless or agitated: Change at Day 7
categories
measurements
group Id
OG000
spread
15.430
value
8.33
denoms
counts
group Id
OG000
value
8
units
Participants
title
Restless or agitated: Change at Day 28
categories
measurements
group Id
OG000
spread
25.198
value
0.00
denoms
counts
group Id
OG000
value
8
units
Participants
title
Restless or agitated: Change at Day 56
categories
measurements
group Id
OG000
spread
17.817
value
0.00
denoms
counts
group Id
OG000
value
8
units
Participants
title
Restless or agitated: Change at Day 78
categories
measurements
group Id
OG000
spread
17.817
value
0.00
denoms
counts
group Id
OG000
value
8
units
Participants
title
Restless or agitated: Change at Day 100
categories
measurements
group Id
OG000
spread
25.198
value
0.00
denoms
counts
group Id
OG000
value
8
units
Participants
title
Restless or agitated: Change at Day 128
categories
measurements
group Id
OG000
spread
15.430
value
-8.33
denoms
counts
group Id
OG000
value
8
units
Participants
title
Restless or agitated: Change at Day 156
categories
measurements
group Id
OG000
spread
21.362
value
-4.17
denoms
counts
group Id
OG000
value
8
units
Participants
title
Restless or agitated: Change at Day 184
categories
measurements
group Id
OG000
spread
13.608
value
-5.56
denoms
counts
group Id
OG000
value
6
units
Participants
title
Restless or agitated: Change at Day 212
categories
measurements
group Id
OG000
spread
19.245
value
-11.11
denoms
counts
group Id
OG000
value
3
units
Participants
title
Restless or agitated: Change at Day 240
categories
measurements
group Id
OG000
spread
23.570
value
-16.67
denoms
counts
group Id
OG000
value
2
units
Participants
title
Restless or agitated: Change at Day 268
categories
measurements
group Id
OG000
spread
0.000
value
0.00
denoms
counts
group Id
OG000
value
2
units
Participants
title
Restless or agitated: Change at Day 296
denoms
counts
group Id
OG000
value
8
units
Participants
description
EORTC QLQ-MY20 scale comprised of 20 questions that addressed four myeloma-specific HRQoL domains: disease symptoms (includes bone aches or pain, back pain, hip pain, arm or shoulder pain, chest pain, and pain increasing with activity), side effects of treatment (includes drowsiness, thirst, feeling ill, dry mouth, hair loss, upset by hair loss, tingling hands or feet, restlessness/agitation, acid indigestion/heartburn, and burning or sore eyes), future perspective (includes worry about death and health in the future, and thinking about illness) and body image. The scale was administered to assess 4 single items: feel restless or agitated, thinking about your illness, worried about dying, worried about health in the future. Scores were averaged and scales were transformed on a 0 to 100 scale. A high score for side effects of treatment represented a high level of symptomatology or problems, whereas a high score for future perspective represented better outcomes.
dispersion Type
Standard Deviation
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
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 EORTC QLQ-MY20 at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324
Triangle