Phase 2 (US Population): Change From Baseline in EORTC QLQ-MY20 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
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)
54
Reported measurements
Restless or agitated: 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)
5.7
Not reported
0.6
10.8
Not reported
Restless or agitated: 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)
-5.5
Not reported
-10.7
-0.3
Not reported
Restless or agitated: 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)
1.6
Not reported
-3.6
6.7
Not reported
Restless or agitated: 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)
-2.7
Not reported
-8.1
2.8
Not reported
Restless or agitated: 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)
-3.3
Not reported
-8.6
2
Not reported
Restless or agitated: 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)
-3.9
Not reported
-9.6
1.9
Not reported
Restless or agitated: 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)
0.9
Not reported
-5
6.9
Not reported
Restless or agitated: 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)
-3.6
Not reported
-9.4
2.1
Not reported
Restless or agitated: 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)
-3.9
Not reported
-10.1
2.3
Not reported
Restless or agitated: 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)
-12.7
Not reported
-19
-6.5
Not reported
Restless or agitated: Change at Day 268
Analysis denominator · Participants
Group
Source count
Phase 2 (US Population)
35
Values in Score on a scale · Interval/dispersion: 95% Confidence Interval
Group
Value
Spread
Lower
Upper
Comment
Phase 2 (US Population)
-1.7
Not reported
-7.8
4.3
Not reported
Restless or agitated: Change at Day 296
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)
-7.8
Not reported
-14
-1.5
Not reported
Restless or agitated: 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)
-11.5
Not reported
-20.4
-2.5
Not reported
Restless or agitated: 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)
1.1
Not reported
-11.1
13.4
Not reported
Restless or agitated: 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)
-23.2
Not reported
-45.8
-0.6
Not reported
Thinking about illness: 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)
7.8
Not reported
1.7
14
Not reported
Thinking about illness: 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)
15
Not reported
8.8
21.2
Not reported
Thinking about illness: 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)
17.1
Not reported
10.8
23.3
Not reported
Thinking about illness: 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)
23.1
Not reported
16.7
29.6
Not reported
Thinking about illness: 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)
25.7
Not reported
19.4
32
Not reported
Thinking about illness: 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)
27.6
Not reported
20.8
34.3
Not reported
Thinking about illness: Change at Day 156
Analysis denominator · Participants
Group
Source count
Phase 2 (US Population)
35
Values in Score on a scale · Interval/dispersion: 95% Confidence Interval
Group
Value
Spread
Lower
Upper
Comment
Phase 2 (US Population)
29.9
Not reported
22.8
36.9
Not reported
Thinking about illness: 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)
27.9
Not reported
21.2
34.7
Not reported
Thinking about illness: 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)
34.7
Not reported
27.5
41.8
Not reported
Thinking about illness: 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)
32.1
Not reported
24.8
39.3
Not reported
Thinking about illness: Change at Day 268
Analysis denominator · Participants
Group
Source count
Phase 2 (US Population)
35
Values in Score on a scale · Interval/dispersion: 95% Confidence Interval
Group
Value
Spread
Lower
Upper
Comment
Phase 2 (US Population)
34.9
Not reported
27.8
41.9
Not reported
Thinking about illness: Change at Day 296
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)
32.6
Not reported
25.3
39.8
Not reported
Thinking about illness: 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)
35.1
Not reported
25.3
45
Not reported
Thinking about illness: 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)
33.5
Not reported
20.3
46.8
Not reported
Thinking about illness: 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)
34.3
Not reported
10.2
58.4
Not reported
Worried about dying: 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)
13.2
Not reported
8.5
17.8
Not reported
Worried about dying: 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)
18.2
Not reported
13.6
22.9
Not reported
Worried about dying: 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)
16.8
Not reported
12.1
21.5
Not reported
Worried about dying: 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)
18.3
Not reported
13.4
23.1
Not reported
Worried about dying: 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)
18.9
Not reported
14.1
23.7
Not reported
Worried about dying: 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)
16.8
Not reported
11.7
21.9
Not reported
Worried about dying: 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)
14.9
Not reported
9.6
20.2
Not reported
Worried about dying: 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)
15.8
Not reported
10.7
21
Not reported
Worried about dying: 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)
13.3
Not reported
7.9
18.8
Not reported
Worried about dying: 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)
14.7
Not reported
9.1
20.2
Not reported
Worried about dying: Change at Day 268
Analysis denominator · Participants
Group
Source count
Phase 2 (US Population)
35
Values in Score on a scale · Interval/dispersion: 95% Confidence Interval
Group
Value
Spread
Lower
Upper
Comment
Phase 2 (US Population)
10
Not reported
4.7
15.4
Not reported
Worried about dying: Change at Day 296
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)
16.3
Not reported
10.8
21.8
Not reported
Worried about dying: 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)
17.6
Not reported
9.9
25.3
Not reported
Worried about dying: 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)
14.9
Not reported
4.5
25.3
Not reported
Worried about dying: 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)
27.1
Not reported
8
46.1
Not reported
Worried about health in future: 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)
8.2
Not reported
2.2
14.2
Not reported
Worried about health in future: 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)
18.2
Not reported
12.2
24.2
Not reported
Worried about health in future: 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)
15.5
Not reported
9.4
21.5
Not reported
Worried about health in future: 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)
19.7
Not reported
13.4
26
Not reported
Worried about health in future: 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)
14.3
Not reported
8.1
20.4
Not reported
Worried about health in future: 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)
20.4
Not reported
13.8
26.9
Not reported
Worried about health in future: Change at Day 156
Analysis denominator · Participants
Group
Source count
Phase 2 (US Population)
35
Values in Score on a scale · Interval/dispersion: 95% Confidence Interval
Group
Value
Spread
Lower
Upper
Comment
Phase 2 (US Population)
18.9
Not reported
12
25.7
Not reported
Worried about health in future: Change at Day 184
Analysis denominator · Participants
Group
Source count
Phase 2 (US Population)
39
Values in Score on a scale · Interval/dispersion: 95% Confidence Interval
Group
Value
Spread
Lower
Upper
Comment
Phase 2 (US Population)
19
Not reported
12.3
25.6
Not reported
Worried about health in future: 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)
19.9
Not reported
12.9
26.9
Not reported
Worried about health in future: 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)
19.7
Not reported
12.6
26.8
Not reported
Worried about health in future: Change at Day 268
Analysis denominator · Participants
Group
Source count
Phase 2 (US Population)
35
Values in Score on a scale · Interval/dispersion: 95% Confidence Interval
Group
Value
Spread
Lower
Upper
Comment
Phase 2 (US Population)
17.1
Not reported
10.2
23.9
Not reported
Worried about health in future: Change at Day 296
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)
24.2
Not reported
17.2
31.3
Not reported
Worried about health in future: 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)
20.2
Not reported
10.5
29.8
Not reported
Worried about health in future: 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)
25.1
Not reported
12.1
38
Not reported
Worried about health in future: 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)
7.7
Not reported
-15.8
31.2
Not reported
Complete source fields
classes
categories
measurements
group Id
OG000
lower Limit
0.6
upper Limit
10.8
value
5.7
denoms
counts
group Id
OG000
value
54
units
Participants
title
Restless or agitated: Change at Day 7
categories
measurements
group Id
OG000
lower Limit
-10.7
upper Limit
-0.3
value
-5.5
denoms
counts
group Id
OG000
value
53
units
Participants
title
Restless or agitated: Change at Day 28
categories
measurements
group Id
OG000
lower Limit
-3.6
upper Limit
6.7
value
1.6
denoms
counts
group Id
OG000
value
52
units
Participants
title
Restless or agitated: Change at Day 56
categories
measurements
group Id
OG000
lower Limit
-8.1
upper Limit
2.8
value
-2.7
denoms
counts
group Id
OG000
value
46
units
Participants
title
Restless or agitated: Change at Day 78
categories
measurements
group Id
OG000
lower Limit
-8.6
upper Limit
2
value
-3.3
denoms
counts
group Id
OG000
value
49
units
Participants
title
Restless or agitated: Change at Day 100
categories
measurements
group Id
OG000
lower Limit
-9.6
upper Limit
1.9
value
-3.9
denoms
counts
group Id
OG000
value
40
units
Participants
title
Restless or agitated: Change at Day 128
categories
measurements
group Id
OG000
lower Limit
-5
upper Limit
6.9
value
0.9
denoms
counts
group Id
OG000
value
36
units
Participants
title
Restless or agitated: Change at Day 156
categories
measurements
group Id
OG000
lower Limit
-9.4
upper Limit
2.1
value
-3.6
denoms
counts
group Id
OG000
value
40
units
Participants
title
Restless or agitated: Change at Day 184
categories
measurements
group Id
OG000
lower Limit
-10.1
upper Limit
2.3
value
-3.9
denoms
counts
group Id
OG000
value
33
units
Participants
title
Restless or agitated: Change at Day 212
categories
measurements
group Id
OG000
lower Limit
-19
upper Limit
-6.5
value
-12.7
denoms
counts
group Id
OG000
value
32
units
Participants
title
Restless or agitated: Change at Day 240
categories
measurements
group Id
OG000
lower Limit
-7.8
upper Limit
4.3
value
-1.7
denoms
counts
group Id
OG000
value
35
units
Participants
title
Restless or agitated: Change at Day 268
categories
measurements
group Id
OG000
lower Limit
-14
upper Limit
-1.5
value
-7.8
denoms
counts
group Id
OG000
value
32
units
Participants
title
Restless or agitated: Change at Day 296
denoms
counts
group Id
OG000
value
54
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
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 EORTC QLQ-MY20 at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380
Triangle