NCT03548207 · OUTCOME
Phase 2: Patient Global Impression of Change (PGIC) Score at Days 28, 56, 78, 100
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
- Days 28, 56, 78, 100
What was measured
PGIC was a single item to assess the participant's perception in change of their overall health status using a 7-point verbal rating scale ranging from 1(a lot better now) to 7 (a lot verse now), where 1: a lot better now; 2: moderately better now; 3: a little better now; 4: neither better nor worse; 5: a little worse now; 6: moderately worse now; 7: a lot worse now. Higher score indicated worse health status.
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 at 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.
Phase 2 (Japan 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 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 |
|---|
| Phase 2 (Japan Population) | 8 |
|---|
Reported measurements
Change at Day 28
Analysis denominator · Participants
| Group | Source count |
|---|
| Phase 2 (US Population) | 52 |
|---|
| Phase 2 (Japan Population) | 8 |
|---|
Values in Score on a scale · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Phase 2 (US Population) | 2.7 | 1.63 | Not reported | Not reported | Not reported |
|---|
| Phase 2 (Japan Population) | 2.8 | 0.89 | Not reported | Not reported | Not reported |
|---|
Change at Day 56
Analysis denominator · Participants
| Group | Source count |
|---|
| Phase 2 (US Population) | 54 |
|---|
| Phase 2 (Japan Population) | 8 |
|---|
Values in Score on a scale · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Phase 2 (US Population) | 2.5 | 1.66 | Not reported | Not reported | Not reported |
|---|
| Phase 2 (Japan Population) | 2.9 | 1.25 | Not reported | Not reported | Not reported |
|---|
Change at Day 78
Analysis denominator · Participants
| Group | Source count |
|---|
| Phase 2 (US Population) | 49 |
|---|
| Phase 2 (Japan Population) | 8 |
|---|
Values in Score on a scale · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Phase 2 (US Population) | 2.2 | 1.51 | Not reported | Not reported | Not reported |
|---|
| Phase 2 (Japan Population) | 2.5 | 0.93 | Not reported | Not reported | Not reported |
|---|
Change at Day 100
Analysis denominator · Participants
| Group | Source count |
|---|
| Phase 2 (US Population) | 54 |
|---|
| Phase 2 (Japan Population) | 7 |
|---|
Values in Score on a scale · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Phase 2 (US Population) | 2.0 | 1.43 | Not reported | Not reported | Not reported |
|---|
| Phase 2 (Japan Population) | 2.4 | 0.79 | Not reported | Not reported | Not reported |
|---|
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 1.63
- value
- 2.7
- group Id
- OG001
- spread
- 0.89
- value
- 2.8
- denoms
- counts
- group Id
- OG000
- value
- 52
- group Id
- OG001
- value
- 8
- units
- Participants
- title
- Change at Day 28
- categories
- measurements
- group Id
- OG000
- spread
- 1.66
- value
- 2.5
- group Id
- OG001
- spread
- 1.25
- value
- 2.9
- denoms
- counts
- group Id
- OG000
- value
- 54
- group Id
- OG001
- value
- 8
- units
- Participants
- title
- Change at Day 56
- categories
- measurements
- group Id
- OG000
- spread
- 1.51
- value
- 2.2
- group Id
- OG001
- spread
- 0.93
- value
- 2.5
- denoms
- counts
- group Id
- OG000
- value
- 49
- group Id
- OG001
- value
- 8
- units
- Participants
- title
- Change at Day 78
- categories
- measurements
- group Id
- OG000
- spread
- 1.43
- value
- 2.0
- group Id
- OG001
- spread
- 0.79
- value
- 2.4
- denoms
- counts
- group Id
- OG000
- value
- 54
- group Id
- OG001
- value
- 7
- units
- Participants
- title
- Change at Day 100
- denoms
- counts
- group Id
- OG000
- value
- 54
- group Id
- OG001
- value
- 8
- units
- Participants
- description
- PGIC was a single item to assess the participant's perception in change of their overall health status using a 7-point verbal rating scale ranging from 1(a lot better now) to 7 (a lot verse now), where 1: a lot better now; 2: moderately better now; 3: a little better now; 4: neither better nor worse; 5: a little worse now; 6: moderately worse now; 7: a lot worse now. Higher score indicated worse health status.
- 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)
- 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 RP2D dose of JNJ-68284528 0.75\*10\^6 CAR positive viable T cells/kg as IV infusion.
- id
- OG001
- title
- Phase 2 (Japan 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 at specified time points.
- reporting Status
- POSTED
- time Frame
- Days 28, 56, 78, 100
- title
- Phase 2: Patient Global Impression of Change (PGIC) Score at Days 28, 56, 78, 100
- type
- SECONDARY
- unit Of Measure
- Score on a scale
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
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