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NCT03548207 · OUTCOME

Phase 2: Change From Baseline in Patient Global Impression of Severity (PGIS) Score at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352, 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
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, 324, 352, 380

What was measured

PGIS was a single item to assess severity of pain on a 5-point verbal rating scale ranged from 1 (no pain) to 5 (very severe pain), where 1: none; 2: mild; 3: moderate; 4: severe; 5: very severe. A higher score indicated a more severe pain.

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.

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

GroupSource count
Phase 2 (US Population)54
Phase 2 (Japan Population)8

Reported measurements

Change at Day 7

Analysis denominator · Participants

GroupSource count
Phase 2 (US Population)54
Phase 2 (Japan Population)8
Values in Score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Phase 2 (US Population)-0.30.96Not reportedNot reportedNot reported
Phase 2 (Japan Population)0.30.71Not reportedNot reportedNot reported
Change at Day 28

Analysis denominator · Participants

GroupSource count
Phase 2 (US Population)52
Phase 2 (Japan Population)8
Values in Score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Phase 2 (US Population)-0.30.94Not reportedNot reportedNot reported
Phase 2 (Japan Population)-0.10.64Not reportedNot reportedNot reported
Change at Day 56

Analysis denominator · Participants

GroupSource count
Phase 2 (US Population)52
Phase 2 (Japan Population)8
Values in Score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Phase 2 (US Population)-0.30.79Not reportedNot reportedNot reported
Phase 2 (Japan Population)0.30.46Not reportedNot reportedNot reported
Change at Day 78

Analysis denominator · Participants

GroupSource count
Phase 2 (US Population)46
Phase 2 (Japan Population)8
Values in Score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Phase 2 (US Population)-0.30.87Not reportedNot reportedNot reported
Phase 2 (Japan Population)0.00.53Not reportedNot reportedNot reported
Change at Day 100

Analysis denominator · Participants

GroupSource count
Phase 2 (US Population)49
Phase 2 (Japan Population)8
Values in Score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Phase 2 (US Population)-0.30.93Not reportedNot reportedNot reported
Phase 2 (Japan Population)0.00.53Not reportedNot reportedNot reported
Change at Day 128

Analysis denominator · Participants

GroupSource count
Phase 2 (US Population)40
Phase 2 (Japan Population)8
Values in Score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Phase 2 (US Population)-0.31.06Not reportedNot reportedNot reported
Phase 2 (Japan Population)0.00.53Not reportedNot reportedNot reported
Change at Day 156

Analysis denominator · Participants

GroupSource count
Phase 2 (US Population)36
Phase 2 (Japan Population)8
Values in Score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Phase 2 (US Population)-0.40.90Not reportedNot reportedNot reported
Phase 2 (Japan Population)0.00.93Not reportedNot reportedNot reported
Change at Day 184

Analysis denominator · Participants

GroupSource count
Phase 2 (US Population)39
Phase 2 (Japan Population)8
Values in Score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Phase 2 (US Population)-0.31.06Not reportedNot reportedNot reported
Phase 2 (Japan Population)0.30.46Not reportedNot reportedNot reported
Change at Day 212

Analysis denominator · Participants

GroupSource count
Phase 2 (US Population)33
Phase 2 (Japan Population)6
Values in Score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Phase 2 (US Population)-0.20.97Not reportedNot reportedNot reported
Phase 2 (Japan Population)0.00.63Not reportedNot reportedNot reported
Change at Day 240

Analysis denominator · Participants

GroupSource count
Phase 2 (US Population)31
Phase 2 (Japan Population)3
Values in Score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Phase 2 (US Population)-0.30.86Not reportedNot reportedNot reported
Phase 2 (Japan Population)0.00.00Not reportedNot reportedNot reported
Change at Day 268

Analysis denominator · Participants

GroupSource count
Phase 2 (US Population)34
Phase 2 (Japan Population)1
Values in Score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Phase 2 (US Population)-0.50.93Not reportedNot reportedNot reported
Phase 2 (Japan Population)0.0NANot reportedNot reportedHere, 'NA' signifies that SD could not be calculated as only 1 participant was evaluated.
Change at Day 296

Analysis denominator · Participants

GroupSource count
Phase 2 (US Population)33
Phase 2 (Japan Population)2
Values in Score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Phase 2 (US Population)-0.21.20Not reportedNot reportedNot reported
Phase 2 (Japan Population)0.00.00Not reportedNot reportedNot reported
Change at Day 324

Analysis denominator · Participants

GroupSource count
Phase 2 (US Population)13
Phase 2 (Japan Population)1
Values in Score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Phase 2 (US Population)-0.61.12Not reportedNot reportedNot reported
Phase 2 (Japan Population)0.0NANot reportedNot reportedHere, 'NA' signifies that SD could not be calculated as only 1 participant was analyzed.
Change at Day 352

Analysis denominator · Participants

GroupSource count
Phase 2 (US Population)7
Phase 2 (Japan Population)0
Values in Score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Phase 2 (US Population)-0.91.21Not reportedNot reportedNot reported
Change at Day 380

Analysis denominator · Participants

GroupSource count
Phase 2 (US Population)2
Phase 2 (Japan Population)0
Values in Score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Phase 2 (US Population)-0.50.71Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.96
        value
        -0.3
      2. group Id
        OG001
        spread
        0.71
        value
        0.3
    denoms
    1. counts
      1. group Id
        OG000
        value
        54
      2. group Id
        OG001
        value
        8
      units
      Participants
    title
    Change at Day 7
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.94
        value
        -0.3
      2. group Id
        OG001
        spread
        0.64
        value
        -0.1
    denoms
    1. counts
      1. group Id
        OG000
        value
        52
      2. group Id
        OG001
        value
        8
      units
      Participants
    title
    Change at Day 28
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.79
        value
        -0.3
      2. group Id
        OG001
        spread
        0.46
        value
        0.3
    denoms
    1. counts
      1. group Id
        OG000
        value
        52
      2. group Id
        OG001
        value
        8
      units
      Participants
    title
    Change at Day 56
  4. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.87
        value
        -0.3
      2. group Id
        OG001
        spread
        0.53
        value
        0.0
    denoms
    1. counts
      1. group Id
        OG000
        value
        46
      2. group Id
        OG001
        value
        8
      units
      Participants
    title
    Change at Day 78
  5. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.93
        value
        -0.3
      2. group Id
        OG001
        spread
        0.53
        value
        0.0
    denoms
    1. counts
      1. group Id
        OG000
        value
        49
      2. group Id
        OG001
        value
        8
      units
      Participants
    title
    Change at Day 100
  6. categories
    1. measurements
      1. group Id
        OG000
        spread
        1.06
        value
        -0.3
      2. group Id
        OG001
        spread
        0.53
        value
        0.0
    denoms
    1. counts
      1. group Id
        OG000
        value
        40
      2. group Id
        OG001
        value
        8
      units
      Participants
    title
    Change at Day 128
  7. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.90
        value
        -0.4
      2. group Id
        OG001
        spread
        0.93
        value
        0.0
    denoms
    1. counts
      1. group Id
        OG000
        value
        36
      2. group Id
        OG001
        value
        8
      units
      Participants
    title
    Change at Day 156
  8. categories
    1. measurements
      1. group Id
        OG000
        spread
        1.06
        value
        -0.3
      2. group Id
        OG001
        spread
        0.46
        value
        0.3
    denoms
    1. counts
      1. group Id
        OG000
        value
        39
      2. group Id
        OG001
        value
        8
      units
      Participants
    title
    Change at Day 184
  9. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.97
        value
        -0.2
      2. group Id
        OG001
        spread
        0.63
        value
        0.0
    denoms
    1. counts
      1. group Id
        OG000
        value
        33
      2. group Id
        OG001
        value
        6
      units
      Participants
    title
    Change at Day 212
  10. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.86
        value
        -0.3
      2. group Id
        OG001
        spread
        0.00
        value
        0.0
    denoms
    1. counts
      1. group Id
        OG000
        value
        31
      2. group Id
        OG001
        value
        3
      units
      Participants
    title
    Change at Day 240
  11. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.93
        value
        -0.5
      2. comment
        Here, 'NA' signifies that SD could not be calculated as only 1 participant was evaluated.
        group Id
        OG001
        spread
        NA
        value
        0.0
    denoms
    1. counts
      1. group Id
        OG000
        value
        34
      2. group Id
        OG001
        value
        1
      units
      Participants
    title
    Change at Day 268
  12. categories
    1. measurements
      1. group Id
        OG000
        spread
        1.20
        value
        -0.2
      2. group Id
        OG001
        spread
        0.00
        value
        0.0
    denoms
    1. counts
      1. group Id
        OG000
        value
        33
      2. group Id
        OG001
        value
        2
      units
      Participants
    title
    Change at Day 296
denoms
  1. counts
    1. group Id
      OG000
      value
      54
    2. group Id
      OG001
      value
      8
    units
    Participants
description
PGIS was a single item to assess severity of pain on a 5-point verbal rating scale ranged from 1 (no pain) to 5 (very severe pain), where 1: none; 2: mild; 3: moderate; 4: severe; 5: very severe. A higher score indicated a more severe pain.
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)
  2. 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 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, 380
title
Phase 2: Change From Baseline in Patient Global Impression of Severity (PGIS) Score at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352, 380
type
SECONDARY
unit Of Measure
Score on a scale

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

Preserved source evidence · Not medical advice