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NCT05347485 · OUTCOME

Number of Participants With Treatment-emergent Adverse Event of Special Interest (AESIs): Cytokine Release Syndrome (CRS), Immune Effector Cell-Associated Neurotoxicity (ICANS), Other Neurotoxicities, and Secondary Primary Malignancies

A Study of JNJ-68284528 Out-of-Specification (OOS) for Commercial Release in Participants With Multiple Myeloma · Source last updated 2025-04-25

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
From Day 1 up to 100 days post cilta-cel OOS infusion (Up to 100 days)

What was measured

Number of participants with treatment-emergent AESIs: CRS, ICANS, other neurotoxicities, and secondary primary malignancies were reported. AESIs include the anticipated risks of treatment with study drug and events that may be related to multiple sclerosis comorbidities. Treatment-emergent AESIs were defined as any AESI that occurs on or after the start of cilta-cel OOS infusion through 100 days after the cilta-cel OOS infusion or the start of subsequent anti-myeloma therapy, whichever was earlier; or any AESI that was considered related to study intervention regardless of the start date of the event; or any AESI that was present at baseline but worsens in toxicity grade or was subsequently considered related to study intervention by the investigator.

Analysis population: The all treated analysis set included all participants who received study intervention (cilta-cel OOS).

Groups in this outcome

Ciltacabtagene Autoleucel (Cilta-cel) Out-of-Specification (OOS)

Adult participants aged 18 years or older, with multiple myeloma received the lymphodepleting chemotherapy (cyclophosphamide 300 milligrams per meter square \[mg/m\^2\] intravenous \[IV\] infusion and fludarabine 30 mg/m\^2 IV infusion daily, for 3 days \[Day -7 to Day -5\]). After 5 to 7 days of initiating lymphodepleting chemotherapy, participants received IV infusion of cilta-cel OOS at a total targeted dose of 0.75\*10\^6 chimeric antigen receptor (CAR)-positive viable T-cells/kg (dose range 0.5\*10\^6 CAR-positive viable T cells/kg to 1.0\*10\^6 CAR-positive viable T cells/kg) based on participant's body weight at apheresis or per exceptional release criteria determined alternative dose.

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Ciltacabtagene Autoleucel (Cilta-cel) Out-of-Specification (OOS)82

Reported measurements

Cytokine Release Syndrome (CRS)
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Ciltacabtagene Autoleucel (Cilta-cel) Out-of-Specification (OOS)61Not reportedNot reportedNot reportedNot reported
Immune Effector Cell-Associated Neurotoxicity (ICANS)
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Ciltacabtagene Autoleucel (Cilta-cel) Out-of-Specification (OOS)12Not reportedNot reportedNot reportedNot reported
Other neurotoxicities
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Ciltacabtagene Autoleucel (Cilta-cel) Out-of-Specification (OOS)8Not reportedNot reportedNot reportedNot reported
Secondary primary malignancies
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Ciltacabtagene Autoleucel (Cilta-cel) Out-of-Specification (OOS)5Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        61
    title
    Cytokine Release Syndrome (CRS)
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        12
    title
    Immune Effector Cell-Associated Neurotoxicity (ICANS)
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        8
    title
    Other neurotoxicities
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        5
    title
    Secondary primary malignancies
denoms
  1. counts
    1. group Id
      OG000
      value
      82
    units
    Participants
description
Number of participants with treatment-emergent AESIs: CRS, ICANS, other neurotoxicities, and secondary primary malignancies were reported. AESIs include the anticipated risks of treatment with study drug and events that may be related to multiple sclerosis comorbidities. Treatment-emergent AESIs were defined as any AESI that occurs on or after the start of cilta-cel OOS infusion through 100 days after the cilta-cel OOS infusion or the start of subsequent anti-myeloma therapy, whichever was earlier; or any AESI that was considered related to study intervention regardless of the start date of the event; or any AESI that was present at baseline but worsens in toxicity grade or was subsequently considered related to study intervention by the investigator.
groups
  1. description
    Adult participants aged 18 years or older, with multiple myeloma received the lymphodepleting chemotherapy (cyclophosphamide 300 milligrams per meter square \[mg/m\^2\] intravenous \[IV\] infusion and fludarabine 30 mg/m\^2 IV infusion daily, for 3 days \[Day -7 to Day -5\]). After 5 to 7 days of initiating lymphodepleting chemotherapy, participants received IV infusion of cilta-cel OOS at a total targeted dose of 0.75\*10\^6 chimeric antigen receptor (CAR)-positive viable T-cells/kg (dose range 0.5\*10\^6 CAR-positive viable T cells/kg to 1.0\*10\^6 CAR-positive viable T cells/kg) based on participant's body weight at apheresis or per exceptional release criteria determined alternative dose.
    id
    OG000
    title
    Ciltacabtagene Autoleucel (Cilta-cel) Out-of-Specification (OOS)
param Type
COUNT_OF_PARTICIPANTS
population Description
The all treated analysis set included all participants who received study intervention (cilta-cel OOS).
reporting Status
POSTED
time Frame
From Day 1 up to 100 days post cilta-cel OOS infusion (Up to 100 days)
title
Number of Participants With Treatment-emergent Adverse Event of Special Interest (AESIs): Cytokine Release Syndrome (CRS), Immune Effector Cell-Associated Neurotoxicity (ICANS), Other Neurotoxicities, and Secondary Primary Malignancies
type
SECONDARY
unit Of Measure
Participants

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Preserved source evidence · Not medical advice