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NCT05347485 · OUTCOME

Progression Free Survival (PFS)

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
MEDIAN
Unit
Months
Interval / dispersion
95% Confidence Interval
Time frame
From Day 1 (post infusion) up to 18.6 months

What was measured

PFS defined as the time from the date of the initial infusion of cilta-cel OOS to the date of first documented disease progression as per IMWG criteria, or death due to any cause, whichever occurs first. PD: increase of 25% from lowest response value: serum and urine M-component (absolute increase must be \>=0.5 g/dL and \>=200 mg/24 hours, respectively); only in participants without measurable serum and/or urine M-protein levels the difference between involved and uninvolved FLC levels (absolute increase must be \>10 mg/dL); only in participants without measurable serum and urine M-protein levels and without measurable disease by FLC levels, bone marrow PC percentage (absolute increase must be \>=10%), appearance of a new lesion; definite development of new bone lesions or definite increase in the size of existing bone lesions, \>=50% increase in circulating PCs (minimum of 200 cells per uL) if this was the only measure of disease.

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

Source class 1
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Ciltacabtagene Autoleucel (Cilta-cel) Out-of-Specification (OOS)NANot reported7.39NAMedian and upper limit of 95% CI could not be estimated due to low number of participants with events.
Complete source fields
classes
  1. categories
    1. measurements
      1. comment
        Median and upper limit of 95% CI could not be estimated due to low number of participants with events.
        group Id
        OG000
        lower Limit
        7.39
        upper Limit
        NA
        value
        NA
denoms
  1. counts
    1. group Id
      OG000
      value
      82
    units
    Participants
description
PFS defined as the time from the date of the initial infusion of cilta-cel OOS to the date of first documented disease progression as per IMWG criteria, or death due to any cause, whichever occurs first. PD: increase of 25% from lowest response value: serum and urine M-component (absolute increase must be \>=0.5 g/dL and \>=200 mg/24 hours, respectively); only in participants without measurable serum and/or urine M-protein levels the difference between involved and uninvolved FLC levels (absolute increase must be \>10 mg/dL); only in participants without measurable serum and urine M-protein levels and without measurable disease by FLC levels, bone marrow PC percentage (absolute increase must be \>=10%), appearance of a new lesion; definite development of new bone lesions or definite increase in the size of existing bone lesions, \>=50% increase in circulating PCs (minimum of 200 cells per uL) if this was the only measure of disease.
dispersion Type
95% Confidence Interval
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
MEDIAN
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 (post infusion) up to 18.6 months
title
Progression Free Survival (PFS)
type
SECONDARY
unit Of Measure
Months

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice