Skip to content
Triangle logo TriangleGet started
← Full study record

NCT05347485 · OUTCOME

Minimal Residual Disease (MRD)-Negative Rate

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
NUMBER
Unit
Percentage of participants
Interval / dispersion
95% Confidence Interval
Time frame
From Day 1 (post infusion) up to 18.6 months

What was measured

MRD-negative rate is defined as the percentage of participants with negative MRD status (at 10\^-4, 10\^-5 and 10\^-6 cutoffs) by bone marrow aspirate.

Analysis population: All participants who received cilta-cel OOS and had evaluable MRD samples in all treated analysis set. The all treated analysis set included all participants who received study intervention (cilta-cel OOS). Here, 'N' (number of participants analyzed) signifies number of participants analyzed for this outcome measure.

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)15

Reported measurements

10^-4 cutoff
Values in Percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Ciltacabtagene Autoleucel (Cilta-cel) Out-of-Specification (OOS)66.7Not reported38.488.2Not reported
10^-5 cutoff
Values in Percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Ciltacabtagene Autoleucel (Cilta-cel) Out-of-Specification (OOS)66.7Not reported38.488.2Not reported
10^-6 cutoff
Values in Percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Ciltacabtagene Autoleucel (Cilta-cel) Out-of-Specification (OOS)53.3Not reported26.678.7Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        38.4
        upper Limit
        88.2
        value
        66.7
    title
    10^-4 cutoff
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        38.4
        upper Limit
        88.2
        value
        66.7
    title
    10^-5 cutoff
  3. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        26.6
        upper Limit
        78.7
        value
        53.3
    title
    10^-6 cutoff
denoms
  1. counts
    1. group Id
      OG000
      value
      15
    units
    Participants
description
MRD-negative rate is defined as the percentage of participants with negative MRD status (at 10\^-4, 10\^-5 and 10\^-6 cutoffs) by bone marrow aspirate.
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
NUMBER
population Description
All participants who received cilta-cel OOS and had evaluable MRD samples in all treated analysis set. The all treated analysis set included all participants who received study intervention (cilta-cel OOS). Here, 'N' (number of participants analyzed) signifies number of participants analyzed for this outcome measure.
reporting Status
POSTED
time Frame
From Day 1 (post infusion) up to 18.6 months
title
Minimal Residual Disease (MRD)-Negative Rate
type
SECONDARY
unit Of Measure
Percentage of participants

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

Preserved source evidence · Not medical advice