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NCT05347485 · OUTCOME

Overall Response Rate (ORR)

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

ORR is defined as the percentage of participants who had partial response (PR) or better (sCR+CR+VGPR+PR) according to the International Myeloma Working Group (IMWG) response criteria, as assessed by the investigator. CR: Negative immunofixation on the serum and urine and disappearance of any soft tissue plasmacytomas and less than (\<) 5 percentage (%) plasma cells (PCs) in bone marrow; sCR: CR+Normal free light chain ratio and absence of clonal cells in bone marrow by immunohistochemistry or immuno fluorescence; PR: greater than equal to (\>=) 50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by \>= 90 percentage (%) or to \<200 mg/24 hours; VGPR: Serum and urine M-protein detectable by immunofixation but not on electrophoresis or 90% or greater reduction in serum M-protein plus urine M-protein level \<100 mg per 24 hour.

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 Percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Ciltacabtagene Autoleucel (Cilta-cel) Out-of-Specification (OOS)57.3Not reported45.968.2Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        45.9
        upper Limit
        68.2
        value
        57.3
denoms
  1. counts
    1. group Id
      OG000
      value
      82
    units
    Participants
description
ORR is defined as the percentage of participants who had partial response (PR) or better (sCR+CR+VGPR+PR) according to the International Myeloma Working Group (IMWG) response criteria, as assessed by the investigator. CR: Negative immunofixation on the serum and urine and disappearance of any soft tissue plasmacytomas and less than (\<) 5 percentage (%) plasma cells (PCs) in bone marrow; sCR: CR+Normal free light chain ratio and absence of clonal cells in bone marrow by immunohistochemistry or immuno fluorescence; PR: greater than equal to (\>=) 50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by \>= 90 percentage (%) or to \<200 mg/24 hours; VGPR: Serum and urine M-protein detectable by immunofixation but not on electrophoresis or 90% or greater reduction in serum M-protein plus urine M-protein level \<100 mg per 24 hour.
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
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
Overall Response Rate (ORR)
type
PRIMARY
unit Of Measure
Percentage of participants

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

Preserved source evidence · Not medical advice