Number of Participants With Treatment-emergent Adverse Event of Special Interest (AESIs): Prolonged and Recurrent Cytopenias
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: prolonged and recurrent cytopenias were reported. AESIs include the anticipated risks of treatment with study drug and events that may be related to multiple sclerosis comorbidities. It included Thrombocytopenia, Neutropenia, Lymphopenia, and Anaemia. 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. Severity was assessed using NCI-CTCAE version 5.0 as: Grade 1: Mild; Grade 2: Moderate; Grade 3: Severe; Grade 4: Life-threatening; Grade 5: Death related to adverse event.
Analysis population: The all treated analysis set included all participants who received study intervention (cilta-cel 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.
Thrombocytopenia: Initial Grade 3/4 Not Recovered to <= Grade 2 by Day 30
categories
measurements
group Id
OG000
value
29
title
Thrombocytopenia: Initial Grade 3/4 Not Recovered to <= Grade 2 by Day 60
categories
measurements
group Id
OG000
value
1
title
Thrombocytopenia: Grade 3/4 > Day 60 (After Initial Recovery of Grade 3/4 within Day 60)
categories
measurements
group Id
OG000
value
75
title
Neutropenia: Grade 3/4 After Day 1 Dosing
categories
measurements
group Id
OG000
value
36
title
Neutropenia: Initial Grade 3/4 Not Recovered to <= Grade 2 by Day 30
categories
measurements
group Id
OG000
value
18
title
Neutropenia: Initial Grade 3/4 Not Recovered to <= Grade 2 by Day 60
categories
measurements
group Id
OG000
value
1
title
Neutropenia: Grade 3/4 > Day 60 (After Initial Recovery of Grade 3/4 within Day 60)
categories
measurements
group Id
OG000
value
75
title
Lymphopenia: Grade 3/4 After Day 1 Dosing
categories
measurements
group Id
OG000
value
32
title
Lymphopenia: Initial Grade 3/4 Not Recovered to <= Grade 2 by Day 30
categories
measurements
group Id
OG000
value
21
title
Lymphopenia: Initial Grade 3/4 Not Recovered to <= Grade 2 by Day 60
categories
measurements
group Id
OG000
value
4
title
Lymphopenia: Grade 3/4 > Day 60 (After Initial Recovery of Grade 3/4 within Day 60)
denoms
counts
group Id
OG000
value
82
units
Participants
description
Number of participants with treatment-emergent AESIs: prolonged and recurrent cytopenias were reported. AESIs include the anticipated risks of treatment with study drug and events that may be related to multiple sclerosis comorbidities. It included Thrombocytopenia, Neutropenia, Lymphopenia, and Anaemia. 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. Severity was assessed using NCI-CTCAE version 5.0 as: Grade 1: Mild; Grade 2: Moderate; Grade 3: Severe; Grade 4: Life-threatening; Grade 5: Death related to adverse event.
groups
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.
Triangle