NCT05347485 · OUTCOME
Number of Participants With Presence of Replication Competent Lentivirus
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
- Predose, 3, 6, 12 months after cilta-cel infusion on Day 1
What was measured
Number of participants with presence of replication competent lentivirus (with evaluable sample) were reported.
Analysis population: 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. Here, 'n' (number analyzed) signifies number of participants analyzed at each specified categories.
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
| Group | Source count |
|---|
| Ciltacabtagene Autoleucel (Cilta-cel) Out-of-Specification (OOS) | 57 |
|---|
Reported measurements
Predose of cilta-cel infusion
Analysis denominator · Participants
| Group | Source count |
|---|
| Ciltacabtagene Autoleucel (Cilta-cel) Out-of-Specification (OOS) | 57 |
|---|
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Ciltacabtagene Autoleucel (Cilta-cel) Out-of-Specification (OOS) | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
3 months after cilta-cel infusion
Analysis denominator · Participants
| Group | Source count |
|---|
| Ciltacabtagene Autoleucel (Cilta-cel) Out-of-Specification (OOS) | 26 |
|---|
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Ciltacabtagene Autoleucel (Cilta-cel) Out-of-Specification (OOS) | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
6 months after cilta-cel infusion
Analysis denominator · Participants
| Group | Source count |
|---|
| Ciltacabtagene Autoleucel (Cilta-cel) Out-of-Specification (OOS) | 30 |
|---|
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Ciltacabtagene Autoleucel (Cilta-cel) Out-of-Specification (OOS) | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
12 months after cilta-cel infusion
Analysis denominator · Participants
| Group | Source count |
|---|
| Ciltacabtagene Autoleucel (Cilta-cel) Out-of-Specification (OOS) | 12 |
|---|
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Ciltacabtagene Autoleucel (Cilta-cel) Out-of-Specification (OOS) | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
Complete source fields
- classes
- title
- Predose of cilta-cel infusion
- title
- 3 months after cilta-cel infusion
- title
- 6 months after cilta-cel infusion
- title
- 12 months after cilta-cel infusion
- description
- Number of participants with presence of replication competent lentivirus (with evaluable sample) were reported.
- 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.
- 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). Here, 'N' (number of participants analyzed) signifies number of participants analyzed for this outcome measure. Here, 'n' (number analyzed) signifies number of participants analyzed at each specified categories.
- reporting Status
- POSTED
- time Frame
- Predose, 3, 6, 12 months after cilta-cel infusion on Day 1
- title
- Number of Participants With Presence of Replication Competent Lentivirus
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice
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