TriangleNCT05347485 · OUTCOME
Overall Survival (OS)
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
OS is measured from the date of the initial infusion of cilta-cel OOS to the date of the participant's death. If the participant is alive or the vital status is unknown, then the participant's data was censored at the date the participant was last known to be alive.
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 | Source count |
|---|---|
| Ciltacabtagene Autoleucel (Cilta-cel) Out-of-Specification (OOS) | 82 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Ciltacabtagene Autoleucel (Cilta-cel) Out-of-Specification (OOS) | NA | Not reported | 13.67 | NA | Median and upper limit of 95% CI could not be estimated due to low number of participants with events. |
Complete source fields
- classes
- categories
- measurements
- 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
- 13.67
- upper Limit
- NA
- value
- NA
- denoms
- counts
- group Id
- OG000
- value
- 82
- units
- Participants
- description
- OS is measured from the date of the initial infusion of cilta-cel OOS to the date of the participant's death. If the participant is alive or the vital status is unknown, then the participant's data was censored at the date the participant was last known to be alive.
- dispersion Type
- 95% Confidence Interval
- 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
- 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
- Overall Survival (OS)
- type
- SECONDARY
- unit Of Measure
- Months
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice