TriangleNCT05347485 · OUTCOME
Stringent Complete Response (sCR) Rate
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
sCR rate is defined as percentage of participants who achieved sCR according to IMWG response criteria. sCR is defined per IMWG criteria as CR plus normal FLC ratio, and absence of clonal PCs by immunohistochemistry or 2- to 4-color flow cytometry. CR is defined as per IMWG as negative immunofixation of serum and urine, and disappearance of any soft tissue plasmacytomas, and \<5% PCs in bone marrow. No evidence of initial monoclonal protein isotype(s) on immunofixation of the serum and urine.
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) | 15.9 | Not reported | 8.7 | 25.6 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 8.7
- upper Limit
- 25.6
- value
- 15.9
- denoms
- counts
- group Id
- OG000
- value
- 82
- units
- Participants
- description
- sCR rate is defined as percentage of participants who achieved sCR according to IMWG response criteria. sCR is defined per IMWG criteria as CR plus normal FLC ratio, and absence of clonal PCs by immunohistochemistry or 2- to 4-color flow cytometry. CR is defined as per IMWG as negative immunofixation of serum and urine, and disappearance of any soft tissue plasmacytomas, and \<5% PCs in bone marrow. No evidence of initial monoclonal protein isotype(s) on immunofixation of the serum and urine.
- 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
- 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
- Stringent Complete Response (sCR) Rate
- type
- SECONDARY
- unit Of Measure
- Percentage of Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice