TriangleNCT05347485 · OUTCOME
Clinical Benefit Rate (CBR)
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
Clinical benefit rate was defined as the percentage of participants who achieved a minimal response (MR) or better (including MR, PR, VGPR, CR, and sCR). MR was defined as per IMWG criteria as \>=25% but less than or equal to (\<=) 49% reduction of serum M-protein and reduction in 24-hour urine M-protein by 50% to 89%. In addition to the above criteria, if present at baseline, \>=50% reduction in the size of soft tissue plasmacytomas was also required.
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) | 59.8 | Not reported | 48.3 | 70.4 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 48.3
- upper Limit
- 70.4
- value
- 59.8
- denoms
- counts
- group Id
- OG000
- value
- 82
- units
- Participants
- description
- Clinical benefit rate was defined as the percentage of participants who achieved a minimal response (MR) or better (including MR, PR, VGPR, CR, and sCR). MR was defined as per IMWG criteria as \>=25% but less than or equal to (\<=) 49% reduction of serum M-protein and reduction in 24-hour urine M-protein by 50% to 89%. In addition to the above criteria, if present at baseline, \>=50% reduction in the size of soft tissue plasmacytomas was also required.
- 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
- Clinical Benefit Rate (CBR)
- type
- SECONDARY
- unit Of Measure
- Percentage of Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice