TriangleNCT05347485 · OUTCOME
Partial Response (PR) 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
PR rate was defined as percentage of participants who achieved PR according to IMWG response criteria. PR was defined as per IMWG criteria as \>= 50% reduction of serum M-protein and reduction in 24 hours urinary M-protein by \>= 90% or to \< 200 mg/24hours. If the serum and urine M-protein were unmeasurable, a \>= 50% decrease in the difference between involved and uninvolved Free light chain (FLC) levels was required in the place of the M-protein criteria. If serum and urine M-protein were not measurable, and serum free light assay was also not measurable, \>=50% reduction in bone marrow plasma cells is required in place of M-protein, provided baseline bone marrow plasma cells percentage was \>=30%. In addition to the above listed criteria, if present at baseline, a \>= 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) | 9.8 | Not reported | 4.3 | 18.3 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 4.3
- upper Limit
- 18.3
- value
- 9.8
- denoms
- counts
- group Id
- OG000
- value
- 82
- units
- Participants
- description
- PR rate was defined as percentage of participants who achieved PR according to IMWG response criteria. PR was defined as per IMWG criteria as \>= 50% reduction of serum M-protein and reduction in 24 hours urinary M-protein by \>= 90% or to \< 200 mg/24hours. If the serum and urine M-protein were unmeasurable, a \>= 50% decrease in the difference between involved and uninvolved Free light chain (FLC) levels was required in the place of the M-protein criteria. If serum and urine M-protein were not measurable, and serum free light assay was also not measurable, \>=50% reduction in bone marrow plasma cells is required in place of M-protein, provided baseline bone marrow plasma cells percentage was \>=30%. In addition to the above listed criteria, if present at baseline, a \>= 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
- Partial Response (PR) Rate
- type
- SECONDARY
- unit Of Measure
- Percentage of Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice