TriangleNCT05347485 · OUTCOME
Duration of Response (DOR)
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
DOR calculated in responders (with PR or better response) from date of initial documentation of response (PR or better) to date of first documented evidence of progressive disease (PD) as per IMWG criteria, or death due to any cause, whichever occurs first. PD: increase of 25% from lowest response value: serum and urine M-component (absolute increase must be \>=0.5 grams/deciliter \[g/dL\] and \>=200 mg/24 hours, respectively); only in participants without measurable serum and urine M-protein levels, difference between involved and uninvolved FLC levels (absolute increase must be \>10 mg/dL); only in participants without measurable serum and/or urine M-protein levels and without measurable disease by FLC levels, bone marrow PC % (absolute increase must be \>=10%), appearance of new lesion; definite development of new bone lesions or definite increase in the size of existing bone lesions, \>=50% increase in circulating PCs (minimum of 200 cells per uL) if this was the only measure of disease.
Analysis population: Analysis population included responders (who achieved PR or better response) in all treated analysis set. 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.
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) | 47 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Ciltacabtagene Autoleucel (Cilta-cel) Out-of-Specification (OOS) | NA | Not reported | 7.75 | 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
- 7.75
- upper Limit
- NA
- value
- NA
- denoms
- counts
- group Id
- OG000
- value
- 47
- units
- Participants
- description
- DOR calculated in responders (with PR or better response) from date of initial documentation of response (PR or better) to date of first documented evidence of progressive disease (PD) as per IMWG criteria, or death due to any cause, whichever occurs first. PD: increase of 25% from lowest response value: serum and urine M-component (absolute increase must be \>=0.5 grams/deciliter \[g/dL\] and \>=200 mg/24 hours, respectively); only in participants without measurable serum and urine M-protein levels, difference between involved and uninvolved FLC levels (absolute increase must be \>10 mg/dL); only in participants without measurable serum and/or urine M-protein levels and without measurable disease by FLC levels, bone marrow PC % (absolute increase must be \>=10%), appearance of new lesion; definite development of new bone lesions or definite increase in the size of existing bone lesions, \>=50% increase in circulating PCs (minimum of 200 cells per uL) if this was the only measure of disease.
- 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
- Analysis population included responders (who achieved PR or better response) in all treated analysis set. 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.
- reporting Status
- POSTED
- time Frame
- From Day 1 (post infusion) up to 18.6 months
- title
- Duration of Response (DOR)
- type
- SECONDARY
- unit Of Measure
- Months
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice