TriangleNCT03318861 · OUTCOME
Time to Next Treatment (TTNT)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- months
- Interval / dispersion
- Not reported
- Time frame
- From KITE-585 infusion to the earlier date of data cutoff and first administration of other anti-cancer therapies including stem cell transplant (maximum: 17.6 months)
What was measured
TTNT is defined as the length of time between the date of KITE-585 infusion to the date of initiation of the next therapy or death due to any cause, whichever is earlier.
Analysis population: Participants in the Safety Analysis Set were to be analyzed. Estimates of the proportion of participants who have not required additional treatment for progressive multiple myeloma at selected time points were to be provided. As per changes in planned analysis, this outcome measure could not be analyzed at the data cutoff date due to a lack of events. Kite/Gilead did not collect data to analyze TTNT after the data cutoff date.
Groups in this outcome
Dose Escalation: 3 x 10^7 KITE-585
Participants with RRMM, received conditioning chemotherapy consisting of cyclophosphamide 300 mg/m\^2/day and fludarabine 30 mg/m\^2/day IV infusion for 3 days followed by a single infusion of KITE-585 at a dose of 3 x 10\^7 autologous anti-BCMA CAR T cells on Day 0.
Dose Escalation: 1 x 10^8 KITE-585
Participants with RRMM, received conditioning chemotherapy consisting of cyclophosphamide 300 mg/m\^2/day and fludarabine 30 mg/m\^2/day IV infusion for 3 days followed by a single infusion of KITE-585 at a dose of 1 x 10\^8 autologous anti-BCMA CAR T cells on Day 0.
Dose Escalation: 3 x 10^8 KITE-585
Participants with RRMM, received conditioning chemotherapy consisting of cyclophosphamide 300 mg/m\^2/day and fludarabine 30 mg/m\^2/day IV infusion for 3 days followed by a single infusion of KITE-585 at a dose of 3 x 10\^8 autologous anti-BCMA CAR T cells on Day 0.
Dose Escalation: 1 x 10^9 KITE-585
Participants with RRMM, received conditioning chemotherapy consisting of cyclophosphamide 300 mg/m\^2/day and fludarabine 30 mg/m\^2/day IV infusion for 3 days followed by a single infusion of KITE-585 at a dose of 1 x 10\^9 autologous anti-BCMA CAR T cells on Day 0.
Dose Expansion (Renal Impairment): 3 x 10^7 KITE-585
RRMM participants with moderate renal impairment (creatinine clearance 30 to 59 mL/min \[Grade 2 chronic kidney disease\]) received conditioning chemotherapy consisting of cyclophosphamide 300 mg/m\^2/day and fludarabine 24 mg/m\^2/day IV infusion for 3 days followed by single infusion of KITE-585 at a tolerable dose of 3 x 10\^7 autologous anti-BCMA CAR T cells on Day 0.
| Group | Source count |
|---|---|
| Dose Escalation: 3 x 10^7 KITE-585 | 3 |
| Dose Escalation: 1 x 10^8 KITE-585 | 3 |
| Dose Escalation: 3 x 10^8 KITE-585 | 3 |
| Dose Escalation: 1 x 10^9 KITE-585 | 3 |
| Dose Expansion (Renal Impairment): 3 x 10^7 KITE-585 | 2 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Dose Escalation: 3 x 10^7 KITE-585 | NA | Not reported | Not reported | Not reported | Due to lack of events, this outcome measure was not analyzed. |
| Dose Escalation: 1 x 10^8 KITE-585 | NA | Not reported | Not reported | Not reported | Due to lack of events, this outcome measure was not analyzed. |
| Dose Escalation: 3 x 10^8 KITE-585 | NA | Not reported | Not reported | Not reported | Due to lack of events, this outcome measure was not analyzed. |
| Dose Escalation: 1 x 10^9 KITE-585 | NA | Not reported | Not reported | Not reported | Due to lack of events, this outcome measure was not analyzed. |
| Dose Expansion (Renal Impairment): 3 x 10^7 KITE-585 | NA | Not reported | Not reported | Not reported | Due to lack of events, this outcome measure was not analyzed. |
Complete source fields
- classes
- categories
- measurements
- comment
- Due to lack of events, this outcome measure was not analyzed.
- group Id
- OG000
- value
- NA
- comment
- Due to lack of events, this outcome measure was not analyzed.
- group Id
- OG001
- value
- NA
- comment
- Due to lack of events, this outcome measure was not analyzed.
- group Id
- OG002
- value
- NA
- comment
- Due to lack of events, this outcome measure was not analyzed.
- group Id
- OG003
- value
- NA
- comment
- Due to lack of events, this outcome measure was not analyzed.
- group Id
- OG004
- value
- NA
- denoms
- counts
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 3
- group Id
- OG002
- value
- 3
- group Id
- OG003
- value
- 3
- group Id
- OG004
- value
- 2
- units
- Participants
- description
- TTNT is defined as the length of time between the date of KITE-585 infusion to the date of initiation of the next therapy or death due to any cause, whichever is earlier.
- groups
- description
- Participants with RRMM, received conditioning chemotherapy consisting of cyclophosphamide 300 mg/m\^2/day and fludarabine 30 mg/m\^2/day IV infusion for 3 days followed by a single infusion of KITE-585 at a dose of 3 x 10\^7 autologous anti-BCMA CAR T cells on Day 0.
- id
- OG000
- title
- Dose Escalation: 3 x 10^7 KITE-585
- description
- Participants with RRMM, received conditioning chemotherapy consisting of cyclophosphamide 300 mg/m\^2/day and fludarabine 30 mg/m\^2/day IV infusion for 3 days followed by a single infusion of KITE-585 at a dose of 1 x 10\^8 autologous anti-BCMA CAR T cells on Day 0.
- id
- OG001
- title
- Dose Escalation: 1 x 10^8 KITE-585
- description
- Participants with RRMM, received conditioning chemotherapy consisting of cyclophosphamide 300 mg/m\^2/day and fludarabine 30 mg/m\^2/day IV infusion for 3 days followed by a single infusion of KITE-585 at a dose of 3 x 10\^8 autologous anti-BCMA CAR T cells on Day 0.
- id
- OG002
- title
- Dose Escalation: 3 x 10^8 KITE-585
- description
- Participants with RRMM, received conditioning chemotherapy consisting of cyclophosphamide 300 mg/m\^2/day and fludarabine 30 mg/m\^2/day IV infusion for 3 days followed by a single infusion of KITE-585 at a dose of 1 x 10\^9 autologous anti-BCMA CAR T cells on Day 0.
- id
- OG003
- title
- Dose Escalation: 1 x 10^9 KITE-585
- description
- RRMM participants with moderate renal impairment (creatinine clearance 30 to 59 mL/min \[Grade 2 chronic kidney disease\]) received conditioning chemotherapy consisting of cyclophosphamide 300 mg/m\^2/day and fludarabine 24 mg/m\^2/day IV infusion for 3 days followed by single infusion of KITE-585 at a tolerable dose of 3 x 10\^7 autologous anti-BCMA CAR T cells on Day 0.
- id
- OG004
- title
- Dose Expansion (Renal Impairment): 3 x 10^7 KITE-585
- param Type
- NUMBER
- population Description
- Participants in the Safety Analysis Set were to be analyzed. Estimates of the proportion of participants who have not required additional treatment for progressive multiple myeloma at selected time points were to be provided. As per changes in planned analysis, this outcome measure could not be analyzed at the data cutoff date due to a lack of events. Kite/Gilead did not collect data to analyze TTNT after the data cutoff date.
- reporting Status
- POSTED
- time Frame
- From KITE-585 infusion to the earlier date of data cutoff and first administration of other anti-cancer therapies including stem cell transplant (maximum: 17.6 months)
- title
- Time to Next Treatment (TTNT)
- type
- SECONDARY
- unit Of Measure
- months
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Preserved source evidence · Not medical advice