TriangleNCT03318861 · OUTCOME
Percentage of Participants Experiencing Treatment-Emergent Adverse Events
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
- Not reported
- Time frame
- Enrollment through 24 months after treatment with KITE-585 or up to disease progression or initiation of another anti-cancer therapy, whichever occurs first (maximum: 2.9 months)
Analysis population: Participants in the Safety Analysis Set were analyzed.
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 | 100.0 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation: 1 x 10^8 KITE-585 | 100.0 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation: 3 x 10^8 KITE-585 | 100.0 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation: 1 x 10^9 KITE-585 | 100.0 | Not reported | Not reported | Not reported | Not reported |
| Dose Expansion (Renal Impairment): 3 x 10^7 KITE-585 | 100.0 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 100.0
- group Id
- OG001
- value
- 100.0
- group Id
- OG002
- value
- 100.0
- group Id
- OG003
- value
- 100.0
- group Id
- OG004
- value
- 100.0
- 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
- 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 analyzed.
- reporting Status
- POSTED
- time Frame
- Enrollment through 24 months after treatment with KITE-585 or up to disease progression or initiation of another anti-cancer therapy, whichever occurs first (maximum: 2.9 months)
- title
- Percentage of Participants Experiencing Treatment-Emergent Adverse Events
- type
- SECONDARY
- unit Of Measure
- percentage of participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice