NCT05032820 · OUTCOME
Cumulative Incidence of Disease Progression
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- Percent probability
- Interval / dispersion
- 90% Confidence Interval
- Time frame
- 1 Year
What was measured
Diseases will be assessed by response categories based on the International Myeloma Working Group: Stringent Complete Response (sCR), Complete Remission (CR), Very Good Partial Remission (VGPR), Partial Remission (PR), Minimal Response (MR), Stable Disease (SD).
Analysis population: Participants who received an infusion
Groups in this outcome
Lenalidomide and bb2121
Patients complete apheresis and proceed to lymphodepleting chemotherapy with cyclophosphamide 300mg/m\^2 and fludarabine 30mg/m\^2 for 3 consecutive days followed by the infusion of BCMA CAR T-cells at a target dose of 450 x10\^6 cells. Maintenance lenalidomide, starting at 5mg a day for 21 days of a 28-day cycle will be initiated at a minimum of at least 30 days, but no later than 180 days after the CAR T-cell infusion and will continue until the patient reaches 12 months post CAR T-cell infusion and continue free of progression. Lenalidomide: Maintenance lenalidomide, starting at 5 mg a day for 21 days of a 28-day cycle, will be initiated at a minimum of at least 30 days, but no later than 180 days after the CAR T-cell infusion and will continue until the participant reaches 12 months post CAR T-cell infusion and continues free of progression bb2121: Participants receive infusion of BCMA CAR T-cells at a target dose of 450 x 10\^6 cells. Cyclophosphamide: 300 mg/m\^2/day for 3 consecutive days prior to the CAR T infusion Fludarabine: 30 mg/m\^2/day or 3 consecutive days prior to the CAR T infusion leukapheresis: Placement of central line catheter and leukapheresis
| Group | Source count |
|---|---|
| Lenalidomide and bb2121 | 38 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Lenalidomide and bb2121 | 2.6 | Not reported | 0.3 | 9.9 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0.3
- upper Limit
- 9.9
- value
- 2.6
- denoms
- counts
- group Id
- OG000
- value
- 38
- units
- Participants
- description
- Diseases will be assessed by response categories based on the International Myeloma Working Group: Stringent Complete Response (sCR), Complete Remission (CR), Very Good Partial Remission (VGPR), Partial Remission (PR), Minimal Response (MR), Stable Disease (SD).
- dispersion Type
- 90% Confidence Interval
- groups
- description
- Patients complete apheresis and proceed to lymphodepleting chemotherapy with cyclophosphamide 300mg/m\^2 and fludarabine 30mg/m\^2 for 3 consecutive days followed by the infusion of BCMA CAR T-cells at a target dose of 450 x10\^6 cells. Maintenance lenalidomide, starting at 5mg a day for 21 days of a 28-day cycle will be initiated at a minimum of at least 30 days, but no later than 180 days after the CAR T-cell infusion and will continue until the patient reaches 12 months post CAR T-cell infusion and continue free of progression. Lenalidomide: Maintenance lenalidomide, starting at 5 mg a day for 21 days of a 28-day cycle, will be initiated at a minimum of at least 30 days, but no later than 180 days after the CAR T-cell infusion and will continue until the participant reaches 12 months post CAR T-cell infusion and continues free of progression bb2121: Participants receive infusion of BCMA CAR T-cells at a target dose of 450 x 10\^6 cells. Cyclophosphamide: 300 mg/m\^2/day for 3 consecutive days prior to the CAR T infusion Fludarabine: 30 mg/m\^2/day or 3 consecutive days prior to the CAR T infusion leukapheresis: Placement of central line catheter and leukapheresis
- id
- OG000
- title
- Lenalidomide and bb2121
- param Type
- NUMBER
- population Description
- Participants who received an infusion
- reporting Status
- POSTED
- time Frame
- 1 Year
- title
- Cumulative Incidence of Disease Progression
- type
- SECONDARY
- unit Of Measure
- Percent probability
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice
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