NCT05032820 · OUTCOME
Proportion of Patients Achieving an Upgrade in Response Based on Their Best Disease Response
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- COUNT_OF_PARTICIPANTS
- Unit
- Participants
- Interval / dispersion
- Not reported
- Time frame
- 1 Year
What was measured
Proportion of patients achieving upgrade in response following enrollment (SD to MR or greater, MR to PR or greater, or PR to VGPR or greater) and Conversion to MRD negativity. MRD will be assessed by multi-color flow at 10-5 level
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 | 34 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 34
- denoms
- counts
- group Id
- OG000
- value
- 38
- units
- Participants
- description
- Proportion of patients achieving upgrade in response following enrollment (SD to MR or greater, MR to PR or greater, or PR to VGPR or greater) and Conversion to MRD negativity. MRD will be assessed by multi-color flow at 10-5 level
- 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
- COUNT_OF_PARTICIPANTS
- population Description
- Participants who received an infusion
- reporting Status
- POSTED
- time Frame
- 1 Year
- title
- Proportion of Patients Achieving an Upgrade in Response Based on Their Best Disease Response
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice
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