NCT05032820 · OUTCOME
Exploratory Objective 2: CAR T-cell Persistence Area Under the Curve Over the First 6 Months Post CAR T-cell Infusion
Upfront Chimeric Antigen Receptor T-Cell to Upgrade Response in Multiple Myeloma · Source last updated 2026-05-19
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- months*(copies/mcg of DNA)
- Interval / dispersion
- Standard Deviation
- Time frame
- 6 months, 1 Year
What was measured
Quantitation of CAR T-cells in peripheral blood will be determined at specified timepoints by quantitative PCR assay, measured in copies/mcg genomic DNA. Persistence will be measured in 2 ways: 1) as an area under the curve (AUC) over first 6 months post CAR T-cell infusion; and 2) as still having detectable CAR T-cells at 6 months post CAR T-cell infusion. AUC6mos and 6-month persistence will be compared between subjects who are and are not in CR at 6 months and 12 months.
Analysis population: Participants who received and 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 identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.
Analysis denominator · Participants
| Group | Source count |
|---|
| Lenalidomide and bb2121 | 38 |
|---|
Reported measurements
In CR/sCR at 6 mth
Analysis denominator · Participants
| Group | Source count |
|---|
| Lenalidomide and bb2121 | 24 |
|---|
Values in months*(copies/mcg of DNA) · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Lenalidomide and bb2121 | 1811283.45 | 1649413.714 | Not reported | Not reported | Not reported |
|---|
Not in CR/sCR at 6 mth
Analysis denominator · Participants
| Group | Source count |
|---|
| Lenalidomide and bb2121 | 14 |
|---|
Values in months*(copies/mcg of DNA) · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Lenalidomide and bb2121 | 1156887.25 | 6810471.278 | Not reported | Not reported | Not reported |
|---|
In CR/sCR at 12 mth
Analysis denominator · Participants
| Group | Source count |
|---|
| Lenalidomide and bb2121 | 30 |
|---|
Values in months*(copies/mcg of DNA) · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Lenalidomide and bb2121 | 1811283.45 | 4757894.776 | Not reported | Not reported | Not reported |
|---|
Not in CR/sCR at 12 mth
Analysis denominator · Participants
| Group | Source count |
|---|
| Lenalidomide and bb2121 | 8 |
|---|
Values in months*(copies/mcg of DNA) · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Lenalidomide and bb2121 | 1019484.20 | 1535876.342 | Not reported | Not reported | Not reported |
|---|
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 1649413.714
- value
- 1811283.45
- title
- In CR/sCR at 6 mth
- categories
- measurements
- group Id
- OG000
- spread
- 6810471.278
- value
- 1156887.25
- title
- Not in CR/sCR at 6 mth
- categories
- measurements
- group Id
- OG000
- spread
- 4757894.776
- value
- 1811283.45
- title
- In CR/sCR at 12 mth
- categories
- measurements
- group Id
- OG000
- spread
- 1535876.342
- value
- 1019484.20
- title
- Not in CR/sCR at 12 mth
- description
- Quantitation of CAR T-cells in peripheral blood will be determined at specified timepoints by quantitative PCR assay, measured in copies/mcg genomic DNA. Persistence will be measured in 2 ways: 1) as an area under the curve (AUC) over first 6 months post CAR T-cell infusion; and 2) as still having detectable CAR T-cells at 6 months post CAR T-cell infusion. AUC6mos and 6-month persistence will be compared between subjects who are and are not in CR at 6 months and 12 months.
- dispersion Type
- Standard Deviation
- 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
- MEDIAN
- population Description
- Participants who received and infusion
- reporting Status
- POSTED
- time Frame
- 6 months, 1 Year
- title
- Exploratory Objective 2: CAR T-cell Persistence Area Under the Curve Over the First 6 Months Post CAR T-cell Infusion
- type
- OTHER_PRE_SPECIFIED
- unit Of Measure
- months*(copies/mcg of DNA)
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice
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