NCT05032820 · OUTCOME
Exploratory Objective 2: Summary Statistics of CAR T-cell Expansion
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
- CAR T-cells (copies/mcg DNA)
- Interval / dispersion
- Standard Deviation
- Time frame
- pre-LD chemo, day 4, 7, 14, 21, 30, 60, 90, 180, 270, 365
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.
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 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
Pre-LD chemo
Values in CAR T-cells (copies/mcg DNA) · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Lenalidomide and bb2121 | 0.00 | 0.000 | Not reported | Not reported | Not reported |
|---|
Day 4
Values in CAR T-cells (copies/mcg DNA) · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Lenalidomide and bb2121 | 5271.59 | 14554.838 | Not reported | Not reported | Not reported |
|---|
Day 7
Values in CAR T-cells (copies/mcg DNA) · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Lenalidomide and bb2121 | 99960.98 | 100449.434 | Not reported | Not reported | Not reported |
|---|
Day 14
Values in CAR T-cells (copies/mcg DNA) · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Lenalidomide and bb2121 | 46586.56 | 180377.654 | Not reported | Not reported | Not reported |
|---|
Day 21
Values in CAR T-cells (copies/mcg DNA) · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Lenalidomide and bb2121 | 16290.81 | 86387.497 | Not reported | Not reported | Not reported |
|---|
Day 30
Values in CAR T-cells (copies/mcg DNA) · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Lenalidomide and bb2121 | 7249.38 | 53549.080 | Not reported | Not reported | Not reported |
|---|
Day 60
Values in CAR T-cells (copies/mcg DNA) · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Lenalidomide and bb2121 | 567.88 | 18645.673 | Not reported | Not reported | Not reported |
|---|
Day 90
Values in CAR T-cells (copies/mcg DNA) · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Lenalidomide and bb2121 | 251.52 | 11118.975 | Not reported | Not reported | Not reported |
|---|
Day 180
Values in CAR T-cells (copies/mcg DNA) · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Lenalidomide and bb2121 | 90.52 | 2414.251 | Not reported | Not reported | Not reported |
|---|
Day 270
Values in CAR T-cells (copies/mcg DNA) · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Lenalidomide and bb2121 | 64.81 | 1346.240 | Not reported | Not reported | Not reported |
|---|
Day 365
Values in CAR T-cells (copies/mcg DNA) · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Lenalidomide and bb2121 | 41.26 | 626.792 | Not reported | Not reported | Not reported |
|---|
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 0.000
- value
- 0.00
- title
- Pre-LD chemo
- categories
- measurements
- group Id
- OG000
- spread
- 14554.838
- value
- 5271.59
- title
- Day 4
- categories
- measurements
- group Id
- OG000
- spread
- 100449.434
- value
- 99960.98
- title
- Day 7
- categories
- measurements
- group Id
- OG000
- spread
- 180377.654
- value
- 46586.56
- title
- Day 14
- categories
- measurements
- group Id
- OG000
- spread
- 86387.497
- value
- 16290.81
- title
- Day 21
- categories
- measurements
- group Id
- OG000
- spread
- 53549.080
- value
- 7249.38
- title
- Day 30
- categories
- measurements
- group Id
- OG000
- spread
- 18645.673
- value
- 567.88
- title
- Day 60
- categories
- measurements
- group Id
- OG000
- spread
- 11118.975
- value
- 251.52
- title
- Day 90
- categories
- measurements
- group Id
- OG000
- spread
- 2414.251
- value
- 90.52
- title
- Day 180
- categories
- measurements
- group Id
- OG000
- spread
- 1346.240
- value
- 64.81
- title
- Day 270
- categories
- measurements
- group Id
- OG000
- spread
- 626.792
- value
- 41.26
- title
- Day 365
- 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.
- 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 an infusion
- reporting Status
- POSTED
- time Frame
- pre-LD chemo, day 4, 7, 14, 21, 30, 60, 90, 180, 270, 365
- title
- Exploratory Objective 2: Summary Statistics of CAR T-cell Expansion
- type
- OTHER_PRE_SPECIFIED
- unit Of Measure
- CAR T-cells (copies/mcg DNA)
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