NCT05032820 · OUTCOME
Incidence of Cytokine Release Syndrome (CRS)
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
- COUNT_OF_PARTICIPANTS
- Unit
- Participants
- Interval / dispersion
- Not reported
- Time frame
- Day 4, Day 7, Day 10, Day 14, and Day 21 post-infusion
What was measured
Overall incidence of CRS of any grade and grade 3 or 4 CRS post CAR T-cell infusion will be reported on all patients.
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
Day 4
Grade 1
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Lenalidomide and bb2121 | 25 | Not reported | Not reported | Not reported | Not reported |
|---|
Grade 2
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Lenalidomide and bb2121 | 5 | Not reported | Not reported | Not reported | Not reported |
|---|
Grade 3
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Lenalidomide and bb2121 | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
Grade 4
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Lenalidomide and bb2121 | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
Grade 5
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Lenalidomide and bb2121 | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
No CRS
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Lenalidomide and bb2121 | 8 | Not reported | Not reported | Not reported | Not reported |
|---|
Day 7
Grade 1
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Lenalidomide and bb2121 | 8 | Not reported | Not reported | Not reported | Not reported |
|---|
Grade 2
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Lenalidomide and bb2121 | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
Grade 3
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Lenalidomide and bb2121 | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
Grade 4
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Lenalidomide and bb2121 | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
Grade 5
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Lenalidomide and bb2121 | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
No CRS
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Lenalidomide and bb2121 | 29 | Not reported | Not reported | Not reported | Not reported |
|---|
Day 10
Grade 1
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Lenalidomide and bb2121 | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
Grade 2
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Lenalidomide and bb2121 | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
Grade 3
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Lenalidomide and bb2121 | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
Grade 4
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Lenalidomide and bb2121 | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
Grade 5
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Lenalidomide and bb2121 | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
No CRS
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Lenalidomide and bb2121 | 38 | Not reported | Not reported | Not reported | Not reported |
|---|
Day 14
Grade 1
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Lenalidomide and bb2121 | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
Grade 2
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Lenalidomide and bb2121 | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
Grade 3
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Lenalidomide and bb2121 | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
Grade 4
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Lenalidomide and bb2121 | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
Grade 5
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Lenalidomide and bb2121 | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
No CRS
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Lenalidomide and bb2121 | 38 | Not reported | Not reported | Not reported | Not reported |
|---|
Day 21
Grade 1
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Lenalidomide and bb2121 | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
Grade 2
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Lenalidomide and bb2121 | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
Grade 3
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Lenalidomide and bb2121 | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
Grade 4
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Lenalidomide and bb2121 | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
Grade 5
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Lenalidomide and bb2121 | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
No CRS
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Lenalidomide and bb2121 | 38 | Not reported | Not reported | Not reported | Not reported |
|---|
Complete source fields
- classes
- categories
- title
- Grade 1
- title
- Grade 2
- title
- Grade 3
- title
- Grade 4
- title
- Grade 5
- title
- No CRS
- title
- Day 4
- categories
- title
- Grade 1
- title
- Grade 2
- title
- Grade 3
- title
- Grade 4
- title
- Grade 5
- title
- No CRS
- title
- Day 7
- categories
- title
- Grade 1
- title
- Grade 2
- title
- Grade 3
- title
- Grade 4
- title
- Grade 5
- title
- No CRS
- title
- Day 10
- categories
- title
- Grade 1
- title
- Grade 2
- title
- Grade 3
- title
- Grade 4
- title
- Grade 5
- title
- No CRS
- title
- Day 14
- categories
- title
- Grade 1
- title
- Grade 2
- title
- Grade 3
- title
- Grade 4
- title
- Grade 5
- title
- No CRS
- title
- Day 21
- description
- Overall incidence of CRS of any grade and grade 3 or 4 CRS post CAR T-cell infusion will be reported on all patients.
- 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
- Day 4, Day 7, Day 10, Day 14, and Day 21 post-infusion
- title
- Incidence of Cytokine Release Syndrome (CRS)
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice