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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

GroupSource count
Lenalidomide and bb212138

Reported measurements

Day 4

Grade 1

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Lenalidomide and bb212125Not reportedNot reportedNot reportedNot reported

Grade 2

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Lenalidomide and bb21215Not reportedNot reportedNot reportedNot reported

Grade 3

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Lenalidomide and bb21210Not reportedNot reportedNot reportedNot reported

Grade 4

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Lenalidomide and bb21210Not reportedNot reportedNot reportedNot reported

Grade 5

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Lenalidomide and bb21210Not reportedNot reportedNot reportedNot reported

No CRS

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Lenalidomide and bb21218Not reportedNot reportedNot reportedNot reported
Day 7

Grade 1

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Lenalidomide and bb21218Not reportedNot reportedNot reportedNot reported

Grade 2

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Lenalidomide and bb21211Not reportedNot reportedNot reportedNot reported

Grade 3

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Lenalidomide and bb21210Not reportedNot reportedNot reportedNot reported

Grade 4

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Lenalidomide and bb21210Not reportedNot reportedNot reportedNot reported

Grade 5

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Lenalidomide and bb21210Not reportedNot reportedNot reportedNot reported

No CRS

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Lenalidomide and bb212129Not reportedNot reportedNot reportedNot reported
Day 10

Grade 1

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Lenalidomide and bb21210Not reportedNot reportedNot reportedNot reported

Grade 2

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Lenalidomide and bb21210Not reportedNot reportedNot reportedNot reported

Grade 3

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Lenalidomide and bb21210Not reportedNot reportedNot reportedNot reported

Grade 4

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Lenalidomide and bb21210Not reportedNot reportedNot reportedNot reported

Grade 5

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Lenalidomide and bb21210Not reportedNot reportedNot reportedNot reported

No CRS

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Lenalidomide and bb212138Not reportedNot reportedNot reportedNot reported
Day 14

Grade 1

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Lenalidomide and bb21210Not reportedNot reportedNot reportedNot reported

Grade 2

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Lenalidomide and bb21210Not reportedNot reportedNot reportedNot reported

Grade 3

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Lenalidomide and bb21210Not reportedNot reportedNot reportedNot reported

Grade 4

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Lenalidomide and bb21210Not reportedNot reportedNot reportedNot reported

Grade 5

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Lenalidomide and bb21210Not reportedNot reportedNot reportedNot reported

No CRS

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Lenalidomide and bb212138Not reportedNot reportedNot reportedNot reported
Day 21

Grade 1

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Lenalidomide and bb21210Not reportedNot reportedNot reportedNot reported

Grade 2

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Lenalidomide and bb21210Not reportedNot reportedNot reportedNot reported

Grade 3

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Lenalidomide and bb21210Not reportedNot reportedNot reportedNot reported

Grade 4

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Lenalidomide and bb21210Not reportedNot reportedNot reportedNot reported

Grade 5

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Lenalidomide and bb21210Not reportedNot reportedNot reportedNot reported

No CRS

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Lenalidomide and bb212138Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        25
      title
      Grade 1
    2. measurements
      1. group Id
        OG000
        value
        5
      title
      Grade 2
    3. measurements
      1. group Id
        OG000
        value
        0
      title
      Grade 3
    4. measurements
      1. group Id
        OG000
        value
        0
      title
      Grade 4
    5. measurements
      1. group Id
        OG000
        value
        0
      title
      Grade 5
    6. measurements
      1. group Id
        OG000
        value
        8
      title
      No CRS
    title
    Day 4
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        8
      title
      Grade 1
    2. measurements
      1. group Id
        OG000
        value
        1
      title
      Grade 2
    3. measurements
      1. group Id
        OG000
        value
        0
      title
      Grade 3
    4. measurements
      1. group Id
        OG000
        value
        0
      title
      Grade 4
    5. measurements
      1. group Id
        OG000
        value
        0
      title
      Grade 5
    6. measurements
      1. group Id
        OG000
        value
        29
      title
      No CRS
    title
    Day 7
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      title
      Grade 1
    2. measurements
      1. group Id
        OG000
        value
        0
      title
      Grade 2
    3. measurements
      1. group Id
        OG000
        value
        0
      title
      Grade 3
    4. measurements
      1. group Id
        OG000
        value
        0
      title
      Grade 4
    5. measurements
      1. group Id
        OG000
        value
        0
      title
      Grade 5
    6. measurements
      1. group Id
        OG000
        value
        38
      title
      No CRS
    title
    Day 10
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      title
      Grade 1
    2. measurements
      1. group Id
        OG000
        value
        0
      title
      Grade 2
    3. measurements
      1. group Id
        OG000
        value
        0
      title
      Grade 3
    4. measurements
      1. group Id
        OG000
        value
        0
      title
      Grade 4
    5. measurements
      1. group Id
        OG000
        value
        0
      title
      Grade 5
    6. measurements
      1. group Id
        OG000
        value
        38
      title
      No CRS
    title
    Day 14
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      title
      Grade 1
    2. measurements
      1. group Id
        OG000
        value
        0
      title
      Grade 2
    3. measurements
      1. group Id
        OG000
        value
        0
      title
      Grade 3
    4. measurements
      1. group Id
        OG000
        value
        0
      title
      Grade 4
    5. measurements
      1. group Id
        OG000
        value
        0
      title
      Grade 5
    6. measurements
      1. group Id
        OG000
        value
        38
      title
      No CRS
    title
    Day 21
denoms
  1. counts
    1. group Id
      OG000
      value
      38
    units
    Participants
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
  1. 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

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Preserved source evidence · Not medical advice