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NCT05032820 · ADVERSE EVENTS

Adverse events

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.

Adverse events occurred during the study; they are not necessarily caused by treatment. Serious events are not interchangeable with severe/grade 3–4 events. These safety populations may differ from efficacy populations.

Collection time frame
All SAEs and AEs were collected from enrollment to study completion, or for 12 months after bb2121 infusion.
Other-event reporting threshold
0%

Adverse events are collected on the adverse event form, toxicity form, and myelotoxicity form.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
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

9 / 4038 / 400 / 40

Group identifiers: EG000: Lenalidomide and bb2121

Serious adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Hepatobiliary disorders
    source Vocabulary
    MedDRA v28.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      40
      num Events
      1
    term
    Bile duct stone
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Immune system disorders
    source Vocabulary
    MedDRA v28.1
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      40
      num Events
      5
    term
    Cytokine Release Syndrome
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA v28.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      40
      num Events
      2
    term
    Pneumonia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA v28.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      40
      num Events
      1
    term
    Pyelonephritis
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    MedDRA v28.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      40
      num Events
      1
    term
    Transient ischaemic attack

Other reported adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v28.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      40
      num Events
      1
    term
    Abdominal pain
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    source Vocabulary
    MedDRA v28.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      40
      num Events
      2
    term
    Acute kidney injury
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA v28.1
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      40
      num Events
      3
    term
    Alanine aminotransferase increased
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    MedDRA v28.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      40
      num Events
      1
    term
    Alopecia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    MedDRA v28.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      40
      num Events
      1
    term
    Arthralgia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA v28.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      40
      num Events
      2
    term
    Aspartate aminotransferase increased
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    MedDRA v28.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      40
      num Events
      1
    term
    Back pain
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA v28.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      40
      num Events
      1
    term
    Blood alkaline phosphatase
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    MedDRA v28.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      40
      num Events
      1
    term
    Bone pain
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA v28.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      40
      num Events
      1
    term
    COVID-19
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    MedDRA v28.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      40
      num Events
      1
    term
    Cognitive disorder
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v28.1
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      40
      num Events
      9
    term
    Constipation
Complete source fields
description
Adverse events are collected on the adverse event form, toxicity form, and myelotoxicity form.
event Groups
  1. deaths Num Affected
    0
    deaths Num At Risk
    40
    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
    EG000
    other Num Affected
    38
    other Num At Risk
    40
    serious Num Affected
    9
    serious Num At Risk
    40
    title
    Lenalidomide and bb2121
frequency Threshold
0
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v28.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      40
      num Events
      1
    term
    Abdominal pain
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    source Vocabulary
    MedDRA v28.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      40
      num Events
      2
    term
    Acute kidney injury
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA v28.1
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      40
      num Events
      3
    term
    Alanine aminotransferase increased
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    MedDRA v28.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      40
      num Events
      1
    term
    Alopecia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    MedDRA v28.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      40
      num Events
      1
    term
    Arthralgia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA v28.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      40
      num Events
      2
    term
    Aspartate aminotransferase increased
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    MedDRA v28.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      40
      num Events
      1
    term
    Back pain
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA v28.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      40
      num Events
      1
    term
    Blood alkaline phosphatase
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    MedDRA v28.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      40
      num Events
      1
    term
    Bone pain
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA v28.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      40
      num Events
      1
    term
    COVID-19
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    MedDRA v28.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      40
      num Events
      1
    term
    Cognitive disorder
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v28.1
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      40
      num Events
      9
    term
    Constipation
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Hepatobiliary disorders
    source Vocabulary
    MedDRA v28.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      40
      num Events
      1
    term
    Bile duct stone
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Immune system disorders
    source Vocabulary
    MedDRA v28.1
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      40
      num Events
      5
    term
    Cytokine Release Syndrome
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA v28.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      40
      num Events
      2
    term
    Pneumonia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA v28.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      40
      num Events
      1
    term
    Pyelonephritis
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    MedDRA v28.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      40
      num Events
      1
    term
    Transient ischaemic attack
time Frame
All SAEs and AEs were collected from enrollment to study completion, or for 12 months after bb2121 infusion.

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Preserved source evidence · Not medical advice