NCT05032820 · ADVERSE EVENTS
Adverse events
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.
| Safety group | Serious events | Other events | Deaths |
|---|---|---|---|
| Lenalidomide and bb2121 | 9 / 40 | 38 / 40 | 0 / 40 |
Serious adverse events
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Hepatobiliary disorders
- source Vocabulary
- MedDRA v28.1
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 40
- num Events
- 1
- term
- Bile duct stone
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Immune system disorders
- source Vocabulary
- MedDRA v28.1
- stats
- group Id
- EG000
- num Affected
- 5
- num At Risk
- 40
- num Events
- 5
- term
- Cytokine Release Syndrome
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Infections and infestations
- source Vocabulary
- MedDRA v28.1
- stats
- group Id
- EG000
- num Affected
- 2
- num At Risk
- 40
- num Events
- 2
- term
- Pneumonia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Infections and infestations
- source Vocabulary
- MedDRA v28.1
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 40
- num Events
- 1
- term
- Pyelonephritis
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Nervous system disorders
- source Vocabulary
- MedDRA v28.1
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 40
- num Events
- 1
- term
- Transient ischaemic attack
Other reported adverse events
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA v28.1
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 40
- num Events
- 1
- term
- Abdominal pain
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Renal and urinary disorders
- source Vocabulary
- MedDRA v28.1
- stats
- group Id
- EG000
- num Affected
- 2
- num At Risk
- 40
- num Events
- 2
- term
- Acute kidney injury
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Investigations
- source Vocabulary
- MedDRA v28.1
- stats
- group Id
- EG000
- num Affected
- 3
- num At Risk
- 40
- num Events
- 3
- term
- Alanine aminotransferase increased
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Skin and subcutaneous tissue disorders
- source Vocabulary
- MedDRA v28.1
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 40
- num Events
- 1
- term
- Alopecia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Musculoskeletal and connective tissue disorders
- source Vocabulary
- MedDRA v28.1
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 40
- num Events
- 1
- term
- Arthralgia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Investigations
- source Vocabulary
- MedDRA v28.1
- stats
- group Id
- EG000
- num Affected
- 2
- num At Risk
- 40
- num Events
- 2
- term
- Aspartate aminotransferase increased
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Musculoskeletal and connective tissue disorders
- source Vocabulary
- MedDRA v28.1
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 40
- num Events
- 1
- term
- Back pain
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Investigations
- source Vocabulary
- MedDRA v28.1
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 40
- num Events
- 1
- term
- Blood alkaline phosphatase
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Musculoskeletal and connective tissue disorders
- source Vocabulary
- MedDRA v28.1
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 40
- num Events
- 1
- term
- Bone pain
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Infections and infestations
- source Vocabulary
- MedDRA v28.1
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 40
- num Events
- 1
- term
- COVID-19
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Nervous system disorders
- source Vocabulary
- MedDRA v28.1
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 40
- num Events
- 1
- term
- Cognitive disorder
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA v28.1
- stats
- 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
- 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
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA v28.1
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 40
- num Events
- 1
- term
- Abdominal pain
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Renal and urinary disorders
- source Vocabulary
- MedDRA v28.1
- stats
- group Id
- EG000
- num Affected
- 2
- num At Risk
- 40
- num Events
- 2
- term
- Acute kidney injury
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Investigations
- source Vocabulary
- MedDRA v28.1
- stats
- group Id
- EG000
- num Affected
- 3
- num At Risk
- 40
- num Events
- 3
- term
- Alanine aminotransferase increased
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Skin and subcutaneous tissue disorders
- source Vocabulary
- MedDRA v28.1
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 40
- num Events
- 1
- term
- Alopecia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Musculoskeletal and connective tissue disorders
- source Vocabulary
- MedDRA v28.1
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 40
- num Events
- 1
- term
- Arthralgia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Investigations
- source Vocabulary
- MedDRA v28.1
- stats
- group Id
- EG000
- num Affected
- 2
- num At Risk
- 40
- num Events
- 2
- term
- Aspartate aminotransferase increased
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Musculoskeletal and connective tissue disorders
- source Vocabulary
- MedDRA v28.1
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 40
- num Events
- 1
- term
- Back pain
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Investigations
- source Vocabulary
- MedDRA v28.1
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 40
- num Events
- 1
- term
- Blood alkaline phosphatase
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Musculoskeletal and connective tissue disorders
- source Vocabulary
- MedDRA v28.1
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 40
- num Events
- 1
- term
- Bone pain
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Infections and infestations
- source Vocabulary
- MedDRA v28.1
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 40
- num Events
- 1
- term
- COVID-19
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Nervous system disorders
- source Vocabulary
- MedDRA v28.1
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 40
- num Events
- 1
- term
- Cognitive disorder
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA v28.1
- stats
- group Id
- EG000
- num Affected
- 5
- num At Risk
- 40
- num Events
- 9
- term
- Constipation
- serious Events
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Hepatobiliary disorders
- source Vocabulary
- MedDRA v28.1
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 40
- num Events
- 1
- term
- Bile duct stone
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Immune system disorders
- source Vocabulary
- MedDRA v28.1
- stats
- group Id
- EG000
- num Affected
- 5
- num At Risk
- 40
- num Events
- 5
- term
- Cytokine Release Syndrome
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Infections and infestations
- source Vocabulary
- MedDRA v28.1
- stats
- group Id
- EG000
- num Affected
- 2
- num At Risk
- 40
- num Events
- 2
- term
- Pneumonia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Infections and infestations
- source Vocabulary
- MedDRA v28.1
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 40
- num Events
- 1
- term
- Pyelonephritis
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Nervous system disorders
- source Vocabulary
- MedDRA v28.1
- stats
- 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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