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NCT05032820 · BASELINE

Baseline characteristics

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.

denoms
  1. counts
    1. group Id
      BG000
      value
      40
    units
    Participants
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
    BG000
    title
    Lenalidomide and bb2121
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          7.72
          value
          61.2
      denoms
      1. counts
        1. group Id
          BG000
          value
          38
        units
        Participants
    description
    Age at Infusion (years)
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    population Description
    This row is only for infused patients and therefore has less participants in this row than others as not all enrolled participants were infused.
    title
    Age, Continuous
    unit Of Measure
    years
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          11
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          29
        title
        Male
      denoms
      1. counts
        1. group Id
          BG000
          value
          40
        units
        Participants
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          3
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          34
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          3
        title
        Unknown or Not Reported
      denoms
      1. counts
        1. group Id
          BG000
          value
          40
        units
        Participants
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Ethnicity (NIH/OMB)
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          2
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          0
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          5
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          29
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          1
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          3
        title
        Unknown or Not Reported
      denoms
      1. counts
        1. group Id
          BG000
          value
          40
        units
        Participants
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          17
        title
        70 or 80
      2. measurements
        1. group Id
          BG000
          value
          23
        title
        90 or 100
      denoms
      1. counts
        1. group Id
          BG000
          value
          40
        units
        Participants
    description
    KPS describes patient-perceived global quality of life and functioning on a scale of 0-100. 100: No evidence of disease; 90: Normal activity. Minor signs or symptoms of disease; 80: Normal activity with effort. Some signs or symptoms of disease; 70: Cares for self. Unable to continue normal activity; 60: Needs occasional assistance, but cares for most personal needs; 50: Needs considerable assistance and medical care; 40: Disabled. Needs special care and assistance; 30: Severely disabled. Hospital admission indicated; 20: Very sick. Active supportive therapy needed; 10: Moribund; 0: Dead
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Karnofsky Performance Score
    unit Of Measure
    Participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        title
        IgA Kappa
      2. measurements
        1. group Id
          BG000
          value
          2
        title
        IgA Lambda
      3. measurements
        1. group Id
          BG000
          value
          20
        title
        IgG Kappa
      4. measurements
        1. group Id
          BG000
          value
          6
        title
        IgG Lamda
      5. measurements
        1. group Id
          BG000
          value
          8
        title
        Kappa light chain
      6. measurements
        1. group Id
          BG000
          value
          2
        title
        Lambda light chain
      denoms
      1. counts
        1. group Id
          BG000
          value
          40
        units
        Participants
    description
    There are 5 types of heavy chains: IgG, IgA, IgD, IgE, and IgM. There are 2 types of light chains: kappa and lambda Immunoglobulins are made up of a heavy chain and a light chain. The diagnosis of myeloma is labelled according to the type of immunoglobulin that has become abnormal.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Multiple Myeloma Paraprotein Type
    unit Of Measure
    Participants
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          14
        title
        I
      2. measurements
        1. group Id
          BG000
          value
          18
        title
        II
      3. measurements
        1. group Id
          BG000
          value
          6
        title
        III
      4. measurements
        1. group Id
          BG000
          value
          2
        title
        Unknown
      denoms
      1. counts
        1. group Id
          BG000
          value
          40
        units
        Participants
    description
    Stage I: Serum B2 microglobulin \< 3.5mg/L; serum albumin \>= 3.5 g/dL Stage II: Serum B2 microglobulin \< 3.5mg/L; serum albumin \< 3.5 g/dL; OR Serum B2 microglobulin 3.5 to 5.5 mg/L, irrespective of serum albumin Stage III: Serum B2 microglobulin \> 5.5. mg/L
    param Type
    COUNT_OF_PARTICIPANTS
    title
    ISS Stage at Diagnosis
    unit Of Measure
    Participants
  8. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          11
        title
        I
      2. measurements
        1. group Id
          BG000
          value
          20
        title
        II
      3. measurements
        1. group Id
          BG000
          value
          2
        title
        III
      4. measurements
        1. group Id
          BG000
          value
          7
        title
        Unknown
      denoms
      1. counts
        1. group Id
          BG000
          value
          40
        units
        Participants
    description
    Stage I: Serum B2 microglobulin \< 3.5 mg/L; Serum albumin \>= 3.5 g/dL; Standard-risk chromosomal abnormalities (CA) by iFISH; normal lactate dehydrogenase levels (LDH) Stage II: Nor R-ISS Stage I or III Stage III: Serum B2 microglobulin \>= 5.5 mg/L and either high risk CA by iFISH or high LDH
    param Type
    COUNT_OF_PARTICIPANTS
    title
    R-ISS Stage at Diagnosis
    unit Of Measure
    Participants
  9. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          9
        title
        High risk
      2. measurements
        1. group Id
          BG000
          value
          7
        title
        No abnormalities
      3. measurements
        1. group Id
          BG000
          value
          23
        title
        Standard risk
      4. measurements
        1. group Id
          BG000
          value
          1
        title
        Unknown
      denoms
      1. counts
        1. group Id
          BG000
          value
          40
        units
        Participants
    description
    Cytogenetic abnormalities can assess the risk and prognosis of multiple myeloma. High risk includes t(4;14), t(14;16), t(14;20), del17p, 1q amplification, and \>=2 HRCA. Standard risk includes chromosomal hyperdiploid. High risk indicates worse outcomes.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Cytogenetics
    unit Of Measure
    Participants
  10. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          12
        title
        High risk
      2. measurements
        1. group Id
          BG000
          value
          28
        title
        Standard risk
      denoms
      1. counts
        1. group Id
          BG000
          value
          40
        units
        Participants
    description
    myeloma risk defines high risk disease based on ISS 3 and or high risk cytogenetics (t(4;14), t(14;16), t(14;20), deletion 17p or p53 deletion or amplification of 1q). Others are included in standard risk. High risk indicates worse outcomes.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Myeloma Risk Status
    unit Of Measure
    Participants
  11. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          32
        title
        1 Line
      2. measurements
        1. group Id
          BG000
          value
          6
        title
        2 Lines
      3. measurements
        1. group Id
          BG000
          value
          2
        title
        3 Lines
      denoms
      1. counts
        1. group Id
          BG000
          value
          40
        units
        Participants
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Number of Lines of Initial Systemic Anti-Myeloma Therapy
    unit Of Measure
    Participants
  12. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          7
        title
        VGPR
      2. measurements
        1. group Id
          BG000
          value
          30
        title
        PR
      3. measurements
        1. group Id
          BG000
          value
          3
        title
        SD
      denoms
      1. counts
        1. group Id
          BG000
          value
          40
        units
        Participants
    description
    PR: \>=50% reduction (RED) in serum monoclonal paraprotein (PP) \& RED in 24hr urinary monoclonal PP by \>=90% or to \<200 mg/24hr; or if M protein unmeasurable: \>=50% RED in difference b/w involved \& uninvolved FLC levels or 50% RED of involved FLC w/ 50% RED in ratio; or only bone marrow (BM) measurable: \>=50% RED in BM plasma cells if baseline \>=30%; or \>=50% RED in size of soft tissue plasmacytomas. VGPR: PR \& Serum or urine PP detectable by immunofixation but not electrophoresis; OR \>=90% serum PP RED + urine PP \<100 mg/24hr \& \>90% involved light chain RED. SD: none of above \& no progression.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Disease Status Prior to Transplant
    unit Of Measure
    Participants
population Description
Enrolled Participants
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      40
    units
    Participants
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
    BG000
    title
    Lenalidomide and bb2121
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          7.72
          value
          61.2
      denoms
      1. counts
        1. group Id
          BG000
          value
          38
        units
        Participants
    description
    Age at Infusion (years)
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    population Description
    This row is only for infused patients and therefore has less participants in this row than others as not all enrolled participants were infused.
    title
    Age, Continuous
    unit Of Measure
    years
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          11
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          29
        title
        Male
      denoms
      1. counts
        1. group Id
          BG000
          value
          40
        units
        Participants
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          3
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          34
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          3
        title
        Unknown or Not Reported
      denoms
      1. counts
        1. group Id
          BG000
          value
          40
        units
        Participants
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Ethnicity (NIH/OMB)
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          2
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          0
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          5
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          29
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          1
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          3
        title
        Unknown or Not Reported
      denoms
      1. counts
        1. group Id
          BG000
          value
          40
        units
        Participants
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          17
        title
        70 or 80
      2. measurements
        1. group Id
          BG000
          value
          23
        title
        90 or 100
      denoms
      1. counts
        1. group Id
          BG000
          value
          40
        units
        Participants
    description
    KPS describes patient-perceived global quality of life and functioning on a scale of 0-100. 100: No evidence of disease; 90: Normal activity. Minor signs or symptoms of disease; 80: Normal activity with effort. Some signs or symptoms of disease; 70: Cares for self. Unable to continue normal activity; 60: Needs occasional assistance, but cares for most personal needs; 50: Needs considerable assistance and medical care; 40: Disabled. Needs special care and assistance; 30: Severely disabled. Hospital admission indicated; 20: Very sick. Active supportive therapy needed; 10: Moribund; 0: Dead
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Karnofsky Performance Score
    unit Of Measure
    Participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        title
        IgA Kappa
      2. measurements
        1. group Id
          BG000
          value
          2
        title
        IgA Lambda
      3. measurements
        1. group Id
          BG000
          value
          20
        title
        IgG Kappa
      4. measurements
        1. group Id
          BG000
          value
          6
        title
        IgG Lamda
      5. measurements
        1. group Id
          BG000
          value
          8
        title
        Kappa light chain
      6. measurements
        1. group Id
          BG000
          value
          2
        title
        Lambda light chain
      denoms
      1. counts
        1. group Id
          BG000
          value
          40
        units
        Participants
    description
    There are 5 types of heavy chains: IgG, IgA, IgD, IgE, and IgM. There are 2 types of light chains: kappa and lambda Immunoglobulins are made up of a heavy chain and a light chain. The diagnosis of myeloma is labelled according to the type of immunoglobulin that has become abnormal.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Multiple Myeloma Paraprotein Type
    unit Of Measure
    Participants
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          14
        title
        I
      2. measurements
        1. group Id
          BG000
          value
          18
        title
        II
      3. measurements
        1. group Id
          BG000
          value
          6
        title
        III
      4. measurements
        1. group Id
          BG000
          value
          2
        title
        Unknown
      denoms
      1. counts
        1. group Id
          BG000
          value
          40
        units
        Participants
    description
    Stage I: Serum B2 microglobulin \< 3.5mg/L; serum albumin \>= 3.5 g/dL Stage II: Serum B2 microglobulin \< 3.5mg/L; serum albumin \< 3.5 g/dL; OR Serum B2 microglobulin 3.5 to 5.5 mg/L, irrespective of serum albumin Stage III: Serum B2 microglobulin \> 5.5. mg/L
    param Type
    COUNT_OF_PARTICIPANTS
    title
    ISS Stage at Diagnosis
    unit Of Measure
    Participants
  8. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          11
        title
        I
      2. measurements
        1. group Id
          BG000
          value
          20
        title
        II
      3. measurements
        1. group Id
          BG000
          value
          2
        title
        III
      4. measurements
        1. group Id
          BG000
          value
          7
        title
        Unknown
      denoms
      1. counts
        1. group Id
          BG000
          value
          40
        units
        Participants
    description
    Stage I: Serum B2 microglobulin \< 3.5 mg/L; Serum albumin \>= 3.5 g/dL; Standard-risk chromosomal abnormalities (CA) by iFISH; normal lactate dehydrogenase levels (LDH) Stage II: Nor R-ISS Stage I or III Stage III: Serum B2 microglobulin \>= 5.5 mg/L and either high risk CA by iFISH or high LDH
    param Type
    COUNT_OF_PARTICIPANTS
    title
    R-ISS Stage at Diagnosis
    unit Of Measure
    Participants
  9. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          9
        title
        High risk
      2. measurements
        1. group Id
          BG000
          value
          7
        title
        No abnormalities
      3. measurements
        1. group Id
          BG000
          value
          23
        title
        Standard risk
      4. measurements
        1. group Id
          BG000
          value
          1
        title
        Unknown
      denoms
      1. counts
        1. group Id
          BG000
          value
          40
        units
        Participants
    description
    Cytogenetic abnormalities can assess the risk and prognosis of multiple myeloma. High risk includes t(4;14), t(14;16), t(14;20), del17p, 1q amplification, and \>=2 HRCA. Standard risk includes chromosomal hyperdiploid. High risk indicates worse outcomes.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Cytogenetics
    unit Of Measure
    Participants
  10. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          12
        title
        High risk
      2. measurements
        1. group Id
          BG000
          value
          28
        title
        Standard risk
      denoms
      1. counts
        1. group Id
          BG000
          value
          40
        units
        Participants
    description
    myeloma risk defines high risk disease based on ISS 3 and or high risk cytogenetics (t(4;14), t(14;16), t(14;20), deletion 17p or p53 deletion or amplification of 1q). Others are included in standard risk. High risk indicates worse outcomes.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Myeloma Risk Status
    unit Of Measure
    Participants
  11. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          32
        title
        1 Line
      2. measurements
        1. group Id
          BG000
          value
          6
        title
        2 Lines
      3. measurements
        1. group Id
          BG000
          value
          2
        title
        3 Lines
      denoms
      1. counts
        1. group Id
          BG000
          value
          40
        units
        Participants
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Number of Lines of Initial Systemic Anti-Myeloma Therapy
    unit Of Measure
    Participants
  12. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          7
        title
        VGPR
      2. measurements
        1. group Id
          BG000
          value
          30
        title
        PR
      3. measurements
        1. group Id
          BG000
          value
          3
        title
        SD
      denoms
      1. counts
        1. group Id
          BG000
          value
          40
        units
        Participants
    description
    PR: \>=50% reduction (RED) in serum monoclonal paraprotein (PP) \& RED in 24hr urinary monoclonal PP by \>=90% or to \<200 mg/24hr; or if M protein unmeasurable: \>=50% RED in difference b/w involved \& uninvolved FLC levels or 50% RED of involved FLC w/ 50% RED in ratio; or only bone marrow (BM) measurable: \>=50% RED in BM plasma cells if baseline \>=30%; or \>=50% RED in size of soft tissue plasmacytomas. VGPR: PR \& Serum or urine PP detectable by immunofixation but not electrophoresis; OR \>=90% serum PP RED + urine PP \<100 mg/24hr \& \>90% involved light chain RED. SD: none of above \& no progression.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Disease Status Prior to Transplant
    unit Of Measure
    Participants
population Description
Enrolled Participants

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Preserved source evidence · Not medical advice