Skip to content
Triangle logo TriangleGet started
← Full study record

NCT02728102 · BASELINE

Baseline characteristics

Dendritic Cell/Myeloma Fusion Vaccine for Multiple Myeloma (BMT CTN 1401) · Source last updated 2024-05-07

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
      68
    2. group Id
      BG001
      value
      37
    3. group Id
      BG002
      value
      35
    4. group Id
      BG003
      value
      140
    units
    Participants
groups
  1. description
    Patients will undergo tumor cell collection and autologous stem cell transplant with melphalan. Patients will undergo leukapheresis and then will receive maintenance lenalidomide with myeloma vaccine and GM-CSF. Tumor Cell Collection: Patients will undergo aspiration of 30 mL of bone marrow from which myeloma cell will be isolated and frozen for subsequent vaccine generation. Autologous Stem Cell Transplant: Patients will receive an autologous graft of a minimum cell dose of 2.0 x 10\^6 CD34+ cells/kg patient actual body weight per transplantation with high-dose melphalan of 200mg/m\^2 at the schedule and timing according to institutional practices. Leukapheresis: Blood samples will be collected through a catheter in the neck or chest and leukapheresis will be performed using standard clinical procedures. Lenalidomide: Maintenance therapy with lenalidomide will begin between 90 and 100 days after stem cell infusion. Lenalidomide will be administered initially at a dose of 10 mg per day continuously. Cycle duration during maintenance therapy is 28 days. Patients will continue lenalidomide for two years from initiation of therapy. Myeloma vaccine: The target dose is 3 x 10\^6 fusion cells per vaccine. A minimum of 3 x 10\^6 total fusion cells will be required to proceed with vaccine administration. Patients will receive the DC/MM fusion vaccine on day 1 of cycles 2, 3, and 4 of lenalidomide maintenance. GM-CSF: 100 ug GM-CSF will be given for a total of 4 days of each cycle.
    id
    BG000
    title
    Lenalidomide, Vaccine, and GM-CSF
  2. description
    Patients will undergo tumor cell collection and autologous stem cell transplant with melphalan. Patients will receive maintenance lenalidomide with GM-CSF. Tumor Cell Collection: Patients will undergo aspiration of 30 mL of bone marrow from which myeloma cell preparations will be generated. Myeloma cells will be isolated and frozen for subsequent vaccine generation for patients randomized to the vaccine arm (randomization occurs after transplant and recovery). Autologous Stem Cell Transplant: Patients will receive an autologous graft with a minimum cell dose of 2.0 x 10\^6 CD34+ cells/kg patient actual body weight per autologous transplantation. Melphalan: Autologous hematopoietic cell transplant will be done with high-dose melphalan of 200mg/m\^2 at the schedule and timing according to institutional practices. Lenalidomide: Maintenance therapy with lenalidomide will begin between 90 and 100 days after stem cell infusion. Lenalidomide will be administered initially at a dose of 10 mg per day continuously. Cycle duration during maintenance therapy is 28 days. Patients will continue lenalidomide for two years from initiation of therapy. GM-CSF: 100 ug GM-CSF will be given subcutaneously in the upper thigh and daily for a total of 4 days of each cycle.
    id
    BG001
    title
    Lenalidomide and GM-CSF
  3. description
    Patients will undergo tumor cell collection and autologous stem cell transplant with melphalan. Patients will receive maintenance lenalidomide. Tumor Cell Collection: Patients will undergo aspiration of 30 mL of bone marrow from which myeloma cell preparations will be generated. Myeloma cells will be isolated and frozen for subsequent vaccine generation for patients randomized to the vaccine arm (randomization occurs after transplant and recovery). Autologous Stem Cell Transplant: Patients will receive an autologous graft with a minimum cell dose of 2.0 x 10\^6 CD34+ cells/kg patient actual body weight per autologous transplantation. Melphalan: Autologous hematopoietic cell transplant will be done with high-dose melphalan of 200mg/m\^2 at the schedule and timing according to institutional practices. Lenalidomide: Maintenance therapy with lenalidomide will begin between 90 and 100 days after stem cell infusion. Lenalidomide will be administered initially at a dose of 10 mg per day continuously. Cycle duration during maintenance therapy is 28 days. Patients will continue lenalidomide for two years from initiation of therapy.
    id
    BG002
    title
    Maintenance Lenalidomide
  4. description
    Total of all reporting groups
    id
    BG003
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          41.6
          upper Limit
          70.2
          value
          59.3
        2. group Id
          BG001
          lower Limit
          44.2
          upper Limit
          70.2
          value
          62.3
        3. group Id
          BG002
          lower Limit
          35.2
          upper Limit
          70.9
          value
          59.1
        4. group Id
          BG003
          lower Limit
          35.2
          upper Limit
          70.9
          value
          60.0
    dispersion Type
    FULL_RANGE
    param Type
    MEAN
    title
    Age, Continuous
    unit Of Measure
    years
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          27
        2. group Id
          BG001
          value
          18
        3. group Id
          BG002
          value
          18
        4. group Id
          BG003
          value
          63
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          41
        2. group Id
          BG001
          value
          19
        3. group Id
          BG002
          value
          17
        4. group Id
          BG003
          value
          77
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          4
        4. group Id
          BG003
          value
          11
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          61
        2. group Id
          BG001
          value
          33
        3. group Id
          BG002
          value
          30
        4. group Id
          BG003
          value
          124
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          5
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Ethnicity (NIH/OMB)
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          1
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          4
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          8
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          5
        4. group Id
          BG003
          value
          15
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          54
        2. group Id
          BG001
          value
          30
        3. group Id
          BG002
          value
          28
        4. group Id
          BG003
          value
          112
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          8
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          16
        2. group Id
          BG001
          value
          7
        3. group Id
          BG002
          value
          9
        4. group Id
          BG003
          value
          32
        title
        100
      2. measurements
        1. group Id
          BG000
          value
          29
        2. group Id
          BG001
          value
          10
        3. group Id
          BG002
          value
          14
        4. group Id
          BG003
          value
          53
        title
        90
      3. measurements
        1. group Id
          BG000
          value
          17
        2. group Id
          BG001
          value
          15
        3. group Id
          BG002
          value
          9
        4. group Id
          BG003
          value
          41
        title
        80
      4. measurements
        1. group Id
          BG000
          value
          6
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          14
        title
        70
    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 (KPS)
    unit Of Measure
    Participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          11
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          4
        4. group Id
          BG003
          value
          21
        title
        Stringent Complete Response (sCR)
      2. measurements
        1. group Id
          BG000
          value
          11
        2. group Id
          BG001
          value
          9
        3. group Id
          BG002
          value
          9
        4. group Id
          BG003
          value
          29
        title
        Complete Response (CR)
      3. measurements
        1. group Id
          BG000
          value
          37
        2. group Id
          BG001
          value
          15
        3. group Id
          BG002
          value
          17
        4. group Id
          BG003
          value
          69
        title
        Very Good Partial Response (VGPR)
      4. measurements
        1. group Id
          BG000
          value
          9
        2. group Id
          BG001
          value
          7
        3. group Id
          BG002
          value
          5
        4. group Id
          BG003
          value
          21
        title
        Partial Response (PR)
      5. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        title
        Stable Response
    description
    CR: no original monoclonal paraprotein, \< 5% BM plasma cells, no lytic bone lesions increase, and no soft tissue plasmacytomas. sCR: CR, normal FLC ratio, and no clonal cells. PR: \>= 50% serum monoclonal paraprotein decrease and 24 hr urinary monoclonal decrease, or \>= 50% involved and uninvolved FLC decrease or a 50% decrease in involved FLC w/ 50% ratio decrease, or \>= 50% BM plasma cells decrease, or \>= 50% soft tissue plasmacytomas decrease. VGPR: PR, paraprotein decrease or \>= 90% serum paraprotein decrease, and a 90% involved light chain decrease. SD: none of above and no progression.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Disease Response at Randomization
    unit Of Measure
    Participants
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      68
    2. group Id
      BG001
      value
      37
    3. group Id
      BG002
      value
      35
    4. group Id
      BG003
      value
      140
    units
    Participants
groups
  1. description
    Patients will undergo tumor cell collection and autologous stem cell transplant with melphalan. Patients will undergo leukapheresis and then will receive maintenance lenalidomide with myeloma vaccine and GM-CSF. Tumor Cell Collection: Patients will undergo aspiration of 30 mL of bone marrow from which myeloma cell will be isolated and frozen for subsequent vaccine generation. Autologous Stem Cell Transplant: Patients will receive an autologous graft of a minimum cell dose of 2.0 x 10\^6 CD34+ cells/kg patient actual body weight per transplantation with high-dose melphalan of 200mg/m\^2 at the schedule and timing according to institutional practices. Leukapheresis: Blood samples will be collected through a catheter in the neck or chest and leukapheresis will be performed using standard clinical procedures. Lenalidomide: Maintenance therapy with lenalidomide will begin between 90 and 100 days after stem cell infusion. Lenalidomide will be administered initially at a dose of 10 mg per day continuously. Cycle duration during maintenance therapy is 28 days. Patients will continue lenalidomide for two years from initiation of therapy. Myeloma vaccine: The target dose is 3 x 10\^6 fusion cells per vaccine. A minimum of 3 x 10\^6 total fusion cells will be required to proceed with vaccine administration. Patients will receive the DC/MM fusion vaccine on day 1 of cycles 2, 3, and 4 of lenalidomide maintenance. GM-CSF: 100 ug GM-CSF will be given for a total of 4 days of each cycle.
    id
    BG000
    title
    Lenalidomide, Vaccine, and GM-CSF
  2. description
    Patients will undergo tumor cell collection and autologous stem cell transplant with melphalan. Patients will receive maintenance lenalidomide with GM-CSF. Tumor Cell Collection: Patients will undergo aspiration of 30 mL of bone marrow from which myeloma cell preparations will be generated. Myeloma cells will be isolated and frozen for subsequent vaccine generation for patients randomized to the vaccine arm (randomization occurs after transplant and recovery). Autologous Stem Cell Transplant: Patients will receive an autologous graft with a minimum cell dose of 2.0 x 10\^6 CD34+ cells/kg patient actual body weight per autologous transplantation. Melphalan: Autologous hematopoietic cell transplant will be done with high-dose melphalan of 200mg/m\^2 at the schedule and timing according to institutional practices. Lenalidomide: Maintenance therapy with lenalidomide will begin between 90 and 100 days after stem cell infusion. Lenalidomide will be administered initially at a dose of 10 mg per day continuously. Cycle duration during maintenance therapy is 28 days. Patients will continue lenalidomide for two years from initiation of therapy. GM-CSF: 100 ug GM-CSF will be given subcutaneously in the upper thigh and daily for a total of 4 days of each cycle.
    id
    BG001
    title
    Lenalidomide and GM-CSF
  3. description
    Patients will undergo tumor cell collection and autologous stem cell transplant with melphalan. Patients will receive maintenance lenalidomide. Tumor Cell Collection: Patients will undergo aspiration of 30 mL of bone marrow from which myeloma cell preparations will be generated. Myeloma cells will be isolated and frozen for subsequent vaccine generation for patients randomized to the vaccine arm (randomization occurs after transplant and recovery). Autologous Stem Cell Transplant: Patients will receive an autologous graft with a minimum cell dose of 2.0 x 10\^6 CD34+ cells/kg patient actual body weight per autologous transplantation. Melphalan: Autologous hematopoietic cell transplant will be done with high-dose melphalan of 200mg/m\^2 at the schedule and timing according to institutional practices. Lenalidomide: Maintenance therapy with lenalidomide will begin between 90 and 100 days after stem cell infusion. Lenalidomide will be administered initially at a dose of 10 mg per day continuously. Cycle duration during maintenance therapy is 28 days. Patients will continue lenalidomide for two years from initiation of therapy.
    id
    BG002
    title
    Maintenance Lenalidomide
  4. description
    Total of all reporting groups
    id
    BG003
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          41.6
          upper Limit
          70.2
          value
          59.3
        2. group Id
          BG001
          lower Limit
          44.2
          upper Limit
          70.2
          value
          62.3
        3. group Id
          BG002
          lower Limit
          35.2
          upper Limit
          70.9
          value
          59.1
        4. group Id
          BG003
          lower Limit
          35.2
          upper Limit
          70.9
          value
          60.0
    dispersion Type
    FULL_RANGE
    param Type
    MEAN
    title
    Age, Continuous
    unit Of Measure
    years
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          27
        2. group Id
          BG001
          value
          18
        3. group Id
          BG002
          value
          18
        4. group Id
          BG003
          value
          63
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          41
        2. group Id
          BG001
          value
          19
        3. group Id
          BG002
          value
          17
        4. group Id
          BG003
          value
          77
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          4
        4. group Id
          BG003
          value
          11
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          61
        2. group Id
          BG001
          value
          33
        3. group Id
          BG002
          value
          30
        4. group Id
          BG003
          value
          124
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          5
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Ethnicity (NIH/OMB)
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          1
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          4
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          8
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          5
        4. group Id
          BG003
          value
          15
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          54
        2. group Id
          BG001
          value
          30
        3. group Id
          BG002
          value
          28
        4. group Id
          BG003
          value
          112
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          8
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          16
        2. group Id
          BG001
          value
          7
        3. group Id
          BG002
          value
          9
        4. group Id
          BG003
          value
          32
        title
        100
      2. measurements
        1. group Id
          BG000
          value
          29
        2. group Id
          BG001
          value
          10
        3. group Id
          BG002
          value
          14
        4. group Id
          BG003
          value
          53
        title
        90
      3. measurements
        1. group Id
          BG000
          value
          17
        2. group Id
          BG001
          value
          15
        3. group Id
          BG002
          value
          9
        4. group Id
          BG003
          value
          41
        title
        80
      4. measurements
        1. group Id
          BG000
          value
          6
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          14
        title
        70
    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 (KPS)
    unit Of Measure
    Participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          11
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          4
        4. group Id
          BG003
          value
          21
        title
        Stringent Complete Response (sCR)
      2. measurements
        1. group Id
          BG000
          value
          11
        2. group Id
          BG001
          value
          9
        3. group Id
          BG002
          value
          9
        4. group Id
          BG003
          value
          29
        title
        Complete Response (CR)
      3. measurements
        1. group Id
          BG000
          value
          37
        2. group Id
          BG001
          value
          15
        3. group Id
          BG002
          value
          17
        4. group Id
          BG003
          value
          69
        title
        Very Good Partial Response (VGPR)
      4. measurements
        1. group Id
          BG000
          value
          9
        2. group Id
          BG001
          value
          7
        3. group Id
          BG002
          value
          5
        4. group Id
          BG003
          value
          21
        title
        Partial Response (PR)
      5. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        title
        Stable Response
    description
    CR: no original monoclonal paraprotein, \< 5% BM plasma cells, no lytic bone lesions increase, and no soft tissue plasmacytomas. sCR: CR, normal FLC ratio, and no clonal cells. PR: \>= 50% serum monoclonal paraprotein decrease and 24 hr urinary monoclonal decrease, or \>= 50% involved and uninvolved FLC decrease or a 50% decrease in involved FLC w/ 50% ratio decrease, or \>= 50% BM plasma cells decrease, or \>= 50% soft tissue plasmacytomas decrease. VGPR: PR, paraprotein decrease or \>= 90% serum paraprotein decrease, and a 90% involved light chain decrease. SD: none of above and no progression.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Disease Response at Randomization
    unit Of Measure
    Participants

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice