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NCT03417284 · BASELINE

Baseline characteristics

Melphalan Hydrochloride in Treating Participants With Newly-Diagnosed Multiple Myeloma Undergoing Donor Stem Cell Transplantation · Source last updated 2025-05-01

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
      4
    2. group Id
      BG001
      value
      27
    3. group Id
      BG002
      value
      4
    4. group Id
      BG003
      value
      27
    5. group Id
      BG004
      value
      62
    units
    Participants
groups
  1. description
    PREPARATIVE REGIMEN: Participants receive melphalan IV over 30-60 minutes on day -2. TRANSPLANT: Participants in both groups undergo donor stem cell transplantation IV on day 0 over 30-60 minutes. POST-TRANSPLANT: Participants in both groups receive filgrastim-sndz SC QD starting on day 5 and continuing in the absence of disease progression, unacceptable toxicity, or until evidence of an ANC of 0.5 x 10\^9/L. Autologous Hematopoietic Stem Cell Transplantation: Undergo HSCT Filgrastim-sndz: Given SC Melphalan Hydrochloride: Given IV
    id
    BG000
    title
    Group1_Dose 1 200mgm2
  2. description
    PREPARATIVE REGIMEN: Participants receive melphalan IV over 30-60 minutes on day -2. TRANSPLANT: Participants in both groups undergo donor stem cell transplantation IV on day 0 over 30-60 minutes. POST-TRANSPLANT: Participants in both groups receive filgrastim-sndz SC QD starting on day 5 and continuing in the absence of disease progression, unacceptable toxicity, or until evidence of an ANC of 0.5 x 10\^9/L. Autologous Hematopoietic Stem Cell Transplantation: Undergo HSCT Filgrastim-sndz: Given SC Melphalan Hydrochloride: Given IV
    id
    BG001
    title
    Group 1_Dose 2 225mgm2
  3. description
    PREPARATIVE REGIMEN: Participants receive melphalan IV over 8-9 hours on day -2. TRANSPLANT: Participants in both groups undergo donor stem cell transplantation IV on day 0 over 30-60 minutes. POST-TRANSPLANT: Participants in both groups receive filgrastim-sndz SC QD starting on day 5 and continuing in the absence of disease progression, unacceptable toxicity, or until evidence of an ANC of 0.5 x 10\^9/L. Autologous Hematopoietic Stem Cell Transplantation: Undergo HSCT Filgrastim-sndz: Given SC Melphalan Hydrochloride: Given IV
    id
    BG002
    title
    Group 2_Dose 1 200mgm2
  4. description
    PREPARATIVE REGIMEN: Participants receive melphalan IV over 8-9 hours on day -2. TRANSPLANT: Participants in both groups undergo donor stem cell transplantation IV on day 0 over 30-60 minutes. POST-TRANSPLANT: Participants in both groups receive filgrastim-sndz SC QD starting on day 5 and continuing in the absence of disease progression, unacceptable toxicity, or until evidence of an ANC of 0.5 x 10\^9/L. Autologous Hematopoietic Stem Cell Transplantation: Undergo HSCT Filgrastim-sndz: Given SC Melphalan Hydrochloride: Given IV
    id
    BG003
    title
    Group 2_Dose 225mgm2
  5. description
    Total of all reporting groups
    id
    BG004
    title
    Total
measures
  1. classes
    1. categories
      1. 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
        5. group Id
          BG004
          value
          0
        title
        <=18 years
      2. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          19
        3. group Id
          BG002
          value
          4
        4. group Id
          BG003
          value
          22
        5. group Id
          BG004
          value
          47
        title
        Between 18 and 65 years
      3. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          8
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          5
        5. group Id
          BG004
          value
          15
        title
        >=65 years
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Age, Categorical
    unit Of Measure
    Participants
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          12
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          5
        5. group Id
          BG004
          value
          20
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          15
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          22
        5. group Id
          BG004
          value
          42
        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
          1
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          4
        5. group Id
          BG004
          value
          9
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          24
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          23
        5. group Id
          BG004
          value
          53
        title
        Not Hispanic or Latino
      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
        5. group Id
          BG004
          value
          0
        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
          4
        2. group Id
          BG001
          value
          27
        3. group Id
          BG002
          value
          4
        4. group Id
          BG003
          value
          27
        5. group Id
          BG004
          value
          62
      title
      United States
    param Type
    NUMBER
    title
    Region of Enrollment
    unit Of Measure
    participants
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      4
    2. group Id
      BG001
      value
      27
    3. group Id
      BG002
      value
      4
    4. group Id
      BG003
      value
      27
    5. group Id
      BG004
      value
      62
    units
    Participants
groups
  1. description
    PREPARATIVE REGIMEN: Participants receive melphalan IV over 30-60 minutes on day -2. TRANSPLANT: Participants in both groups undergo donor stem cell transplantation IV on day 0 over 30-60 minutes. POST-TRANSPLANT: Participants in both groups receive filgrastim-sndz SC QD starting on day 5 and continuing in the absence of disease progression, unacceptable toxicity, or until evidence of an ANC of 0.5 x 10\^9/L. Autologous Hematopoietic Stem Cell Transplantation: Undergo HSCT Filgrastim-sndz: Given SC Melphalan Hydrochloride: Given IV
    id
    BG000
    title
    Group1_Dose 1 200mgm2
  2. description
    PREPARATIVE REGIMEN: Participants receive melphalan IV over 30-60 minutes on day -2. TRANSPLANT: Participants in both groups undergo donor stem cell transplantation IV on day 0 over 30-60 minutes. POST-TRANSPLANT: Participants in both groups receive filgrastim-sndz SC QD starting on day 5 and continuing in the absence of disease progression, unacceptable toxicity, or until evidence of an ANC of 0.5 x 10\^9/L. Autologous Hematopoietic Stem Cell Transplantation: Undergo HSCT Filgrastim-sndz: Given SC Melphalan Hydrochloride: Given IV
    id
    BG001
    title
    Group 1_Dose 2 225mgm2
  3. description
    PREPARATIVE REGIMEN: Participants receive melphalan IV over 8-9 hours on day -2. TRANSPLANT: Participants in both groups undergo donor stem cell transplantation IV on day 0 over 30-60 minutes. POST-TRANSPLANT: Participants in both groups receive filgrastim-sndz SC QD starting on day 5 and continuing in the absence of disease progression, unacceptable toxicity, or until evidence of an ANC of 0.5 x 10\^9/L. Autologous Hematopoietic Stem Cell Transplantation: Undergo HSCT Filgrastim-sndz: Given SC Melphalan Hydrochloride: Given IV
    id
    BG002
    title
    Group 2_Dose 1 200mgm2
  4. description
    PREPARATIVE REGIMEN: Participants receive melphalan IV over 8-9 hours on day -2. TRANSPLANT: Participants in both groups undergo donor stem cell transplantation IV on day 0 over 30-60 minutes. POST-TRANSPLANT: Participants in both groups receive filgrastim-sndz SC QD starting on day 5 and continuing in the absence of disease progression, unacceptable toxicity, or until evidence of an ANC of 0.5 x 10\^9/L. Autologous Hematopoietic Stem Cell Transplantation: Undergo HSCT Filgrastim-sndz: Given SC Melphalan Hydrochloride: Given IV
    id
    BG003
    title
    Group 2_Dose 225mgm2
  5. description
    Total of all reporting groups
    id
    BG004
    title
    Total
measures
  1. classes
    1. categories
      1. 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
        5. group Id
          BG004
          value
          0
        title
        <=18 years
      2. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          19
        3. group Id
          BG002
          value
          4
        4. group Id
          BG003
          value
          22
        5. group Id
          BG004
          value
          47
        title
        Between 18 and 65 years
      3. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          8
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          5
        5. group Id
          BG004
          value
          15
        title
        >=65 years
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Age, Categorical
    unit Of Measure
    Participants
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          12
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          5
        5. group Id
          BG004
          value
          20
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          15
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          22
        5. group Id
          BG004
          value
          42
        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
          1
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          4
        5. group Id
          BG004
          value
          9
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          24
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          23
        5. group Id
          BG004
          value
          53
        title
        Not Hispanic or Latino
      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
        5. group Id
          BG004
          value
          0
        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
          4
        2. group Id
          BG001
          value
          27
        3. group Id
          BG002
          value
          4
        4. group Id
          BG003
          value
          27
        5. group Id
          BG004
          value
          62
      title
      United States
    param Type
    NUMBER
    title
    Region of Enrollment
    unit Of Measure
    participants

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

Preserved source evidence · Not medical advice