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NCT03417284 · FLOW

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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.

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
    FG000
    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
    FG001
    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
    FG002
    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
    FG003
    title
    Group 2_Dose 225mgm2
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      type
      Inadequate supply on study drug
    2. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        1
      4. group Id
        FG003
        num Subjects
        0
      type
      Disease Progression
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        4
      2. group Id
        FG001
        num Subjects
        27
      3. group Id
        FG002
        num Subjects
        4
      4. group Id
        FG003
        num Subjects
        27
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        3
      2. group Id
        FG001
        num Subjects
        27
      3. group Id
        FG002
        num Subjects
        3
      4. group Id
        FG003
        num Subjects
        27
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        1
      4. group Id
        FG003
        num Subjects
        0
      type
      NOT COMPLETED
    title
    Overall Study
recruitment Details
All participants were registered in MD Anderson Cancer Center.
Complete source fields
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
    FG000
    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
    FG001
    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
    FG002
    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
    FG003
    title
    Group 2_Dose 225mgm2
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      type
      Inadequate supply on study drug
    2. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        1
      4. group Id
        FG003
        num Subjects
        0
      type
      Disease Progression
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        4
      2. group Id
        FG001
        num Subjects
        27
      3. group Id
        FG002
        num Subjects
        4
      4. group Id
        FG003
        num Subjects
        27
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        3
      2. group Id
        FG001
        num Subjects
        27
      3. group Id
        FG002
        num Subjects
        3
      4. group Id
        FG003
        num Subjects
        27
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        1
      4. group Id
        FG003
        num Subjects
        0
      type
      NOT COMPLETED
    title
    Overall Study
recruitment Details
All participants were registered in MD Anderson Cancer Center.

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Preserved source evidence · Not medical advice