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NCT02761187 · FLOW

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An Observational Study of Presentation, Treatment Patterns, and Outcomes in Multiple Myeloma Participants · Source last updated 2025-02-24

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

groups
  1. description
    Participants newly diagnosed with MM within 3 months from initiation of treatment were enrolled for 3 years, and followed for at least 2 years, until death, or the end of the study, whichever comes first (up to approximately 5 years).
    id
    FG000
    title
    Newly Diagnosed (ND) MM
  2. description
    Participants diagnosed with RRMM who previously received 1 to 3 prior lines of therapy were enrolled for 3 years, and followed for at least 2 years, until death, or the end of the study, whichever comes first (up to approximately 5 years).
    id
    FG001
    title
    Relapsed/Refractory (R/R) MM
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        13
      2. group Id
        FG001
        num Subjects
        8
      type
      Too ill to Participate
    2. reasons
      1. group Id
        FG000
        num Subjects
        34
      2. group Id
        FG001
        num Subjects
        26
      type
      Patient declined participation and declined follow-up for survival
    3. reasons
      1. group Id
        FG000
        num Subjects
        64
      2. group Id
        FG001
        num Subjects
        58
      type
      Patient withdrew consent
    4. reasons
      1. group Id
        FG000
        num Subjects
        4
      2. group Id
        FG001
        num Subjects
        8
      type
      Physician discretion
    5. reasons
      1. group Id
        FG000
        num Subjects
        72
      2. group Id
        FG001
        num Subjects
        62
      type
      Change in physician or transferred to another treatment center
    6. reasons
      1. group Id
        FG000
        num Subjects
        20
      2. group Id
        FG001
        num Subjects
        26
      type
      On Hospice
    7. reasons
      1. group Id
        FG000
        num Subjects
        474
      2. group Id
        FG001
        num Subjects
        642
      type
      Deceased
    8. reasons
      1. group Id
        FG000
        num Subjects
        73
      2. group Id
        FG001
        num Subjects
        63
      type
      Lost to Follow-up
    9. reasons
      1. group Id
        FG000
        num Subjects
        100
      2. group Id
        FG001
        num Subjects
        85
      type
      Due to study discontinued at site
    10. reasons
      1. group Id
        FG000
        num Subjects
        1484
      2. group Id
        FG001
        num Subjects
        937
      type
      Reason not Specified
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        2338
      2. group Id
        FG001
        num Subjects
        1915
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        2193
      2. group Id
        FG001
        num Subjects
        68
      comment
      The most common treatment regimens prescribed in participants treated in 1st line of therapy were proteosome inhibitor (PI)+ immunomodulatory drug (IMiD), PI+ alkylating agent (AA), and PI treatment as part of their index regimen while enrolled in the study and were observed until study discontinuation, death or end of study (up to approximately 5 years).
      type
      1st Line of Therapy
    3. achievements
      1. group Id
        FG000
        num Subjects
        928
      2. group Id
        FG001
        num Subjects
        950
      comment
      The most common treatment regimens prescribed in participants treated in 2nd line of therapy were PI+IMiD, IMiD, and PI treatment as part of their index regimen while enrolled in the study and were observed until study discontinuation, death or end of study (up to approximately 5 years).
      type
      2nd Line of Therapy
    4. achievements
      1. group Id
        FG000
        num Subjects
        406
      2. group Id
        FG001
        num Subjects
        1049
      comment
      The most common treatment regimens prescribed in participants treated in 3rd line of therapy were IMiD, PI+IMiD, and monoclonal antibody (mAB)+IMiD treatment as part of their index regimen while enrolled in the study and were observed until study discontinuation, death or end of study (up to approximately 5 years).
      type
      3rd Line of Therapy
    5. achievements
      1. group Id
        FG000
        num Subjects
        185
      2. group Id
        FG001
        num Subjects
        727
      comment
      The most common treatment regimens prescribed in participants treated in 4th line of therapy were mAb, mAb+IMiD, and mAB+PI treatment as part of their index regimen while enrolled in the study and were observed until study discontinuation, death or end of study (up to approximately 5 years).
      type
      4th Line of Therapy
    6. achievements
      1. group Id
        FG000
        num Subjects
        153
      2. group Id
        FG001
        num Subjects
        767
      comment
      The most common treatment regimens prescribed in participants treated in \>4th line of therapy were mAb, PI, and IMiD+AA treatment as part of their index regimen while enrolled in the study and were observed until study discontinuation, death or end of study (up to approximately 5 years).
      type
      >4th Line of Therapy
    7. achievements
      1. group Id
        FG000
        num Subjects
        54
      2. group Id
        FG001
        num Subjects
        93
      comment
      Missing line of therapy with respect to recorded regimen or have not observed any regimen with line of therapy on or after study entry. Participants were observed until study discontinuation, death or end of study (up to approximately 5 years).
      type
      Line of Therapy: Unknown
    8. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      type
      COMPLETED
    9. achievements
      1. group Id
        FG000
        num Subjects
        2338
      2. group Id
        FG001
        num Subjects
        1915
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
Prospective data was collected for newly diagnosed multiple myeloma (NDMM) and Relapsed/Refractory multiple myeloma (RRMM) participants. Participants were also divided for analysis of some part of this study according to lines of therapy (LOT) they received. The final outcomes analysis performed at the end of study included 3263 participants excluding 990 participants from 4253 due to concerns around the robustness of data. Participants who received \>1 LOT were counted more than once.
recruitment Details
Participants took part in the study at 130 investigative sites in China, Taiwan, Belgium, France, Germany, Greece, Israel, Italy, Spain, Turkey, United Kingdom, Brazil, Colombia, Mexico, United States from 1 July 2016 to 30 September 2021. A total of 4253 participants were enrolled in this study.
Complete source fields
groups
  1. description
    Participants newly diagnosed with MM within 3 months from initiation of treatment were enrolled for 3 years, and followed for at least 2 years, until death, or the end of the study, whichever comes first (up to approximately 5 years).
    id
    FG000
    title
    Newly Diagnosed (ND) MM
  2. description
    Participants diagnosed with RRMM who previously received 1 to 3 prior lines of therapy were enrolled for 3 years, and followed for at least 2 years, until death, or the end of the study, whichever comes first (up to approximately 5 years).
    id
    FG001
    title
    Relapsed/Refractory (R/R) MM
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        13
      2. group Id
        FG001
        num Subjects
        8
      type
      Too ill to Participate
    2. reasons
      1. group Id
        FG000
        num Subjects
        34
      2. group Id
        FG001
        num Subjects
        26
      type
      Patient declined participation and declined follow-up for survival
    3. reasons
      1. group Id
        FG000
        num Subjects
        64
      2. group Id
        FG001
        num Subjects
        58
      type
      Patient withdrew consent
    4. reasons
      1. group Id
        FG000
        num Subjects
        4
      2. group Id
        FG001
        num Subjects
        8
      type
      Physician discretion
    5. reasons
      1. group Id
        FG000
        num Subjects
        72
      2. group Id
        FG001
        num Subjects
        62
      type
      Change in physician or transferred to another treatment center
    6. reasons
      1. group Id
        FG000
        num Subjects
        20
      2. group Id
        FG001
        num Subjects
        26
      type
      On Hospice
    7. reasons
      1. group Id
        FG000
        num Subjects
        474
      2. group Id
        FG001
        num Subjects
        642
      type
      Deceased
    8. reasons
      1. group Id
        FG000
        num Subjects
        73
      2. group Id
        FG001
        num Subjects
        63
      type
      Lost to Follow-up
    9. reasons
      1. group Id
        FG000
        num Subjects
        100
      2. group Id
        FG001
        num Subjects
        85
      type
      Due to study discontinued at site
    10. reasons
      1. group Id
        FG000
        num Subjects
        1484
      2. group Id
        FG001
        num Subjects
        937
      type
      Reason not Specified
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        2338
      2. group Id
        FG001
        num Subjects
        1915
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        2193
      2. group Id
        FG001
        num Subjects
        68
      comment
      The most common treatment regimens prescribed in participants treated in 1st line of therapy were proteosome inhibitor (PI)+ immunomodulatory drug (IMiD), PI+ alkylating agent (AA), and PI treatment as part of their index regimen while enrolled in the study and were observed until study discontinuation, death or end of study (up to approximately 5 years).
      type
      1st Line of Therapy
    3. achievements
      1. group Id
        FG000
        num Subjects
        928
      2. group Id
        FG001
        num Subjects
        950
      comment
      The most common treatment regimens prescribed in participants treated in 2nd line of therapy were PI+IMiD, IMiD, and PI treatment as part of their index regimen while enrolled in the study and were observed until study discontinuation, death or end of study (up to approximately 5 years).
      type
      2nd Line of Therapy
    4. achievements
      1. group Id
        FG000
        num Subjects
        406
      2. group Id
        FG001
        num Subjects
        1049
      comment
      The most common treatment regimens prescribed in participants treated in 3rd line of therapy were IMiD, PI+IMiD, and monoclonal antibody (mAB)+IMiD treatment as part of their index regimen while enrolled in the study and were observed until study discontinuation, death or end of study (up to approximately 5 years).
      type
      3rd Line of Therapy
    5. achievements
      1. group Id
        FG000
        num Subjects
        185
      2. group Id
        FG001
        num Subjects
        727
      comment
      The most common treatment regimens prescribed in participants treated in 4th line of therapy were mAb, mAb+IMiD, and mAB+PI treatment as part of their index regimen while enrolled in the study and were observed until study discontinuation, death or end of study (up to approximately 5 years).
      type
      4th Line of Therapy
    6. achievements
      1. group Id
        FG000
        num Subjects
        153
      2. group Id
        FG001
        num Subjects
        767
      comment
      The most common treatment regimens prescribed in participants treated in \>4th line of therapy were mAb, PI, and IMiD+AA treatment as part of their index regimen while enrolled in the study and were observed until study discontinuation, death or end of study (up to approximately 5 years).
      type
      >4th Line of Therapy
    7. achievements
      1. group Id
        FG000
        num Subjects
        54
      2. group Id
        FG001
        num Subjects
        93
      comment
      Missing line of therapy with respect to recorded regimen or have not observed any regimen with line of therapy on or after study entry. Participants were observed until study discontinuation, death or end of study (up to approximately 5 years).
      type
      Line of Therapy: Unknown
    8. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      type
      COMPLETED
    9. achievements
      1. group Id
        FG000
        num Subjects
        2338
      2. group Id
        FG001
        num Subjects
        1915
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
Prospective data was collected for newly diagnosed multiple myeloma (NDMM) and Relapsed/Refractory multiple myeloma (RRMM) participants. Participants were also divided for analysis of some part of this study according to lines of therapy (LOT) they received. The final outcomes analysis performed at the end of study included 3263 participants excluding 990 participants from 4253 due to concerns around the robustness of data. Participants who received \>1 LOT were counted more than once.
recruitment Details
Participants took part in the study at 130 investigative sites in China, Taiwan, Belgium, France, Germany, Greece, Israel, Italy, Spain, Turkey, United Kingdom, Brazil, Colombia, Mexico, United States from 1 July 2016 to 30 September 2021. A total of 4253 participants were enrolled in this study.

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Preserved source evidence · Not medical advice