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NCT02541383 · FLOW

Participant flow

A Study to Evaluate Daratumumab in Transplant Eligible Participants With Previously Untreated Multiple Myeloma · Source last updated 2025-04-13

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

groups
  1. description
    All patients randomized to the VTd group (Bortezomib (VELCADE), Thalidomide, and Dexamethasone) at rando 1 (even those who didn't receive any study treatment), not re-randomized in maintenance phase.
    id
    FG000
    title
    VTd Only
  2. description
    All patients randomized to the DVTd group (Daratumumab, Bortezomib (VELCADE), Thalidomide, and Dexamethasone) at rando 1 (even those who didn't receive any study treatment), not re-randomized in maintenance phase.
    id
    FG001
    title
    DVTd Only * Arm/Group Title: Characters Remaining: 91
  3. description
    All patients randomized to the VTd group (Bortezomib (VELCADE), Thalidomide, and Dexamethasone) at rando 1 (even those who didn't receive any study treatment), re-randomized to observation
    id
    FG002
    title
    VTd-OBS
  4. description
    All patients randomized to the VTd group (Bortezomib (VELCADE), Thalidomide, and Dexamethasone) at rando 1 (even those who didn't receive any study treatment), re-randomized to daratumumab monotherapy
    id
    FG003
    title
    VTd-DARA
  5. description
    All patients randomized to the DVTd group (Daratumumab, Bortezomib (VELCADE), Thalidomide, and Dexamethasone) at rando 1 (even those who didn't receive any study treatment), re-randomized to observation.
    id
    FG004
    title
    DVTd-OBS
  6. description
    All patients randomized to the DVTd group (Daratumumab, Bortezomib (VELCADE), Thalidomide, and Dexamethasone) at rando 1 (even those who didn't receive any study treatment), re-randomized to daratumumab monotherapy.
    id
    FG005
    title
    DVTd-DARA
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        50
      2. group Id
        FG001
        num Subjects
        37
      3. group Id
        FG002
        num Subjects
        48
      4. group Id
        FG003
        num Subjects
        41
      5. group Id
        FG004
        num Subjects
        21
      6. group Id
        FG005
        num Subjects
        25
      type
      Death
    2. reasons
      1. group Id
        FG000
        num Subjects
        5
      2. group Id
        FG001
        num Subjects
        3
      3. group Id
        FG002
        num Subjects
        1
      4. group Id
        FG003
        num Subjects
        1
      5. group Id
        FG004
        num Subjects
        3
      6. group Id
        FG005
        num Subjects
        0
      type
      Lost to Follow-up
    3. reasons
      1. group Id
        FG000
        num Subjects
        5
      2. group Id
        FG001
        num Subjects
        6
      3. group Id
        FG002
        num Subjects
        1
      4. group Id
        FG003
        num Subjects
        1
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        0
      type
      Consent withdrawn
    4. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        0
      type
      Sponsor's decision
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        114
      2. group Id
        FG001
        num Subjects
        85
      3. group Id
        FG002
        num Subjects
        215
      4. group Id
        FG003
        num Subjects
        213
      5. group Id
        FG004
        num Subjects
        229
      6. group Id
        FG005
        num Subjects
        229
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        53
      2. group Id
        FG001
        num Subjects
        38
      3. group Id
        FG002
        num Subjects
        165
      4. group Id
        FG003
        num Subjects
        170
      5. group Id
        FG004
        num Subjects
        205
      6. group Id
        FG005
        num Subjects
        204
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        61
      2. group Id
        FG001
        num Subjects
        47
      3. group Id
        FG002
        num Subjects
        50
      4. group Id
        FG003
        num Subjects
        43
      5. group Id
        FG004
        num Subjects
        24
      6. group Id
        FG005
        num Subjects
        25
      type
      NOT COMPLETED
    title
    Overall Study
Complete source fields
groups
  1. description
    All patients randomized to the VTd group (Bortezomib (VELCADE), Thalidomide, and Dexamethasone) at rando 1 (even those who didn't receive any study treatment), not re-randomized in maintenance phase.
    id
    FG000
    title
    VTd Only
  2. description
    All patients randomized to the DVTd group (Daratumumab, Bortezomib (VELCADE), Thalidomide, and Dexamethasone) at rando 1 (even those who didn't receive any study treatment), not re-randomized in maintenance phase.
    id
    FG001
    title
    DVTd Only * Arm/Group Title: Characters Remaining: 91
  3. description
    All patients randomized to the VTd group (Bortezomib (VELCADE), Thalidomide, and Dexamethasone) at rando 1 (even those who didn't receive any study treatment), re-randomized to observation
    id
    FG002
    title
    VTd-OBS
  4. description
    All patients randomized to the VTd group (Bortezomib (VELCADE), Thalidomide, and Dexamethasone) at rando 1 (even those who didn't receive any study treatment), re-randomized to daratumumab monotherapy
    id
    FG003
    title
    VTd-DARA
  5. description
    All patients randomized to the DVTd group (Daratumumab, Bortezomib (VELCADE), Thalidomide, and Dexamethasone) at rando 1 (even those who didn't receive any study treatment), re-randomized to observation.
    id
    FG004
    title
    DVTd-OBS
  6. description
    All patients randomized to the DVTd group (Daratumumab, Bortezomib (VELCADE), Thalidomide, and Dexamethasone) at rando 1 (even those who didn't receive any study treatment), re-randomized to daratumumab monotherapy.
    id
    FG005
    title
    DVTd-DARA
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        50
      2. group Id
        FG001
        num Subjects
        37
      3. group Id
        FG002
        num Subjects
        48
      4. group Id
        FG003
        num Subjects
        41
      5. group Id
        FG004
        num Subjects
        21
      6. group Id
        FG005
        num Subjects
        25
      type
      Death
    2. reasons
      1. group Id
        FG000
        num Subjects
        5
      2. group Id
        FG001
        num Subjects
        3
      3. group Id
        FG002
        num Subjects
        1
      4. group Id
        FG003
        num Subjects
        1
      5. group Id
        FG004
        num Subjects
        3
      6. group Id
        FG005
        num Subjects
        0
      type
      Lost to Follow-up
    3. reasons
      1. group Id
        FG000
        num Subjects
        5
      2. group Id
        FG001
        num Subjects
        6
      3. group Id
        FG002
        num Subjects
        1
      4. group Id
        FG003
        num Subjects
        1
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        0
      type
      Consent withdrawn
    4. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        0
      type
      Sponsor's decision
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        114
      2. group Id
        FG001
        num Subjects
        85
      3. group Id
        FG002
        num Subjects
        215
      4. group Id
        FG003
        num Subjects
        213
      5. group Id
        FG004
        num Subjects
        229
      6. group Id
        FG005
        num Subjects
        229
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        53
      2. group Id
        FG001
        num Subjects
        38
      3. group Id
        FG002
        num Subjects
        165
      4. group Id
        FG003
        num Subjects
        170
      5. group Id
        FG004
        num Subjects
        205
      6. group Id
        FG005
        num Subjects
        204
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        61
      2. group Id
        FG001
        num Subjects
        47
      3. group Id
        FG002
        num Subjects
        50
      4. group Id
        FG003
        num Subjects
        43
      5. group Id
        FG004
        num Subjects
        24
      6. group Id
        FG005
        num Subjects
        25
      type
      NOT COMPLETED
    title
    Overall Study

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Preserved source evidence · Not medical advice