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NCT01208662 · FLOW

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Randomized Trial of Lenalidomide, Bortezomib, Dexamethasone vs High-Dose Treatment With SCT in MM Patients up to Age 65 · Source last updated 2026-01-22

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

groups
  1. description
    All participants received one cycle of lenalidomide (R), bortezomib (V) and dexamethasone (D) and then were randomized. All participants then received two additional RVD cycles, followed by stem-cell collection. RVD Alone participants received five additional RVD cycles. Maintenance in both arms comprised daily lenalidomide 10 mg, escalated to 15 mg if tolerated, until disease progression, unacceptable toxicity, or withdrawal from treatment or study. After finishing protocol-specified treatment, off-study salvage transplantation was recommended but not mandated for RVD Alone participants at relapse. RVD cycle duration=21 days R: 25 mg oral on days 1-14 V: 1.3 mg per square meter of body surface area IV or subcutaneous on days 1, 4, 8, and 11 D: 20 mg oral (cycles 1-3) or 10 mg (cycles 4-8) on days 1, 2, 4, 5, 8, 9, 11, and 12
    id
    FG000
    title
    RVD Alone
  2. description
    All participants received one cycle of lenalidomide (R), bortezomib (V) and dexamethasone (d) and then were randomized. All participants then received two additional RVD cycles, followed by stem-cell collection. RVD plus autologous stem cell transplant (ASCT) participants received high-dose melphalan (200 mg/m2, adjusted for ideal body weight) ASCT and, upon recovery (\~day 60), two additional RVD cycles. Maintenance in both arms comprised daily lenalidomide 10 mg, escalated to 15 mg if tolerated, until disease progression, unacceptable toxicity, or withdrawal from treatment or study. After finishing protocol-specified treatment, RVD plus ASCT participants could undergo a second transplant. RVD cycle duration=21 days R: 25 mg oral on days 1-14 V: 1.3 mg per square meter of body surface area IV or subcutaneous on days 1, 4, 8, and 11 D: 20 mg oral (cycles 1-3) or 10 mg (cycles 4-8) on days 1, 2, 4, 5, 8, 9, 11, and 12
    id
    FG001
    title
    RVD Plus ASCT
  3. description
    Some participants started cycle 1 lenalidomide (R), bortezomib (V) and dexamethasone (D) therapy but were not randomized. RVD cycle duration=21 days R: 25 mg oral on days 1-14 V: 1.3 mg per square meter of body surface area IV or subcutaneous on days 1, 4, 8, and 11 D: 20 mg oral (cycles 1) on days 1, 2, 4, 5, 8, 9, 11, and 12
    id
    FG002
    title
    RVD Cycle 1 Only
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        23
      2. group Id
        FG001
        num Subjects
        13
      3. group Id
        FG002
        num Subjects
        0
      type
      Disease Progression
    2. reasons
      1. group Id
        FG000
        num Subjects
        16
      2. group Id
        FG001
        num Subjects
        18
      3. group Id
        FG002
        num Subjects
        2
      type
      Adverse Event
    3. reasons
      1. group Id
        FG000
        num Subjects
        16
      2. group Id
        FG001
        num Subjects
        34
      3. group Id
        FG002
        num Subjects
        4
      type
      MD or Participant Decision
    4. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        3
      3. group Id
        FG002
        num Subjects
        1
      type
      Death
    5. reasons
      1. group Id
        FG000
        num Subjects
        10
      2. group Id
        FG001
        num Subjects
        8
      3. group Id
        FG002
        num Subjects
        0
      type
      Discontinued for other reasons
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        357
      2. group Id
        FG001
        num Subjects
        365
      3. group Id
        FG002
        num Subjects
        7
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        357
      2. group Id
        FG001
        num Subjects
        365
      3. group Id
        FG002
        num Subjects
        0
      comment
      Participants were randomized after 1 cycle of therapy only if cycle 1 therapy was completed and/or participant did not withdraw.
      type
      Randomized
    3. achievements
      1. group Id
        FG000
        num Subjects
        324
      2. group Id
        FG001
        num Subjects
        330
      3. group Id
        FG002
        num Subjects
        0
      type
      Underwent Stem Cell Mobilization
    4. achievements
      1. group Id
        FG000
        num Subjects
        291
      2. group Id
        FG001
        num Subjects
        289
      3. group Id
        FG002
        num Subjects
        0
      type
      COMPLETED
    5. achievements
      1. group Id
        FG000
        num Subjects
        66
      2. group Id
        FG001
        num Subjects
        76
      3. group Id
        FG002
        num Subjects
        7
      type
      NOT COMPLETED
    title
    Induction and Consolidation
  2. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        156
      2. group Id
        FG001
        num Subjects
        102
      3. group Id
        FG002
        num Subjects
        0
      type
      Disease Progression
    2. reasons
      1. group Id
        FG000
        num Subjects
        12
      2. group Id
        FG001
        num Subjects
        28
      3. group Id
        FG002
        num Subjects
        0
      type
      Adverse Event
    3. reasons
      1. group Id
        FG000
        num Subjects
        24
      2. group Id
        FG001
        num Subjects
        36
      3. group Id
        FG002
        num Subjects
        0
      type
      MD or Participant Decision
    4. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        3
      3. group Id
        FG002
        num Subjects
        0
      type
      Death
    5. reasons
      1. group Id
        FG000
        num Subjects
        21
      2. group Id
        FG001
        num Subjects
        31
      3. group Id
        FG002
        num Subjects
        0
      type
      Discontinued for other reasons
    6. reasons
      1. group Id
        FG000
        num Subjects
        78
      2. group Id
        FG001
        num Subjects
        89
      3. group Id
        FG002
        num Subjects
        0
      type
      Still on Treatment
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        291
      2. group Id
        FG001
        num Subjects
        289
      3. group Id
        FG002
        num Subjects
        0
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        108
      2. group Id
        FG001
        num Subjects
        90
      3. group Id
        FG002
        num Subjects
        0
      comment
      MRD evaluable subset represents participants with clonal sequence identified at baseline plus MRD assessment at start of maintenance.
      type
      Minimal Residual Disease (MRD) Evaluable at Maintenance Start
    3. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      comment
      Given maintenance treatment duration is not fixed, all participants are considered as 'Not Completed'.
      type
      COMPLETED
    4. achievements
      1. group Id
        FG000
        num Subjects
        291
      2. group Id
        FG001
        num Subjects
        289
      3. group Id
        FG002
        num Subjects
        0
      type
      NOT COMPLETED
    title
    Maintenance
recruitment Details
Participants were enrolled at 56 clinical sites in the U.S. from Oct 1, 2010 to January 30, 2018.
Complete source fields
groups
  1. description
    All participants received one cycle of lenalidomide (R), bortezomib (V) and dexamethasone (D) and then were randomized. All participants then received two additional RVD cycles, followed by stem-cell collection. RVD Alone participants received five additional RVD cycles. Maintenance in both arms comprised daily lenalidomide 10 mg, escalated to 15 mg if tolerated, until disease progression, unacceptable toxicity, or withdrawal from treatment or study. After finishing protocol-specified treatment, off-study salvage transplantation was recommended but not mandated for RVD Alone participants at relapse. RVD cycle duration=21 days R: 25 mg oral on days 1-14 V: 1.3 mg per square meter of body surface area IV or subcutaneous on days 1, 4, 8, and 11 D: 20 mg oral (cycles 1-3) or 10 mg (cycles 4-8) on days 1, 2, 4, 5, 8, 9, 11, and 12
    id
    FG000
    title
    RVD Alone
  2. description
    All participants received one cycle of lenalidomide (R), bortezomib (V) and dexamethasone (d) and then were randomized. All participants then received two additional RVD cycles, followed by stem-cell collection. RVD plus autologous stem cell transplant (ASCT) participants received high-dose melphalan (200 mg/m2, adjusted for ideal body weight) ASCT and, upon recovery (\~day 60), two additional RVD cycles. Maintenance in both arms comprised daily lenalidomide 10 mg, escalated to 15 mg if tolerated, until disease progression, unacceptable toxicity, or withdrawal from treatment or study. After finishing protocol-specified treatment, RVD plus ASCT participants could undergo a second transplant. RVD cycle duration=21 days R: 25 mg oral on days 1-14 V: 1.3 mg per square meter of body surface area IV or subcutaneous on days 1, 4, 8, and 11 D: 20 mg oral (cycles 1-3) or 10 mg (cycles 4-8) on days 1, 2, 4, 5, 8, 9, 11, and 12
    id
    FG001
    title
    RVD Plus ASCT
  3. description
    Some participants started cycle 1 lenalidomide (R), bortezomib (V) and dexamethasone (D) therapy but were not randomized. RVD cycle duration=21 days R: 25 mg oral on days 1-14 V: 1.3 mg per square meter of body surface area IV or subcutaneous on days 1, 4, 8, and 11 D: 20 mg oral (cycles 1) on days 1, 2, 4, 5, 8, 9, 11, and 12
    id
    FG002
    title
    RVD Cycle 1 Only
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        23
      2. group Id
        FG001
        num Subjects
        13
      3. group Id
        FG002
        num Subjects
        0
      type
      Disease Progression
    2. reasons
      1. group Id
        FG000
        num Subjects
        16
      2. group Id
        FG001
        num Subjects
        18
      3. group Id
        FG002
        num Subjects
        2
      type
      Adverse Event
    3. reasons
      1. group Id
        FG000
        num Subjects
        16
      2. group Id
        FG001
        num Subjects
        34
      3. group Id
        FG002
        num Subjects
        4
      type
      MD or Participant Decision
    4. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        3
      3. group Id
        FG002
        num Subjects
        1
      type
      Death
    5. reasons
      1. group Id
        FG000
        num Subjects
        10
      2. group Id
        FG001
        num Subjects
        8
      3. group Id
        FG002
        num Subjects
        0
      type
      Discontinued for other reasons
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        357
      2. group Id
        FG001
        num Subjects
        365
      3. group Id
        FG002
        num Subjects
        7
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        357
      2. group Id
        FG001
        num Subjects
        365
      3. group Id
        FG002
        num Subjects
        0
      comment
      Participants were randomized after 1 cycle of therapy only if cycle 1 therapy was completed and/or participant did not withdraw.
      type
      Randomized
    3. achievements
      1. group Id
        FG000
        num Subjects
        324
      2. group Id
        FG001
        num Subjects
        330
      3. group Id
        FG002
        num Subjects
        0
      type
      Underwent Stem Cell Mobilization
    4. achievements
      1. group Id
        FG000
        num Subjects
        291
      2. group Id
        FG001
        num Subjects
        289
      3. group Id
        FG002
        num Subjects
        0
      type
      COMPLETED
    5. achievements
      1. group Id
        FG000
        num Subjects
        66
      2. group Id
        FG001
        num Subjects
        76
      3. group Id
        FG002
        num Subjects
        7
      type
      NOT COMPLETED
    title
    Induction and Consolidation
  2. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        156
      2. group Id
        FG001
        num Subjects
        102
      3. group Id
        FG002
        num Subjects
        0
      type
      Disease Progression
    2. reasons
      1. group Id
        FG000
        num Subjects
        12
      2. group Id
        FG001
        num Subjects
        28
      3. group Id
        FG002
        num Subjects
        0
      type
      Adverse Event
    3. reasons
      1. group Id
        FG000
        num Subjects
        24
      2. group Id
        FG001
        num Subjects
        36
      3. group Id
        FG002
        num Subjects
        0
      type
      MD or Participant Decision
    4. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        3
      3. group Id
        FG002
        num Subjects
        0
      type
      Death
    5. reasons
      1. group Id
        FG000
        num Subjects
        21
      2. group Id
        FG001
        num Subjects
        31
      3. group Id
        FG002
        num Subjects
        0
      type
      Discontinued for other reasons
    6. reasons
      1. group Id
        FG000
        num Subjects
        78
      2. group Id
        FG001
        num Subjects
        89
      3. group Id
        FG002
        num Subjects
        0
      type
      Still on Treatment
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        291
      2. group Id
        FG001
        num Subjects
        289
      3. group Id
        FG002
        num Subjects
        0
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        108
      2. group Id
        FG001
        num Subjects
        90
      3. group Id
        FG002
        num Subjects
        0
      comment
      MRD evaluable subset represents participants with clonal sequence identified at baseline plus MRD assessment at start of maintenance.
      type
      Minimal Residual Disease (MRD) Evaluable at Maintenance Start
    3. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      comment
      Given maintenance treatment duration is not fixed, all participants are considered as 'Not Completed'.
      type
      COMPLETED
    4. achievements
      1. group Id
        FG000
        num Subjects
        291
      2. group Id
        FG001
        num Subjects
        289
      3. group Id
        FG002
        num Subjects
        0
      type
      NOT COMPLETED
    title
    Maintenance
recruitment Details
Participants were enrolled at 56 clinical sites in the U.S. from Oct 1, 2010 to January 30, 2018.

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Preserved source evidence · Not medical advice