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NCT00689936 · FLOW

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Study to Determine Efficacy and Safety of Lenalidomide Plus Low-dose Dexamethasone Versus Melphalan, Prednisone, Thalidomide in Patients With Previously Untreated Multiple Myeloma · Source last updated 2019-11-20

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

groups
  1. description
    Participants ≤ 75 years old received 25 mg lenalidomide (R) administered by mouth (PO) on days 1 to 21 of each 28-day cycle plus 40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle until disease progression or intolerable toxicity. Participants \> 75 years old received lenalidomide 25 mg PO on the same schedule and frequency plus 20 mg dexamethasone at the same schedule. Participants with moderate renal insufficiency received 10-15 mg lenalidomide (R) PO on days 1-21 of each 28-day treatment cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle until disease progression or intolerable toxicity. Participants with severe renal insufficiency received 15 mg lenalidomide (R) PO every other day on days 1-21 of each 28-day treatment cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle until disease progression or intolerable toxicity.
    id
    FG000
    title
    Lenalidomide and Low-Dose Dexamethasone (Rd)
  2. description
    Participants ≤ 75 years old received 25 mg lenalidomide (R) PO on days 1 to 21 of each 28-day treatment cycle 40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless progressive disease (PD) or intolerable toxicity occurred. Those \> 75 years old received lenalidomide 25 mg PO on the same schedule and frequency plus 20 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity. Those with moderate renal insufficiency received 10-15 mg lenalidomide (R) PO on days 1-21 of each 28-day cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity. Participants with severe renal insufficiency received 15 mg lenalidomide (R) PO every other day (QOD) on days 1-21 of each 28-day cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity.
    id
    FG001
    title
    Lenalidomide and Dexamethasone Rd18
  3. description
    Participants received melphalan (M) 0.25 mg/kg PO daily (QD) on days 1 to 4 of each 42-day cycle plus prednisone (P) at 2 mg/kg PO on days 1 to 4 of each 42-day cycle and thalidomide 200 mg PO QD on days 1 to 41 of each 42-day cycle. MPT therapy was given for up to 12 cycles unless PD or intolerable toxicity occurred. Participants with moderate to severe renal insufficiency received melphalan (M) 0.10-0.125 mg/kg PO daily (QD) on days 1 to 4 of each 42-day cycle plus prednisone (P) at 2 mg/kg PO on days 1 to 4 of each 42-day cycle and thalidomide 100-200 mg PO QD on days 1 to 41 of each 42-day cycle. MPT therapy was given for up to 12 cycles unless PD or intolerable toxicity occurred.
    id
    FG002
    title
    Melphalan + Prednisone + Thalidomide (MPT)
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        68
      2. group Id
        FG001
        num Subjects
        71
      3. group Id
        FG002
        num Subjects
        76
      type
      Adverse Event
    2. reasons
      1. group Id
        FG000
        num Subjects
        273
      2. group Id
        FG001
        num Subjects
        362
      3. group Id
        FG002
        num Subjects
        339
      type
      Disease Progression
    3. reasons
      1. group Id
        FG000
        num Subjects
        16
      2. group Id
        FG001
        num Subjects
        16
      3. group Id
        FG002
        num Subjects
        21
      type
      Withdrawal by Subject
    4. reasons
      1. group Id
        FG000
        num Subjects
        60
      2. group Id
        FG001
        num Subjects
        28
      3. group Id
        FG002
        num Subjects
        37
      type
      Death
    5. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        2
      3. group Id
        FG002
        num Subjects
        2
      type
      Lost to Follow-up
    6. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        2
      3. group Id
        FG002
        num Subjects
        4
      type
      Protocol Violation
    7. reasons
      1. group Id
        FG000
        num Subjects
        64
      2. group Id
        FG001
        num Subjects
        26
      3. group Id
        FG002
        num Subjects
        21
      type
      Study Close Out
    8. reasons
      1. group Id
        FG000
        num Subjects
        52
      2. group Id
        FG001
        num Subjects
        34
      3. group Id
        FG002
        num Subjects
        47
      type
      Miscellaneous
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        535
      2. group Id
        FG001
        num Subjects
        541
      3. group Id
        FG002
        num Subjects
        547
      type
      STARTED
    2. achievements
      1. comment
        Safety population = all randomized participants who received at least 1 dose of study treatment.
        group Id
        FG000
        num Subjects
        532
      2. comment
        Safety population = all randomized participants who received at least 1 dose of study treatment.
        group Id
        FG001
        num Subjects
        540
      3. comment
        Safety population = all randomized participants who received at least 1 dose of study treatment.
        group Id
        FG002
        num Subjects
        541
      type
      Safety Population
    3. achievements
      1. comment
        Participants randomized, but did not receive any study drug treatment.
        group Id
        FG000
        num Subjects
        3
      2. comment
        Participants randomized, but did not receive any study drug treatment.
        group Id
        FG001
        num Subjects
        1
      3. comment
        Participants randomized, but did not receive any study drug treatment.
        group Id
        FG002
        num Subjects
        6
      type
      Untreated
    4. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      type
      COMPLETED
    5. achievements
      1. group Id
        FG000
        num Subjects
        535
      2. group Id
        FG001
        num Subjects
        541
      3. group Id
        FG002
        num Subjects
        547
      type
      NOT COMPLETED
    title
    Active Treatment Phase
  2. milestones
    1. achievements
      1. comment
        Includes participants who discontinued treatment for reasons other than progressive disease.
        group Id
        FG000
        num Subjects
        87
      2. comment
        Includes participants who completed 18 cycles (Rd18) and did not experience progressive disease.
        group Id
        FG001
        num Subjects
        300
      3. comment
        Includes participants who completed 12 cycles MPT and did not experience progressive disease.
        group Id
        FG002
        num Subjects
        273
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        87
      2. group Id
        FG001
        num Subjects
        300
      3. group Id
        FG002
        num Subjects
        273
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      type
      NOT COMPLETED
    title
    Progression Free Survival-PFS-Follow-Up
  3. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        127
      2. group Id
        FG001
        num Subjects
        188
      3. group Id
        FG002
        num Subjects
        144
      type
      Continue in Long Term Follow Up
    milestones
    1. achievements
      1. comment
        Includes participants from both the active treatment phase and from the PFS follow-up phase.
        group Id
        FG000
        num Subjects
        382
      2. comment
        Includes participants from both the active treatment phase and from the PFS follow-up phase.
        group Id
        FG001
        num Subjects
        463
      3. comment
        Includes participants from both the active treatment phase and from the PFS follow-up phase.
        group Id
        FG002
        num Subjects
        459
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        255
      2. group Id
        FG001
        num Subjects
        275
      3. group Id
        FG002
        num Subjects
        315
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        127
      2. group Id
        FG001
        num Subjects
        188
      3. group Id
        FG002
        num Subjects
        144
      type
      NOT COMPLETED
    title
    Long-Term Follow Up Phase
pre Assignment Details
Participants were stratified at randomization by 1) age (≤ 75 versus \> 75 years), 2) stage (International Staging System Stages I or II versus Stage III), and 3) country.
recruitment Details
This study was conducted in the Europe, Asia, North America and Pacific regions. Participants were randomized at 246 sites (165 in Europe, 23 in Asia, 39 in North America, and 19 in the Pacific). The study was co-sponsored by Intergroupe Francophone du Myélome (IFM) (for sites in France, Switzerland, and Belgium) and Celgene Corporation.
Complete source fields
groups
  1. description
    Participants ≤ 75 years old received 25 mg lenalidomide (R) administered by mouth (PO) on days 1 to 21 of each 28-day cycle plus 40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle until disease progression or intolerable toxicity. Participants \> 75 years old received lenalidomide 25 mg PO on the same schedule and frequency plus 20 mg dexamethasone at the same schedule. Participants with moderate renal insufficiency received 10-15 mg lenalidomide (R) PO on days 1-21 of each 28-day treatment cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle until disease progression or intolerable toxicity. Participants with severe renal insufficiency received 15 mg lenalidomide (R) PO every other day on days 1-21 of each 28-day treatment cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle until disease progression or intolerable toxicity.
    id
    FG000
    title
    Lenalidomide and Low-Dose Dexamethasone (Rd)
  2. description
    Participants ≤ 75 years old received 25 mg lenalidomide (R) PO on days 1 to 21 of each 28-day treatment cycle 40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless progressive disease (PD) or intolerable toxicity occurred. Those \> 75 years old received lenalidomide 25 mg PO on the same schedule and frequency plus 20 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity. Those with moderate renal insufficiency received 10-15 mg lenalidomide (R) PO on days 1-21 of each 28-day cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity. Participants with severe renal insufficiency received 15 mg lenalidomide (R) PO every other day (QOD) on days 1-21 of each 28-day cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity.
    id
    FG001
    title
    Lenalidomide and Dexamethasone Rd18
  3. description
    Participants received melphalan (M) 0.25 mg/kg PO daily (QD) on days 1 to 4 of each 42-day cycle plus prednisone (P) at 2 mg/kg PO on days 1 to 4 of each 42-day cycle and thalidomide 200 mg PO QD on days 1 to 41 of each 42-day cycle. MPT therapy was given for up to 12 cycles unless PD or intolerable toxicity occurred. Participants with moderate to severe renal insufficiency received melphalan (M) 0.10-0.125 mg/kg PO daily (QD) on days 1 to 4 of each 42-day cycle plus prednisone (P) at 2 mg/kg PO on days 1 to 4 of each 42-day cycle and thalidomide 100-200 mg PO QD on days 1 to 41 of each 42-day cycle. MPT therapy was given for up to 12 cycles unless PD or intolerable toxicity occurred.
    id
    FG002
    title
    Melphalan + Prednisone + Thalidomide (MPT)
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        68
      2. group Id
        FG001
        num Subjects
        71
      3. group Id
        FG002
        num Subjects
        76
      type
      Adverse Event
    2. reasons
      1. group Id
        FG000
        num Subjects
        273
      2. group Id
        FG001
        num Subjects
        362
      3. group Id
        FG002
        num Subjects
        339
      type
      Disease Progression
    3. reasons
      1. group Id
        FG000
        num Subjects
        16
      2. group Id
        FG001
        num Subjects
        16
      3. group Id
        FG002
        num Subjects
        21
      type
      Withdrawal by Subject
    4. reasons
      1. group Id
        FG000
        num Subjects
        60
      2. group Id
        FG001
        num Subjects
        28
      3. group Id
        FG002
        num Subjects
        37
      type
      Death
    5. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        2
      3. group Id
        FG002
        num Subjects
        2
      type
      Lost to Follow-up
    6. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        2
      3. group Id
        FG002
        num Subjects
        4
      type
      Protocol Violation
    7. reasons
      1. group Id
        FG000
        num Subjects
        64
      2. group Id
        FG001
        num Subjects
        26
      3. group Id
        FG002
        num Subjects
        21
      type
      Study Close Out
    8. reasons
      1. group Id
        FG000
        num Subjects
        52
      2. group Id
        FG001
        num Subjects
        34
      3. group Id
        FG002
        num Subjects
        47
      type
      Miscellaneous
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        535
      2. group Id
        FG001
        num Subjects
        541
      3. group Id
        FG002
        num Subjects
        547
      type
      STARTED
    2. achievements
      1. comment
        Safety population = all randomized participants who received at least 1 dose of study treatment.
        group Id
        FG000
        num Subjects
        532
      2. comment
        Safety population = all randomized participants who received at least 1 dose of study treatment.
        group Id
        FG001
        num Subjects
        540
      3. comment
        Safety population = all randomized participants who received at least 1 dose of study treatment.
        group Id
        FG002
        num Subjects
        541
      type
      Safety Population
    3. achievements
      1. comment
        Participants randomized, but did not receive any study drug treatment.
        group Id
        FG000
        num Subjects
        3
      2. comment
        Participants randomized, but did not receive any study drug treatment.
        group Id
        FG001
        num Subjects
        1
      3. comment
        Participants randomized, but did not receive any study drug treatment.
        group Id
        FG002
        num Subjects
        6
      type
      Untreated
    4. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      type
      COMPLETED
    5. achievements
      1. group Id
        FG000
        num Subjects
        535
      2. group Id
        FG001
        num Subjects
        541
      3. group Id
        FG002
        num Subjects
        547
      type
      NOT COMPLETED
    title
    Active Treatment Phase
  2. milestones
    1. achievements
      1. comment
        Includes participants who discontinued treatment for reasons other than progressive disease.
        group Id
        FG000
        num Subjects
        87
      2. comment
        Includes participants who completed 18 cycles (Rd18) and did not experience progressive disease.
        group Id
        FG001
        num Subjects
        300
      3. comment
        Includes participants who completed 12 cycles MPT and did not experience progressive disease.
        group Id
        FG002
        num Subjects
        273
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        87
      2. group Id
        FG001
        num Subjects
        300
      3. group Id
        FG002
        num Subjects
        273
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      type
      NOT COMPLETED
    title
    Progression Free Survival-PFS-Follow-Up
  3. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        127
      2. group Id
        FG001
        num Subjects
        188
      3. group Id
        FG002
        num Subjects
        144
      type
      Continue in Long Term Follow Up
    milestones
    1. achievements
      1. comment
        Includes participants from both the active treatment phase and from the PFS follow-up phase.
        group Id
        FG000
        num Subjects
        382
      2. comment
        Includes participants from both the active treatment phase and from the PFS follow-up phase.
        group Id
        FG001
        num Subjects
        463
      3. comment
        Includes participants from both the active treatment phase and from the PFS follow-up phase.
        group Id
        FG002
        num Subjects
        459
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        255
      2. group Id
        FG001
        num Subjects
        275
      3. group Id
        FG002
        num Subjects
        315
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        127
      2. group Id
        FG001
        num Subjects
        188
      3. group Id
        FG002
        num Subjects
        144
      type
      NOT COMPLETED
    title
    Long-Term Follow Up Phase
pre Assignment Details
Participants were stratified at randomization by 1) age (≤ 75 versus \> 75 years), 2) stage (International Staging System Stages I or II versus Stage III), and 3) country.
recruitment Details
This study was conducted in the Europe, Asia, North America and Pacific regions. Participants were randomized at 246 sites (165 in Europe, 23 in Asia, 39 in North America, and 19 in the Pacific). The study was co-sponsored by Intergroupe Francophone du Myélome (IFM) (for sites in France, Switzerland, and Belgium) and Celgene Corporation.

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Preserved source evidence · Not medical advice