Skip to content
← Full study record

NCT00602641 · FLOW

Participant flow

Melphalan, Prednisone, and Thalidomide or Lenalidomide in Treating Patients With Newly Diagnosed Multiple Myeloma · Source last updated 2026-08-28

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

groups
  1. description
    Patients receive melphalan, prednisone and thalidomide induction plus thalidomide maintenance (MPT-T). INDUCTION THERAPY: Patients receive melphalan 9 mg/m\^2 PO and prednisone 100 mg PO daily on days 1-4, and thalidomide 100 mg PO daily on days 1-28. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. MAINTENANCE THERAPY: Patients receive thalidomide 100 mg PO daily and continue in the absence of disease progression.
    id
    FG000
    title
    Arm I (MPT-T)
  2. description
    Patients receive lower-dose melphalan, prednisone and lenalidomide (Revlimid®) induction plus lenalidomide maintenance (mPR-R). INDUCTION THERAPY: Patients receive melphalan 5 mg/m\^2 PO and prednisone 100 mg PO daily on days 1-4, and lenalidomide 10 mg PO on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. MAINTENANCE THERAPY: Patients receive lenalidomide 10 mg PO daily on days 1-21. Courses repeat every 28 days in the absence of disease progression.
    id
    FG001
    title
    Arm II (mPR-R)
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        6
      2. group Id
        FG001
        num Subjects
        2
      type
      Never started protocol therapy
    2. reasons
      1. group Id
        FG000
        num Subjects
        8
      2. group Id
        FG001
        num Subjects
        15
      type
      Still on treatment at time of analysis
    3. reasons
      1. group Id
        FG000
        num Subjects
        62
      2. group Id
        FG001
        num Subjects
        53
      type
      Adverse Event
    4. reasons
      1. group Id
        FG000
        num Subjects
        38
      2. group Id
        FG001
        num Subjects
        55
      type
      Disease progression
    5. reasons
      1. group Id
        FG000
        num Subjects
        6
      2. group Id
        FG001
        num Subjects
        5
      type
      Death
    6. reasons
      1. group Id
        FG000
        num Subjects
        15
      2. group Id
        FG001
        num Subjects
        12
      type
      Withdrawal by Subject
    7. reasons
      1. group Id
        FG000
        num Subjects
        5
      2. group Id
        FG001
        num Subjects
        2
      type
      Alternative therapy
    8. reasons
      1. group Id
        FG000
        num Subjects
        5
      2. group Id
        FG001
        num Subjects
        2
      type
      Other Complicating Disease
    9. reasons
      1. group Id
        FG000
        num Subjects
        5
      2. group Id
        FG001
        num Subjects
        4
      type
      Physician Decision
    10. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        1
      type
      Administrative Closure
    11. reasons
      1. group Id
        FG000
        num Subjects
        3
      2. group Id
        FG001
        num Subjects
        1
      type
      Other
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        154
      2. group Id
        FG001
        num Subjects
        152
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        148
      2. group Id
        FG001
        num Subjects
        150
      type
      Started Protocol Therapy
    3. achievements
      1. comment
        Treatment continued until progression of disease, unacceptable toxicity or patient withdrawal.
        group Id
        FG000
        num Subjects
        0
      2. comment
        Treatment continued until progression of disease, unacceptable toxicity or patient withdrawal.
        group Id
        FG001
        num Subjects
        0
      type
      COMPLETED
    4. achievements
      1. group Id
        FG000
        num Subjects
        154
      2. group Id
        FG001
        num Subjects
        152
      type
      NOT COMPLETED
    title
    Overall Study
recruitment Details
The study was activated on February 29, 2008 and closed to accrual on November 30, 2011 with final accrual of 306 patients.
Complete source fields
groups
  1. description
    Patients receive melphalan, prednisone and thalidomide induction plus thalidomide maintenance (MPT-T). INDUCTION THERAPY: Patients receive melphalan 9 mg/m\^2 PO and prednisone 100 mg PO daily on days 1-4, and thalidomide 100 mg PO daily on days 1-28. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. MAINTENANCE THERAPY: Patients receive thalidomide 100 mg PO daily and continue in the absence of disease progression.
    id
    FG000
    title
    Arm I (MPT-T)
  2. description
    Patients receive lower-dose melphalan, prednisone and lenalidomide (Revlimid®) induction plus lenalidomide maintenance (mPR-R). INDUCTION THERAPY: Patients receive melphalan 5 mg/m\^2 PO and prednisone 100 mg PO daily on days 1-4, and lenalidomide 10 mg PO on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. MAINTENANCE THERAPY: Patients receive lenalidomide 10 mg PO daily on days 1-21. Courses repeat every 28 days in the absence of disease progression.
    id
    FG001
    title
    Arm II (mPR-R)
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        6
      2. group Id
        FG001
        num Subjects
        2
      type
      Never started protocol therapy
    2. reasons
      1. group Id
        FG000
        num Subjects
        8
      2. group Id
        FG001
        num Subjects
        15
      type
      Still on treatment at time of analysis
    3. reasons
      1. group Id
        FG000
        num Subjects
        62
      2. group Id
        FG001
        num Subjects
        53
      type
      Adverse Event
    4. reasons
      1. group Id
        FG000
        num Subjects
        38
      2. group Id
        FG001
        num Subjects
        55
      type
      Disease progression
    5. reasons
      1. group Id
        FG000
        num Subjects
        6
      2. group Id
        FG001
        num Subjects
        5
      type
      Death
    6. reasons
      1. group Id
        FG000
        num Subjects
        15
      2. group Id
        FG001
        num Subjects
        12
      type
      Withdrawal by Subject
    7. reasons
      1. group Id
        FG000
        num Subjects
        5
      2. group Id
        FG001
        num Subjects
        2
      type
      Alternative therapy
    8. reasons
      1. group Id
        FG000
        num Subjects
        5
      2. group Id
        FG001
        num Subjects
        2
      type
      Other Complicating Disease
    9. reasons
      1. group Id
        FG000
        num Subjects
        5
      2. group Id
        FG001
        num Subjects
        4
      type
      Physician Decision
    10. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        1
      type
      Administrative Closure
    11. reasons
      1. group Id
        FG000
        num Subjects
        3
      2. group Id
        FG001
        num Subjects
        1
      type
      Other
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        154
      2. group Id
        FG001
        num Subjects
        152
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        148
      2. group Id
        FG001
        num Subjects
        150
      type
      Started Protocol Therapy
    3. achievements
      1. comment
        Treatment continued until progression of disease, unacceptable toxicity or patient withdrawal.
        group Id
        FG000
        num Subjects
        0
      2. comment
        Treatment continued until progression of disease, unacceptable toxicity or patient withdrawal.
        group Id
        FG001
        num Subjects
        0
      type
      COMPLETED
    4. achievements
      1. group Id
        FG000
        num Subjects
        154
      2. group Id
        FG001
        num Subjects
        152
      type
      NOT COMPLETED
    title
    Overall Study
recruitment Details
The study was activated on February 29, 2008 and closed to accrual on November 30, 2011 with final accrual of 306 patients.

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice