NCT00602641 · FLOW
Participant flow
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- groups
- 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)
- 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
- drop Withdraws
- reasons
- group Id
- FG000
- num Subjects
- 6
- group Id
- FG001
- num Subjects
- 2
- type
- Never started protocol therapy
- reasons
- group Id
- FG000
- num Subjects
- 8
- group Id
- FG001
- num Subjects
- 15
- type
- Still on treatment at time of analysis
- reasons
- group Id
- FG000
- num Subjects
- 62
- group Id
- FG001
- num Subjects
- 53
- type
- Adverse Event
- reasons
- group Id
- FG000
- num Subjects
- 38
- group Id
- FG001
- num Subjects
- 55
- type
- Disease progression
- reasons
- group Id
- FG000
- num Subjects
- 6
- group Id
- FG001
- num Subjects
- 5
- type
- Death
- reasons
- group Id
- FG000
- num Subjects
- 15
- group Id
- FG001
- num Subjects
- 12
- type
- Withdrawal by Subject
- reasons
- group Id
- FG000
- num Subjects
- 5
- group Id
- FG001
- num Subjects
- 2
- type
- Alternative therapy
- reasons
- group Id
- FG000
- num Subjects
- 5
- group Id
- FG001
- num Subjects
- 2
- type
- Other Complicating Disease
- reasons
- group Id
- FG000
- num Subjects
- 5
- group Id
- FG001
- num Subjects
- 4
- type
- Physician Decision
- reasons
- group Id
- FG000
- num Subjects
- 1
- group Id
- FG001
- num Subjects
- 1
- type
- Administrative Closure
- reasons
- group Id
- FG000
- num Subjects
- 3
- group Id
- FG001
- num Subjects
- 1
- type
- Other
- milestones
- achievements
- group Id
- FG000
- num Subjects
- 154
- group Id
- FG001
- num Subjects
- 152
- type
- STARTED
- achievements
- group Id
- FG000
- num Subjects
- 148
- group Id
- FG001
- num Subjects
- 150
- type
- Started Protocol Therapy
- achievements
- comment
- Treatment continued until progression of disease, unacceptable toxicity or patient withdrawal.
- group Id
- FG000
- num Subjects
- 0
- comment
- Treatment continued until progression of disease, unacceptable toxicity or patient withdrawal.
- group Id
- FG001
- num Subjects
- 0
- type
- COMPLETED
- achievements
- group Id
- FG000
- num Subjects
- 154
- 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
- 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)
- 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
- drop Withdraws
- reasons
- group Id
- FG000
- num Subjects
- 6
- group Id
- FG001
- num Subjects
- 2
- type
- Never started protocol therapy
- reasons
- group Id
- FG000
- num Subjects
- 8
- group Id
- FG001
- num Subjects
- 15
- type
- Still on treatment at time of analysis
- reasons
- group Id
- FG000
- num Subjects
- 62
- group Id
- FG001
- num Subjects
- 53
- type
- Adverse Event
- reasons
- group Id
- FG000
- num Subjects
- 38
- group Id
- FG001
- num Subjects
- 55
- type
- Disease progression
- reasons
- group Id
- FG000
- num Subjects
- 6
- group Id
- FG001
- num Subjects
- 5
- type
- Death
- reasons
- group Id
- FG000
- num Subjects
- 15
- group Id
- FG001
- num Subjects
- 12
- type
- Withdrawal by Subject
- reasons
- group Id
- FG000
- num Subjects
- 5
- group Id
- FG001
- num Subjects
- 2
- type
- Alternative therapy
- reasons
- group Id
- FG000
- num Subjects
- 5
- group Id
- FG001
- num Subjects
- 2
- type
- Other Complicating Disease
- reasons
- group Id
- FG000
- num Subjects
- 5
- group Id
- FG001
- num Subjects
- 4
- type
- Physician Decision
- reasons
- group Id
- FG000
- num Subjects
- 1
- group Id
- FG001
- num Subjects
- 1
- type
- Administrative Closure
- reasons
- group Id
- FG000
- num Subjects
- 3
- group Id
- FG001
- num Subjects
- 1
- type
- Other
- milestones
- achievements
- group Id
- FG000
- num Subjects
- 154
- group Id
- FG001
- num Subjects
- 152
- type
- STARTED
- achievements
- group Id
- FG000
- num Subjects
- 148
- group Id
- FG001
- num Subjects
- 150
- type
- Started Protocol Therapy
- achievements
- comment
- Treatment continued until progression of disease, unacceptable toxicity or patient withdrawal.
- group Id
- FG000
- num Subjects
- 0
- comment
- Treatment continued until progression of disease, unacceptable toxicity or patient withdrawal.
- group Id
- FG001
- num Subjects
- 0
- type
- COMPLETED
- achievements
- group Id
- FG000
- num Subjects
- 154
- 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
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