Skip to content
Triangle logo TriangleGet started
← Full study record

NCT00691704 · FLOW

Participant flow

Celgene High Risk Multiple Myeloma (MM) Revlimid Induction and Maintenance Therapy · Source last updated 2014-08-19

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

groups
  1. description
    Lenalidomide Induction (with Low Dose Dexamethasone) Therapy Followed by Low Dose Melphalan, Prednisone, Lenalidomide and Bortezomib Sequential Maintenance Therapy Lenalidomide Induction: Induction: Lenalidomide 25 mg daily on Days 1-21 followed by 7 day rest and Dexamethasone 40 mg by mouth (po) daily on Days 1, 8, 15 and 22 every 28 days for 4 cycles. Sequential Maintenance Therapy: Subjects who achieve \>partial response (PR) following induction therapy will receive repeating triplet cycles of alternating low dose therapy until progression, poor tolerance or toxicity. Subjects who complete 24 months of maintenance will be removed from study unless they achieved \> stable disease (SD) from maintenance (per discussion with physician): * 325 mg aspirin for deep vein thrombosis (DVT) prophylaxis * Cycle 1, 4, 7, etc. - bortezomib 1.3 mg/m2 on day 1 and 8 of a 28-day cycle * Cycle 2, 5, 8 etc. - Melphalan 6 mg/m2 by mouth (po) daily on Days 1-7 * Prednisone 60 mg /m2 po daily on
    id
    FG000
    title
    High-risk Multiple Myeloma
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        1
      type
      Disease Progression
    2. reasons
      1. group Id
        FG000
        num Subjects
        1
      type
      Active Hepatitis
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        18
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        16
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        2
      type
      NOT COMPLETED
    title
    Induction Therapy
  2. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        8
      type
      Disease Progression
    2. reasons
      1. group Id
        FG000
        num Subjects
        4
      type
      Physician Decision
    3. reasons
      1. group Id
        FG000
        num Subjects
        1
      type
      Withdrawal by Subject
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        16
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        3
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        13
      type
      NOT COMPLETED
    title
    Two Years of Maintenance Therapy
recruitment Details
Recruitment began in July, 2008 and ended in October, 2010. Subjects were identified from Duke University Medical Center Hematologic Malignancies and Cellular Therapy program and University of North Carolina at Chapel Hill Lineberger Cancer Center for all demographic groups who meet the eligibility criteria.
Complete source fields
groups
  1. description
    Lenalidomide Induction (with Low Dose Dexamethasone) Therapy Followed by Low Dose Melphalan, Prednisone, Lenalidomide and Bortezomib Sequential Maintenance Therapy Lenalidomide Induction: Induction: Lenalidomide 25 mg daily on Days 1-21 followed by 7 day rest and Dexamethasone 40 mg by mouth (po) daily on Days 1, 8, 15 and 22 every 28 days for 4 cycles. Sequential Maintenance Therapy: Subjects who achieve \>partial response (PR) following induction therapy will receive repeating triplet cycles of alternating low dose therapy until progression, poor tolerance or toxicity. Subjects who complete 24 months of maintenance will be removed from study unless they achieved \> stable disease (SD) from maintenance (per discussion with physician): * 325 mg aspirin for deep vein thrombosis (DVT) prophylaxis * Cycle 1, 4, 7, etc. - bortezomib 1.3 mg/m2 on day 1 and 8 of a 28-day cycle * Cycle 2, 5, 8 etc. - Melphalan 6 mg/m2 by mouth (po) daily on Days 1-7 * Prednisone 60 mg /m2 po daily on
    id
    FG000
    title
    High-risk Multiple Myeloma
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        1
      type
      Disease Progression
    2. reasons
      1. group Id
        FG000
        num Subjects
        1
      type
      Active Hepatitis
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        18
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        16
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        2
      type
      NOT COMPLETED
    title
    Induction Therapy
  2. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        8
      type
      Disease Progression
    2. reasons
      1. group Id
        FG000
        num Subjects
        4
      type
      Physician Decision
    3. reasons
      1. group Id
        FG000
        num Subjects
        1
      type
      Withdrawal by Subject
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        16
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        3
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        13
      type
      NOT COMPLETED
    title
    Two Years of Maintenance Therapy
recruitment Details
Recruitment began in July, 2008 and ended in October, 2010. Subjects were identified from Duke University Medical Center Hematologic Malignancies and Cellular Therapy program and University of North Carolina at Chapel Hill Lineberger Cancer Center for all demographic groups who meet the eligibility criteria.

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

Preserved source evidence · Not medical advice