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NCT01160484 · FLOW

Participant flow

Pegylated Liposomal Doxorubicin, Bortezomib, Dexamethasone and Lenalidomide for Relapsed/Refractory Multiple Myeloma · Source last updated 2015-05-04

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

groups
  1. description
    Dose schematic of Dexamethasone + Bortezomib + Pegylated Liposomal Doxorubicin (PLD)+ Lenalidomide (DVD-R) Therapy: Per 28 Day Cycle, patients will received drug in the following order, dosing and schedule: 1\) Dexamethasone- 40 mg intravenous infusion (IV) on Days 1, 4, 8 and 11; 2) Bortezomib- 1.0 mg/m2 infused over 3 to 5 seconds followed by a standard saline flush on Days 1, 4, 8 and 11; 3) Pegylated Liposomal Doxorubicin- 4.0 mg/m2 IV as a 90 minute infusion on Day 1 of Cycle 1 and subsequent doses may be administered over 30 to 60 minutes on Days 4, 8 and 11 of Cycle 1 and on Days 1, 4, 8, and 11 of each subsequent cycle; and 4) Lenalidomide- 10 mg PO on days 1-14
    id
    FG000
    title
    DVD-R Single Arm
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        9
      type
      Lack of Efficacy
    2. reasons
      1. group Id
        FG000
        num Subjects
        6
      type
      Adverse Event
    3. reasons
      1. group Id
        FG000
        num Subjects
        2
      type
      Withdrawal by Subject
    4. reasons
      1. group Id
        FG000
        num Subjects
        1
      type
      inclusion/exclusion criteria failure
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        40
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        22
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        18
      type
      NOT COMPLETED
    title
    Overall Study
recruitment Details
This study enrolled patients from eight different clinical sites sites in the United States. Data was collected from September 2009 until July 25, 2011
Complete source fields
groups
  1. description
    Dose schematic of Dexamethasone + Bortezomib + Pegylated Liposomal Doxorubicin (PLD)+ Lenalidomide (DVD-R) Therapy: Per 28 Day Cycle, patients will received drug in the following order, dosing and schedule: 1\) Dexamethasone- 40 mg intravenous infusion (IV) on Days 1, 4, 8 and 11; 2) Bortezomib- 1.0 mg/m2 infused over 3 to 5 seconds followed by a standard saline flush on Days 1, 4, 8 and 11; 3) Pegylated Liposomal Doxorubicin- 4.0 mg/m2 IV as a 90 minute infusion on Day 1 of Cycle 1 and subsequent doses may be administered over 30 to 60 minutes on Days 4, 8 and 11 of Cycle 1 and on Days 1, 4, 8, and 11 of each subsequent cycle; and 4) Lenalidomide- 10 mg PO on days 1-14
    id
    FG000
    title
    DVD-R Single Arm
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        9
      type
      Lack of Efficacy
    2. reasons
      1. group Id
        FG000
        num Subjects
        6
      type
      Adverse Event
    3. reasons
      1. group Id
        FG000
        num Subjects
        2
      type
      Withdrawal by Subject
    4. reasons
      1. group Id
        FG000
        num Subjects
        1
      type
      inclusion/exclusion criteria failure
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        40
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        22
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        18
      type
      NOT COMPLETED
    title
    Overall Study
recruitment Details
This study enrolled patients from eight different clinical sites sites in the United States. Data was collected from September 2009 until July 25, 2011

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

Preserved source evidence · Not medical advice