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NCT00617591 · FLOW

Participant flow

Pegylated Liposomal Doxorubicin, Low Freq Dexamethasone & Revlimid (Dd-R) in Newly Diagnosed Multiple Myeloma (MM) · Source last updated 2014-01-17

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

groups
  1. description
    Induction Phase Followed by Maintenance Therapy. Patients received lenalidomide 25 mg orally on days 1-21, dexamethasone 40 mg orally on days on 1-4, and Pegylated Liposomal Doxorubicin (PLD) 40 mg/m\^2 intravenously on day 1 (reduced to 30 mg/m\^2 after the initial 29 patients were treated). Cycles were repeated every 28 days. At the best response (4-8 cycles of induction), patients could proceed with either high-dose therapy or maintenance with lenalidomide and dexamethasone at the tolerated doses on the same schedule until disease progression. Dd-R: Lenalidomide (Revlimid®) combined with Pegylated Liposomal Doxorubicin (Doxil®) and Dexamethasone (Decadron®) as outlined in the Detailed Description.
    id
    FG000
    title
    Induction and Maintenance Therapy
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        4
      type
      Withdrew consent during Induction
    2. reasons
      1. group Id
        FG000
        num Subjects
        6
      type
      Withdrew consent during Maintenance
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        57
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        47
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        10
      type
      NOT COMPLETED
    title
    Overall Study
recruitment Details
57 Eligible participants were enrolled at Moffitt Cancer Center between February 2008 and February 2011.
Complete source fields
groups
  1. description
    Induction Phase Followed by Maintenance Therapy. Patients received lenalidomide 25 mg orally on days 1-21, dexamethasone 40 mg orally on days on 1-4, and Pegylated Liposomal Doxorubicin (PLD) 40 mg/m\^2 intravenously on day 1 (reduced to 30 mg/m\^2 after the initial 29 patients were treated). Cycles were repeated every 28 days. At the best response (4-8 cycles of induction), patients could proceed with either high-dose therapy or maintenance with lenalidomide and dexamethasone at the tolerated doses on the same schedule until disease progression. Dd-R: Lenalidomide (Revlimid®) combined with Pegylated Liposomal Doxorubicin (Doxil®) and Dexamethasone (Decadron®) as outlined in the Detailed Description.
    id
    FG000
    title
    Induction and Maintenance Therapy
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        4
      type
      Withdrew consent during Induction
    2. reasons
      1. group Id
        FG000
        num Subjects
        6
      type
      Withdrew consent during Maintenance
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        57
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        47
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        10
      type
      NOT COMPLETED
    title
    Overall Study
recruitment Details
57 Eligible participants were enrolled at Moffitt Cancer Center between February 2008 and February 2011.

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Preserved source evidence · Not medical advice