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NCT00750815 · FLOW

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Cyclophosphamide, VELCADE, DOXIL, and Dexamethasone, (CVDD) in Newly Diagnosed Patients With Multiple Myeloma (MM) · Source last updated 2014-01-20

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

groups
  1. description
    Dose of Cyclophosphamide depended on how many patients we had treated. Three participants were treated at each level: * Dose Level 1: Cyclophosphamide 250 mg /m\^2 IV Day 1; VELCADE, 1.0 mg/m\^2 IV days 1,4,8, and 11; DOXIL 30 mg/m\^2 Day 4; Dexamethasone 20 mg orally daily on days 1-2,4-5,8-9,11-12 * Dose Level 2: Cyclophosphamide 500 mg /m\^2 IV Day 1; VELCADE, 1.0 mg/m\^2 IV days 1,4,8, and 11; DOXIL 30 mg/m\^2 Day 4; Dexamethasone 20 mg orally daily on days 1-2,4-5,8-9,11-12 * Dose Level 3: Cyclophosphamide 750 mg /m\^2 IV Day 1; VELCADE, 1.0 mg/m\^2 IV days 1,4,8, and 11; DOXIL 30 mg/m\^2 Day 4; Dexamethasone 20 mg orally daily on days 1-2,4-5,8-9,11-12 * Dose Level 4: Cyclophosphamide 750 mg /m\^2 IV Day 1; VELCADE, 1.3 mg/m\^2 IV days 1,4,8, and 11; DOXIL 30 mg/m\^2 Day 4; Dexamethasone 20 mg orally daily on days 1-2,4-5,8-9,11-12
    id
    FG000
    title
    A. Phase I - Dose Escalation
  2. description
    Participants received Cyclophosphamide and VELCADE at Level 4 (the MPD) at the same schedule of the Phase I study. Pegylated doxorubicin and Dexamethasone were given at the same doses and schedule as the Phase I part of study.
    id
    FG001
    title
    B. Phase II - Maximum Planned Dose (MPD)
periods
  1. milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        12
      2. group Id
        FG001
        num Subjects
        46
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        12
      2. group Id
        FG001
        num Subjects
        46
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      type
      NOT COMPLETED
    title
    Overall Study
recruitment Details
Participants were recruited at Moffitt Cancer Center from September 2008 to August 2011.
Complete source fields
groups
  1. description
    Dose of Cyclophosphamide depended on how many patients we had treated. Three participants were treated at each level: * Dose Level 1: Cyclophosphamide 250 mg /m\^2 IV Day 1; VELCADE, 1.0 mg/m\^2 IV days 1,4,8, and 11; DOXIL 30 mg/m\^2 Day 4; Dexamethasone 20 mg orally daily on days 1-2,4-5,8-9,11-12 * Dose Level 2: Cyclophosphamide 500 mg /m\^2 IV Day 1; VELCADE, 1.0 mg/m\^2 IV days 1,4,8, and 11; DOXIL 30 mg/m\^2 Day 4; Dexamethasone 20 mg orally daily on days 1-2,4-5,8-9,11-12 * Dose Level 3: Cyclophosphamide 750 mg /m\^2 IV Day 1; VELCADE, 1.0 mg/m\^2 IV days 1,4,8, and 11; DOXIL 30 mg/m\^2 Day 4; Dexamethasone 20 mg orally daily on days 1-2,4-5,8-9,11-12 * Dose Level 4: Cyclophosphamide 750 mg /m\^2 IV Day 1; VELCADE, 1.3 mg/m\^2 IV days 1,4,8, and 11; DOXIL 30 mg/m\^2 Day 4; Dexamethasone 20 mg orally daily on days 1-2,4-5,8-9,11-12
    id
    FG000
    title
    A. Phase I - Dose Escalation
  2. description
    Participants received Cyclophosphamide and VELCADE at Level 4 (the MPD) at the same schedule of the Phase I study. Pegylated doxorubicin and Dexamethasone were given at the same doses and schedule as the Phase I part of study.
    id
    FG001
    title
    B. Phase II - Maximum Planned Dose (MPD)
periods
  1. milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        12
      2. group Id
        FG001
        num Subjects
        46
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        12
      2. group Id
        FG001
        num Subjects
        46
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      type
      NOT COMPLETED
    title
    Overall Study
recruitment Details
Participants were recruited at Moffitt Cancer Center from September 2008 to August 2011.

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

Preserved source evidence · Not medical advice