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NCT00724568 · OUTCOME

Maximum Tolerated Dose (MTD) of Combination Therapy With VELCADE, Dexamethasone, and Doxil, (RVDD)

Combination Study of Revlimid®, Velcade® Dexamethasone and Doxil® (RVDD)for Newly Diagnosed Multiple Myeloma · Source last updated 2017-06-02

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

Measure
NUMBER
Unit
mg
Interval / dispersion
Not reported
Time frame
1 month post treatment

What was measured

Dose Level 1: 15 mg Revlimid daily on days 1-14 followed by 7-day rest every 21 days 1.3 mg/m2 Velcade daily on days 1, 4, 8 and 11 20 mg dexamethasone daily on Days 1, 2, 4, 5, 8, 9, 11, 12\* and 20 mg/m2 Doxil daily on day 4 Dose Level 2: 20 mg Revlimid daily on days 1-14 followed by 7-day rest every 21 days 1.3 mg/m2 Velcade daily on days 1, 4, 8 and 11 20 mg dexamethasone daily on Days 1, 2, 4, 5, 8, 9, 11, 12\* and 20 mg/m2 Doxil daily on day 4 Dose Level 3: 25 mg Revlimid daily on days 1-14 followed by 7-day rest every 21 days 1.3 mg/m2 Velcade daily on days 1, 4, 8 and 11 20 mg dexamethasone daily on Days 1, 2, 4, 5, 8, 9, 11, 12\* and 20 mg/m2 Doxil daily on day 4 Dose Level 4: 25 mg Revlimid daily on days 1-14 followed by 7-day rest every 21 days 1.3 mg/m2 Velcade daily on days 1, 4, 8 and 11 20 mg dexamethasone daily on Days 1, 2, 4, 5, 8, 9, 11, 12\* and 30 mg/m2 Doxil daily on day 4

Analysis population: A total of 74 patients were enrolled in this phase 1/2 study: 42 in phase 1.

Groups in this outcome

Combination Drug Therapy

Patients will be treated with Velcade at 1.3 mg/m2 on days 1, 4, 8, and 11, Doxil at indicated doses on day 4, Dexamethasone at 20 mg orally on days of Velcade and the day after for all dose levels, and Revlimid at indicated doses on days 1-14 in 3-week cycles for 4-8 cycles.

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Combination Drug Therapy42

Reported measurements

Revlimid
Values in mg · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Combination Drug Therapy25Not reportedNot reportedNot reportedNot reported
VELCADE
Values in mg · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Combination Drug Therapy1.3Not reportedNot reportedNot reportedNot reported
Dexamethasone
Values in mg · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Combination Drug Therapy20Not reportedNot reportedNot reportedNot reported
Doxil
Values in mg · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Combination Drug Therapy30Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        25
    title
    Revlimid
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        1.3
    title
    VELCADE
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        20
    title
    Dexamethasone
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        30
    title
    Doxil
denoms
  1. counts
    1. group Id
      OG000
      value
      42
    units
    Participants
description
Dose Level 1: 15 mg Revlimid daily on days 1-14 followed by 7-day rest every 21 days 1.3 mg/m2 Velcade daily on days 1, 4, 8 and 11 20 mg dexamethasone daily on Days 1, 2, 4, 5, 8, 9, 11, 12\* and 20 mg/m2 Doxil daily on day 4 Dose Level 2: 20 mg Revlimid daily on days 1-14 followed by 7-day rest every 21 days 1.3 mg/m2 Velcade daily on days 1, 4, 8 and 11 20 mg dexamethasone daily on Days 1, 2, 4, 5, 8, 9, 11, 12\* and 20 mg/m2 Doxil daily on day 4 Dose Level 3: 25 mg Revlimid daily on days 1-14 followed by 7-day rest every 21 days 1.3 mg/m2 Velcade daily on days 1, 4, 8 and 11 20 mg dexamethasone daily on Days 1, 2, 4, 5, 8, 9, 11, 12\* and 20 mg/m2 Doxil daily on day 4 Dose Level 4: 25 mg Revlimid daily on days 1-14 followed by 7-day rest every 21 days 1.3 mg/m2 Velcade daily on days 1, 4, 8 and 11 20 mg dexamethasone daily on Days 1, 2, 4, 5, 8, 9, 11, 12\* and 30 mg/m2 Doxil daily on day 4
groups
  1. description
    Patients will be treated with Velcade at 1.3 mg/m2 on days 1, 4, 8, and 11, Doxil at indicated doses on day 4, Dexamethasone at 20 mg orally on days of Velcade and the day after for all dose levels, and Revlimid at indicated doses on days 1-14 in 3-week cycles for 4-8 cycles.
    id
    OG000
    title
    Combination Drug Therapy
param Type
NUMBER
population Description
A total of 74 patients were enrolled in this phase 1/2 study: 42 in phase 1.
reporting Status
POSTED
time Frame
1 month post treatment
title
Maximum Tolerated Dose (MTD) of Combination Therapy With VELCADE, Dexamethasone, and Doxil, (RVDD)
type
PRIMARY
unit Of Measure
mg

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

Preserved source evidence · Not medical advice