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NCT00750815 · OUTCOME

Phase II: Progression-Free Survival (PFS)

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.

Measure
MEDIAN
Unit
months
Interval / dispersion
95% Confidence Interval
Time frame
Up to 50.9 months

What was measured

Progression-free survival after CVDD in participants with newly diagnosed active multiple myeloma. PFS: time from the initiation of therapy to progression, relapse or death from any causes. Progressive Disease (PD): Progressive Disease requires any one or more of the following: Increase of ≥ 25% from baseline in: * serum M-component and /or (the absolute increase must be ≥ 0.5 g/dL) * urine M-component and/or (the absolute increase must be ≥ 200 mg/24 h)

Groups in this outcome

All Participants

Arm A: * 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 Arm B: 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.

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

Analysis denominator · Participants

GroupSource count
All Participants58

Reported measurements

Source class 1
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
All Participants31.3Not reported24.5NAHas not been reached
Complete source fields
classes
  1. categories
    1. measurements
      1. comment
        Has not been reached
        group Id
        OG000
        lower Limit
        24.5
        upper Limit
        NA
        value
        31.3
denoms
  1. counts
    1. group Id
      OG000
      value
      58
    units
    Participants
description
Progression-free survival after CVDD in participants with newly diagnosed active multiple myeloma. PFS: time from the initiation of therapy to progression, relapse or death from any causes. Progressive Disease (PD): Progressive Disease requires any one or more of the following: Increase of ≥ 25% from baseline in: * serum M-component and /or (the absolute increase must be ≥ 0.5 g/dL) * urine M-component and/or (the absolute increase must be ≥ 200 mg/24 h)
dispersion Type
95% Confidence Interval
groups
  1. description
    Arm A: * 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 Arm B: 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
    OG000
    title
    All Participants
param Type
MEDIAN
reporting Status
POSTED
time Frame
Up to 50.9 months
title
Phase II: Progression-Free Survival (PFS)
type
SECONDARY
unit Of Measure
months

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

Preserved source evidence · Not medical advice