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NCT00507442 · OUTCOME

Probability of 1-year Survival

Phase 1/2 Study of VELCADE® in Combination With Other Drugs to Treat Previously Untreated Multiple Myeloma Patients · Source last updated 2013-07-26

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

Measure
NUMBER
Unit
percentage of patients
Interval / dispersion
Not reported
Time frame
survival probability at 1 year after randomization

Analysis population: The modified intent-to-treat population is defined as phase 2 patients received at least one dose of any drug.

Groups in this outcome

V-DR

Bortezomib: 1.3 mg/m\^2/dose IV on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles, then on Days 1, 8, 15, and 22 of a 6-week cycle for 4 cycles. Dexamethasone: 40 mg orally \[PO\] on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop. Lenalidomide: 25 mg PO on Days 1 through 14 of a 3-week cycle for 8 cycles, then stop.

VDCR

Bortezomib: 1.3 mg/m\^2/dose IV on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles, then on Days 1, 8, 15, and 22 of a 6-week cycle for 4 cycles. Dexamethasone: 40 mg PO on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop. Cyclophosphamide: 500 mg/m\^2 dose PO on Days 1 and 8 of a 3-week cycle for 8 cycles, then stop. Lenalidomide: 15 mg PO on Days 1 through 14 of a 3-week cycle for 8 cycles, then stop.

V-DC

Bortezomib: 1.3 mg/m\^2/dose IV on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles, then on Days 1, 8, 15, and 22 of a 6-week cycle for 4 cycles. Dexamethasone: 40 mg orally PO on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop. Cyclophosphamide: 500 mg/m\^2 dose PO on Days 1 and 8 of a 3-week cycle for 8 cycles, then stop.

VDC-mod

Bortezomib: 1.3 mg/m\^2/dose IV on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles, then on Days 1, 8, 15, and 22 of a 6-week cycle for 4 cycles. Dexamethasone: 40 mg PO on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop. Cyclophosphamide: 500 mg/m\^2 dose PO on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop.

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

Analysis denominator · Participants

GroupSource count
V-DR42
VDCR48
V-DC33
VDC-mod17

Reported measurements

Source class 1
Values in percentage of patients · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
V-DR100Not reportedNot reportedNot reportedNot reported
VDCR91.6Not reportedNot reportedNot reportedNot reported
V-DC100Not reportedNot reportedNot reportedNot reported
VDC-mod100Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        100
      2. group Id
        OG001
        value
        91.6
      3. group Id
        OG002
        value
        100
      4. group Id
        OG003
        value
        100
denoms
  1. counts
    1. group Id
      OG000
      value
      42
    2. group Id
      OG001
      value
      48
    3. group Id
      OG002
      value
      33
    4. group Id
      OG003
      value
      17
    units
    Participants
groups
  1. description
    Bortezomib: 1.3 mg/m\^2/dose IV on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles, then on Days 1, 8, 15, and 22 of a 6-week cycle for 4 cycles. Dexamethasone: 40 mg orally \[PO\] on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop. Lenalidomide: 25 mg PO on Days 1 through 14 of a 3-week cycle for 8 cycles, then stop.
    id
    OG000
    title
    V-DR
  2. description
    Bortezomib: 1.3 mg/m\^2/dose IV on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles, then on Days 1, 8, 15, and 22 of a 6-week cycle for 4 cycles. Dexamethasone: 40 mg PO on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop. Cyclophosphamide: 500 mg/m\^2 dose PO on Days 1 and 8 of a 3-week cycle for 8 cycles, then stop. Lenalidomide: 15 mg PO on Days 1 through 14 of a 3-week cycle for 8 cycles, then stop.
    id
    OG001
    title
    VDCR
  3. description
    Bortezomib: 1.3 mg/m\^2/dose IV on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles, then on Days 1, 8, 15, and 22 of a 6-week cycle for 4 cycles. Dexamethasone: 40 mg orally PO on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop. Cyclophosphamide: 500 mg/m\^2 dose PO on Days 1 and 8 of a 3-week cycle for 8 cycles, then stop.
    id
    OG002
    title
    V-DC
  4. description
    Bortezomib: 1.3 mg/m\^2/dose IV on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles, then on Days 1, 8, 15, and 22 of a 6-week cycle for 4 cycles. Dexamethasone: 40 mg PO on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop. Cyclophosphamide: 500 mg/m\^2 dose PO on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop.
    id
    OG003
    title
    VDC-mod
param Type
NUMBER
population Description
The modified intent-to-treat population is defined as phase 2 patients received at least one dose of any drug.
reporting Status
POSTED
time Frame
survival probability at 1 year after randomization
title
Probability of 1-year Survival
type
SECONDARY
unit Of Measure
percentage of patients

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

Preserved source evidence · Not medical advice