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NCT00507442 · OUTCOME

Number of Patients With Adverse Events (AEs)

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
participants
Interval / dispersion
Not reported
Time frame
From first dose of study drug through the 30 day post-treatment AE assessment visit

What was measured

Evaluate the safety and tolerability of the combination therapy

Analysis population: The safety population includes patients received any dose of any study drug.

Groups in this outcome

V-DR

VELCADE (bortezomib), dexamethasone, and Revlimid (lenalidomide) 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

VELCADE (bortezomib), dexamethasone, cyclophosphamide, Revlimid (lenalidomide) 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: 100 - 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

VELCADE (bortezomib), dexamethasone, cyclophosphamide 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

Modified dosing of VELCADE (bortezomib), dexamethasone, cyclophosphamide 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
VDCR66
V-DC33
VDC-mod17

Reported measurements

Source class 1
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
V-DR42Not reportedNot reportedNot reportedNot reported
VDCR65Not reportedNot reportedNot reportedNot reported
V-DC33Not reportedNot reportedNot reportedNot reported
VDC-mod17Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        42
      2. group Id
        OG001
        value
        65
      3. group Id
        OG002
        value
        33
      4. group Id
        OG003
        value
        17
denoms
  1. counts
    1. group Id
      OG000
      value
      42
    2. group Id
      OG001
      value
      66
    3. group Id
      OG002
      value
      33
    4. group Id
      OG003
      value
      17
    units
    Participants
description
Evaluate the safety and tolerability of the combination therapy
groups
  1. description
    VELCADE (bortezomib), dexamethasone, and Revlimid (lenalidomide) 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
    VELCADE (bortezomib), dexamethasone, cyclophosphamide, Revlimid (lenalidomide) 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: 100 - 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
    VELCADE (bortezomib), dexamethasone, cyclophosphamide 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
    Modified dosing of VELCADE (bortezomib), dexamethasone, cyclophosphamide 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 safety population includes patients received any dose of any study drug.
reporting Status
POSTED
time Frame
From first dose of study drug through the 30 day post-treatment AE assessment visit
title
Number of Patients With Adverse Events (AEs)
type
SECONDARY
unit Of Measure
participants

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

Preserved source evidence · Not medical advice