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NCT00097981 · OUTCOME

Engraftment: Number of Participants Who Underwent Engraftment

A Study of Thalidomide Plus Dexamethasone (Thal-Dex) Versus DOXIL plusThalidomide Plus Dexamethasone (DOXIL -Thal-Dex) in Patients With Newly Diagnosed Multiple Myeloma · Source last updated 2017-04-07

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 randomization until death or as assessed up to 2 years post last participant last treatment visit

What was measured

Engraftment is the process of transplanted stem cells reproducing new cells.

Analysis population: Intent-to-treat: Participants who were randomized to receive the treatment and who underwent transplantation.

Groups in this outcome

Thalidomide + Dexamethasone

Participants received thalidomide every night (at bedtime) without food on Days 1 to 28 and dosing was gradually increased during Cycle 1 starting at 50 mg on Days 1 to 7, 100 mg on Days 8 to 14, 150 mg on 15 to 21, and 200 mg on Days 22 to 28. Thalidomide 200 mg per day was administered for subsequent cycles. Dexamethasone 40 mg was administered by mouth on Days 1 to 4, 9 to 12 and 17 to 20.

DOXIL + Thalidomide + Dexamethasone

DOXIL 40 mg/m2 was administered intravenously on Day 1 and thalidomide every night (at bedtime) without food on Days 1-28 and dosing was gradually increased during Cycle 1 starting at 50 mg on Days 1 to 7, 100 mg on Days 8 to 14, 150 mg on 15 to 21, and 200 mg on Days 22 to 28. Thalidomide 200 mg per day was administered for subsequent cycles. Dexamethasone 40 mg was administered by mouth on Days 1 to 4, 9 to 12 and 17 to 20.

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

Analysis denominator · Participants

GroupSource count
Thalidomide + Dexamethasone30
DOXIL + Thalidomide + Dexamethasone28

Reported measurements

Source class 1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Thalidomide + Dexamethasone25Not reportedNot reportedNot reportedNot reported
DOXIL + Thalidomide + Dexamethasone25Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        25
      2. group Id
        OG001
        value
        25
denoms
  1. counts
    1. group Id
      OG000
      value
      30
    2. group Id
      OG001
      value
      28
    units
    Participants
description
Engraftment is the process of transplanted stem cells reproducing new cells.
groups
  1. description
    Participants received thalidomide every night (at bedtime) without food on Days 1 to 28 and dosing was gradually increased during Cycle 1 starting at 50 mg on Days 1 to 7, 100 mg on Days 8 to 14, 150 mg on 15 to 21, and 200 mg on Days 22 to 28. Thalidomide 200 mg per day was administered for subsequent cycles. Dexamethasone 40 mg was administered by mouth on Days 1 to 4, 9 to 12 and 17 to 20.
    id
    OG000
    title
    Thalidomide + Dexamethasone
  2. description
    DOXIL 40 mg/m2 was administered intravenously on Day 1 and thalidomide every night (at bedtime) without food on Days 1-28 and dosing was gradually increased during Cycle 1 starting at 50 mg on Days 1 to 7, 100 mg on Days 8 to 14, 150 mg on 15 to 21, and 200 mg on Days 22 to 28. Thalidomide 200 mg per day was administered for subsequent cycles. Dexamethasone 40 mg was administered by mouth on Days 1 to 4, 9 to 12 and 17 to 20.
    id
    OG001
    title
    DOXIL + Thalidomide + Dexamethasone
param Type
NUMBER
population Description
Intent-to-treat: Participants who were randomized to receive the treatment and who underwent transplantation.
reporting Status
POSTED
time Frame
From randomization until death or as assessed up to 2 years post last participant last treatment visit
title
Engraftment: Number of Participants Who Underwent Engraftment
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice