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NCT00124579 · OUTCOME

Progression-Free Survival

S0417 Bortezomib, Thalidomide, and Dexamethasone in Treating Patients With Relapsed or Refractory Multiple Myeloma · Source last updated 2018-08-09

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
about 12-18 months

What was measured

From date of initial registration to date of progression/relapse of disease (\> 25% increase from baseline in myeloma protein production or other signs of disease progression such as hypercalcemia, etc.) or death from any cause, whichever came first, up to 5 years

Analysis population: With ninety patients, we will have 82% power to rule out a null hypothesis of a 12-month median survival versus an alternative hypothesis of an 18-month median survival at a significance level of 5%.

Groups in this outcome

Bortezomib With Thalidomide and Dexamethasone

Induction (per 21-day cycle): Bortezomib - 1.0 mg/m2 (Days 1, 4, 8, and 11). Dexamethasone - 20 mg/d PO (Days 1, 2, 4, 5, 8, 9, 11, and 12). Thalidomide 100 mg (Days 1-21). Maintenance (per 28-day cycle): thalidomide 100mg (Days 1-28). Dexamethasone 40 mg Days 1-4.

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

Analysis denominator · Participants

GroupSource count
Bortezomib With Thalidomide and Dexamethasone7

Reported measurements

Source class 1
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Bortezomib With Thalidomide and Dexamethasone8Not reported412Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        4
        upper Limit
        12
        value
        8
denoms
  1. counts
    1. group Id
      OG000
      value
      7
    units
    Participants
description
From date of initial registration to date of progression/relapse of disease (\> 25% increase from baseline in myeloma protein production or other signs of disease progression such as hypercalcemia, etc.) or death from any cause, whichever came first, up to 5 years
dispersion Type
95% Confidence Interval
groups
  1. description
    Induction (per 21-day cycle): Bortezomib - 1.0 mg/m2 (Days 1, 4, 8, and 11). Dexamethasone - 20 mg/d PO (Days 1, 2, 4, 5, 8, 9, 11, and 12). Thalidomide 100 mg (Days 1-21). Maintenance (per 28-day cycle): thalidomide 100mg (Days 1-28). Dexamethasone 40 mg Days 1-4.
    id
    OG000
    title
    Bortezomib With Thalidomide and Dexamethasone
param Type
MEDIAN
population Description
With ninety patients, we will have 82% power to rule out a null hypothesis of a 12-month median survival versus an alternative hypothesis of an 18-month median survival at a significance level of 5%.
reporting Status
POSTED
time Frame
about 12-18 months
title
Progression-Free Survival
type
SECONDARY
unit Of Measure
Months

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

Preserved source evidence · Not medical advice