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NCT00903968 · OUTCOME

Duration of Response (DOR) [Phase II]

Combination Plerixafor (AMD3100)and Bortezomib in Relapsed or Relapsed/Refractory Multiple Myeloma · Source last updated 2020-06-02

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
DIsease was assessed to document response every cycle on treatment and post-treatment every 12 weeks until progression.

What was measured

DOR is defined as the time from response to disease progression or death, or date last known progression-free and alive for those who have not progressed or died. DOR was estimated using the Kaplan-Meier method.

Analysis population: All Phase II participants with measureable disease present at baseline and received at least one dose of the study drug were evaluable for DOR.

Groups in this outcome

All Phase II Participants

All Phase II participants received plerixafor 320ug/kg by injection on days 1, 2, 3, 6, 10, and 13, bortezomib 1.3 mg/m2 intravenously or subcutaneously days 3, 6, 10, and 13, and dexamethasone 40mg orally days 3, 6, 10, and 13 of each 21 day cycle during induction. In maintenance, participants received plerixafor, bortezomib, and dexamethasone days 1, 8, 15, and 22 of each 35 day cycle. Participants were treated until disease progression or unacceptable toxicity.

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 Phase II Participants33

Reported measurements

Source class 1
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
All Phase II Participants12.9Not reported7.833.3Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        7.8
        upper Limit
        33.3
        value
        12.9
denoms
  1. counts
    1. group Id
      OG000
      value
      33
    units
    Participants
description
DOR is defined as the time from response to disease progression or death, or date last known progression-free and alive for those who have not progressed or died. DOR was estimated using the Kaplan-Meier method.
dispersion Type
95% Confidence Interval
groups
  1. description
    All Phase II participants received plerixafor 320ug/kg by injection on days 1, 2, 3, 6, 10, and 13, bortezomib 1.3 mg/m2 intravenously or subcutaneously days 3, 6, 10, and 13, and dexamethasone 40mg orally days 3, 6, 10, and 13 of each 21 day cycle during induction. In maintenance, participants received plerixafor, bortezomib, and dexamethasone days 1, 8, 15, and 22 of each 35 day cycle. Participants were treated until disease progression or unacceptable toxicity.
    id
    OG000
    title
    All Phase II Participants
param Type
MEDIAN
population Description
All Phase II participants with measureable disease present at baseline and received at least one dose of the study drug were evaluable for DOR.
reporting Status
POSTED
time Frame
DIsease was assessed to document response every cycle on treatment and post-treatment every 12 weeks until progression.
title
Duration of Response (DOR) [Phase II]
type
SECONDARY
unit Of Measure
Months

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

Preserved source evidence · Not medical advice