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NCT01286077 · OUTCOME

Tumor Response: Percentage of Participants With Partial Response (PR) Based on International Myeloma Working Group (IMWG) Response Criteria

Velcade Consolidation Bone Study · Source last updated 2016-05-30

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

Measure
NUMBER
Unit
Percentage of participants
Interval / dispersion
Not reported
Time frame
Baseline up to end of study (approximately 4 years 7 months)

What was measured

Tumor response was assessed as PR based on IMWG response criteria as \>=50% reduction of serum and reduction in 24-h urinary M protein by \>=90% or to \<200 mg/24 h; or serum/urine M protein unmeasurable:\>=50% decrease in the difference between involved and uninvolved FLC levels; or serum/urine M protein and FLC assay unmeasurable: \>=50% reduction in plasma cells provided baseline bone marrow plasma cell percentage was \>=30%; or plus if present at baseline: \>=50% reduction in size of soft tissue plasmocytomas.

Analysis population: FAS included all the randomized subjects who were eligible for efficacy analysis, that is, excluding subjects who did not have baseline and/or post-baseline data. "N" (number of subjects analyzed) signifies the subjects evaluable this measure.

Groups in this outcome

Bortezomib

bortezomib (Velcade) 1.6 mg/m² bolus injection on Days 1, 8, 15 and 22 every 5 weeks for 4 cycles

Non-treated Control

no treatment, observation only

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

Analysis denominator · Participants

GroupSource count
Bortezomib46
Non-treated Control47

Reported measurements

Source class 1
Values in Percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Bortezomib8.71.48Not reportedNot reportedNot reported
Non-treated Control8.51.26Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        1.48
        value
        8.7
      2. group Id
        OG001
        spread
        1.26
        value
        8.5
denoms
  1. counts
    1. group Id
      OG000
      value
      46
    2. group Id
      OG001
      value
      47
    units
    Participants
description
Tumor response was assessed as PR based on IMWG response criteria as \>=50% reduction of serum and reduction in 24-h urinary M protein by \>=90% or to \<200 mg/24 h; or serum/urine M protein unmeasurable:\>=50% decrease in the difference between involved and uninvolved FLC levels; or serum/urine M protein and FLC assay unmeasurable: \>=50% reduction in plasma cells provided baseline bone marrow plasma cell percentage was \>=30%; or plus if present at baseline: \>=50% reduction in size of soft tissue plasmocytomas.
groups
  1. description
    bortezomib (Velcade) 1.6 mg/m² bolus injection on Days 1, 8, 15 and 22 every 5 weeks for 4 cycles
    id
    OG000
    title
    Bortezomib
  2. description
    no treatment, observation only
    id
    OG001
    title
    Non-treated Control
param Type
NUMBER
population Description
FAS included all the randomized subjects who were eligible for efficacy analysis, that is, excluding subjects who did not have baseline and/or post-baseline data. "N" (number of subjects analyzed) signifies the subjects evaluable this measure.
reporting Status
POSTED
time Frame
Baseline up to end of study (approximately 4 years 7 months)
title
Tumor Response: Percentage of Participants With Partial Response (PR) Based on International Myeloma Working Group (IMWG) Response Criteria
type
SECONDARY
unit Of Measure
Percentage of participants

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

Preserved source evidence · Not medical advice