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NCT00920855 · OUTCOME

Participants' Best Tumor Response as Assessed by the Investigator

Study of Bendamustine Combined With Bortezomib for Patients With Relapsed/Refractory Multiple Myeloma · Source last updated 2012-10-04

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
up to 7.5 months (eight 28-day cycles)

What was measured

Abbreviated criteria for response categories: CR includes the disappearance of the original monoclonal protein (M-protein) from blood and urine, and \<5% plasma cells in the bone marrow, and no increase in size/number of lytic bone lesions, and disappearance of soft tissue plasmacytomas for \>=4 weeks. VGPR includes serum and urine M-protein detectable by immunofixation but not electrophoresis, and reduction in 24-hr urinary light chain excretion by \<100 mg, and disappearance of soft tissue plasmacytomas for \>= 4 weeks, and no increase in size/number of lytic bone lesions. PR includes a \>=50% reduction in serum M-protein, and reduction in 24-hr urinary light chain excretion by either \>=90% or to \<200 mg, and \>=50% reduction in size of soft tissue plasmacytomas, and no increase in size/number of lytic bone lesions. MR includes a \>=25% and \<=49% reduction in serum M-protein. SD does not meet criteria for the other response categories. See outcome #4 for a definition of PD.

Analysis population: Efficacy population

Groups in this outcome

Bendamustine 50 mg/m^2 Cohort

Bortezomib 1.0 mg/m\^2/dose (days 1, 4, 8 and 11) by intravenous push and Bendamustine 50 mg/m\^2/dose (days 1 and 4) intravenously for up to eight 28 day cycles.

Bendamustine 70 mg/m^2 Cohort

Bortezomib 1.0 mg/m\^2/dose (days 1, 4, 8 and 11) by intravenous push and Bendamustine 70 mg/m\^2/dose (days 1 and 4) intravenously for up to eight 28 day cycles.

Bendamustine 90 mg/m^2 Cohort

Bortezomib 1.0 mg/m\^2/dose (days 1, 4, 8 and 11) by intravenous push and Bendamustine 90 mg/m\^2/dose (days 1 and 4) intravenously for up to eight 28 day cycles.

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

Analysis denominator · Participants

GroupSource count
Bendamustine 50 mg/m^2 Cohort5
Bendamustine 70 mg/m^2 Cohort4
Bendamustine 90 mg/m^2 Cohort31

Reported measurements

Complete response (CR)
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Bendamustine 50 mg/m^2 Cohort0Not reportedNot reportedNot reportedNot reported
Bendamustine 70 mg/m^2 Cohort0Not reportedNot reportedNot reportedNot reported
Bendamustine 90 mg/m^2 Cohort1Not reportedNot reportedNot reportedNot reported
Very good partial response (VGPR)
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Bendamustine 50 mg/m^2 Cohort0Not reportedNot reportedNot reportedNot reported
Bendamustine 70 mg/m^2 Cohort0Not reportedNot reportedNot reportedNot reported
Bendamustine 90 mg/m^2 Cohort2Not reportedNot reportedNot reportedNot reported
Partial response (PR)
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Bendamustine 50 mg/m^2 Cohort1Not reportedNot reportedNot reportedNot reported
Bendamustine 70 mg/m^2 Cohort0Not reportedNot reportedNot reportedNot reported
Bendamustine 90 mg/m^2 Cohort8Not reportedNot reportedNot reportedNot reported
Minimal response (MR)
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Bendamustine 50 mg/m^2 Cohort1Not reportedNot reportedNot reportedNot reported
Bendamustine 70 mg/m^2 Cohort1Not reportedNot reportedNot reportedNot reported
Bendamustine 90 mg/m^2 Cohort5Not reportedNot reportedNot reportedNot reported
Stable disease (SD)
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Bendamustine 50 mg/m^2 Cohort2Not reportedNot reportedNot reportedNot reported
Bendamustine 70 mg/m^2 Cohort2Not reportedNot reportedNot reportedNot reported
Bendamustine 90 mg/m^2 Cohort13Not reportedNot reportedNot reportedNot reported
Progressive disease (PD)
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Bendamustine 50 mg/m^2 Cohort1Not reportedNot reportedNot reportedNot reported
Bendamustine 70 mg/m^2 Cohort1Not reportedNot reportedNot reportedNot reported
Bendamustine 90 mg/m^2 Cohort2Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        1
    title
    Complete response (CR)
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        2
    title
    Very good partial response (VGPR)
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        8
    title
    Partial response (PR)
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        1
      3. group Id
        OG002
        value
        5
    title
    Minimal response (MR)
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        2
      2. group Id
        OG001
        value
        2
      3. group Id
        OG002
        value
        13
    title
    Stable disease (SD)
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        1
      3. group Id
        OG002
        value
        2
    title
    Progressive disease (PD)
denoms
  1. counts
    1. group Id
      OG000
      value
      5
    2. group Id
      OG001
      value
      4
    3. group Id
      OG002
      value
      31
    units
    Participants
description
Abbreviated criteria for response categories: CR includes the disappearance of the original monoclonal protein (M-protein) from blood and urine, and \<5% plasma cells in the bone marrow, and no increase in size/number of lytic bone lesions, and disappearance of soft tissue plasmacytomas for \>=4 weeks. VGPR includes serum and urine M-protein detectable by immunofixation but not electrophoresis, and reduction in 24-hr urinary light chain excretion by \<100 mg, and disappearance of soft tissue plasmacytomas for \>= 4 weeks, and no increase in size/number of lytic bone lesions. PR includes a \>=50% reduction in serum M-protein, and reduction in 24-hr urinary light chain excretion by either \>=90% or to \<200 mg, and \>=50% reduction in size of soft tissue plasmacytomas, and no increase in size/number of lytic bone lesions. MR includes a \>=25% and \<=49% reduction in serum M-protein. SD does not meet criteria for the other response categories. See outcome #4 for a definition of PD.
groups
  1. description
    Bortezomib 1.0 mg/m\^2/dose (days 1, 4, 8 and 11) by intravenous push and Bendamustine 50 mg/m\^2/dose (days 1 and 4) intravenously for up to eight 28 day cycles.
    id
    OG000
    title
    Bendamustine 50 mg/m^2 Cohort
  2. description
    Bortezomib 1.0 mg/m\^2/dose (days 1, 4, 8 and 11) by intravenous push and Bendamustine 70 mg/m\^2/dose (days 1 and 4) intravenously for up to eight 28 day cycles.
    id
    OG001
    title
    Bendamustine 70 mg/m^2 Cohort
  3. description
    Bortezomib 1.0 mg/m\^2/dose (days 1, 4, 8 and 11) by intravenous push and Bendamustine 90 mg/m\^2/dose (days 1 and 4) intravenously for up to eight 28 day cycles.
    id
    OG002
    title
    Bendamustine 90 mg/m^2 Cohort
param Type
NUMBER
population Description
Efficacy population
reporting Status
POSTED
time Frame
up to 7.5 months (eight 28-day cycles)
title
Participants' Best Tumor Response as Assessed by the Investigator
type
SECONDARY
unit Of Measure
participants

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

Preserved source evidence · Not medical advice