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NCT00920855 · OUTCOME

Participants With Dose Limiting Toxicity (DLT)

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
Day 1 - 28

What was measured

Maximum tolerated dose was the dose that was 1 step lower than the dose where at least one third of patients experienced DLT. A DLT was defined as any of the following occurring during the first cycle: * grade 4 hematologic toxicity without regard for relationship to study drug treatment * thrombocytopenia grade 3 with grade 3 or grade 4 hemorrhage * grade 3 febrile neutropenia * grade 3 or grade 4 nausea and vomiting refractory to anti emetic therapy * any study drug related grade 3 or grade 4 nonhematologic toxicity * any drug related death Toxicity grades (3=severe AE and 4=life-threatening or disabling AE) were assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v3.

Analysis population: Safety 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

Source class 1
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 Cohort0Not 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
        0
denoms
  1. counts
    1. group Id
      OG000
      value
      5
    2. group Id
      OG001
      value
      4
    3. group Id
      OG002
      value
      31
    units
    Participants
description
Maximum tolerated dose was the dose that was 1 step lower than the dose where at least one third of patients experienced DLT. A DLT was defined as any of the following occurring during the first cycle: * grade 4 hematologic toxicity without regard for relationship to study drug treatment * thrombocytopenia grade 3 with grade 3 or grade 4 hemorrhage * grade 3 febrile neutropenia * grade 3 or grade 4 nausea and vomiting refractory to anti emetic therapy * any study drug related grade 3 or grade 4 nonhematologic toxicity * any drug related death Toxicity grades (3=severe AE and 4=life-threatening or disabling AE) were assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v3.
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
Safety population
reporting Status
POSTED
time Frame
Day 1 - 28
title
Participants With Dose Limiting Toxicity (DLT)
type
PRIMARY
unit Of Measure
participants

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

Preserved source evidence · Not medical advice