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NCT02477215 · OUTCOME

Maximum Tolerated Dose of Bendamustine

Study of Bendamustine and IXAZOMIB (MLN9708) Plus Dexamethasone in Relapsed/Refractory Multiple Myeloma · Source last updated 2020-10-22

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

Measure
NUMBER
Unit
mg/m^2
Interval / dispersion
Not reported
Time frame
Six months for each dosing cohort

What was measured

Maximum tolerated dose of bendamustine in combination with fixed doses of ixazomib (MLN9708) and dexamethasone will be determined from the incidence of dose limiting toxicities at each dosage.

Analysis population: All participants received at least ne dose of Bendamustine at either 70 mg/m\^2, 80 mg\^2 or 90 mg/m\^2.

Groups in this outcome

MLN9708, Bendamustine and Dexamethasone

MLN9708: 4 mg of MLN9708 delivered on days 1, 8 and 15 of a 28 day cycle. Dexamethasone: 40 mg oral on Days 1, 8, 15 of each 28 day cycle. Bendamustine:70 mg/m\^2, 80 mg/m\^2, or 90 mg/m\^2 on days 1 and 2

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

Analysis denominator · Participants

GroupSource count
MLN9708, Bendamustine and Dexamethasone15

Reported measurements

Source class 1
Values in mg/m^2 · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
MLN9708, Bendamustine and Dexamethasone80Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        80
denoms
  1. counts
    1. group Id
      OG000
      value
      15
    units
    Participants
description
Maximum tolerated dose of bendamustine in combination with fixed doses of ixazomib (MLN9708) and dexamethasone will be determined from the incidence of dose limiting toxicities at each dosage.
groups
  1. description
    MLN9708: 4 mg of MLN9708 delivered on days 1, 8 and 15 of a 28 day cycle. Dexamethasone: 40 mg oral on Days 1, 8, 15 of each 28 day cycle. Bendamustine:70 mg/m\^2, 80 mg/m\^2, or 90 mg/m\^2 on days 1 and 2
    id
    OG000
    title
    MLN9708, Bendamustine and Dexamethasone
param Type
NUMBER
population Description
All participants received at least ne dose of Bendamustine at either 70 mg/m\^2, 80 mg\^2 or 90 mg/m\^2.
reporting Status
POSTED
time Frame
Six months for each dosing cohort
title
Maximum Tolerated Dose of Bendamustine
type
PRIMARY
unit Of Measure
mg/m^2

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

Preserved source evidence · Not medical advice