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NCT02477215 · OUTCOME

Duration of Response (DoR)

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
MEDIAN
Unit
MONTHS
Interval / dispersion
Full Range
Time frame
36 months

What was measured

Median time in months participants maintain CR, PR or stable disease.

Analysis population: Subjects receiving the fixed dose of 80 mg/m\^2 Bendamustine were included in this analysis. Results from five of the subjects in the Dose Escalation Phase of this study who also received 80 mg/m\^2 Bendamustine were included in the analysis. One of the Dose Expansion Phase subjects did not complete sufficient dosing cycles for inclusion.

Groups in this outcome

MLN9708, Bendamustine and Dexamethasone

Ixazomib 4 mg, days 1, 8, 15. Dexamethasone 40 mg oral weekly. Bendamustine dose levels: 80mg/m2 days 1,2 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: 80mg/m2 days 1,2

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 Dexamethasone18

Reported measurements

Source class 1
Values in MONTHS · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
MLN9708, Bendamustine and Dexamethasone5.1Not reported15.2Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        1
        upper Limit
        5.2
        value
        5.1
denoms
  1. counts
    1. group Id
      OG000
      value
      18
    units
    Participants
description
Median time in months participants maintain CR, PR or stable disease.
dispersion Type
Full Range
groups
  1. description
    Ixazomib 4 mg, days 1, 8, 15. Dexamethasone 40 mg oral weekly. Bendamustine dose levels: 80mg/m2 days 1,2 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: 80mg/m2 days 1,2
    id
    OG000
    title
    MLN9708, Bendamustine and Dexamethasone
param Type
MEDIAN
population Description
Subjects receiving the fixed dose of 80 mg/m\^2 Bendamustine were included in this analysis. Results from five of the subjects in the Dose Escalation Phase of this study who also received 80 mg/m\^2 Bendamustine were included in the analysis. One of the Dose Expansion Phase subjects did not complete sufficient dosing cycles for inclusion.
reporting Status
POSTED
time Frame
36 months
title
Duration of Response (DoR)
type
SECONDARY
unit Of Measure
MONTHS

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

Preserved source evidence · Not medical advice