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NCT02477215 · OUTCOME

Objective Response Rate

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
participants
Interval / dispersion
Not reported
Time frame
18 months

What was measured

Objective response rate was defined as the number of subjects achieving a complete response (CR) or partial response (PR) after at least four cycles of ixazomib (MLN9708) and bendamustine plus dexamethasone.

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 participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
MLN9708, Bendamustine and Dexamethasone11Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        11
denoms
  1. counts
    1. group Id
      OG000
      value
      18
    units
    Participants
description
Objective response rate was defined as the number of subjects achieving a complete response (CR) or partial response (PR) after at least four cycles of ixazomib (MLN9708) and bendamustine plus dexamethasone.
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
NUMBER
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
18 months
title
Objective Response Rate
type
PRIMARY
unit Of Measure
participants

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

Preserved source evidence · Not medical advice