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NCT02477215 · OUTCOME

Progression Free Survival (PFS)

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
95% Confidence Interval
Time frame
18 months

What was measured

This measure is the number of months participants remain free from evidence of disease.

Analysis population: For this analysis, all 20 participants who received the fixed dose of 80 mg/m\^2 Bendamustine and all 8 participants who received Bendamustine (80 mg/m\^2) in the Dose Escalation phase, were combined.

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 Dexamethasone28

Reported measurements

Source class 1
Values in MONTHS · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
MLN9708, Bendamustine and Dexamethasone5.2Not reported1.968.3Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        1.96
        upper Limit
        8.3
        value
        5.2
denoms
  1. counts
    1. group Id
      OG000
      value
      28
    units
    Participants
description
This measure is the number of months participants remain free from evidence of disease.
dispersion Type
95% Confidence Interval
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
For this analysis, all 20 participants who received the fixed dose of 80 mg/m\^2 Bendamustine and all 8 participants who received Bendamustine (80 mg/m\^2) in the Dose Escalation phase, were combined.
reporting Status
POSTED
time Frame
18 months
title
Progression Free Survival (PFS)
type
SECONDARY
unit Of Measure
MONTHS

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

Preserved source evidence · Not medical advice