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NCT02046070 · OUTCOME

Time to Progression (TTP) in NDMM Participants

Phase 2 Study to Evaluate the Oral Combination of Ixazomib (MLN9708) With Cyclophosphamide and Dexamethasone in Patients With Newly Diagnosed or Relapsed and/or Refractory Multiple Myeloma · Source last updated 2019-07-17

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
Up to 45 months

What was measured

TTP is defined as the time from the date of first dose of study treatment to the date of first documentation of disease progression.

Analysis population: Safety Population was defined as all participants who received at least 1 dose of any study drug. Participants without documentation of PD were censored at the date of last response assessment that is SD or better prior to the date of the alternative therapy.

Groups in this outcome

Ixazomib 4.0 mg + CYC 300 mg/m^2 + DEX 40 mg (NDMM)

Ixazomib 4.0 mg, capsules, orally, on Days 1, 8, 15 of a 28-day cycle until progressive disease (PD)/death or unacceptable toxicity \[13 cycles in the Induction Phase continuing in the Maintenance Phase for up to 36 Months\] and cyclophosphamide (CYC) 300 mg/m\^2, tablets, orally, on Days 1, 8 and 15 of a 28-day cycle for 13 cycles or until PD/death or unacceptable toxicity and dexamethasone (DEX) 40 mg, tablets, orally, on Days 1, 8, 15 and 22 (dose reduced to 20 mg for patients \>75 years) of a 28-day cycle for 13 cycles or until PD/death or unacceptable toxicity in participants with NDMM.

Ixazomib 4.0 mg + CYC 400 mg/m^2 + DEX 40 mg (NDMM)

Ixazomib 4.0 mg, capsules, orally, on Days 1, 8, 15 of a 28-day cycle until PD/death or unacceptable toxicity \[13 cycles in the Induction Phase continuing in the Maintenance Phase for up to 36 Months\] and cyclophosphamide (CYC) 400 mg/m\^2, tablets, orally, on Days 1, 8 and 15 of a 28-day cycle for 13 cycles or until PD/death or unacceptable toxicity and dexamethasone (DEX) 40 mg, tablets, orally, on Days 1, 8, 15 and 22 (dose reduced to 20 mg for patients \>75 years) of a 28-day cycle for 13 cycles or until PD/death or unacceptable toxicity in participants with NDMM.

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

Analysis denominator · Participants

GroupSource count
Ixazomib 4.0 mg + CYC 300 mg/m^2 + DEX 40 mg (NDMM)36
Ixazomib 4.0 mg + CYC 400 mg/m^2 + DEX 40 mg (NDMM)34

Reported measurements

Source class 1
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Ixazomib 4.0 mg + CYC 300 mg/m^2 + DEX 40 mg (NDMM)30.9Not reported19.5841.66Not reported
Ixazomib 4.0 mg + CYC 400 mg/m^2 + DEX 40 mg (NDMM)32.2Not reported20.27NA95% CI Upper Limit was not estimable due to the low number of participants with events.
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        19.58
        upper Limit
        41.66
        value
        30.9
      2. comment
        95% CI Upper Limit was not estimable due to the low number of participants with events.
        group Id
        OG001
        lower Limit
        20.27
        upper Limit
        NA
        value
        32.2
denoms
  1. counts
    1. group Id
      OG000
      value
      36
    2. group Id
      OG001
      value
      34
    units
    Participants
description
TTP is defined as the time from the date of first dose of study treatment to the date of first documentation of disease progression.
dispersion Type
95% Confidence Interval
groups
  1. description
    Ixazomib 4.0 mg, capsules, orally, on Days 1, 8, 15 of a 28-day cycle until progressive disease (PD)/death or unacceptable toxicity \[13 cycles in the Induction Phase continuing in the Maintenance Phase for up to 36 Months\] and cyclophosphamide (CYC) 300 mg/m\^2, tablets, orally, on Days 1, 8 and 15 of a 28-day cycle for 13 cycles or until PD/death or unacceptable toxicity and dexamethasone (DEX) 40 mg, tablets, orally, on Days 1, 8, 15 and 22 (dose reduced to 20 mg for patients \>75 years) of a 28-day cycle for 13 cycles or until PD/death or unacceptable toxicity in participants with NDMM.
    id
    OG000
    title
    Ixazomib 4.0 mg + CYC 300 mg/m^2 + DEX 40 mg (NDMM)
  2. description
    Ixazomib 4.0 mg, capsules, orally, on Days 1, 8, 15 of a 28-day cycle until PD/death or unacceptable toxicity \[13 cycles in the Induction Phase continuing in the Maintenance Phase for up to 36 Months\] and cyclophosphamide (CYC) 400 mg/m\^2, tablets, orally, on Days 1, 8 and 15 of a 28-day cycle for 13 cycles or until PD/death or unacceptable toxicity and dexamethasone (DEX) 40 mg, tablets, orally, on Days 1, 8, 15 and 22 (dose reduced to 20 mg for patients \>75 years) of a 28-day cycle for 13 cycles or until PD/death or unacceptable toxicity in participants with NDMM.
    id
    OG001
    title
    Ixazomib 4.0 mg + CYC 400 mg/m^2 + DEX 40 mg (NDMM)
param Type
MEDIAN
population Description
Safety Population was defined as all participants who received at least 1 dose of any study drug. Participants without documentation of PD were censored at the date of last response assessment that is SD or better prior to the date of the alternative therapy.
reporting Status
POSTED
time Frame
Up to 45 months
title
Time to Progression (TTP) in NDMM Participants
type
SECONDARY
unit Of Measure
months

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

Preserved source evidence · Not medical advice