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NCT01217957 · OUTCOME

Phase 2: Progression Free Survival (PFS)

A Study of Ixazomib Administered in Combination With Lenalidomide and Low-Dose Dexamethasone in Patients With Newly Diagnosed Multiple Myeloma · Source last updated 2018-03-14

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 787 days

What was measured

PFS was measured as the time in months from the first dose of study treatment to the date of the first documented PD or death.

Analysis population: The mITT population was defined as all patients who received at least one dose of any study drug in phase 2 or who received at least one dose of any study drug and were treated at the phase 2 dose level during phase 1.

Groups in this outcome

Phase 2: Ixazomib 4.0 mg + Lenalidomide + Dexamethasone

In phase 2, ixazomib 4.0 mg fixed dose, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once on Days 1 through 21 of a 28-day cycle for up to 12 cycles. Cycle 13 and beyond, single agent ixazomib 4.0 mg fixed dose, capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity.

Phase 2: Ixazomib 4.0 mg/2.23 + Lenalidomide + Dexamethasone

In phase 2, ixazomib 4.0 mg fixed dose, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once, on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once, on Days 1 through 21 of a 28-day cycle for up to 12 cycles. Cycle 13 and beyond, single agent ixazomib 4.0 mg fixed dose, capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity. Includes 3 participants who received 2.23 mg/m\^2 in Phase 1.

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

Analysis denominator · Participants

GroupSource count
Phase 2: Ixazomib 4.0 mg + Lenalidomide + Dexamethasone50
Phase 2: Ixazomib 4.0 mg/2.23 + Lenalidomide + Dexamethasone53

Reported measurements

Source class 1
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Phase 2: Ixazomib 4.0 mg + Lenalidomide + Dexamethasone14.98Not reported13.37NANot estimable due to the low number of participants with events.
Phase 2: Ixazomib 4.0 mg/2.23 + Lenalidomide + DexamethasoneNANot reportedNANANot estimable due to the low number of participants with events.
Complete source fields
classes
  1. categories
    1. measurements
      1. comment
        Not estimable due to the low number of participants with events.
        group Id
        OG000
        lower Limit
        13.37
        upper Limit
        NA
        value
        14.98
      2. comment
        Not estimable due to the low number of participants with events.
        group Id
        OG001
        lower Limit
        NA
        upper Limit
        NA
        value
        NA
denoms
  1. counts
    1. group Id
      OG000
      value
      50
    2. group Id
      OG001
      value
      53
    units
    Participants
description
PFS was measured as the time in months from the first dose of study treatment to the date of the first documented PD or death.
dispersion Type
95% Confidence Interval
groups
  1. description
    In phase 2, ixazomib 4.0 mg fixed dose, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once on Days 1 through 21 of a 28-day cycle for up to 12 cycles. Cycle 13 and beyond, single agent ixazomib 4.0 mg fixed dose, capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity.
    id
    OG000
    title
    Phase 2: Ixazomib 4.0 mg + Lenalidomide + Dexamethasone
  2. description
    In phase 2, ixazomib 4.0 mg fixed dose, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once, on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once, on Days 1 through 21 of a 28-day cycle for up to 12 cycles. Cycle 13 and beyond, single agent ixazomib 4.0 mg fixed dose, capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity. Includes 3 participants who received 2.23 mg/m\^2 in Phase 1.
    id
    OG001
    title
    Phase 2: Ixazomib 4.0 mg/2.23 + Lenalidomide + Dexamethasone
param Type
MEDIAN
population Description
The mITT population was defined as all patients who received at least one dose of any study drug in phase 2 or who received at least one dose of any study drug and were treated at the phase 2 dose level during phase 1.
reporting Status
POSTED
time Frame
Up to 787 days
title
Phase 2: Progression Free Survival (PFS)
type
SECONDARY
unit Of Measure
months

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

Preserved source evidence · Not medical advice