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NCT01217957 · OUTCOME

Phase 2: Time to Best Response

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
Full Range
Time frame
Up to 787 days

What was measured

Time to Best Response was measured as the time in months from the first dose of study treatment to the date of first documented documentation of a confirmed response of partial response (PR) or better.

Analysis population: Participants form the response-evaluable population, defined as all patients who received at least one dose of ixazomib, had measurable disease at baseline, and at least one post-baseline disease assessment, with available data.

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 + Dexamethasone43
Phase 2: Ixazomib 4.0 mg/2.23 + Lenalidomide + Dexamethasone46

Reported measurements

Source class 1
Values in months · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Phase 2: Ixazomib 4.0 mg + Lenalidomide + Dexamethasone2.96Not reported0.911.3Not reported
Phase 2: Ixazomib 4.0 mg/2.23 + Lenalidomide + Dexamethasone3.01Not reported0.912.9Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.9
        upper Limit
        11.3
        value
        2.96
      2. group Id
        OG001
        lower Limit
        0.9
        upper Limit
        12.9
        value
        3.01
denoms
  1. counts
    1. group Id
      OG000
      value
      43
    2. group Id
      OG001
      value
      46
    units
    Participants
description
Time to Best Response was measured as the time in months from the first dose of study treatment to the date of first documented documentation of a confirmed response of partial response (PR) or better.
dispersion Type
Full Range
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
Participants form the response-evaluable population, defined as all patients who received at least one dose of ixazomib, had measurable disease at baseline, and at least one post-baseline disease assessment, with available data.
reporting Status
POSTED
time Frame
Up to 787 days
title
Phase 2: Time to Best Response
type
SECONDARY
unit Of Measure
months

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

Preserved source evidence · Not medical advice