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NCT02181413 · OUTCOME

Number of Participants With Conversion to Minimal Residual Disease (MRD) Negative

A Study of Oral Ixazomib Citrate (MLN9708) Maintenance Therapy in Participants With Multiple Myeloma Following Autologous Stem Cell Transplant · Source last updated 2024-11-19

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
Baseline up to EOT (up to 24 months)

What was measured

MRD negativity (MRD-) is defined as absence of MRD and MRD positivity (MRD+) is defined as presence of MRD. The conversion rate from MRD positive to MRD negative was assessed and reported. Bone marrow aspirates and blood samples were sent to a central laboratory and were assessed for MRD using flow cytometry and a sequencing methodology.

Analysis population: ITT population was defined as all participants who were randomized and had post randomization data. Overall number of participants analyzed indicates the number of participants with MRD+ at Baseline.

Groups in this outcome

Placebo

Ixazomib citrate placebo-matching capsules, orally, once on Days 1, 8 and 15 in a 28-day cycle for Cycles 1 through 26 until progressive disease (PD), unacceptable toxicity, or discontinuation for alternate reasons.

Ixazomib Citrate

Ixazomib citrate 3 mg, capsules, orally, once, on Days 1, 8 and 15 in a 28-day cycle for Cycles 1 through 4. Ixazomib citrate 4 mg, capsules, orally, once, on Days 1, 8 and 15 in a 28-day cycle for Cycles 5 through 26 until PD, unacceptable toxicity, or discontinuation for alternate reasons. Participants who had any dose reductions due to AEs were not dose escalated.

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

Analysis denominator · Participants

GroupSource count
Placebo139
Ixazomib Citrate225

Reported measurements

Source class 1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Placebo27Not reportedNot reportedNot reportedNot reported
Ixazomib Citrate39Not reportedNot reportedNot reportedNot reported

Source statistical analyses

Group order, estimate direction, methods and comments are retained. No treatment ranking is inferred.

  1. group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.814
    p Value Comment
    P-value was based on Fisher's exact test comparing conversion to MRD- at any time post study entry between treatment groups.
    statistical Method
    Fisher Exact
Complete source fields
analyses
  1. group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.814
    p Value Comment
    P-value was based on Fisher's exact test comparing conversion to MRD- at any time post study entry between treatment groups.
    statistical Method
    Fisher Exact
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        27
      2. group Id
        OG001
        value
        39
denoms
  1. counts
    1. group Id
      OG000
      value
      139
    2. group Id
      OG001
      value
      225
    units
    Participants
description
MRD negativity (MRD-) is defined as absence of MRD and MRD positivity (MRD+) is defined as presence of MRD. The conversion rate from MRD positive to MRD negative was assessed and reported. Bone marrow aspirates and blood samples were sent to a central laboratory and were assessed for MRD using flow cytometry and a sequencing methodology.
groups
  1. description
    Ixazomib citrate placebo-matching capsules, orally, once on Days 1, 8 and 15 in a 28-day cycle for Cycles 1 through 26 until progressive disease (PD), unacceptable toxicity, or discontinuation for alternate reasons.
    id
    OG000
    title
    Placebo
  2. description
    Ixazomib citrate 3 mg, capsules, orally, once, on Days 1, 8 and 15 in a 28-day cycle for Cycles 1 through 4. Ixazomib citrate 4 mg, capsules, orally, once, on Days 1, 8 and 15 in a 28-day cycle for Cycles 5 through 26 until PD, unacceptable toxicity, or discontinuation for alternate reasons. Participants who had any dose reductions due to AEs were not dose escalated.
    id
    OG001
    title
    Ixazomib Citrate
param Type
COUNT_OF_PARTICIPANTS
population Description
ITT population was defined as all participants who were randomized and had post randomization data. Overall number of participants analyzed indicates the number of participants with MRD+ at Baseline.
reporting Status
POSTED
time Frame
Baseline up to EOT (up to 24 months)
title
Number of Participants With Conversion to Minimal Residual Disease (MRD) Negative
type
SECONDARY
unit Of Measure
Participants

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice