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NCT02765854 · OUTCOME

Time to Treatment Failure

Ixazomib and Dexamethasone Versus Ixazomib, Dexamethasone and Lenalidomide, Randomized With NFKB2 Rearrangement · Source last updated 2025-06-26

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

Measure
MEAN
Unit
Months
Interval / dispersion
95% Confidence Interval
Time frame
Up to 30 months

What was measured

Kaplan-Meier curves will be used for the time to treatment failure according to the Arm of treatment utilized. Kaplan-Meyer curve analysis was performed to evaluate the time to treatment failure comparison.

Groups in this outcome

Arm B (Ixazomib and Dexamethasone)

MUTATED NFKB2 REARRANGEMENT: Patients receive ixazomib and dexamethasone as in arm A. Dexamethasone: Given PO Ixazomib: Given PO

Arm C (Ixazomib, Dexamethasone, Lenalidomide)

MUTATED NFKB2 REARRANGEMENT: Patients receive ixazomib and dexamethasone as in arm A and lenalidomide PO daily on days 1-21. Dexamethasone: Given PO Ixazomib: Given PO Lenalidomide: Given PO

Arm A (Ixazomib and Dexamethasone)

UNMUTATED NFKB2 REARRANGEMENT: Patients receive ixazomib and dexamethasone. Dexamethasone: Given PO Ixazomib: Given PO

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

Analysis denominator · Participants

GroupSource count
Arm B (Ixazomib and Dexamethasone)22
Arm C (Ixazomib, Dexamethasone, Lenalidomide)21
Arm A (Ixazomib and Dexamethasone)27

Reported measurements

6 Months
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Arm B (Ixazomib and Dexamethasone)0.495Not reported0.2590.693Not reported
Arm C (Ixazomib, Dexamethasone, Lenalidomide)0.683Not reported0.4190.847Not reported
Arm A (Ixazomib and Dexamethasone)0.729Not reported0.5120.861Not reported
12 Months
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Arm B (Ixazomib and Dexamethasone)0.353Not reported0.1420.575Not reported
Arm C (Ixazomib, Dexamethasone, Lenalidomide)0.312Not reported0.1030.551Not reported
Arm A (Ixazomib and Dexamethasone)0.729Not reported0.5120.861Not reported
18 Months
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Arm B (Ixazomib and Dexamethasone)0.283Not reported0.0950.508Not reported
Arm C (Ixazomib, Dexamethasone, Lenalidomide)0.312Not reported0.1030.551Not reported
Arm A (Ixazomib and Dexamethasone)0.663Not reported0.4250.821Not reported
24 Months
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Arm B (Ixazomib and Dexamethasone)0.141Not reported0.0240.357Not reported
Arm C (Ixazomib, Dexamethasone, Lenalidomide)0.156Not reported0.0260.388Not reported
Arm A (Ixazomib and Dexamethasone)0.505Not reported0.2490.715Not reported
30 Months
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Arm B (Ixazomib and Dexamethasone)0.141Not reported0.0240.357Not reported
Arm C (Ixazomib, Dexamethasone, Lenalidomide)0.078Not reported0.0050.294Not reported
Arm A (Ixazomib and Dexamethasone)0.421Not reported0.1760.65Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.259
        upper Limit
        0.693
        value
        0.495
      2. group Id
        OG001
        lower Limit
        0.419
        upper Limit
        0.847
        value
        0.683
      3. group Id
        OG002
        lower Limit
        0.512
        upper Limit
        0.861
        value
        0.729
    title
    6 Months
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.142
        upper Limit
        0.575
        value
        0.353
      2. group Id
        OG001
        lower Limit
        0.103
        upper Limit
        0.551
        value
        0.312
      3. group Id
        OG002
        lower Limit
        0.512
        upper Limit
        0.861
        value
        0.729
    title
    12 Months
  3. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.095
        upper Limit
        0.508
        value
        0.283
      2. group Id
        OG001
        lower Limit
        0.103
        upper Limit
        0.551
        value
        0.312
      3. group Id
        OG002
        lower Limit
        0.425
        upper Limit
        0.821
        value
        0.663
    title
    18 Months
  4. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.024
        upper Limit
        0.357
        value
        0.141
      2. group Id
        OG001
        lower Limit
        0.026
        upper Limit
        0.388
        value
        0.156
      3. group Id
        OG002
        lower Limit
        0.249
        upper Limit
        0.715
        value
        0.505
    title
    24 Months
  5. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.024
        upper Limit
        0.357
        value
        0.141
      2. group Id
        OG001
        lower Limit
        0.005
        upper Limit
        0.294
        value
        0.078
      3. group Id
        OG002
        lower Limit
        0.176
        upper Limit
        0.65
        value
        0.421
    title
    30 Months
denoms
  1. counts
    1. group Id
      OG000
      value
      22
    2. group Id
      OG001
      value
      21
    3. group Id
      OG002
      value
      27
    units
    Participants
description
Kaplan-Meier curves will be used for the time to treatment failure according to the Arm of treatment utilized. Kaplan-Meyer curve analysis was performed to evaluate the time to treatment failure comparison.
dispersion Type
95% Confidence Interval
groups
  1. description
    MUTATED NFKB2 REARRANGEMENT: Patients receive ixazomib and dexamethasone as in arm A. Dexamethasone: Given PO Ixazomib: Given PO
    id
    OG000
    title
    Arm B (Ixazomib and Dexamethasone)
  2. description
    MUTATED NFKB2 REARRANGEMENT: Patients receive ixazomib and dexamethasone as in arm A and lenalidomide PO daily on days 1-21. Dexamethasone: Given PO Ixazomib: Given PO Lenalidomide: Given PO
    id
    OG001
    title
    Arm C (Ixazomib, Dexamethasone, Lenalidomide)
  3. description
    UNMUTATED NFKB2 REARRANGEMENT: Patients receive ixazomib and dexamethasone. Dexamethasone: Given PO Ixazomib: Given PO
    id
    OG002
    title
    Arm A (Ixazomib and Dexamethasone)
param Type
MEAN
reporting Status
POSTED
time Frame
Up to 30 months
title
Time to Treatment Failure
type
SECONDARY
unit Of Measure
Months

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Preserved source evidence · Not medical advice