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NCT01318902 · OUTCOME

Organ Disease Progression-Free Survival (PFS)

Study of Oral Ixazomib in Adult Participants With Relapsed or Refractory Light Chain Amyloidosis · Source last updated 2020-04-01

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
From the date of the first dose of ixazomib to the date of organ disease progression or death (Up to approximately 12 months)

What was measured

Organ disease PFS, measured as the time from the date of the first dose of ixazomib to the date of organ disease progression or death.

Analysis population: Organ Response-Evaluable population included participants who received at least 1 cycle of ixazomib, who had amyloid involvement of at least kidney or heart at baseline, and who had at least 1 postbaseline organ response assessment.

Groups in this outcome

Dose Escalation Cohort: Ixazomib 4.0 mg

Ixazomib 4.0 mg, capsule, orally, once weekly on Days 1, 8 and 15 during each 28-day treatment cycle for 3 cycles. If there was no hematologic response, dexamethasone 40 mg, tablet, orally was added once on Days 1 to 4 of every cycle, beginning in Cycle 4 for 3 additional cycles. If there was no hematologic response the participant was discontinued. Participants with hematologic response continued treatment up to maximum 12 cycles.

Dose Escalation Cohort: Ixazomib 5.5 mg

Ixazomib 5.5 mg, capsule, orally, once weekly on Days 1, 8 and 15 during each 28-day treatment cycle for 3 cycles. If there was no hematologic response, dexamethasone 40 mg, tablet, orally was added once on Days 1 to 4 of every cycle, beginning in Cycle 4 for 3 additional cycles. If there was no hematologic response the participant was discontinued. Participants with hematologic response continued treatment up to maximum 12 cycles.

Dose Expansion Cohort: Ixazomib 4.0 mg (PI Naive)

Ixazomib 4.0 mg, capsule, orally, on Days 1, 8 and 15 during a 28-day treatment cycle until progressive disease (PD) or unacceptable toxicity, for participants with relapsed or refractory amyloidosis and who were not treated with any other proteasome inhibitor (PI). Duration of treatment was up to 12 months unless the investigator and sponsor determined the participant would benefit from therapy beyond 12 months.

Dose Expansion Cohort: Ixazomib 4.0 mg (PI Exposed)

Ixazomib 4.0 mg, capsule, orally, on Days 1, 8 and 15 during a 28-day treatment cycle until PD or unacceptable toxicity, for participants with relapsed or refractory amyloidosis and who were previously treated with any other PI. Duration of treatment was up to 12 months unless the investigator and sponsor determined the participant would benefit from therapy beyond 12 months.

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

Analysis denominator · Participants

GroupSource count
Dose Escalation Cohort: Ixazomib 4.0 mg6
Dose Escalation Cohort: Ixazomib 5.5 mg2
Dose Expansion Cohort: Ixazomib 4.0 mg (PI Naive)4
Dose Expansion Cohort: Ixazomib 4.0 mg (PI Exposed)8

Reported measurements

Source class 1
Values in months · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Dose Escalation Cohort: Ixazomib 4.0 mgNANot reportedNANAData was not estimable due to low number of participants with events.
Dose Escalation Cohort: Ixazomib 5.5 mgNANot reportedNANAData was not estimable due to low number of participants with events.
Dose Expansion Cohort: Ixazomib 4.0 mg (PI Naive)NANot reportedNANAData was not estimable due to low number of participants with events.
Dose Expansion Cohort: Ixazomib 4.0 mg (PI Exposed)NANot reportedNANAData was not estimable due to low number of participants with events.
Complete source fields
classes
  1. categories
    1. measurements
      1. comment
        Data was not estimable due to low number of participants with events.
        group Id
        OG000
        lower Limit
        NA
        upper Limit
        NA
        value
        NA
      2. comment
        Data was not estimable due to low number of participants with events.
        group Id
        OG001
        lower Limit
        NA
        upper Limit
        NA
        value
        NA
      3. comment
        Data was not estimable due to low number of participants with events.
        group Id
        OG002
        lower Limit
        NA
        upper Limit
        NA
        value
        NA
      4. comment
        Data was not estimable due to low number of participants with events.
        group Id
        OG003
        lower Limit
        NA
        upper Limit
        NA
        value
        NA
denoms
  1. counts
    1. group Id
      OG000
      value
      6
    2. group Id
      OG001
      value
      2
    3. group Id
      OG002
      value
      4
    4. group Id
      OG003
      value
      8
    units
    Participants
description
Organ disease PFS, measured as the time from the date of the first dose of ixazomib to the date of organ disease progression or death.
dispersion Type
Full Range
groups
  1. description
    Ixazomib 4.0 mg, capsule, orally, once weekly on Days 1, 8 and 15 during each 28-day treatment cycle for 3 cycles. If there was no hematologic response, dexamethasone 40 mg, tablet, orally was added once on Days 1 to 4 of every cycle, beginning in Cycle 4 for 3 additional cycles. If there was no hematologic response the participant was discontinued. Participants with hematologic response continued treatment up to maximum 12 cycles.
    id
    OG000
    title
    Dose Escalation Cohort: Ixazomib 4.0 mg
  2. description
    Ixazomib 5.5 mg, capsule, orally, once weekly on Days 1, 8 and 15 during each 28-day treatment cycle for 3 cycles. If there was no hematologic response, dexamethasone 40 mg, tablet, orally was added once on Days 1 to 4 of every cycle, beginning in Cycle 4 for 3 additional cycles. If there was no hematologic response the participant was discontinued. Participants with hematologic response continued treatment up to maximum 12 cycles.
    id
    OG001
    title
    Dose Escalation Cohort: Ixazomib 5.5 mg
  3. description
    Ixazomib 4.0 mg, capsule, orally, on Days 1, 8 and 15 during a 28-day treatment cycle until progressive disease (PD) or unacceptable toxicity, for participants with relapsed or refractory amyloidosis and who were not treated with any other proteasome inhibitor (PI). Duration of treatment was up to 12 months unless the investigator and sponsor determined the participant would benefit from therapy beyond 12 months.
    id
    OG002
    title
    Dose Expansion Cohort: Ixazomib 4.0 mg (PI Naive)
  4. description
    Ixazomib 4.0 mg, capsule, orally, on Days 1, 8 and 15 during a 28-day treatment cycle until PD or unacceptable toxicity, for participants with relapsed or refractory amyloidosis and who were previously treated with any other PI. Duration of treatment was up to 12 months unless the investigator and sponsor determined the participant would benefit from therapy beyond 12 months.
    id
    OG003
    title
    Dose Expansion Cohort: Ixazomib 4.0 mg (PI Exposed)
param Type
MEDIAN
population Description
Organ Response-Evaluable population included participants who received at least 1 cycle of ixazomib, who had amyloid involvement of at least kidney or heart at baseline, and who had at least 1 postbaseline organ response assessment.
reporting Status
POSTED
time Frame
From the date of the first dose of ixazomib to the date of organ disease progression or death (Up to approximately 12 months)
title
Organ Disease Progression-Free Survival (PFS)
type
SECONDARY
unit Of Measure
months

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Preserved source evidence · Not medical advice