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NCT01318902 · OUTCOME

Time to First Hematologic Response

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 first documentation of a hematologic response (Up to approximately 12 months)

What was measured

Time to first hematologic response, measured as the time from the first dose of ixazomib to the date of first documentation of a hematologic response.

Analysis population: Hematologic response-evaluable population: all participants who received at least 1 cycle of ixazomib, had measureable disease at baseline, had \>=1 postbaseline hematologic response. No participants had hematologic response for ixazomib 5.5 mg arm group thus were not analyzed. Data is reported for participants evaluable for this outcome measure.

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 mg4
Dose Escalation Cohort: Ixazomib 5.5 mg0
Dose Expansion Cohort: Ixazomib 4.0 mg (PI Naive)4
Dose Expansion Cohort: Ixazomib 4.0 mg (PI Exposed)3

Reported measurements

Source class 1
Values in months · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Dose Escalation Cohort: Ixazomib 4.0 mg0.79Not reported0.71.8Not reported
Dose Expansion Cohort: Ixazomib 4.0 mg (PI Naive)3.45Not reported0.94.4Not reported
Dose Expansion Cohort: Ixazomib 4.0 mg (PI Exposed)2.11Not reported1.03.7Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.7
        upper Limit
        1.8
        value
        0.79
      2. group Id
        OG002
        lower Limit
        0.9
        upper Limit
        4.4
        value
        3.45
      3. group Id
        OG003
        lower Limit
        1.0
        upper Limit
        3.7
        value
        2.11
denoms
  1. counts
    1. group Id
      OG000
      value
      4
    2. group Id
      OG001
      value
      0
    3. group Id
      OG002
      value
      4
    4. group Id
      OG003
      value
      3
    units
    Participants
description
Time to first hematologic response, measured as the time from the first dose of ixazomib to the date of first documentation of a hematologic response.
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
Hematologic response-evaluable population: all participants who received at least 1 cycle of ixazomib, had measureable disease at baseline, had \>=1 postbaseline hematologic response. No participants had hematologic response for ixazomib 5.5 mg arm group thus were not analyzed. Data is reported for participants evaluable for this outcome measure.
reporting Status
POSTED
time Frame
From the date of the first dose of ixazomib to the date of first documentation of a hematologic response (Up to approximately 12 months)
title
Time to First Hematologic Response
type
SECONDARY
unit Of Measure
months

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Preserved source evidence · Not medical advice