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NCT00932698 · OUTCOME

Emax: Maximum Observed Effect for Ixazomib

Study of Oral Ixazomib in Adult Participants With Relapsed and/or Refractory (RR) Multiple Myeloma · Source last updated 2019-08-07

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

Measure
Not reported
Unit
Not reported
Interval / dispersion
Not reported
Time frame
Cycle 1, Days 1 and 11: Predose and at multiple time points (Up to 264 hours) postdose

What was measured

Emax was determined to characterize the whole blood 20S proteasome inhibition parameters.

Analysis population: No data is reported due to concerns about the third-party laboratory's performance of the 20S assay that precluded the ability to confirm the accuracy of the data generated. The data was not considered reliable.

Groups in this outcome

Dose Escalation Cohort 1: Ixazomib 0.24 mg/m^2

Ixazomib 0.24 mg/m\^2, capsule, orally, on Days 1, 4, 8 and 11 during a 21-day treatment cycle until progressive disease (PD) or unacceptable toxicity up to 12 months unless the investigator and sponsor determined the participant would benefit from therapy beyond 12 months (Up to 220 days).

Dose Escalation Cohort 2: Ixazomib 0.48 mg/m^2

Ixazomib 0.48 mg/m\^2, capsule, orally, on Days 1, 4, 8 and 11 during a 21-day treatment cycle until progressive disease (PD) or unacceptable toxicity up to 12 months unless the investigator and sponsor determined the participant would benefit from therapy beyond 12 months (Up to 270 days).

Dose Escalation Cohort 3: Ixazomib 0.8 mg/m^2

Ixazomib 0.8 mg/m\^2, capsule, orally, on Days 1, 4, 8 and 11 during a 21-day treatment cycle until progressive disease (PD) or unacceptable toxicity up to 12 months unless the investigator and sponsor determined the participant would benefit from therapy beyond 12 months (Up to 137 days).

Dose Escalation Cohort 4: Ixazomib 1.2 mg/m^2

Ixazomib 1.2 mg/m\^2, capsule, orally, on Days 1, 4, 8 and 11 during a 21-day treatment cycle until progressive disease (PD) or unacceptable toxicity up to 12 months unless the investigator and sponsor determined the participant would benefit from therapy beyond 12 months (Up to 1436 days).

Dose Escalation Cohort 5: Ixazomib 1.68 mg/m^2

Ixazomib 1.68 mg/m\^2, capsule, orally, on Days 1, 4, 8 and 11 during a 21-day treatment cycle until progressive disease (PD) or unacceptable toxicity up to 12 months unless the investigator and sponsor determined the participant would benefit from therapy beyond 12 months (Up to 456 days).

Dose Escalation Cohort 6: Ixazomib 2.0 mg/m^2

Ixazomib 2.0 mg/m\^2, capsule, orally, on Days 1, 4, 8 and 11 during a 21-day treatment cycle until progressive disease (PD) or unacceptable toxicity up to 12 months unless the investigator and sponsor determined the participant would benefit from therapy beyond 12 months (Up to 1621 days).

Dose Escalation Cohort 7: Ixazomib 2.23 mg/m^2

Ixazomib 2.23 mg/m\^2, capsule, orally, on Days 1, 4, 8 and 11 during a 21-day treatment cycle until progressive disease (PD) or unacceptable toxicity up to 12 months unless the investigator and sponsor determined the participant would benefit from therapy beyond 12 months (Up to 2434 days).

Relapsed and Refractory Expansion Cohort: Ixazomib 2.0 mg/m^2

Ixazomib 2.0 mg/m\^2, capsule, orally, on Days 1, 4, 8 and 11 during a 21-day treatment cycle until progressive disease (PD) or unacceptable toxicity up to 12 months unless the investigator and sponsor determined the participant would benefit from therapy beyond 12 months, Participants must also be refractory to their most recent therapy as evidenced by PD while on therapy or within 60 days after their last dose of therapy (Up to 1621 days).

VELCADE-Relapsed Expansion Cohort: MLN9708 2.0 mg/m^2

Ixazomib (MLN9708) 2 mg/m\^2 (MTD), capsule, orally, twice weekly on Days 1, 4, 8 and 11 in 21-day treatment cycles until PD or unacceptable toxicity in participants with relapsed multiple myeloma previously treated with VELCADE during Part 2 (dose expansion cohort) of the study.

Proteasome Inhibitor-Naive Expansion Cohort: Ixazomib 2 mg/m^2

Ixazomib 2.0 mg/m\^2, capsule, orally, on Days 1, 4, 8 and 11 during a 21-day treatment cycle until progressive disease (PD) or unacceptable toxicity up to 12 months unless the investigator and sponsor determine the participant would benefit from therapy beyond 12 months. Participants with relapsed or refractory disease after \>=1 prior therapy which must include thalidomide (or lenalidomide) and corticosteroid, but who never received a proteasome inhibitor.

Carfilzomib Expansion Cohort: Ixazomib 2.0 mg/m^2

Ixazomib 2.0 mg/m\^2, capsule, orally, on Days 1, 4, 8 and 11 during a 21-day treatment cycle until progressive disease (PD) or unacceptable toxicity up to 12 months unless the investigator and sponsor determined the participant would benefit from therapy beyond 12 months. Participants who previously received carfilzomib and had relapsed or refractory disease (Up to 123 days).

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 1: Ixazomib 0.24 mg/m^20
Dose Escalation Cohort 2: Ixazomib 0.48 mg/m^20
Dose Escalation Cohort 3: Ixazomib 0.8 mg/m^20
Dose Escalation Cohort 4: Ixazomib 1.2 mg/m^20
Dose Escalation Cohort 5: Ixazomib 1.68 mg/m^20
Dose Escalation Cohort 6: Ixazomib 2.0 mg/m^20
Dose Escalation Cohort 7: Ixazomib 2.23 mg/m^20
Relapsed and Refractory Expansion Cohort: Ixazomib 2.0 mg/m^20
VELCADE-Relapsed Expansion Cohort: MLN9708 2.0 mg/m^20
Proteasome Inhibitor-Naive Expansion Cohort: Ixazomib 2 mg/m^20
Carfilzomib Expansion Cohort: Ixazomib 2.0 mg/m^20

Reported measurements

No numerical measurement classes were posted for this outcome. Missing is not zero.

Complete source fields
denoms
  1. counts
    1. group Id
      OG000
      value
      0
    2. group Id
      OG001
      value
      0
    3. group Id
      OG002
      value
      0
    4. group Id
      OG003
      value
      0
    5. group Id
      OG004
      value
      0
    6. group Id
      OG005
      value
      0
    7. group Id
      OG006
      value
      0
    8. group Id
      OG007
      value
      0
    9. group Id
      OG008
      value
      0
    10. group Id
      OG009
      value
      0
    11. group Id
      OG010
      value
      0
    units
    Participants
description
Emax was determined to characterize the whole blood 20S proteasome inhibition parameters.
groups
  1. description
    Ixazomib 0.24 mg/m\^2, capsule, orally, on Days 1, 4, 8 and 11 during a 21-day treatment cycle until progressive disease (PD) or unacceptable toxicity up to 12 months unless the investigator and sponsor determined the participant would benefit from therapy beyond 12 months (Up to 220 days).
    id
    OG000
    title
    Dose Escalation Cohort 1: Ixazomib 0.24 mg/m^2
  2. description
    Ixazomib 0.48 mg/m\^2, capsule, orally, on Days 1, 4, 8 and 11 during a 21-day treatment cycle until progressive disease (PD) or unacceptable toxicity up to 12 months unless the investigator and sponsor determined the participant would benefit from therapy beyond 12 months (Up to 270 days).
    id
    OG001
    title
    Dose Escalation Cohort 2: Ixazomib 0.48 mg/m^2
  3. description
    Ixazomib 0.8 mg/m\^2, capsule, orally, on Days 1, 4, 8 and 11 during a 21-day treatment cycle until progressive disease (PD) or unacceptable toxicity up to 12 months unless the investigator and sponsor determined the participant would benefit from therapy beyond 12 months (Up to 137 days).
    id
    OG002
    title
    Dose Escalation Cohort 3: Ixazomib 0.8 mg/m^2
  4. description
    Ixazomib 1.2 mg/m\^2, capsule, orally, on Days 1, 4, 8 and 11 during a 21-day treatment cycle until progressive disease (PD) or unacceptable toxicity up to 12 months unless the investigator and sponsor determined the participant would benefit from therapy beyond 12 months (Up to 1436 days).
    id
    OG003
    title
    Dose Escalation Cohort 4: Ixazomib 1.2 mg/m^2
  5. description
    Ixazomib 1.68 mg/m\^2, capsule, orally, on Days 1, 4, 8 and 11 during a 21-day treatment cycle until progressive disease (PD) or unacceptable toxicity up to 12 months unless the investigator and sponsor determined the participant would benefit from therapy beyond 12 months (Up to 456 days).
    id
    OG004
    title
    Dose Escalation Cohort 5: Ixazomib 1.68 mg/m^2
  6. description
    Ixazomib 2.0 mg/m\^2, capsule, orally, on Days 1, 4, 8 and 11 during a 21-day treatment cycle until progressive disease (PD) or unacceptable toxicity up to 12 months unless the investigator and sponsor determined the participant would benefit from therapy beyond 12 months (Up to 1621 days).
    id
    OG005
    title
    Dose Escalation Cohort 6: Ixazomib 2.0 mg/m^2
  7. description
    Ixazomib 2.23 mg/m\^2, capsule, orally, on Days 1, 4, 8 and 11 during a 21-day treatment cycle until progressive disease (PD) or unacceptable toxicity up to 12 months unless the investigator and sponsor determined the participant would benefit from therapy beyond 12 months (Up to 2434 days).
    id
    OG006
    title
    Dose Escalation Cohort 7: Ixazomib 2.23 mg/m^2
  8. description
    Ixazomib 2.0 mg/m\^2, capsule, orally, on Days 1, 4, 8 and 11 during a 21-day treatment cycle until progressive disease (PD) or unacceptable toxicity up to 12 months unless the investigator and sponsor determined the participant would benefit from therapy beyond 12 months, Participants must also be refractory to their most recent therapy as evidenced by PD while on therapy or within 60 days after their last dose of therapy (Up to 1621 days).
    id
    OG007
    title
    Relapsed and Refractory Expansion Cohort: Ixazomib 2.0 mg/m^2
  9. description
    Ixazomib (MLN9708) 2 mg/m\^2 (MTD), capsule, orally, twice weekly on Days 1, 4, 8 and 11 in 21-day treatment cycles until PD or unacceptable toxicity in participants with relapsed multiple myeloma previously treated with VELCADE during Part 2 (dose expansion cohort) of the study.
    id
    OG008
    title
    VELCADE-Relapsed Expansion Cohort: MLN9708 2.0 mg/m^2
  10. description
    Ixazomib 2.0 mg/m\^2, capsule, orally, on Days 1, 4, 8 and 11 during a 21-day treatment cycle until progressive disease (PD) or unacceptable toxicity up to 12 months unless the investigator and sponsor determine the participant would benefit from therapy beyond 12 months. Participants with relapsed or refractory disease after \>=1 prior therapy which must include thalidomide (or lenalidomide) and corticosteroid, but who never received a proteasome inhibitor.
    id
    OG009
    title
    Proteasome Inhibitor-Naive Expansion Cohort: Ixazomib 2 mg/m^2
  11. description
    Ixazomib 2.0 mg/m\^2, capsule, orally, on Days 1, 4, 8 and 11 during a 21-day treatment cycle until progressive disease (PD) or unacceptable toxicity up to 12 months unless the investigator and sponsor determined the participant would benefit from therapy beyond 12 months. Participants who previously received carfilzomib and had relapsed or refractory disease (Up to 123 days).
    id
    OG010
    title
    Carfilzomib Expansion Cohort: Ixazomib 2.0 mg/m^2
population Description
No data is reported due to concerns about the third-party laboratory's performance of the 20S assay that precluded the ability to confirm the accuracy of the data generated. The data was not considered reliable.
reporting Status
POSTED
time Frame
Cycle 1, Days 1 and 11: Predose and at multiple time points (Up to 264 hours) postdose
title
Emax: Maximum Observed Effect for Ixazomib
type
SECONDARY

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

Preserved source evidence · Not medical advice