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NCT03770260 · OUTCOME

Characterize the Pharmacokinetics (PK) of Pevonedistat and Ixazomib (Dose Escalation)

Ixazomib and Pevonedistat in Treating Patients With Multiple Myeloma That Has Come Back or Does Not Respond to Treatment · Source last updated 2025-06-19

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
Up to 3 months

What was measured

To understand the concentration-effect relationship of both agents when taken together

Analysis population: This data was not collected.

Groups in this outcome

Dose Level 1

Patients receive pevonedistat 20 mg/meter squared by infusion and ixazomib citrate 4 mg by mouth on days 1, 8, and 15 of each 28-day cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Dose Level 2

Patients receive pevonedistat 40 mg/meter squared by infusion and ixazomib citrate 4 mg by mouth on days 1, 8, and 15 of each 28-day cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Dose Level 3

Patients receive pevonedistat 20 mg/meter squared by infusion and ixazomib citrate 4 mg by mouth on days 1, 8, and 15 of each 28-day cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.

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 Level 10
Dose Level 20
Dose Level 30

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
    units
    Participants
description
To understand the concentration-effect relationship of both agents when taken together
groups
  1. description
    Patients receive pevonedistat 20 mg/meter squared by infusion and ixazomib citrate 4 mg by mouth on days 1, 8, and 15 of each 28-day cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
    id
    OG000
    title
    Dose Level 1
  2. description
    Patients receive pevonedistat 40 mg/meter squared by infusion and ixazomib citrate 4 mg by mouth on days 1, 8, and 15 of each 28-day cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
    id
    OG001
    title
    Dose Level 2
  3. description
    Patients receive pevonedistat 20 mg/meter squared by infusion and ixazomib citrate 4 mg by mouth on days 1, 8, and 15 of each 28-day cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
    id
    OG002
    title
    Dose Level 3
population Description
This data was not collected.
reporting Status
POSTED
time Frame
Up to 3 months
title
Characterize the Pharmacokinetics (PK) of Pevonedistat and Ixazomib (Dose Escalation)
type
SECONDARY

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

Preserved source evidence · Not medical advice