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NCT03770260 · OUTCOME

Number of Participants Experiencing a Dose Limiting Toxicity (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
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
At Day 28

What was measured

Number of participants experiencing a dose limiting toxicity to determine the maximum tolerated dose (MTD)

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 13
Dose Level 24
Dose Level 31

Reported measurements

Experienced a Dose Limiting Toxicity
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Dose Level 10Not reportedNot reportedNot reportedNot reported
Dose Level 20Not reportedNot reportedNot reportedNot reported
Dose Level 30Not reportedNot reportedNot reportedNot reported
Did Not Experience a Dose Limiting Toxicity
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Dose Level 13Not reportedNot reportedNot reportedNot reported
Dose Level 23Not reportedNot reportedNot reportedNot reported
Dose Level 31Not reportedNot reportedNot reportedNot reported
Withdrew from Treatment
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Dose Level 10Not reportedNot reportedNot reportedNot reported
Dose Level 21Not reportedNot reportedNot reportedNot reported
Dose Level 30Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
    title
    Experienced a Dose Limiting Toxicity
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        3
      2. group Id
        OG001
        value
        3
      3. group Id
        OG002
        value
        1
    title
    Did Not Experience a Dose Limiting Toxicity
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        1
      3. group Id
        OG002
        value
        0
    title
    Withdrew from Treatment
denoms
  1. counts
    1. group Id
      OG000
      value
      3
    2. group Id
      OG001
      value
      4
    3. group Id
      OG002
      value
      1
    units
    Participants
description
Number of participants experiencing a dose limiting toxicity to determine the maximum tolerated dose (MTD)
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
param Type
COUNT_OF_PARTICIPANTS
reporting Status
POSTED
time Frame
At Day 28
title
Number of Participants Experiencing a Dose Limiting Toxicity (Dose Escalation)
type
PRIMARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice