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NCT02633059 · OUTCOME

The Number of Participants Who Experienced Dose Limiting Toxicities. Maximum Tolerated Dose (MTD) of Ixazomib Citrate and Idasanutlin in Combination With Dexamethasone (Phase I)

Idasanutlin, Ixazomib Citrate, and Dexamethasone in Treating Patients With Relapsed Multiple Myeloma · Source last updated 2024-09-19

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
28 days

What was measured

Defined as the dose level below the lowest dose that induces dose-limiting toxicity (DLT) in at least one-third of patients (at least 2 of a maximum of 6 new patients). DLT is graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.

Groups in this outcome

Phase 1: Dose Level 0

Phase 1: Ixazomib 4.0 mg, Idasanutlin 100 mg, and Dexamethasone 40 mg

Phase 1: Dose Level 1

Phase 1: Ixazomib 4.0 mg, Idasanutlin 200 mg, and Dexamethasone 40 mg

Phase 1: Dose Level 2

Phase 1: Ixazomib 4.0 mg, Idasanutlin 250 mg, and Dexamethasone 40 mg

Phase 2: Dose Level 1

Phase 2: Ixazomib 4.0 mg, Idasanutlin 200 mg, and Dexamethasone 40 mg

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

Analysis denominator · Participants

GroupSource count
Phase 1: Dose Level 04
Phase 1: Dose Level 17
Phase 1: Dose Level 24
Phase 2: Dose Level 118

Reported measurements

Source class 1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 1: Dose Level 00Not reportedNot reportedNot reportedNot reported
Phase 1: Dose Level 10Not reportedNot reportedNot reportedNot reported
Phase 1: Dose Level 22Not reportedNot reportedNot reportedNot reported
Phase 2: Dose Level 11Not 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
        2
      4. group Id
        OG003
        value
        1
denoms
  1. counts
    1. group Id
      OG000
      value
      4
    2. group Id
      OG001
      value
      7
    3. group Id
      OG002
      value
      4
    4. group Id
      OG003
      value
      18
    units
    Participants
description
Defined as the dose level below the lowest dose that induces dose-limiting toxicity (DLT) in at least one-third of patients (at least 2 of a maximum of 6 new patients). DLT is graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
groups
  1. description
    Phase 1: Ixazomib 4.0 mg, Idasanutlin 100 mg, and Dexamethasone 40 mg
    id
    OG000
    title
    Phase 1: Dose Level 0
  2. description
    Phase 1: Ixazomib 4.0 mg, Idasanutlin 200 mg, and Dexamethasone 40 mg
    id
    OG001
    title
    Phase 1: Dose Level 1
  3. description
    Phase 1: Ixazomib 4.0 mg, Idasanutlin 250 mg, and Dexamethasone 40 mg
    id
    OG002
    title
    Phase 1: Dose Level 2
  4. description
    Phase 2: Ixazomib 4.0 mg, Idasanutlin 200 mg, and Dexamethasone 40 mg
    id
    OG003
    title
    Phase 2: Dose Level 1
param Type
COUNT_OF_PARTICIPANTS
reporting Status
POSTED
time Frame
28 days
title
The Number of Participants Who Experienced Dose Limiting Toxicities. Maximum Tolerated Dose (MTD) of Ixazomib Citrate and Idasanutlin in Combination With Dexamethasone (Phase I)
type
PRIMARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice