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NCT01864018 · OUTCOME

Maximum Tolerated (MTD) Dose of Cyclophosphamide With Ixazomib and Dexamethasone (Phase I)

Ixazomib With Cyclophosphamide and Dexamethasone in Patients With Previously Untreated Symptomatic Multiple Myeloma or Light Chain Amyloidosis · Source last updated 2025-07-24

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

Measure
NUMBER
Unit
mg weekly
Interval / dispersion
Not reported
Time frame
At 28 days

What was measured

Will be defined as the dose level below the lowest dose that induces dose-limiting toxicity in at least 1/3 of patients, as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0.

Analysis population: The 10 patients accrued to the phase I portion of the study were analyzed to determine the maximum tolerated dose of ixazomib with cyclophosphamide and dexamethasone

Groups in this outcome

Treatment (Ixazomib Citrate, Cyclophosphamide, Dexamethasone)

INDUCTION THERAPY: Patients receive ixazomib citrate PO on days 1, 8, and 15 and cyclophosphamide PO and dexamethasone PO on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.\> \>\> \> \>\> MAINTENANCE THERAPY: Patients receive ixazomib citrate PO on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.\> \>\> \> \>\> Cyclophosphamide: Given PO\> \>\> \> \>\> Dexamethasone: Given PO\> \>\> \> \>\> Ixazomib Citrate: Given PO\> \>\> \> \>\> Laboratory Biomarker Analysis: Correlative studies\> \>\> \> \>\> Pharmacological Study: Correlative studies\> \>\> \> \>\> Quality-of-Life Assessment: Ancillary studies\> \>\> \> \>\> Questionnaire Administration: Ancillary studies

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

Analysis denominator · Participants

GroupSource count
Treatment (Ixazomib Citrate, Cyclophosphamide, Dexamethasone)10

Reported measurements

MTD of ixazomib
Values in mg weekly · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Treatment (Ixazomib Citrate, Cyclophosphamide, Dexamethasone)4Not reportedNot reportedNot reportedNot reported
MTD of dexamethasone
Values in mg weekly · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Treatment (Ixazomib Citrate, Cyclophosphamide, Dexamethasone)40Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        4
    title
    MTD of ixazomib
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        40
    title
    MTD of dexamethasone
denoms
  1. counts
    1. group Id
      OG000
      value
      10
    units
    Participants
description
Will be defined as the dose level below the lowest dose that induces dose-limiting toxicity in at least 1/3 of patients, as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0.
groups
  1. description
    INDUCTION THERAPY: Patients receive ixazomib citrate PO on days 1, 8, and 15 and cyclophosphamide PO and dexamethasone PO on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.\> \>\> \> \>\> MAINTENANCE THERAPY: Patients receive ixazomib citrate PO on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.\> \>\> \> \>\> Cyclophosphamide: Given PO\> \>\> \> \>\> Dexamethasone: Given PO\> \>\> \> \>\> Ixazomib Citrate: Given PO\> \>\> \> \>\> Laboratory Biomarker Analysis: Correlative studies\> \>\> \> \>\> Pharmacological Study: Correlative studies\> \>\> \> \>\> Quality-of-Life Assessment: Ancillary studies\> \>\> \> \>\> Questionnaire Administration: Ancillary studies
    id
    OG000
    title
    Treatment (Ixazomib Citrate, Cyclophosphamide, Dexamethasone)
param Type
NUMBER
population Description
The 10 patients accrued to the phase I portion of the study were analyzed to determine the maximum tolerated dose of ixazomib with cyclophosphamide and dexamethasone
reporting Status
POSTED
time Frame
At 28 days
title
Maximum Tolerated (MTD) Dose of Cyclophosphamide With Ixazomib and Dexamethasone (Phase I)
type
PRIMARY
unit Of Measure
mg weekly

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Preserved source evidence · Not medical advice