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NCT01864018 · OUTCOME

Percentage of Patients With Complete Response or Very Good Partial Response (Phase II, Cohort A)

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
percentage of participants
Interval / dispersion
95% Confidence Interval
Time frame
Up to 48 weeks

What was measured

The percentage of successes will be estimated by the number of successes divided by the total number of evaluable patients. Exact binomial 95% confidence intervals for the true success proportion will be calculated.

Analysis population: Includes only eligible patients in phase II, cohort A

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)48

Reported measurements

Source class 1
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Treatment (Ixazomib Citrate, Cyclophosphamide, Dexamethasone)35Not reported2250Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        22
        upper Limit
        50
        value
        35
denoms
  1. counts
    1. group Id
      OG000
      value
      48
    units
    Participants
description
The percentage of successes will be estimated by the number of successes divided by the total number of evaluable patients. Exact binomial 95% confidence intervals for the true success proportion will be calculated.
dispersion Type
95% Confidence Interval
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
Includes only eligible patients in phase II, cohort A
reporting Status
POSTED
time Frame
Up to 48 weeks
title
Percentage of Patients With Complete Response or Very Good Partial Response (Phase II, Cohort A)
type
PRIMARY
unit Of Measure
percentage of participants

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

Preserved source evidence · Not medical advice