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NCT03202628 · OUTCOME

Progression-free Survival at 18 Months (PFS18) Defined as the Proportion of Patients Alive and Free From Disease Progression at 18 Months From Study Entry

Ixazomib Citrate, Pomalidomide, Dexamethasone, Stem Cell Transplant in Treating Relapsed or Refractory Multiple Myeloma · Source last updated 2023-09-21

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

Measure
NUMBER
Unit
proportion of participants
Interval / dispersion
95% Confidence Interval
Time frame
18 months

What was measured

The proportion 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. If patients are censored prior to 18 months post registration, a Kaplan Meier (Kaplan, E. and Meier, P., 1958) estimate for PFS18 along with the 95% confidence intervals will be reported.

Groups in this outcome

Treatment (Ixazomib, Pomalidomide, Dexamethasone, ASCT)

INDUCTION (COURSES 1-4): Patients receive ixazomib citrate PO on days 1, 8, and 15, pomalidomide PO on days 1-21, and dexamethasone PO on days 1, 8, 15, and 22. Treatment repeats every 28 days (courses 1-3) and 56 days (course 4) for up to 4 courses in the absence of disease progression or unacceptable toxicity. \> \> TRANSPLANTATION (COURSE 5): Between 2-4 weeks following Induction, patients undergo ASCT. \> \> CONSOLIDATION (COURSES 6-9): Beginning 60-120 days following ASCT, patients receive ixazomib citrate, pomalidomide, and dexamethasone as in Induction. Treatment repeats every 28 days (courses 6-8) and 56 days (course 9) for up to 4 courses in the absence of disease progression or unacceptable toxicity. \> \> MAINTENANCE (COURSES 10+): Beginning 0-4 weeks following Consolidation, patients receive ixazomib citrate as in Induction. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. \> \> Autologous Hematopoietic Stem Cell Transplantation: Undergo ASCT \> \> Dexamethasone: Given PO \> \> Ixazomib Citrate: Given PO \> \> Laboratory Biomarker Analysis: Correlative studies \> \> Pomalidomide: Given PO

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, Pomalidomide, Dexamethasone, ASCT)8

Reported measurements

Source class 1
Values in proportion of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Treatment (Ixazomib, Pomalidomide, Dexamethasone, ASCT)0.3750Not reported0.08520.7551Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.0852
        upper Limit
        0.7551
        value
        0.3750
denoms
  1. counts
    1. group Id
      OG000
      value
      8
    units
    Participants
description
The proportion 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. If patients are censored prior to 18 months post registration, a Kaplan Meier (Kaplan, E. and Meier, P., 1958) estimate for PFS18 along with the 95% confidence intervals will be reported.
dispersion Type
95% Confidence Interval
groups
  1. description
    INDUCTION (COURSES 1-4): Patients receive ixazomib citrate PO on days 1, 8, and 15, pomalidomide PO on days 1-21, and dexamethasone PO on days 1, 8, 15, and 22. Treatment repeats every 28 days (courses 1-3) and 56 days (course 4) for up to 4 courses in the absence of disease progression or unacceptable toxicity. \> \> TRANSPLANTATION (COURSE 5): Between 2-4 weeks following Induction, patients undergo ASCT. \> \> CONSOLIDATION (COURSES 6-9): Beginning 60-120 days following ASCT, patients receive ixazomib citrate, pomalidomide, and dexamethasone as in Induction. Treatment repeats every 28 days (courses 6-8) and 56 days (course 9) for up to 4 courses in the absence of disease progression or unacceptable toxicity. \> \> MAINTENANCE (COURSES 10+): Beginning 0-4 weeks following Consolidation, patients receive ixazomib citrate as in Induction. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. \> \> Autologous Hematopoietic Stem Cell Transplantation: Undergo ASCT \> \> Dexamethasone: Given PO \> \> Ixazomib Citrate: Given PO \> \> Laboratory Biomarker Analysis: Correlative studies \> \> Pomalidomide: Given PO
    id
    OG000
    title
    Treatment (Ixazomib, Pomalidomide, Dexamethasone, ASCT)
param Type
NUMBER
reporting Status
POSTED
time Frame
18 months
title
Progression-free Survival at 18 Months (PFS18) Defined as the Proportion of Patients Alive and Free From Disease Progression at 18 Months From Study Entry
type
PRIMARY
unit Of Measure
proportion of participants

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

Preserved source evidence · Not medical advice