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NCT03202628 · OUTCOME

Number of Patients Experiencing Adverse Events Graded According to the Medical Dictionary for Regulatory Activities (MedDRA) Version (v) 12.1

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
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
36 months

What was measured

The number of patients experiencing a grade 3 or greater adverse event will be reported. The maximum grade for each type of adverse event will be recorded for each patient, and frequency tables will be reviewed to determine patterns. Additionally, the relationship of the adverse event(s) to the study treatment will be taken into consideration.

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 Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Treatment (Ixazomib, Pomalidomide, Dexamethasone, ASCT)7Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        7
denoms
  1. counts
    1. group Id
      OG000
      value
      8
    units
    Participants
description
The number of patients experiencing a grade 3 or greater adverse event will be reported. The maximum grade for each type of adverse event will be recorded for each patient, and frequency tables will be reviewed to determine patterns. Additionally, the relationship of the adverse event(s) to the study treatment will be taken into consideration.
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
COUNT_OF_PARTICIPANTS
reporting Status
POSTED
time Frame
36 months
title
Number of Patients Experiencing Adverse Events Graded According to the Medical Dictionary for Regulatory Activities (MedDRA) Version (v) 12.1
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice