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NCT02224729 · OUTCOME

Incidence of Grade 3-4 Adverse Events From the Combination of Bendamustine Hydrochloride, Bortezomib, and Dexamethasone Based on the Common Terminology Criteria Version 4.0

Bendamustine Hydrochloride, Bortezomib, and Dexamethasone in Treating Patients With Newly Diagnosed Multiple Myeloma · Source last updated 2025-04-30

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

Measure
NUMBER
Unit
Adverse Events
Interval / dispersion
Not reported
Time frame
Up to 1 year

What was measured

All adverse events are tracked during the course of the trial. Adverse events with a grade of 3-4 will be tracked and recorded.

Analysis population: 4 were not evaluable - (1 didn't get any therapy on study, 1 received only first cycle and 2 developed medical issues that took them off study during the first cycle)

Groups in this outcome

Bendamustine, Bortezomib, Dexamethasone (Standard)

Patients receive bendamustine hydrochloride IV over 30 minutes on days 1 and 2; bortezomib SC on days 1, 8, 15, and 22; and dexamethasone PO on days 1, 8, 15, and 22. Treatment repeats every 35 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients achieving less than a VGPR or with more than 10% bone marrow plasmacytosis may receive 2 additional courses. Bendamustine hydrochloride: Given IV Bortezomib: Given SC Dexamethasone: 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
Bendamustine, Bortezomib, Dexamethasone (Standard)20

Reported measurements

Source class 1
Values in Adverse Events · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Bendamustine, Bortezomib, Dexamethasone (Standard)22Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        22
denoms
  1. counts
    1. group Id
      OG000
      value
      20
    units
    Participants
description
All adverse events are tracked during the course of the trial. Adverse events with a grade of 3-4 will be tracked and recorded.
groups
  1. description
    Patients receive bendamustine hydrochloride IV over 30 minutes on days 1 and 2; bortezomib SC on days 1, 8, 15, and 22; and dexamethasone PO on days 1, 8, 15, and 22. Treatment repeats every 35 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients achieving less than a VGPR or with more than 10% bone marrow plasmacytosis may receive 2 additional courses. Bendamustine hydrochloride: Given IV Bortezomib: Given SC Dexamethasone: Given PO
    id
    OG000
    title
    Bendamustine, Bortezomib, Dexamethasone (Standard)
param Type
NUMBER
population Description
4 were not evaluable - (1 didn't get any therapy on study, 1 received only first cycle and 2 developed medical issues that took them off study during the first cycle)
reporting Status
POSTED
time Frame
Up to 1 year
title
Incidence of Grade 3-4 Adverse Events From the Combination of Bendamustine Hydrochloride, Bortezomib, and Dexamethasone Based on the Common Terminology Criteria Version 4.0
type
SECONDARY
unit Of Measure
Adverse Events

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

Preserved source evidence · Not medical advice