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NCT01315873 · OUTCOME

Toxicity of This Regimen.

Bortezomib and Bendamustine to Treat Relapsed/Refractory Myeloma · Source last updated 2018-02-07

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

Measure
Not reported
Unit
Not reported
Interval / dispersion
Not reported
Time frame
Every 4 weeks.

What was measured

Study toxicity will be measured on an ongoing basis, no less then once per 28-day cycle.

Analysis population: Participant data was not analyzed because PI left institution. Data were not available for analysis.

Groups in this outcome

Bortezomib and Bendamustine

Bendamustine: On days 1 and 4 of each cycle, bendamustine is given at 90 mg/m\^2 after bortezomib . Patients will be dose reduced to 75 mg/m\^2, and then to 60 mg/m\^2 bendamustine on days 1 and 4 if ANC is not \>1 x 10\^9/L and platelets are not \>50 x 10\^9/L on day 1 of each cycle. Patients will be treated until disease progression after at least one cycle of treatment. Bortezomib: On days 1 and 4 of each cycle, bortezomib is given first at 1.3 mg/m\^2 followed by bendamustine given at 90 mg/m\^2. Patients will be dose reduced to 75 mg/m\^2, and then to 60 mg/m\^2 bendamustine on days 1 and 4 if ANC is not \>1 x 10\^9/L and platelets are not \>50 x 10\^9/L on day 1 of each cycle. Patients will be treated until disease progression after at least one cycle of treatment.

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

Analysis denominator · Participants

GroupSource count
Bortezomib and Bendamustine0

Reported measurements

No numerical measurement classes were posted for this outcome. Missing is not zero.

Complete source fields
denoms
  1. counts
    1. group Id
      OG000
      value
      0
    units
    Participants
description
Study toxicity will be measured on an ongoing basis, no less then once per 28-day cycle.
groups
  1. description
    Bendamustine: On days 1 and 4 of each cycle, bendamustine is given at 90 mg/m\^2 after bortezomib . Patients will be dose reduced to 75 mg/m\^2, and then to 60 mg/m\^2 bendamustine on days 1 and 4 if ANC is not \>1 x 10\^9/L and platelets are not \>50 x 10\^9/L on day 1 of each cycle. Patients will be treated until disease progression after at least one cycle of treatment. Bortezomib: On days 1 and 4 of each cycle, bortezomib is given first at 1.3 mg/m\^2 followed by bendamustine given at 90 mg/m\^2. Patients will be dose reduced to 75 mg/m\^2, and then to 60 mg/m\^2 bendamustine on days 1 and 4 if ANC is not \>1 x 10\^9/L and platelets are not \>50 x 10\^9/L on day 1 of each cycle. Patients will be treated until disease progression after at least one cycle of treatment.
    id
    OG000
    title
    Bortezomib and Bendamustine
population Description
Participant data was not analyzed because PI left institution. Data were not available for analysis.
reporting Status
POSTED
time Frame
Every 4 weeks.
title
Toxicity of This Regimen.
type
SECONDARY

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

Preserved source evidence · Not medical advice