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NCT01090921 · OUTCOME

Number of Participants With Dose Reductions in Bortezomib, Dexamethasone or Both

Safety and Efficacy Study of Single Weekly Bortezomib in Newly Diagnosed Multiple Myeloma · Source last updated 2020-09-09

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
Data was collected for each subject for the duration of the participation in the study, which was an average of 4.8 cycles.

What was measured

To evaluate the toxicity (safety and tolerability) of weekly bortezomib + dexamethasone in patients with newly diagnosed multiple myeloma who are ineligible for transplant or who are eligible but wish to postpone autologous stem cell transplant.

Groups in this outcome

Bortezomib and Dexamethasone

Bortezomib is administered at a dose of 1.6mg/m2 IV push over 3 to 5 seconds. Treatment is administered once a week for four weeks followed by one week off. This 5 week period is considered a treatment cycle. Dexamethasone is also administered at a dose of 40mg daily on day of and day after each dose of Bortezomib, with a dose reduction to 20mg on the same schedule if the patient cannot tolerate the higher dose of dexamethasone. The study duration for a given subject will be approximately 30 weeks. Bortezomib: Bortezomib will be administered at a dose of 1.6 mg/m2 IV push. Treatment will be administered once a week for four weeks followed by one week off. This 5 week period is considered a treatment cycle. Dexamethasone will also be administered at a dose of 40mg on the day of and day after each dose of bortezomib, with a dose reduction to 20mg on the same schedule if the patient cannot tolerate the higher dose of dexamethasone.

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 Dexamethasone50

Reported measurements

Bortezomib reductions
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Bortezomib and Dexamethasone8Not reportedNot reportedNot reportedNot reported
Dexamethasone reductions
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Bortezomib and Dexamethasone14Not reportedNot reportedNot reportedNot reported
Bortezomib and Dexamethasone reductions
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Bortezomib and Dexamethasone4Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        8
    title
    Bortezomib reductions
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        14
    title
    Dexamethasone reductions
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        4
    title
    Bortezomib and Dexamethasone reductions
denoms
  1. counts
    1. group Id
      OG000
      value
      50
    units
    Participants
description
To evaluate the toxicity (safety and tolerability) of weekly bortezomib + dexamethasone in patients with newly diagnosed multiple myeloma who are ineligible for transplant or who are eligible but wish to postpone autologous stem cell transplant.
groups
  1. description
    Bortezomib is administered at a dose of 1.6mg/m2 IV push over 3 to 5 seconds. Treatment is administered once a week for four weeks followed by one week off. This 5 week period is considered a treatment cycle. Dexamethasone is also administered at a dose of 40mg daily on day of and day after each dose of Bortezomib, with a dose reduction to 20mg on the same schedule if the patient cannot tolerate the higher dose of dexamethasone. The study duration for a given subject will be approximately 30 weeks. Bortezomib: Bortezomib will be administered at a dose of 1.6 mg/m2 IV push. Treatment will be administered once a week for four weeks followed by one week off. This 5 week period is considered a treatment cycle. Dexamethasone will also be administered at a dose of 40mg on the day of and day after each dose of bortezomib, with a dose reduction to 20mg on the same schedule if the patient cannot tolerate the higher dose of dexamethasone.
    id
    OG000
    title
    Bortezomib and Dexamethasone
param Type
COUNT_OF_PARTICIPANTS
reporting Status
POSTED
time Frame
Data was collected for each subject for the duration of the participation in the study, which was an average of 4.8 cycles.
title
Number of Participants With Dose Reductions in Bortezomib, Dexamethasone or Both
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice