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NCT00983346 · OUTCOME

Bone Anabolic Effect of Bortezomib in Patients With Smoldering Myeloma.

Effect of Low Dose Bortezomib on Bone Formation in Smoldering Myeloma Patients · Source last updated 2016-07-11

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

Measure
NUMBER
Unit
Percentage of Baseline Value
Interval / dispersion
Not reported
Time frame
Baseline and 6 weeks

What was measured

The primary endpoint is the change in bone Alkaline Phosphatase at baseline and 6 weeks.

Analysis population: Only 13 patents had bone alkaline phosphatase measured at the appropriate time points out of the 17 that completed the study

Groups in this outcome

Arm 1 Bortezomib

All participants enrolled. Bortezomib: Bortezomib will be administered as a 3-5 second bolus IV injection at the dose of 0.7 mg/m2 on days 1, 8, 15, and 22 of each 42 day cycle. Patients will undergo nine 42-day cycles. At the end of this (day 378), patients will be assessed for bone remodeling changes. Evaluation for toxicities will be evaluated at the beginning of each cycle.

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

Analysis denominator · Participants

GroupSource count
Arm 1 Bortezomib13

Reported measurements

% Base Line Patient 1
Values in Percentage of Baseline Value · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Arm 1 Bortezomib178Not reportedNot reportedNot reportedNot reported
% Base Line Patient 3
Values in Percentage of Baseline Value · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Arm 1 Bortezomib105Not reportedNot reportedNot reportedNot reported
% Base Line Patient 4
Values in Percentage of Baseline Value · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Arm 1 Bortezomib105Not reportedNot reportedNot reportedNot reported
% Base Line Patient 6
Values in Percentage of Baseline Value · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Arm 1 Bortezomib99Not reportedNot reportedNot reportedNot reported
% Base Line Patient 7
Values in Percentage of Baseline Value · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Arm 1 Bortezomib95Not reportedNot reportedNot reportedNot reported
% Base Line Patient 8
Values in Percentage of Baseline Value · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Arm 1 Bortezomib119Not reportedNot reportedNot reportedNot reported
% Base Line Patient 10
Values in Percentage of Baseline Value · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Arm 1 Bortezomib128Not reportedNot reportedNot reportedNot reported
% Base Line Patient 11
Values in Percentage of Baseline Value · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Arm 1 Bortezomib84Not reportedNot reportedNot reportedNot reported
% Base Line Patient 13
Values in Percentage of Baseline Value · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Arm 1 Bortezomib125Not reportedNot reportedNot reportedNot reported
% Base Line Patient 14
Values in Percentage of Baseline Value · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Arm 1 Bortezomib120Not reportedNot reportedNot reportedNot reported
% Base Line Patient 15
Values in Percentage of Baseline Value · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Arm 1 Bortezomib96Not reportedNot reportedNot reportedNot reported
% Base Line Patient 16
Values in Percentage of Baseline Value · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Arm 1 Bortezomib98Not reportedNot reportedNot reportedNot reported
% Base Line Patient 17
Values in Percentage of Baseline Value · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Arm 1 Bortezomib431Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        178
    title
    % Base Line Patient 1
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        105
    title
    % Base Line Patient 3
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        105
    title
    % Base Line Patient 4
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        99
    title
    % Base Line Patient 6
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        95
    title
    % Base Line Patient 7
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        119
    title
    % Base Line Patient 8
  7. categories
    1. measurements
      1. group Id
        OG000
        value
        128
    title
    % Base Line Patient 10
  8. categories
    1. measurements
      1. group Id
        OG000
        value
        84
    title
    % Base Line Patient 11
  9. categories
    1. measurements
      1. group Id
        OG000
        value
        125
    title
    % Base Line Patient 13
  10. categories
    1. measurements
      1. group Id
        OG000
        value
        120
    title
    % Base Line Patient 14
  11. categories
    1. measurements
      1. group Id
        OG000
        value
        96
    title
    % Base Line Patient 15
  12. categories
    1. measurements
      1. group Id
        OG000
        value
        98
    title
    % Base Line Patient 16
denoms
  1. counts
    1. group Id
      OG000
      value
      13
    units
    Participants
description
The primary endpoint is the change in bone Alkaline Phosphatase at baseline and 6 weeks.
groups
  1. description
    All participants enrolled. Bortezomib: Bortezomib will be administered as a 3-5 second bolus IV injection at the dose of 0.7 mg/m2 on days 1, 8, 15, and 22 of each 42 day cycle. Patients will undergo nine 42-day cycles. At the end of this (day 378), patients will be assessed for bone remodeling changes. Evaluation for toxicities will be evaluated at the beginning of each cycle.
    id
    OG000
    title
    Arm 1 Bortezomib
param Type
NUMBER
population Description
Only 13 patents had bone alkaline phosphatase measured at the appropriate time points out of the 17 that completed the study
reporting Status
POSTED
time Frame
Baseline and 6 weeks
title
Bone Anabolic Effect of Bortezomib in Patients With Smoldering Myeloma.
type
PRIMARY
unit Of Measure
Percentage of Baseline Value

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

Preserved source evidence · Not medical advice