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NCT00366106 · OUTCOME

Number of Participants With Treatment Response

Alternative Schedule of Velcade/Dexamethasone Plus Doxil for Patients With Multiple Myeloma · Source last updated 2012-04-06

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

Measure
NUMBER
Unit
Participants
Interval / dispersion
Not reported
Time frame
Every 8 weeks from start of treatment until end of treatment

What was measured

Complete Response (CR), Partial Response (PR), and Minor Response (MR) each required stable bone disease and normal calcium levels. CR also required 100% serum protein electrophoresis (SPEP) reduction, negative immunofixation (IF), 100% urine protein electrophoresis (UPEP)reduction, and \<5% plasma cells in bone marrow. PR also required \>=50% SPEP reduction, \>=90% UPEP reduction, and \>=50% reduction in plasma cells in bone marrow. MR also required \>=25% SPEP reduction, \>=50% UPEP reduction, and \> 25% reduction in plasma cells.

Groups in this outcome

Treatment Group

All subjects received bortezomib 1.3mg/m\^2 on Days 1, 4, 15, and 18 every 28 days and dexamethasone 20mg daily on Days 1, 2, 4, 5, 15, 16, 18, and 19 every 28 days. Following US FDA approval of doxorubicin HCl liposome injection in combination with bortezomib in May 2007, the study was amended to allow combination treatment with both bortezomib and doxorubicin HCl liposome injection 30 mg/m\^2 on Day 4 every 28 days with dexamethasone. The target goal was 8 cycles 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
Treatment Group32

Reported measurements

Source class 1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Treatment GroupNANot reportedNot reportedNot reportedWe were unable to assess participant response to treatment due to missingness of data required for determination of response.
Complete source fields
classes
  1. categories
    1. measurements
      1. comment
        We were unable to assess participant response to treatment due to missingness of data required for determination of response.
        group Id
        OG000
        value
        NA
denoms
  1. counts
    1. group Id
      OG000
      value
      32
    units
    Participants
description
Complete Response (CR), Partial Response (PR), and Minor Response (MR) each required stable bone disease and normal calcium levels. CR also required 100% serum protein electrophoresis (SPEP) reduction, negative immunofixation (IF), 100% urine protein electrophoresis (UPEP)reduction, and \<5% plasma cells in bone marrow. PR also required \>=50% SPEP reduction, \>=90% UPEP reduction, and \>=50% reduction in plasma cells in bone marrow. MR also required \>=25% SPEP reduction, \>=50% UPEP reduction, and \> 25% reduction in plasma cells.
groups
  1. description
    All subjects received bortezomib 1.3mg/m\^2 on Days 1, 4, 15, and 18 every 28 days and dexamethasone 20mg daily on Days 1, 2, 4, 5, 15, 16, 18, and 19 every 28 days. Following US FDA approval of doxorubicin HCl liposome injection in combination with bortezomib in May 2007, the study was amended to allow combination treatment with both bortezomib and doxorubicin HCl liposome injection 30 mg/m\^2 on Day 4 every 28 days with dexamethasone. The target goal was 8 cycles of treatment.
    id
    OG000
    title
    Treatment Group
param Type
NUMBER
reporting Status
POSTED
time Frame
Every 8 weeks from start of treatment until end of treatment
title
Number of Participants With Treatment Response
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice