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NCT00722566 · OUTCOME

Number of Patients With Complete Response

A Study of Subcutaneous and Intravenous VELCADE in Patients With Previously Treated Multiple Myeloma · Source last updated 2011-10-10

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
Over 4 cycles (prior to the addition of dexamethasone)

What was measured

Disease response was measured according to European Group for Blood and Marrow Transplantation (EBMT) criteria with the addition of the response categories of nCR and VGPR. Complete response requires disappearance of monoclonal protein from the blood and urine and \<5% plasma cells in the bone marrow on at least 2 determinations for a minimum of 6 weeks.

Analysis population: The response-evaluable population was defined as subjects who received at least 1 dose of study drug and had measurable, secretory multiple myeloma, defined as a serum monoclonal IgG or IgM of ≥10 g/L or a serum monoclonal IgA or IgE ≥5 g/L, or a serum monoclonal IgD of ≥0.5g/L, or urine M-protein of ≥200 mg/24 hours, at study entry.

Groups in this outcome

VELCADE Subcutaneous

VELCADE 1.3 mg/m\^2 administered by subcutaneous injection on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles.

VELCADE Intravenous

VELCADE 1.3 mg/m\^2 administered by intravenous infusion on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles.

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

Analysis denominator · Participants

GroupSource count
VELCADE Subcutaneous145
VELCADE Intravenous73

Reported measurements

Source class 1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
VELCADE Subcutaneous9Not reportedNot reportedNot reportedNot reported
VELCADE Intravenous6Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        9
      2. group Id
        OG001
        value
        6
denoms
  1. counts
    1. group Id
      OG000
      value
      145
    2. group Id
      OG001
      value
      73
    units
    Participants
description
Disease response was measured according to European Group for Blood and Marrow Transplantation (EBMT) criteria with the addition of the response categories of nCR and VGPR. Complete response requires disappearance of monoclonal protein from the blood and urine and \<5% plasma cells in the bone marrow on at least 2 determinations for a minimum of 6 weeks.
groups
  1. description
    VELCADE 1.3 mg/m\^2 administered by subcutaneous injection on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles.
    id
    OG000
    title
    VELCADE Subcutaneous
  2. description
    VELCADE 1.3 mg/m\^2 administered by intravenous infusion on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles.
    id
    OG001
    title
    VELCADE Intravenous
param Type
NUMBER
population Description
The response-evaluable population was defined as subjects who received at least 1 dose of study drug and had measurable, secretory multiple myeloma, defined as a serum monoclonal IgG or IgM of ≥10 g/L or a serum monoclonal IgA or IgE ≥5 g/L, or a serum monoclonal IgD of ≥0.5g/L, or urine M-protein of ≥200 mg/24 hours, at study entry.
reporting Status
POSTED
time Frame
Over 4 cycles (prior to the addition of dexamethasone)
title
Number of Patients With Complete Response
type
SECONDARY
unit Of Measure
Participants

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice