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NCT00470093 · OUTCOME

Response Rate as Assessed by Number of Participants With Partial or Complete Response by Bladé Criteria.

Interferon Alfa and Interleukin-6 in Treating Patients With Recurrent Multiple Myeloma · Source last updated 2018-11-16

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
Up to 5 months

What was measured

Number of participants with partial or complete response by Bladé criteria where partial response is defined as a \>= 50% decrease in serum paraprotein or 90% decrease in urinary light chains (for participants without measurable serum paraprotein). Complete response is defined as negative serum and urine immunofixation and a bone marrow aspirate with \< 5% plasma cells.

Groups in this outcome

Interleukin-6 and Interferon-α

Subjects will be started on recombinant interferon-α at a dose of 3 million units SQ daily, escalating the dose by 1 million units every week as tolerated to a maximum dose of 3 million units/m2/day. Following a minimum of one month of interferon therapy with two weeks on a stable dose, subjects will begin recombinant interleukin-6 therapy at a dose of 2.5 ug/kg/day. recombinant interferon-α recombinant interleukin-6

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

Analysis denominator · Participants

GroupSource count
Interleukin-6 and Interferon-α2

Reported measurements

Source class 1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Interleukin-6 and Interferon-α0Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        0
denoms
  1. counts
    1. group Id
      OG000
      value
      2
    units
    Participants
description
Number of participants with partial or complete response by Bladé criteria where partial response is defined as a \>= 50% decrease in serum paraprotein or 90% decrease in urinary light chains (for participants without measurable serum paraprotein). Complete response is defined as negative serum and urine immunofixation and a bone marrow aspirate with \< 5% plasma cells.
groups
  1. description
    Subjects will be started on recombinant interferon-α at a dose of 3 million units SQ daily, escalating the dose by 1 million units every week as tolerated to a maximum dose of 3 million units/m2/day. Following a minimum of one month of interferon therapy with two weeks on a stable dose, subjects will begin recombinant interleukin-6 therapy at a dose of 2.5 ug/kg/day. recombinant interferon-α recombinant interleukin-6
    id
    OG000
    title
    Interleukin-6 and Interferon-α
param Type
COUNT_OF_PARTICIPANTS
reporting Status
POSTED
time Frame
Up to 5 months
title
Response Rate as Assessed by Number of Participants With Partial or Complete Response by Bladé Criteria.
type
PRIMARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice