Skip to content
Triangle logo TriangleGet started
← Full study record

NCT00732641 · OUTCOME

Number of Participants With Partial Response (PR) to Treatment

Peginterferon α-2b as a Maintenance Therapy in Participants With Multiple Myeloma Who Responded to Induction Therapy (P01972-AM7) · Source last updated 2017-04-04

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
Month 9 & Month 18

What was measured

PR was defined as: * At least 50% reduction in the level of the serum monoclonal paraprotein, maintained for a minimum of 6 weeks; * Reduction in 24-hour urinary light chain excretion either by ≥ 90% or to \< 200 mg, maintained for a minimum of 6 weeks; * For patients with non-secretory myeloma only, ≥ 50% reduction in plasma cells in a bone marrow aspirate and on a trephine biopsy, if biopsy was performed, maintained for a minimum of 6 weeks; * At least 50% reduction in the size of soft tissue plasmacytomas; * No increase in size or number of lytic bone lesions.

Analysis population: Intent-to-treat population (those who received at least one dose of study drug)

Groups in this outcome

Peginterferon α-2b

Peginterferon α-2b 35 μg, weekly, subcutaneous (SC), until disease progression or relapse, or for up to a maximum of 5 years.

No Treatment

Participants were observed and received no 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
Peginterferon α-2b122
No Treatment121

Reported measurements

Month 9
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Peginterferon α-2b65Not reportedNot reportedNot reportedNot reported
No Treatment54Not reportedNot reportedNot reportedNot reported
Month 18
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Peginterferon α-2b45Not reportedNot reportedNot reportedNot reported
No Treatment29Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        65
      2. group Id
        OG001
        value
        54
    title
    Month 9
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        45
      2. group Id
        OG001
        value
        29
    title
    Month 18
denoms
  1. counts
    1. group Id
      OG000
      value
      122
    2. group Id
      OG001
      value
      121
    units
    Participants
description
PR was defined as: * At least 50% reduction in the level of the serum monoclonal paraprotein, maintained for a minimum of 6 weeks; * Reduction in 24-hour urinary light chain excretion either by ≥ 90% or to \< 200 mg, maintained for a minimum of 6 weeks; * For patients with non-secretory myeloma only, ≥ 50% reduction in plasma cells in a bone marrow aspirate and on a trephine biopsy, if biopsy was performed, maintained for a minimum of 6 weeks; * At least 50% reduction in the size of soft tissue plasmacytomas; * No increase in size or number of lytic bone lesions.
groups
  1. description
    Peginterferon α-2b 35 μg, weekly, subcutaneous (SC), until disease progression or relapse, or for up to a maximum of 5 years.
    id
    OG000
    title
    Peginterferon α-2b
  2. description
    Participants were observed and received no treatment
    id
    OG001
    title
    No Treatment
param Type
NUMBER
population Description
Intent-to-treat population (those who received at least one dose of study drug)
reporting Status
POSTED
time Frame
Month 9 & Month 18
title
Number of Participants With Partial Response (PR) to Treatment
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice