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NCT00732641 · OUTCOME

Number of Participants With Progressive Disease(PD) or Relapse From CR

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

PD (for patients not in CR) required one or more of the following: * 25% increase in serum monoclonal paraprotein level, 24-hour urinary light chain excretion, or plasma cells; * Increase in size of existing or development of new bone lesions/soft tissue plasmacytomas; * Development of hypercalcemia. Relapse from CR required at least one of the following: * Reappearance of serum or urinary paraprotein; * \>5% plasma cells; * Development of new lytic bone lesions or soft tissue plasmacytomas or increase in the size of residual bone lesions; * Development of hypercalcemia.

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-2b36Not reportedNot reportedNot reportedNot reported
No Treatment47Not reportedNot reportedNot reportedNot reported
Month 18
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Peginterferon α-2b63Not reportedNot reportedNot reportedNot reported
No Treatment77Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        36
      2. group Id
        OG001
        value
        47
    title
    Month 9
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        63
      2. group Id
        OG001
        value
        77
    title
    Month 18
denoms
  1. counts
    1. group Id
      OG000
      value
      122
    2. group Id
      OG001
      value
      121
    units
    Participants
description
PD (for patients not in CR) required one or more of the following: * 25% increase in serum monoclonal paraprotein level, 24-hour urinary light chain excretion, or plasma cells; * Increase in size of existing or development of new bone lesions/soft tissue plasmacytomas; * Development of hypercalcemia. Relapse from CR required at least one of the following: * Reappearance of serum or urinary paraprotein; * \>5% plasma cells; * Development of new lytic bone lesions or soft tissue plasmacytomas or increase in the size of residual bone lesions; * Development of hypercalcemia.
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 Progressive Disease(PD) or Relapse From CR
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice