Skip to content
Triangle logo TriangleGet started
← Full study record

NCT00732641 · OUTCOME

Number of Participants With Minimal Response (MR) 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

MR was defined as: * A 25-49% reduction in the level of the serum monoclonal paraprotein maintained for a minimum of 6 weeks; * Reduction in the 24-hour urinary light chain excretion, which still exceeded 200mg/24 hours, maintained for a minimum of 6 weeks; * For patients with non-secretory myeloma only, 25-49% 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; * A 25-49% reduction in the size of soft tissue plasmacytomas; * No increase in the size or number of lityc 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-2b5Not reportedNot reportedNot reportedNot reported
No Treatment4Not reportedNot reportedNot reportedNot reported
Month 18
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Peginterferon α-2b1Not reportedNot reportedNot reportedNot reported
No Treatment3Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        5
      2. group Id
        OG001
        value
        4
    title
    Month 9
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        3
    title
    Month 18
denoms
  1. counts
    1. group Id
      OG000
      value
      122
    2. group Id
      OG001
      value
      121
    units
    Participants
description
MR was defined as: * A 25-49% reduction in the level of the serum monoclonal paraprotein maintained for a minimum of 6 weeks; * Reduction in the 24-hour urinary light chain excretion, which still exceeded 200mg/24 hours, maintained for a minimum of 6 weeks; * For patients with non-secretory myeloma only, 25-49% 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; * A 25-49% reduction in the size of soft tissue plasmacytomas; * No increase in the size or number of lityc 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 Minimal Response (MR) to Treatment
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice