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NCT00635154 · OUTCOME

Number of Patients Who Are Progression-free and Alive at 6 Months

Anakinra With or Without Dexamethasone in Treating Patients With Smoldering or Indolent Multiple Myeloma · Source last updated 2018-06-07

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
at 6 months

What was measured

Disease stability was assessed by evaluating the proportion of participants who are progression free (and alive) at 6 months. Progression was defined as any one or more of the following: An increase of 25% from lowest confirmed response: * Serum M-component (absolute increase \>=1.0 g/dL) * Urine M-component (absolute increase \>=200 mg/24 hours) An increase of 50% above the lowest remission value in bone marrow plasmacytosis (absolute increase 25% bone marrow plasma cells) Development of new bone lesions or soft tissue plasmacytomas.

Groups in this outcome

Anakinra With/Without Dexamethasone

Not reported

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

Analysis denominator · Participants

GroupSource count
Anakinra With/Without Dexamethasone54

Reported measurements

Source class 1
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Anakinra With/Without Dexamethasone49Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        49
denoms
  1. counts
    1. group Id
      OG000
      value
      54
    units
    Participants
description
Disease stability was assessed by evaluating the proportion of participants who are progression free (and alive) at 6 months. Progression was defined as any one or more of the following: An increase of 25% from lowest confirmed response: * Serum M-component (absolute increase \>=1.0 g/dL) * Urine M-component (absolute increase \>=200 mg/24 hours) An increase of 50% above the lowest remission value in bone marrow plasmacytosis (absolute increase 25% bone marrow plasma cells) Development of new bone lesions or soft tissue plasmacytomas.
groups
  1. id
    OG000
    title
    Anakinra With/Without Dexamethasone
param Type
NUMBER
reporting Status
POSTED
time Frame
at 6 months
title
Number of Patients Who Are Progression-free and Alive at 6 Months
type
SECONDARY
unit Of Measure
participants

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

Preserved source evidence · Not medical advice