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NCT00635154 · OUTCOME

Patients With Confirmed Response (Complete Response, Very Good Partial Response, Partial Response, or Minimal Response) on 2 Consecutive Months During the First 6 Months of Treatment With Anakinra Alone

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
6 months

What was measured

Response Definitions: * Complete Response(CR):disappearance of M-Protein from serum \& urine and immunofixation, \<5% bone marrow(BM) plasma cells \& disappearance of soft tissue plasmacytomas(STP); * Very Good Partial Response(VGPR):\>=90% decrease in serum M-Protein, Urine M-protein \<100 mg/24 hours, \<=5% BM plasma cells, disappearance of STP; * Partial response(PR):\>=50% reduction in serum M-protein, \>=90% decrease in Urine M-protein or \<200 mg/24 hours \& \>=50% decrease in STP; * Minor response(MR):25-49% decrease in serum M-protein, 50-89% decrease in urine M-protein \& 25-49% decrease in STP

Analysis population: Participants who met the eligibility criteria, signed the consent form and have began treatment were considered evaluable.

Groups in this outcome

Anakinra Without Dexamethasone

Patients in this outcome received only Anakinra (100mg daily subcutaneously administered).

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 Without Dexamethasone54

Reported measurements

Source class 1
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Anakinra Without Dexamethasone1Not reported0.510Not reported

Source statistical analyses

Group order, estimate direction, methods and comments are retained. No treatment ranking is inferred.

  1. ci Lower Limit
    0.5
    ci Pct Value
    95
    ci Upper Limit
    10
    estimate Comment
    95% Confidence intervals were calculated for the true confirmed response rate using properties of the binomial distribution.
    group Description
    Proportion of confirmed responses to Anakinra alone was estimated by the number of patients who achieved a confirmed response divided by the total number of assessable patients.
    group Ids
    1. OG000
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    param Type
    Proportion of confirmed responses (%)
    param Value
    1.8
Complete source fields
analyses
  1. ci Lower Limit
    0.5
    ci Pct Value
    95
    ci Upper Limit
    10
    estimate Comment
    95% Confidence intervals were calculated for the true confirmed response rate using properties of the binomial distribution.
    group Description
    Proportion of confirmed responses to Anakinra alone was estimated by the number of patients who achieved a confirmed response divided by the total number of assessable patients.
    group Ids
    1. OG000
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    param Type
    Proportion of confirmed responses (%)
    param Value
    1.8
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.5
        upper Limit
        10
        value
        1
denoms
  1. counts
    1. group Id
      OG000
      value
      54
    units
    Participants
description
Response Definitions: * Complete Response(CR):disappearance of M-Protein from serum \& urine and immunofixation, \<5% bone marrow(BM) plasma cells \& disappearance of soft tissue plasmacytomas(STP); * Very Good Partial Response(VGPR):\>=90% decrease in serum M-Protein, Urine M-protein \<100 mg/24 hours, \<=5% BM plasma cells, disappearance of STP; * Partial response(PR):\>=50% reduction in serum M-protein, \>=90% decrease in Urine M-protein or \<200 mg/24 hours \& \>=50% decrease in STP; * Minor response(MR):25-49% decrease in serum M-protein, 50-89% decrease in urine M-protein \& 25-49% decrease in STP
groups
  1. description
    Patients in this outcome received only Anakinra (100mg daily subcutaneously administered).
    id
    OG000
    title
    Anakinra Without Dexamethasone
param Type
NUMBER
population Description
Participants who met the eligibility criteria, signed the consent form and have began treatment were considered evaluable.
reporting Status
POSTED
time Frame
6 months
title
Patients With Confirmed Response (Complete Response, Very Good Partial Response, Partial Response, or Minimal Response) on 2 Consecutive Months During the First 6 Months of Treatment With Anakinra Alone
type
PRIMARY
unit Of Measure
participants

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

Preserved source evidence · Not medical advice