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NCT02654132 · OUTCOME

Objective Response Rate (ORR)

An Investigational Immuno-therapy Trial of Pomalidomide and Low-dose Dexamethasone With or Without Elotuzumab to Treat Refractory and Relapsed and Refractory Multiple Myeloma (ELOQUENT-3) · Source last updated 2022-11-01

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
NUMBER
Unit
Percent of participants
Interval / dispersion
95% Confidence Interval
Time frame
From first dose to disease progression (up to approximately 21 months)

What was measured

ORR is defined as the percentage of participants who achieved a best overall response (BOR) of stringent complete response (sCR), complete response (CR), very good partial response (VGPR) or partial response (PR) using the modified International Myeloma Working Group (IMWG) criteria described as follows, as per investigator's assessment * CR: Negative immunofixation of serum and urine and disappearance of any soft tissue plasmacytomas, and \< 5% plasma cells in bone marrow * sCR: CR, as defined above, plus the following: Normal FLC ratio and absence of clonal cells in bone marrow by immunohistochemistry or immunofluorescence * VGPR: Serum and urine M-protein detectable by immunofixation but not on electrophoresis or \>= 90% reduction in serum M-protein level plus urine M-protein level \< 100 mg per 24 hour * PR: \>= 50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by \>= 90% or to \< 200 mg per 24 hour.

Analysis population: All randomized participants

Groups in this outcome

E-Pd Cohort

Elotuzumab + Pomalidomide + Dexamethasone

Pd Cohort

Pomalidomide + Dexamethasone

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

Analysis denominator · Participants

GroupSource count
E-Pd Cohort60
Pd Cohort57

Reported measurements

Source class 1
Values in Percent of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
E-Pd Cohort58.3Not reported44.970.9Not reported
Pd Cohort24.6Not reported14.137.8Not reported

Source statistical analyses

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

  1. ci Lower Limit
    2.05
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    10.43
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.0002
    param Type
    Odds Ratio (OR)
    param Value
    4.62
    statistical Method
    Cochran-Mantel-Haenszel
Complete source fields
analyses
  1. ci Lower Limit
    2.05
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    10.43
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.0002
    param Type
    Odds Ratio (OR)
    param Value
    4.62
    statistical Method
    Cochran-Mantel-Haenszel
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        44.9
        upper Limit
        70.9
        value
        58.3
      2. group Id
        OG001
        lower Limit
        14.1
        upper Limit
        37.8
        value
        24.6
denoms
  1. counts
    1. group Id
      OG000
      value
      60
    2. group Id
      OG001
      value
      57
    units
    Participants
description
ORR is defined as the percentage of participants who achieved a best overall response (BOR) of stringent complete response (sCR), complete response (CR), very good partial response (VGPR) or partial response (PR) using the modified International Myeloma Working Group (IMWG) criteria described as follows, as per investigator's assessment * CR: Negative immunofixation of serum and urine and disappearance of any soft tissue plasmacytomas, and \< 5% plasma cells in bone marrow * sCR: CR, as defined above, plus the following: Normal FLC ratio and absence of clonal cells in bone marrow by immunohistochemistry or immunofluorescence * VGPR: Serum and urine M-protein detectable by immunofixation but not on electrophoresis or \>= 90% reduction in serum M-protein level plus urine M-protein level \< 100 mg per 24 hour * PR: \>= 50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by \>= 90% or to \< 200 mg per 24 hour.
dispersion Type
95% Confidence Interval
groups
  1. description
    Elotuzumab + Pomalidomide + Dexamethasone
    id
    OG000
    title
    E-Pd Cohort
  2. description
    Pomalidomide + Dexamethasone
    id
    OG001
    title
    Pd Cohort
param Type
NUMBER
population Description
All randomized participants
reporting Status
POSTED
time Frame
From first dose to disease progression (up to approximately 21 months)
title
Objective Response Rate (ORR)
type
SECONDARY
unit Of Measure
Percent of participants

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice