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NCT01734928 · OUTCOME

Overall Response Rate by Independent Response Adjudication Committee (IRAC)

Safety and Efficacy of Pomalidomide, Bortezomib and Low-dose Dexamethasone in Subjects With Relapsed or Refractory Multiple Myeloma · Source last updated 2023-06-06

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

Measure
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
From randomization to progressive disease or death during the IRAC assessment period, up to approximately 42 months

What was measured

The ORR together with the relative proportions in each response category (ie, stringent CR \[sCR\], CR, very good PR \[VGPR\], PR, SD, and PD) by treatment using the IMWG criteria will be examined. Complete Response: Negative immunofixation on the serum and urine and disappearance of any soft tissue plasmacytomas and ≤ 5% plasma cells in bone marrow SCR: CR+ 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% or greater reduction in serum M-protein plus urine Mprotein level \< 100 mg per 24 hours PR: ≥ 50% reduction of serum M-Protein and reduction in 24-hour urinary M-protein by ≥ 90% or to \< 200 mg per 24 hours Progressive Disease: Please refer to Primary outcome measure for definition SD: Not meeting criteria for CR, VGPR, PR, or progressive disease

Analysis population: All randomized participants

Groups in this outcome

Treatment 1: POM+BTZ+LD-DEX

POM (Pomalidomide) * 4 mg/day on Days 1 to 14 of each 21-day treatment cycle BTZ (Bortezomib) * For Cycles 1 - 8: 1.3 mg/m2/dose on Days 1, 4, 8, and 11 of a 21-day cycle * For Cycles 9 onwards: 1.3 mg/m2/dose on Days 1 and 8 of a 21-day cycle DEX (Dexamethasone) * For Cycles 1 to 8, 20 mg/day (≤ 75 years old) or 10 mg/day (\> 75 years old) on Days 1, 2, 4, 5, 8, 9, 11 and 12 of a 21-day cycle. * For Cycles 9 and onward, 20 mg/day (≤ 75 years old) or 10 mg/day (\> 75 years old) on Days 1, 2, 8, and 9 of a 21-day cycle.

Treatment 2: BTZ+LD-DEX

BTZ ((Bortezomib) * For Cycles 1 - 8: 1.3 mg/m2/dose on Days 1, 4, 8, and 11 of a 21-day cycle * For Cycles 9 onwards: 1.3 mg/m2/dose on Days 1 and 8 of a 21-day cycle DEX (Dexamethasone) * For Cycles 1 to 8, 20 mg/day (≤ 75 years old) or 10 mg/day (\> 75 years old) on Days 1, 2, 4, 5, 8, 9, 11 and 12 of a 21-day cycle. * For Cycles 9 and onward, 20 mg/day (≤ 75 years old) or 10 mg/day (\> 75 years old) on Days 1, 2, 8, and 9 of a 21-day cycle.

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

Analysis denominator · Participants

GroupSource count
Treatment 1: POM+BTZ+LD-DEX281
Treatment 2: BTZ+LD-DEX278

Reported measurements

Stringent complete response
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Treatment 1: POM+BTZ+LD-DEX9Not reportedNot reportedNot reportedNot reported
Treatment 2: BTZ+LD-DEX2Not reportedNot reportedNot reportedNot reported
Complete Reponse
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Treatment 1: POM+BTZ+LD-DEX35Not reportedNot reportedNot reportedNot reported
Treatment 2: BTZ+LD-DEX9Not reportedNot reportedNot reportedNot reported
Very Good Partial Response
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Treatment 1: POM+BTZ+LD-DEX104Not reportedNot reportedNot reportedNot reported
Treatment 2: BTZ+LD-DEX40Not reportedNot reportedNot reportedNot reported
Partial Response
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Treatment 1: POM+BTZ+LD-DEX83Not reportedNot reportedNot reportedNot reported
Treatment 2: BTZ+LD-DEX88Not reportedNot reportedNot reportedNot reported
Stable Disease
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Treatment 1: POM+BTZ+LD-DEX32Not reportedNot reportedNot reportedNot reported
Treatment 2: BTZ+LD-DEX106Not reportedNot reportedNot reportedNot reported
Progressive Disease
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Treatment 1: POM+BTZ+LD-DEX11Not reportedNot reportedNot reportedNot reported
Treatment 2: BTZ+LD-DEX16Not reportedNot reportedNot reportedNot reported
Not Evaluable
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Treatment 1: POM+BTZ+LD-DEX7Not reportedNot reportedNot reportedNot reported
Treatment 2: BTZ+LD-DEX17Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        9
      2. group Id
        OG001
        value
        2
    title
    Stringent complete response
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        35
      2. group Id
        OG001
        value
        9
    title
    Complete Reponse
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        104
      2. group Id
        OG001
        value
        40
    title
    Very Good Partial Response
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        83
      2. group Id
        OG001
        value
        88
    title
    Partial Response
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        32
      2. group Id
        OG001
        value
        106
    title
    Stable Disease
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        11
      2. group Id
        OG001
        value
        16
    title
    Progressive Disease
  7. categories
    1. measurements
      1. group Id
        OG000
        value
        7
      2. group Id
        OG001
        value
        17
    title
    Not Evaluable
denoms
  1. counts
    1. group Id
      OG000
      value
      281
    2. group Id
      OG001
      value
      278
    units
    Participants
description
The ORR together with the relative proportions in each response category (ie, stringent CR \[sCR\], CR, very good PR \[VGPR\], PR, SD, and PD) by treatment using the IMWG criteria will be examined. Complete Response: Negative immunofixation on the serum and urine and disappearance of any soft tissue plasmacytomas and ≤ 5% plasma cells in bone marrow SCR: CR+ 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% or greater reduction in serum M-protein plus urine Mprotein level \< 100 mg per 24 hours PR: ≥ 50% reduction of serum M-Protein and reduction in 24-hour urinary M-protein by ≥ 90% or to \< 200 mg per 24 hours Progressive Disease: Please refer to Primary outcome measure for definition SD: Not meeting criteria for CR, VGPR, PR, or progressive disease
groups
  1. description
    POM (Pomalidomide) * 4 mg/day on Days 1 to 14 of each 21-day treatment cycle BTZ (Bortezomib) * For Cycles 1 - 8: 1.3 mg/m2/dose on Days 1, 4, 8, and 11 of a 21-day cycle * For Cycles 9 onwards: 1.3 mg/m2/dose on Days 1 and 8 of a 21-day cycle DEX (Dexamethasone) * For Cycles 1 to 8, 20 mg/day (≤ 75 years old) or 10 mg/day (\> 75 years old) on Days 1, 2, 4, 5, 8, 9, 11 and 12 of a 21-day cycle. * For Cycles 9 and onward, 20 mg/day (≤ 75 years old) or 10 mg/day (\> 75 years old) on Days 1, 2, 8, and 9 of a 21-day cycle.
    id
    OG000
    title
    Treatment 1: POM+BTZ+LD-DEX
  2. description
    BTZ ((Bortezomib) * For Cycles 1 - 8: 1.3 mg/m2/dose on Days 1, 4, 8, and 11 of a 21-day cycle * For Cycles 9 onwards: 1.3 mg/m2/dose on Days 1 and 8 of a 21-day cycle DEX (Dexamethasone) * For Cycles 1 to 8, 20 mg/day (≤ 75 years old) or 10 mg/day (\> 75 years old) on Days 1, 2, 4, 5, 8, 9, 11 and 12 of a 21-day cycle. * For Cycles 9 and onward, 20 mg/day (≤ 75 years old) or 10 mg/day (\> 75 years old) on Days 1, 2, 8, and 9 of a 21-day cycle.
    id
    OG001
    title
    Treatment 2: BTZ+LD-DEX
param Type
COUNT_OF_PARTICIPANTS
population Description
All randomized participants
reporting Status
POSTED
time Frame
From randomization to progressive disease or death during the IRAC assessment period, up to approximately 42 months
title
Overall Response Rate by Independent Response Adjudication Committee (IRAC)
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice