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NCT01568866 · OUTCOME

Change From Baseline in Right Ventricular Fractional Area Change (FAC)

Phase 3 Study With Carfilzomib and Dexamethasone Versus Bortezomib and Dexamethasone for Relapsed Multiple Myeloma Patients · Source last updated 2022-11-14

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

Measure
MEAN
Unit
percent fractional area change
Interval / dispersion
Standard Deviation
Time frame
Baseline and Weeks 12, 24 and 36 and at end of treatment (median duration of treatment was 27 weeks in the bortezomib group and 40 weeks in the carfilzomib treatment group).

What was measured

Right ventricular function was assessed by measuring fractional area change (FAC) on echocardiogram.

Analysis population: Cardiopulmonary Safety Evaluable subgroup with available FAC data at baseline; "n" indicates participants whose results were available at both the baseline and the specified post-baseline visit.

Groups in this outcome

Bortezomib + DEX

Participants received bortezomib 1.3 mg/m² administered intravenously (IV) or subcutaneously (SC) on Days 1, 4, 8, and 11 of a 21-day cycle plus dexamethasone (DEX) 20 mg administered on Days 1, 2, 4, 5, 8, 9, 11, and 12 of each 21-day cycle.

Carfilzomib + DEX

Participants received 20 mg/m² carfilzomib administered by IV infusion on Days 1 and 2 of Cycle 1, followed by 56 mg/m² on Days 8, 9, 15, and 16 of Cycle 1 and for each 28-day cycle thereafter. Additionally, participants received 20 mg dexamethasone on Days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28 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
Bortezomib + DEX52
Carfilzomib + DEX55

Reported measurements

Week 12 (n=40, 40)
Values in percent fractional area change · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Bortezomib + DEX-0.75.00Not reportedNot reportedNot reported
Carfilzomib + DEX-1.15.36Not reportedNot reportedNot reported
Week 24 (n=26, 31)
Values in percent fractional area change · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Bortezomib + DEX0.76.10Not reportedNot reportedNot reported
Carfilzomib + DEX-1.05.03Not reportedNot reportedNot reported
Week 36 (n=15, 18)
Values in percent fractional area change · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Bortezomib + DEX-0.57.27Not reportedNot reportedNot reported
Carfilzomib + DEX-0.56.38Not reportedNot reportedNot reported
End of Treatment (n=23, 18)
Values in percent fractional area change · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Bortezomib + DEX0.44.73Not reportedNot reportedNot reported
Carfilzomib + DEX-1.95.47Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        5.00
        value
        -0.7
      2. group Id
        OG001
        spread
        5.36
        value
        -1.1
    title
    Week 12 (n=40, 40)
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        6.10
        value
        0.7
      2. group Id
        OG001
        spread
        5.03
        value
        -1.0
    title
    Week 24 (n=26, 31)
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        7.27
        value
        -0.5
      2. group Id
        OG001
        spread
        6.38
        value
        -0.5
    title
    Week 36 (n=15, 18)
  4. categories
    1. measurements
      1. group Id
        OG000
        spread
        4.73
        value
        0.4
      2. group Id
        OG001
        spread
        5.47
        value
        -1.9
    title
    End of Treatment (n=23, 18)
denoms
  1. counts
    1. group Id
      OG000
      value
      52
    2. group Id
      OG001
      value
      55
    units
    Participants
description
Right ventricular function was assessed by measuring fractional area change (FAC) on echocardiogram.
dispersion Type
Standard Deviation
groups
  1. description
    Participants received bortezomib 1.3 mg/m² administered intravenously (IV) or subcutaneously (SC) on Days 1, 4, 8, and 11 of a 21-day cycle plus dexamethasone (DEX) 20 mg administered on Days 1, 2, 4, 5, 8, 9, 11, and 12 of each 21-day cycle.
    id
    OG000
    title
    Bortezomib + DEX
  2. description
    Participants received 20 mg/m² carfilzomib administered by IV infusion on Days 1 and 2 of Cycle 1, followed by 56 mg/m² on Days 8, 9, 15, and 16 of Cycle 1 and for each 28-day cycle thereafter. Additionally, participants received 20 mg dexamethasone on Days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28 day cycle.
    id
    OG001
    title
    Carfilzomib + DEX
param Type
MEAN
population Description
Cardiopulmonary Safety Evaluable subgroup with available FAC data at baseline; "n" indicates participants whose results were available at both the baseline and the specified post-baseline visit.
reporting Status
POSTED
time Frame
Baseline and Weeks 12, 24 and 36 and at end of treatment (median duration of treatment was 27 weeks in the bortezomib group and 40 weeks in the carfilzomib treatment group).
title
Change From Baseline in Right Ventricular Fractional Area Change (FAC)
type
SECONDARY
unit Of Measure
percent fractional area change

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

Preserved source evidence · Not medical advice