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NCT03275285 · OUTCOME

Pharmacokinetics: Plasma Concentration of Isatuximab at Ctrough: Primary Analysis

Multinational Clinical Study Comparing Isatuximab, Carfilzomib And Dexamethasone To Carfilzomib And Dexamethasone In Relapse And/Or Refractory Multiple Myeloma Patients · Source last updated 2026-02-09

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

Measure
MEAN
Unit
mcg/mL
Interval / dispersion
Standard Deviation
Time frame
Pre-infusion on Cycle 1 Day 1, Day 8, Day 15 and Day 22, Cycle 2 Day 1, Cycle 3 Day 1, Cycle 4 Day 1, Cycle 5 Day 1, Cycle 6 Day 1, Cycle 7 Day 1, Cycle 8 Day 1, Cycle 9 Day 1 and Cycle 10 Day 1

What was measured

Ctrough was the plasma concentration observed just before treatment administration during repeated dosing.

Analysis population: Analysis was performed on PK population. Data for this OM was not planned to be collected and analyzed for Kd arm. Here,'Number analyzed' signifies participants with available data for each specified category.

Groups in this outcome

Isatuximab + Carfilzomib + Dexamethasone (IKd)

Participants received isatuximab 10 mg/kg, IV infusion on Days 1, 8, 15 and 22 in Cycle 1, and then on Days 1 and Day 15 of each 28-day treatment cycle plus carfilzomib 20 mg/m\^2, IV on Days 1, and 2 in Cycle 1, and then escalated to 56 mg/m\^2 on Days 8, 9, 15 and 16 of Cycle 1 and then on Days 1, 2, 8, 9, 15 and 16 of each subsequent 28-day treatment cycle and dexamethasone 20 mg, PO or IV on Day 1, 2, 8, 9, 15, 16, 22 and 23 of each 28-day treatment cycle until disease progression or unacceptable adverse event or participant's decision to discontinue the study treatment or any other reason, whichever comes first (maximum exposure: 111 weeks).

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

Analysis denominator · Participants

GroupSource count
Isatuximab + Carfilzomib + Dexamethasone (IKd)172

Reported measurements

Cycle 1 Day 1

Analysis denominator · Participants

GroupSource count
Isatuximab + Carfilzomib + Dexamethasone (IKd)166
Values in mcg/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Isatuximab + Carfilzomib + Dexamethasone (IKd)3.6634.40Not reportedNot reportedNot reported
Cycle 1 Day 8

Analysis denominator · Participants

GroupSource count
Isatuximab + Carfilzomib + Dexamethasone (IKd)152
Values in mcg/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Isatuximab + Carfilzomib + Dexamethasone (IKd)82.1443.87Not reportedNot reportedNot reported
Cycle 1 Day 15

Analysis denominator · Participants

GroupSource count
Isatuximab + Carfilzomib + Dexamethasone (IKd)144
Values in mcg/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Isatuximab + Carfilzomib + Dexamethasone (IKd)180.0271.83Not reportedNot reportedNot reported
Cycle 1 Day 22

Analysis denominator · Participants

GroupSource count
Isatuximab + Carfilzomib + Dexamethasone (IKd)147
Values in mcg/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Isatuximab + Carfilzomib + Dexamethasone (IKd)252.63100.16Not reportedNot reportedNot reported
Cycle 2 Day 1

Analysis denominator · Participants

GroupSource count
Isatuximab + Carfilzomib + Dexamethasone (IKd)130
Values in mcg/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Isatuximab + Carfilzomib + Dexamethasone (IKd)324.28132.98Not reportedNot reportedNot reported
Cycle 3 Day 1

Analysis denominator · Participants

GroupSource count
Isatuximab + Carfilzomib + Dexamethasone (IKd)145
Values in mcg/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Isatuximab + Carfilzomib + Dexamethasone (IKd)295.78146.11Not reportedNot reportedNot reported
Cycle 4 Day 1

Analysis denominator · Participants

GroupSource count
Isatuximab + Carfilzomib + Dexamethasone (IKd)137
Values in mcg/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Isatuximab + Carfilzomib + Dexamethasone (IKd)342.48140.94Not reportedNot reportedNot reported
Cycle 5 Day 1

Analysis denominator · Participants

GroupSource count
Isatuximab + Carfilzomib + Dexamethasone (IKd)135
Values in mcg/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Isatuximab + Carfilzomib + Dexamethasone (IKd)389.25172.11Not reportedNot reportedNot reported
Cycle 6 Day 1

Analysis denominator · Participants

GroupSource count
Isatuximab + Carfilzomib + Dexamethasone (IKd)130
Values in mcg/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Isatuximab + Carfilzomib + Dexamethasone (IKd)427.16188.51Not reportedNot reportedNot reported
Cycle 7 Day 1

Analysis denominator · Participants

GroupSource count
Isatuximab + Carfilzomib + Dexamethasone (IKd)123
Values in mcg/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Isatuximab + Carfilzomib + Dexamethasone (IKd)433.22177.11Not reportedNot reportedNot reported
Cycle 8 Day 1

Analysis denominator · Participants

GroupSource count
Isatuximab + Carfilzomib + Dexamethasone (IKd)118
Values in mcg/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Isatuximab + Carfilzomib + Dexamethasone (IKd)490.51198.17Not reportedNot reportedNot reported
Cycle 9 Day 1

Analysis denominator · Participants

GroupSource count
Isatuximab + Carfilzomib + Dexamethasone (IKd)113
Values in mcg/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Isatuximab + Carfilzomib + Dexamethasone (IKd)486.07181.34Not reportedNot reportedNot reported
Cycle 10 Day 1

Analysis denominator · Participants

GroupSource count
Isatuximab + Carfilzomib + Dexamethasone (IKd)100
Values in mcg/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Isatuximab + Carfilzomib + Dexamethasone (IKd)490.08206.53Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        34.40
        value
        3.66
    denoms
    1. counts
      1. group Id
        OG000
        value
        166
      units
      Participants
    title
    Cycle 1 Day 1
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        43.87
        value
        82.14
    denoms
    1. counts
      1. group Id
        OG000
        value
        152
      units
      Participants
    title
    Cycle 1 Day 8
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        71.83
        value
        180.02
    denoms
    1. counts
      1. group Id
        OG000
        value
        144
      units
      Participants
    title
    Cycle 1 Day 15
  4. categories
    1. measurements
      1. group Id
        OG000
        spread
        100.16
        value
        252.63
    denoms
    1. counts
      1. group Id
        OG000
        value
        147
      units
      Participants
    title
    Cycle 1 Day 22
  5. categories
    1. measurements
      1. group Id
        OG000
        spread
        132.98
        value
        324.28
    denoms
    1. counts
      1. group Id
        OG000
        value
        130
      units
      Participants
    title
    Cycle 2 Day 1
  6. categories
    1. measurements
      1. group Id
        OG000
        spread
        146.11
        value
        295.78
    denoms
    1. counts
      1. group Id
        OG000
        value
        145
      units
      Participants
    title
    Cycle 3 Day 1
  7. categories
    1. measurements
      1. group Id
        OG000
        spread
        140.94
        value
        342.48
    denoms
    1. counts
      1. group Id
        OG000
        value
        137
      units
      Participants
    title
    Cycle 4 Day 1
  8. categories
    1. measurements
      1. group Id
        OG000
        spread
        172.11
        value
        389.25
    denoms
    1. counts
      1. group Id
        OG000
        value
        135
      units
      Participants
    title
    Cycle 5 Day 1
  9. categories
    1. measurements
      1. group Id
        OG000
        spread
        188.51
        value
        427.16
    denoms
    1. counts
      1. group Id
        OG000
        value
        130
      units
      Participants
    title
    Cycle 6 Day 1
  10. categories
    1. measurements
      1. group Id
        OG000
        spread
        177.11
        value
        433.22
    denoms
    1. counts
      1. group Id
        OG000
        value
        123
      units
      Participants
    title
    Cycle 7 Day 1
  11. categories
    1. measurements
      1. group Id
        OG000
        spread
        198.17
        value
        490.51
    denoms
    1. counts
      1. group Id
        OG000
        value
        118
      units
      Participants
    title
    Cycle 8 Day 1
  12. categories
    1. measurements
      1. group Id
        OG000
        spread
        181.34
        value
        486.07
    denoms
    1. counts
      1. group Id
        OG000
        value
        113
      units
      Participants
    title
    Cycle 9 Day 1
denoms
  1. counts
    1. group Id
      OG000
      value
      172
    units
    Participants
description
Ctrough was the plasma concentration observed just before treatment administration during repeated dosing.
dispersion Type
Standard Deviation
groups
  1. description
    Participants received isatuximab 10 mg/kg, IV infusion on Days 1, 8, 15 and 22 in Cycle 1, and then on Days 1 and Day 15 of each 28-day treatment cycle plus carfilzomib 20 mg/m\^2, IV on Days 1, and 2 in Cycle 1, and then escalated to 56 mg/m\^2 on Days 8, 9, 15 and 16 of Cycle 1 and then on Days 1, 2, 8, 9, 15 and 16 of each subsequent 28-day treatment cycle and dexamethasone 20 mg, PO or IV on Day 1, 2, 8, 9, 15, 16, 22 and 23 of each 28-day treatment cycle until disease progression or unacceptable adverse event or participant's decision to discontinue the study treatment or any other reason, whichever comes first (maximum exposure: 111 weeks).
    id
    OG000
    title
    Isatuximab + Carfilzomib + Dexamethasone (IKd)
param Type
MEAN
population Description
Analysis was performed on PK population. Data for this OM was not planned to be collected and analyzed for Kd arm. Here,'Number analyzed' signifies participants with available data for each specified category.
reporting Status
POSTED
time Frame
Pre-infusion on Cycle 1 Day 1, Day 8, Day 15 and Day 22, Cycle 2 Day 1, Cycle 3 Day 1, Cycle 4 Day 1, Cycle 5 Day 1, Cycle 6 Day 1, Cycle 7 Day 1, Cycle 8 Day 1, Cycle 9 Day 1 and Cycle 10 Day 1
title
Pharmacokinetics: Plasma Concentration of Isatuximab at Ctrough: Primary Analysis
type
SECONDARY
unit Of Measure
mcg/mL

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Preserved source evidence · Not medical advice