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NCT03275285 · OUTCOME

Pharmacokinetics: Plasma Concentration at End of Infusion (Ceoi) of Isatuximab: 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
microgram/milliliter (mcg/mL)
Interval / dispersion
Standard Deviation
Time frame
End of infusion on Cycle 1 Day 1 and Cycle 1 Day 15; Cycle 2 Day 1

What was measured

Ceoi is the plasma concentration observed at the end of intravenous infusion.

Analysis population: Analysis was performed on pharmacokinetic (PK) population which included participants who received at least 1 dose of Isatuximab, with data for at least 1 PK parameter available. Data for this outcome measure (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)169
Values in microgram/milliliter (mcg/mL) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Isatuximab + Carfilzomib + Dexamethasone (IKd)274.01183.67Not reportedNot reportedNot reported
Cycle 1 Day 15

Analysis denominator · Participants

GroupSource count
Isatuximab + Carfilzomib + Dexamethasone (IKd)27
Values in microgram/milliliter (mcg/mL) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Isatuximab + Carfilzomib + Dexamethasone (IKd)380.2885.70Not reportedNot reportedNot reported
Cycle 2 Day 1

Analysis denominator · Participants

GroupSource count
Isatuximab + Carfilzomib + Dexamethasone (IKd)161
Values in microgram/milliliter (mcg/mL) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Isatuximab + Carfilzomib + Dexamethasone (IKd)522.74204.11Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        183.67
        value
        274.01
    denoms
    1. counts
      1. group Id
        OG000
        value
        169
      units
      Participants
    title
    Cycle 1 Day 1
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        85.70
        value
        380.28
    denoms
    1. counts
      1. group Id
        OG000
        value
        27
      units
      Participants
    title
    Cycle 1 Day 15
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        204.11
        value
        522.74
    denoms
    1. counts
      1. group Id
        OG000
        value
        161
      units
      Participants
    title
    Cycle 2 Day 1
denoms
  1. counts
    1. group Id
      OG000
      value
      172
    units
    Participants
description
Ceoi is the plasma concentration observed at the end of intravenous infusion.
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 pharmacokinetic (PK) population which included participants who received at least 1 dose of Isatuximab, with data for at least 1 PK parameter available. Data for this outcome measure (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
End of infusion on Cycle 1 Day 1 and Cycle 1 Day 15; Cycle 2 Day 1
title
Pharmacokinetics: Plasma Concentration at End of Infusion (Ceoi) of Isatuximab: Primary Analysis
type
SECONDARY
unit Of Measure
microgram/milliliter (mcg/mL)

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Preserved source evidence · Not medical advice