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NCT02990338 · OUTCOME

Pharmacokinetic Parameter: Accumulation Ratio of Isatuximab at Concentration at the End of Infusion (CEOI)

Multinational Clinical Study Comparing Isatuximab, Pomalidomide, and Dexamethasone to Pomalidomide and Dexamethasone in Refractory or Relapsed and Refractory Multiple Myeloma Patients · Source last updated 2025-01-17

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

Measure
GEOMETRIC_MEAN
Unit
ratio
Interval / dispersion
Geometric Coefficient of Variation
Time frame
End of infusion on Cycle 1 Day 1, Cycle 2 Day 1, and Cycle 4 Day 1

What was measured

Accumulation Ratio was defined as the ratio of CEOI of Cycle 2 Day 1 versus Cycle 1 Day 1 and Cycle 4 Day 1 versus Cycle 1 Day 1, where CEOI was the plasma concentration at the end of infusion.

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

Groups in this outcome

IPd (Isatuximab + Pomalidomide + Dexamethasone)

Participants received isatuximab 10 mg/kg IV infusion on Days 1, 8, 15, and 22 at Cycle 1, and then on Days 1 and 15 of subsequent cycles plus pomalidomide 4 mg PO on Days 1 to 21 of each 28-day treatment cycle and dexamethasone 40 mg (participants \>= 75 years of age received 20 mg dexamethasone), PO or IV on Day 1, 8, 15, 22 of each 28-day treatment cycle until disease progression or unacceptable toxicity or participant's wish to discontinue study treatment, or any other reason, whichever comes first (maximum exposure: 76.7 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
IPd (Isatuximab + Pomalidomide + Dexamethasone)149

Reported measurements

C2D1 versus C1D1

Analysis denominator · Participants

GroupSource count
IPd (Isatuximab + Pomalidomide + Dexamethasone)130
Values in ratio · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
IPd (Isatuximab + Pomalidomide + Dexamethasone)1.860170.9185Not reportedNot reportedNot reported
C4D1 versus C1D1

Analysis denominator · Participants

GroupSource count
IPd (Isatuximab + Pomalidomide + Dexamethasone)112
Values in ratio · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
IPd (Isatuximab + Pomalidomide + Dexamethasone)1.777224.2542Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        170.9185
        value
        1.860
    denoms
    1. counts
      1. group Id
        OG000
        value
        130
      units
      Participants
    title
    C2D1 versus C1D1
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        224.2542
        value
        1.777
    denoms
    1. counts
      1. group Id
        OG000
        value
        112
      units
      Participants
    title
    C4D1 versus C1D1
denoms
  1. counts
    1. group Id
      OG000
      value
      149
    units
    Participants
description
Accumulation Ratio was defined as the ratio of CEOI of Cycle 2 Day 1 versus Cycle 1 Day 1 and Cycle 4 Day 1 versus Cycle 1 Day 1, where CEOI was the plasma concentration at the end of infusion.
dispersion Type
Geometric Coefficient of Variation
groups
  1. description
    Participants received isatuximab 10 mg/kg IV infusion on Days 1, 8, 15, and 22 at Cycle 1, and then on Days 1 and 15 of subsequent cycles plus pomalidomide 4 mg PO on Days 1 to 21 of each 28-day treatment cycle and dexamethasone 40 mg (participants \>= 75 years of age received 20 mg dexamethasone), PO or IV on Day 1, 8, 15, 22 of each 28-day treatment cycle until disease progression or unacceptable toxicity or participant's wish to discontinue study treatment, or any other reason, whichever comes first (maximum exposure: 76.7 weeks).
    id
    OG000
    title
    IPd (Isatuximab + Pomalidomide + Dexamethasone)
param Type
GEOMETRIC_MEAN
population Description
Analysis was performed on PK population. Here, 'Number analyzed' = participants with available data for each specified category. Data for this OM was not planned to be collected and analyzed for Pd arm.
reporting Status
POSTED
time Frame
End of infusion on Cycle 1 Day 1, Cycle 2 Day 1, and Cycle 4 Day 1
title
Pharmacokinetic Parameter: Accumulation Ratio of Isatuximab at Concentration at the End of Infusion (CEOI)
type
SECONDARY
unit Of Measure
ratio

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Preserved source evidence · Not medical advice