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NCT02990338 · OUTCOME

PK Parameter: Accumulation Ratio of Isatuximab at Trough Concentration (Ctrough)

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
Pre-infusion on Cycle 1 Day 8, Cycle 2 Day 1, and Cycle 4 Day 1

What was measured

Accumulation Ratio was defined as the ratio of Ctrough of Cycle 2 Day 1 versus Cycle 1 Day 8 and Cycle 4 Day 1 versus Cycle 1 Day 8, where Ctrough is the concentration prior to study drug administration.

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 C1D8

Analysis denominator · Participants

GroupSource count
IPd (Isatuximab + Pomalidomide + Dexamethasone)125
Values in ratio · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
IPd (Isatuximab + Pomalidomide + Dexamethasone)2.689734.5547Not reportedNot reportedNot reported
C4D1 versus C1D8

Analysis denominator · Participants

GroupSource count
IPd (Isatuximab + Pomalidomide + Dexamethasone)108
Values in ratio · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
IPd (Isatuximab + Pomalidomide + Dexamethasone)2.620645.4171Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        734.5547
        value
        2.689
    denoms
    1. counts
      1. group Id
        OG000
        value
        125
      units
      Participants
    title
    C2D1 versus C1D8
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        645.4171
        value
        2.620
    denoms
    1. counts
      1. group Id
        OG000
        value
        108
      units
      Participants
    title
    C4D1 versus C1D8
denoms
  1. counts
    1. group Id
      OG000
      value
      149
    units
    Participants
description
Accumulation Ratio was defined as the ratio of Ctrough of Cycle 2 Day 1 versus Cycle 1 Day 8 and Cycle 4 Day 1 versus Cycle 1 Day 8, where Ctrough is the concentration prior to study drug administration.
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
Pre-infusion on Cycle 1 Day 8, Cycle 2 Day 1, and Cycle 4 Day 1
title
PK Parameter: Accumulation Ratio of Isatuximab at Trough Concentration (Ctrough)
type
SECONDARY
unit Of Measure
ratio

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

Preserved source evidence · Not medical advice