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NCT02812706 · OUTCOME

Phase 2: Trough Plasma Concentrations (Ctrough) of Isatuximab

Isatuximab Single Agent Study in Japanese Relapsed AND Refractory Multiple Myeloma Patients · Source last updated 2024-04-01

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

Measure
MEAN
Unit
micrograms per milliliter
Interval / dispersion
Standard Deviation
Time frame
Pre-infusion on C1 D8, C1 D15, C1 D22, C2 D1, C2 D15, C3 D1, C3 D15, C4 D1, C4 D15, C5 D1, C5 D15, C6 D1, C6 D15, C7 D1, C7 D15, C8 D1, C8 D15, C9 D1, C9 D15, C10 D1, C10 D15

What was measured

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

Analysis population: Analysis was performed on PK population. Here, "Number analyzed" = participants with available data for each specified category.

Groups in this outcome

Phase 2: Isatuximab 20 mg/kg

Participants received Isatuximab 20 mg/kg IV infusion, QW for 4 weeks (i.e., on Day 1, Day 8, Day 15 and Day 22 of Cycle 1), and then Q2W (i.e., on Day 1 and 15) for subsequent treatment cycles (each cycle of 28 days) until unacceptable AEs, disease progression, or any other reason for discontinuation whichever occurs first (maximum duration of exposure: 248 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
Phase 2: Isatuximab 20 mg/kg28

Reported measurements

Cycle 1 Day 8

Analysis denominator · Participants

GroupSource count
Phase 2: Isatuximab 20 mg/kg27
Values in micrograms per milliliter · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Phase 2: Isatuximab 20 mg/kg376.34666.40Not reportedNot reportedNot reported
Cycle 1 Day 15

Analysis denominator · Participants

GroupSource count
Phase 2: Isatuximab 20 mg/kg26
Values in micrograms per milliliter · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Phase 2: Isatuximab 20 mg/kg662.521283.39Not reportedNot reportedNot reported
Cycle 1 Day 22

Analysis denominator · Participants

GroupSource count
Phase 2: Isatuximab 20 mg/kg27
Values in micrograms per milliliter · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Phase 2: Isatuximab 20 mg/kg604.17996.78Not reportedNot reportedNot reported
Cycle 2 Day 1

Analysis denominator · Participants

GroupSource count
Phase 2: Isatuximab 20 mg/kg24
Values in micrograms per milliliter · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Phase 2: Isatuximab 20 mg/kg927.631194.16Not reportedNot reportedNot reported
Cycle 2 Day 15

Analysis denominator · Participants

GroupSource count
Phase 2: Isatuximab 20 mg/kg23
Values in micrograms per milliliter · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Phase 2: Isatuximab 20 mg/kg826.15958.75Not reportedNot reportedNot reported
Cycle 3 Day 1

Analysis denominator · Participants

GroupSource count
Phase 2: Isatuximab 20 mg/kg24
Values in micrograms per milliliter · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Phase 2: Isatuximab 20 mg/kg734.39675.85Not reportedNot reportedNot reported
Cycle 3 Day 15

Analysis denominator · Participants

GroupSource count
Phase 2: Isatuximab 20 mg/kg20
Values in micrograms per milliliter · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Phase 2: Isatuximab 20 mg/kg689.85715.21Not reportedNot reportedNot reported
Cycle 4 Day 1

Analysis denominator · Participants

GroupSource count
Phase 2: Isatuximab 20 mg/kg17
Values in micrograms per milliliter · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Phase 2: Isatuximab 20 mg/kg723.76802.83Not reportedNot reportedNot reported
Cycle 4 Day 15

Analysis denominator · Participants

GroupSource count
Phase 2: Isatuximab 20 mg/kg17
Values in micrograms per milliliter · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Phase 2: Isatuximab 20 mg/kg619.35356.21Not reportedNot reportedNot reported
Cycle 5 Day 1

Analysis denominator · Participants

GroupSource count
Phase 2: Isatuximab 20 mg/kg17
Values in micrograms per milliliter · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Phase 2: Isatuximab 20 mg/kg647.24338.97Not reportedNot reportedNot reported
Cycle 5 Day 15

Analysis denominator · Participants

GroupSource count
Phase 2: Isatuximab 20 mg/kg16
Values in micrograms per milliliter · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Phase 2: Isatuximab 20 mg/kg683.90391.48Not reportedNot reportedNot reported
Cycle 6 Day 1

Analysis denominator · Participants

GroupSource count
Phase 2: Isatuximab 20 mg/kg15
Values in micrograms per milliliter · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Phase 2: Isatuximab 20 mg/kg674.20439.78Not reportedNot reportedNot reported
Cycle 6 Day 15

Analysis denominator · Participants

GroupSource count
Phase 2: Isatuximab 20 mg/kg14
Values in micrograms per milliliter · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Phase 2: Isatuximab 20 mg/kg742.93420.34Not reportedNot reportedNot reported
Cycle 7 Day 1

Analysis denominator · Participants

GroupSource count
Phase 2: Isatuximab 20 mg/kg12
Values in micrograms per milliliter · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Phase 2: Isatuximab 20 mg/kg733.83373.26Not reportedNot reportedNot reported
Cycle 7 Day 15

Analysis denominator · Participants

GroupSource count
Phase 2: Isatuximab 20 mg/kg11
Values in micrograms per milliliter · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Phase 2: Isatuximab 20 mg/kg786.27331.38Not reportedNot reportedNot reported
Cycle 8 Day 1

Analysis denominator · Participants

GroupSource count
Phase 2: Isatuximab 20 mg/kg11
Values in micrograms per milliliter · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Phase 2: Isatuximab 20 mg/kg870.09443.79Not reportedNot reportedNot reported
Cycle 8 Day 15

Analysis denominator · Participants

GroupSource count
Phase 2: Isatuximab 20 mg/kg9
Values in micrograms per milliliter · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Phase 2: Isatuximab 20 mg/kg1004.00463.82Not reportedNot reportedNot reported
Cycle 9 Day 1

Analysis denominator · Participants

GroupSource count
Phase 2: Isatuximab 20 mg/kg8
Values in micrograms per milliliter · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Phase 2: Isatuximab 20 mg/kg946.25369.91Not reportedNot reportedNot reported
Cycle 9 Day 15

Analysis denominator · Participants

GroupSource count
Phase 2: Isatuximab 20 mg/kg8
Values in micrograms per milliliter · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Phase 2: Isatuximab 20 mg/kg878.63313.39Not reportedNot reportedNot reported
Cycle 10 Day 1

Analysis denominator · Participants

GroupSource count
Phase 2: Isatuximab 20 mg/kg8
Values in micrograms per milliliter · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Phase 2: Isatuximab 20 mg/kg823.75314.95Not reportedNot reportedNot reported
Cycle 10 Day 15

Analysis denominator · Participants

GroupSource count
Phase 2: Isatuximab 20 mg/kg8
Values in micrograms per milliliter · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Phase 2: Isatuximab 20 mg/kg845.38322.48Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        666.40
        value
        376.34
    denoms
    1. counts
      1. group Id
        OG000
        value
        27
      units
      Participants
    title
    Cycle 1 Day 8
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        1283.39
        value
        662.52
    denoms
    1. counts
      1. group Id
        OG000
        value
        26
      units
      Participants
    title
    Cycle 1 Day 15
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        996.78
        value
        604.17
    denoms
    1. counts
      1. group Id
        OG000
        value
        27
      units
      Participants
    title
    Cycle 1 Day 22
  4. categories
    1. measurements
      1. group Id
        OG000
        spread
        1194.16
        value
        927.63
    denoms
    1. counts
      1. group Id
        OG000
        value
        24
      units
      Participants
    title
    Cycle 2 Day 1
  5. categories
    1. measurements
      1. group Id
        OG000
        spread
        958.75
        value
        826.15
    denoms
    1. counts
      1. group Id
        OG000
        value
        23
      units
      Participants
    title
    Cycle 2 Day 15
  6. categories
    1. measurements
      1. group Id
        OG000
        spread
        675.85
        value
        734.39
    denoms
    1. counts
      1. group Id
        OG000
        value
        24
      units
      Participants
    title
    Cycle 3 Day 1
  7. categories
    1. measurements
      1. group Id
        OG000
        spread
        715.21
        value
        689.85
    denoms
    1. counts
      1. group Id
        OG000
        value
        20
      units
      Participants
    title
    Cycle 3 Day 15
  8. categories
    1. measurements
      1. group Id
        OG000
        spread
        802.83
        value
        723.76
    denoms
    1. counts
      1. group Id
        OG000
        value
        17
      units
      Participants
    title
    Cycle 4 Day 1
  9. categories
    1. measurements
      1. group Id
        OG000
        spread
        356.21
        value
        619.35
    denoms
    1. counts
      1. group Id
        OG000
        value
        17
      units
      Participants
    title
    Cycle 4 Day 15
  10. categories
    1. measurements
      1. group Id
        OG000
        spread
        338.97
        value
        647.24
    denoms
    1. counts
      1. group Id
        OG000
        value
        17
      units
      Participants
    title
    Cycle 5 Day 1
  11. categories
    1. measurements
      1. group Id
        OG000
        spread
        391.48
        value
        683.90
    denoms
    1. counts
      1. group Id
        OG000
        value
        16
      units
      Participants
    title
    Cycle 5 Day 15
  12. categories
    1. measurements
      1. group Id
        OG000
        spread
        439.78
        value
        674.20
    denoms
    1. counts
      1. group Id
        OG000
        value
        15
      units
      Participants
    title
    Cycle 6 Day 1
denoms
  1. counts
    1. group Id
      OG000
      value
      28
    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 20 mg/kg IV infusion, QW for 4 weeks (i.e., on Day 1, Day 8, Day 15 and Day 22 of Cycle 1), and then Q2W (i.e., on Day 1 and 15) for subsequent treatment cycles (each cycle of 28 days) until unacceptable AEs, disease progression, or any other reason for discontinuation whichever occurs first (maximum duration of exposure: 248 weeks).
    id
    OG000
    title
    Phase 2: Isatuximab 20 mg/kg
param Type
MEAN
population Description
Analysis was performed on PK population. Here, "Number analyzed" = participants with available data for each specified category.
reporting Status
POSTED
time Frame
Pre-infusion on C1 D8, C1 D15, C1 D22, C2 D1, C2 D15, C3 D1, C3 D15, C4 D1, C4 D15, C5 D1, C5 D15, C6 D1, C6 D15, C7 D1, C7 D15, C8 D1, C8 D15, C9 D1, C9 D15, C10 D1, C10 D15
title
Phase 2: Trough Plasma Concentrations (Ctrough) of Isatuximab
type
SECONDARY
unit Of Measure
micrograms per milliliter

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice