Skip to content
Triangle logo TriangleGet started
← Full study record

NCT02812706 · OUTCOME

Phase 1: 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 Cycle 1 Day 8 (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, C11 D1

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 and "0" in the number analyzed field signifies that no participants were available for analysis at specified timepoint.

Groups in this outcome

Phase 1, Cohort 1: Isatuximab 10 mg/kg

Participants received Isatuximab 10 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: 112 weeks).

Phase 1, Cohort 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: 137 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 1, Cohort 1: Isatuximab 10 mg/kg3
Phase 1, Cohort 2: Isatuximab 20 mg/kg5

Reported measurements

Cycle 1 Day 8

Analysis denominator · Participants

GroupSource count
Phase 1, Cohort 1: Isatuximab 10 mg/kg3
Phase 1, Cohort 2: Isatuximab 20 mg/kg5
Values in micrograms per milliliter · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Phase 1, Cohort 1: Isatuximab 10 mg/kg23.778.98Not reportedNot reportedNot reported
Phase 1, Cohort 2: Isatuximab 20 mg/kg78.5238.49Not reportedNot reportedNot reported
Cycle 1 Day 15

Analysis denominator · Participants

GroupSource count
Phase 1, Cohort 1: Isatuximab 10 mg/kg3
Phase 1, Cohort 2: Isatuximab 20 mg/kg4
Values in micrograms per milliliter · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Phase 1, Cohort 1: Isatuximab 10 mg/kg71.3322.87Not reportedNot reportedNot reported
Phase 1, Cohort 2: Isatuximab 20 mg/kg186.3369.29Not reportedNot reportedNot reported
Cycle 1 Day 22

Analysis denominator · Participants

GroupSource count
Phase 1, Cohort 1: Isatuximab 10 mg/kg3
Phase 1, Cohort 2: Isatuximab 20 mg/kg4
Values in micrograms per milliliter · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Phase 1, Cohort 1: Isatuximab 10 mg/kg124.8769.51Not reportedNot reportedNot reported
Phase 1, Cohort 2: Isatuximab 20 mg/kg254.0097.45Not reportedNot reportedNot reported
Cycle 2 Day 1

Analysis denominator · Participants

GroupSource count
Phase 1, Cohort 1: Isatuximab 10 mg/kg3
Phase 1, Cohort 2: Isatuximab 20 mg/kg4
Values in micrograms per milliliter · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Phase 1, Cohort 1: Isatuximab 10 mg/kg135.57125.10Not reportedNot reportedNot reported
Phase 1, Cohort 2: Isatuximab 20 mg/kg367.75127.45Not reportedNot reportedNot reported
Cycle 2 Day 15

Analysis denominator · Participants

GroupSource count
Phase 1, Cohort 1: Isatuximab 10 mg/kg2
Phase 1, Cohort 2: Isatuximab 20 mg/kg4
Values in micrograms per milliliter · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Phase 1, Cohort 1: Isatuximab 10 mg/kg167.80154.43Not reportedNot reportedNot reported
Phase 1, Cohort 2: Isatuximab 20 mg/kg419.08351.57Not reportedNot reportedNot reported
Cycle 3 Day 1

Analysis denominator · Participants

GroupSource count
Phase 1, Cohort 1: Isatuximab 10 mg/kg2
Phase 1, Cohort 2: Isatuximab 20 mg/kg4
Values in micrograms per milliliter · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Phase 1, Cohort 1: Isatuximab 10 mg/kg174.40184.70Not reportedNot reportedNot reported
Phase 1, Cohort 2: Isatuximab 20 mg/kg500.98426.78Not reportedNot reportedNot reported
Cycle 3 Day 15

Analysis denominator · Participants

GroupSource count
Phase 1, Cohort 1: Isatuximab 10 mg/kg2
Phase 1, Cohort 2: Isatuximab 20 mg/kg4
Values in micrograms per milliliter · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Phase 1, Cohort 1: Isatuximab 10 mg/kg193.50154.86Not reportedNot reportedNot reported
Phase 1, Cohort 2: Isatuximab 20 mg/kg347.75259.68Not reportedNot reportedNot reported
Cycle 4 Day 1

Analysis denominator · Participants

GroupSource count
Phase 1, Cohort 1: Isatuximab 10 mg/kg2
Phase 1, Cohort 2: Isatuximab 20 mg/kg4
Values in micrograms per milliliter · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Phase 1, Cohort 1: Isatuximab 10 mg/kg202.85172.75Not reportedNot reportedNot reported
Phase 1, Cohort 2: Isatuximab 20 mg/kg344.30286.74Not reportedNot reportedNot reported
Cycle 4 Day 15

Analysis denominator · Participants

GroupSource count
Phase 1, Cohort 1: Isatuximab 10 mg/kg2
Phase 1, Cohort 2: Isatuximab 20 mg/kg4
Values in micrograms per milliliter · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Phase 1, Cohort 1: Isatuximab 10 mg/kg184.85182.65Not reportedNot reportedNot reported
Phase 1, Cohort 2: Isatuximab 20 mg/kg392.63322.70Not reportedNot reportedNot reported
Cycle 5 Day 1

Analysis denominator · Participants

GroupSource count
Phase 1, Cohort 1: Isatuximab 10 mg/kg2
Phase 1, Cohort 2: Isatuximab 20 mg/kg3
Values in micrograms per milliliter · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Phase 1, Cohort 1: Isatuximab 10 mg/kg220.40228.54Not reportedNot reportedNot reported
Phase 1, Cohort 2: Isatuximab 20 mg/kg608.00351.93Not reportedNot reportedNot reported
Cycle 5 Day 15

Analysis denominator · Participants

GroupSource count
Phase 1, Cohort 1: Isatuximab 10 mg/kg2
Phase 1, Cohort 2: Isatuximab 20 mg/kg3
Values in micrograms per milliliter · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Phase 1, Cohort 1: Isatuximab 10 mg/kg233.00237.59Not reportedNot reportedNot reported
Phase 1, Cohort 2: Isatuximab 20 mg/kg581.33356.35Not reportedNot reportedNot reported
Cycle 6 Day 1

Analysis denominator · Participants

GroupSource count
Phase 1, Cohort 1: Isatuximab 10 mg/kg2
Phase 1, Cohort 2: Isatuximab 20 mg/kg3
Values in micrograms per milliliter · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Phase 1, Cohort 1: Isatuximab 10 mg/kg267.50280.72Not reportedNot reportedNot reported
Phase 1, Cohort 2: Isatuximab 20 mg/kg665.67385.34Not reportedNot reportedNot reported
Cycle 6 Day 15

Analysis denominator · Participants

GroupSource count
Phase 1, Cohort 1: Isatuximab 10 mg/kg2
Phase 1, Cohort 2: Isatuximab 20 mg/kg3
Values in micrograms per milliliter · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Phase 1, Cohort 1: Isatuximab 10 mg/kg160.60116.53Not reportedNot reportedNot reported
Phase 1, Cohort 2: Isatuximab 20 mg/kg714.33451.44Not reportedNot reportedNot reported
Cycle 7 Day 1

Analysis denominator · Participants

GroupSource count
Phase 1, Cohort 1: Isatuximab 10 mg/kg2
Phase 1, Cohort 2: Isatuximab 20 mg/kg3
Values in micrograms per milliliter · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Phase 1, Cohort 1: Isatuximab 10 mg/kg200.15165.25Not reportedNot reportedNot reported
Phase 1, Cohort 2: Isatuximab 20 mg/kg611.67342.27Not reportedNot reportedNot reported
Cycle 7 Day 15

Analysis denominator · Participants

GroupSource count
Phase 1, Cohort 1: Isatuximab 10 mg/kg2
Phase 1, Cohort 2: Isatuximab 20 mg/kg3
Values in micrograms per milliliter · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Phase 1, Cohort 1: Isatuximab 10 mg/kg254.50228.40Not reportedNot reportedNot reported
Phase 1, Cohort 2: Isatuximab 20 mg/kg641.67246.78Not reportedNot reportedNot reported
Cycle 8 Day 1

Analysis denominator · Participants

GroupSource count
Phase 1, Cohort 1: Isatuximab 10 mg/kg2
Phase 1, Cohort 2: Isatuximab 20 mg/kg3
Values in micrograms per milliliter · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Phase 1, Cohort 1: Isatuximab 10 mg/kg303.00278.60Not reportedNot reportedNot reported
Phase 1, Cohort 2: Isatuximab 20 mg/kg874.67408.85Not reportedNot reportedNot reported
Cycle 8 Day 15

Analysis denominator · Participants

GroupSource count
Phase 1, Cohort 1: Isatuximab 10 mg/kg2
Phase 1, Cohort 2: Isatuximab 20 mg/kg3
Values in micrograms per milliliter · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Phase 1, Cohort 1: Isatuximab 10 mg/kg242.5088.39Not reportedNot reportedNot reported
Phase 1, Cohort 2: Isatuximab 20 mg/kg789.67525.08Not reportedNot reportedNot reported
Cycle 9 Day 1

Analysis denominator · Participants

GroupSource count
Phase 1, Cohort 1: Isatuximab 10 mg/kg2
Phase 1, Cohort 2: Isatuximab 20 mg/kg3
Values in micrograms per milliliter · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Phase 1, Cohort 1: Isatuximab 10 mg/kg269.00147.08Not reportedNot reportedNot reported
Phase 1, Cohort 2: Isatuximab 20 mg/kg722.67379.50Not reportedNot reportedNot reported
Cycle 9 Day 15

Analysis denominator · Participants

GroupSource count
Phase 1, Cohort 1: Isatuximab 10 mg/kg2
Phase 1, Cohort 2: Isatuximab 20 mg/kg3
Values in micrograms per milliliter · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Phase 1, Cohort 1: Isatuximab 10 mg/kg444.00463.86Not reportedNot reportedNot reported
Phase 1, Cohort 2: Isatuximab 20 mg/kg758.33393.20Not reportedNot reportedNot reported
Cycle 10 Day 1

Analysis denominator · Participants

GroupSource count
Phase 1, Cohort 1: Isatuximab 10 mg/kg2
Phase 1, Cohort 2: Isatuximab 20 mg/kg3
Values in micrograms per milliliter · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Phase 1, Cohort 1: Isatuximab 10 mg/kg436.50441.94Not reportedNot reportedNot reported
Phase 1, Cohort 2: Isatuximab 20 mg/kg941.67576.67Not reportedNot reportedNot reported
Cycle 10 Day 15

Analysis denominator · Participants

GroupSource count
Phase 1, Cohort 1: Isatuximab 10 mg/kg2
Phase 1, Cohort 2: Isatuximab 20 mg/kg3
Values in micrograms per milliliter · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Phase 1, Cohort 1: Isatuximab 10 mg/kg684.00772.16Not reportedNot reportedNot reported
Phase 1, Cohort 2: Isatuximab 20 mg/kg1224.67719.96Not reportedNot reportedNot reported
Cycle 11 Day 1

Analysis denominator · Participants

GroupSource count
Phase 1, Cohort 1: Isatuximab 10 mg/kg1
Phase 1, Cohort 2: Isatuximab 20 mg/kg0
Values in micrograms per milliliter · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Phase 1, Cohort 1: Isatuximab 10 mg/kg592.00Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        8.98
        value
        23.77
      2. group Id
        OG001
        spread
        38.49
        value
        78.52
    denoms
    1. counts
      1. group Id
        OG000
        value
        3
      2. group Id
        OG001
        value
        5
      units
      Participants
    title
    Cycle 1 Day 8
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        22.87
        value
        71.33
      2. group Id
        OG001
        spread
        69.29
        value
        186.33
    denoms
    1. counts
      1. group Id
        OG000
        value
        3
      2. group Id
        OG001
        value
        4
      units
      Participants
    title
    Cycle 1 Day 15
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        69.51
        value
        124.87
      2. group Id
        OG001
        spread
        97.45
        value
        254.00
    denoms
    1. counts
      1. group Id
        OG000
        value
        3
      2. group Id
        OG001
        value
        4
      units
      Participants
    title
    Cycle 1 Day 22
  4. categories
    1. measurements
      1. group Id
        OG000
        spread
        125.10
        value
        135.57
      2. group Id
        OG001
        spread
        127.45
        value
        367.75
    denoms
    1. counts
      1. group Id
        OG000
        value
        3
      2. group Id
        OG001
        value
        4
      units
      Participants
    title
    Cycle 2 Day 1
  5. categories
    1. measurements
      1. group Id
        OG000
        spread
        154.43
        value
        167.80
      2. group Id
        OG001
        spread
        351.57
        value
        419.08
    denoms
    1. counts
      1. group Id
        OG000
        value
        2
      2. group Id
        OG001
        value
        4
      units
      Participants
    title
    Cycle 2 Day 15
  6. categories
    1. measurements
      1. group Id
        OG000
        spread
        184.70
        value
        174.40
      2. group Id
        OG001
        spread
        426.78
        value
        500.98
    denoms
    1. counts
      1. group Id
        OG000
        value
        2
      2. group Id
        OG001
        value
        4
      units
      Participants
    title
    Cycle 3 Day 1
  7. categories
    1. measurements
      1. group Id
        OG000
        spread
        154.86
        value
        193.50
      2. group Id
        OG001
        spread
        259.68
        value
        347.75
    denoms
    1. counts
      1. group Id
        OG000
        value
        2
      2. group Id
        OG001
        value
        4
      units
      Participants
    title
    Cycle 3 Day 15
  8. categories
    1. measurements
      1. group Id
        OG000
        spread
        172.75
        value
        202.85
      2. group Id
        OG001
        spread
        286.74
        value
        344.30
    denoms
    1. counts
      1. group Id
        OG000
        value
        2
      2. group Id
        OG001
        value
        4
      units
      Participants
    title
    Cycle 4 Day 1
  9. categories
    1. measurements
      1. group Id
        OG000
        spread
        182.65
        value
        184.85
      2. group Id
        OG001
        spread
        322.70
        value
        392.63
    denoms
    1. counts
      1. group Id
        OG000
        value
        2
      2. group Id
        OG001
        value
        4
      units
      Participants
    title
    Cycle 4 Day 15
  10. categories
    1. measurements
      1. group Id
        OG000
        spread
        228.54
        value
        220.40
      2. group Id
        OG001
        spread
        351.93
        value
        608.00
    denoms
    1. counts
      1. group Id
        OG000
        value
        2
      2. group Id
        OG001
        value
        3
      units
      Participants
    title
    Cycle 5 Day 1
  11. categories
    1. measurements
      1. group Id
        OG000
        spread
        237.59
        value
        233.00
      2. group Id
        OG001
        spread
        356.35
        value
        581.33
    denoms
    1. counts
      1. group Id
        OG000
        value
        2
      2. group Id
        OG001
        value
        3
      units
      Participants
    title
    Cycle 5 Day 15
  12. categories
    1. measurements
      1. group Id
        OG000
        spread
        280.72
        value
        267.50
      2. group Id
        OG001
        spread
        385.34
        value
        665.67
    denoms
    1. counts
      1. group Id
        OG000
        value
        2
      2. group Id
        OG001
        value
        3
      units
      Participants
    title
    Cycle 6 Day 1
denoms
  1. counts
    1. group Id
      OG000
      value
      3
    2. group Id
      OG001
      value
      5
    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 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: 112 weeks).
    id
    OG000
    title
    Phase 1, Cohort 1: Isatuximab 10 mg/kg
  2. 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: 137 weeks).
    id
    OG001
    title
    Phase 1, Cohort 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 and "0" in the number analyzed field signifies that no participants were available for analysis at specified timepoint.
reporting Status
POSTED
time Frame
Pre-infusion on Cycle 1 Day 8 (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, C11 D1
title
Phase 1: 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