NCT02812706 · OUTCOME

Phase 2: Area Under the Plasma Concentration Versus Curve Over the Dosing Interval (AUC1-Week) After First Infusion 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 * hours per milliliter
Interval / dispersion: Standard Deviation
Time frame: Multiple timepoints from Cycle 1 to Cycle 10

What was measured

AUC was predicted using population pharmacokinetic model.

Analysis population: Analysis was performed on PK population. Here, "Overall number of participants analyzed" = participants with available data for this outcome measure.

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

Group	Source count
Phase 2: Isatuximab 20 mg/kg	28

Reported measurements

Source class 1

Values in micrograms * hours per milliliter · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Phase 2: Isatuximab 20 mg/kg	65071	55554	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
spread
55554
value
65071

denoms

counts
group Id
OG000
value
28
units
Participants

description

AUC was predicted using population pharmacokinetic model.

dispersion Type

Standard Deviation

groups

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, "Overall number of participants analyzed" = participants with available data for this outcome measure.

reporting Status

POSTED

time Frame

Multiple timepoints from Cycle 1 to Cycle 10

title

Phase 2: Area Under the Plasma Concentration Versus Curve Over the Dosing Interval (AUC1-Week) After First Infusion of Isatuximab

type

SECONDARY

unit Of Measure

micrograms * hours per milliliter

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

Preserved source evidence · Not medical advice