NCT04798586 · OUTCOME

Area Under the Concentration-time Profile From Time Zero to the Time Tau (AUCtau) of Elranatamab

MAGNETISMM-2: Study of Elranatamab (PF-06863135) in Japanese Participants With Multiple Myeloma · Source last updated 2024-09-27

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

Measure: GEOMETRIC_MEAN
Unit: Microgram*day per milliliter
Interval / dispersion: Geometric Coefficient of Variation
Time frame: Cycle 0: from Cycle 0 Day 1 (pre dose to the next dose of study intervention) [maximum of 9 days]; Cycle 1: from Cycle 1 Day 1 (pre dose to the next dose of study intervention) [maximum of 9 days]

What was measured

Area under the concentration-time profile from time zero to the time tau where the dosing interval (tau = 1 week). AUCtau was determined using the linear/log trapezoidal method.

Analysis population: Pharmacokinetic parameter analysis population was defined as all enrolled participants treated who did not have protocol deviations influencing PK assessment, and had sufficient information to estimate at least 1 of the PK parameters of interest. Here, 'Number Analyzed' signifies participants evaluable at specified rows.

Groups in this outcome

Elranatamab

Participants received an initial priming dose of 600 microgram per kilogram elranatamab subcutaneously on Cycle 0 Day 1 (7 days prior to Cycle 1 Day 1). During treatment cycle, participants were administered 1000 microgram per kilogram elranatamab weekly during each cycle (each cycle was of 3 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
Elranatamab	4

Reported measurements

Cycle 0 Day 1

Analysis denominator · Participants

Group	Source count
Elranatamab	4

Values in Microgram*day per milliliter · Interval/dispersion: Geometric Coefficient of Variation
Group	Value	Spread	Lower	Upper	Comment
Elranatamab	21.16	42	Not reported	Not reported	Not reported

Cycle 1 Day 1

Analysis denominator · Participants

Group	Source count
Elranatamab	2

Values in Microgram*day per milliliter · Interval/dispersion: Geometric Coefficient of Variation
Group	Value	Spread	Lower	Upper	Comment
Elranatamab	NA	NA	Not reported	Not reported	It was planned that data would not be summarized when there were less than 3 evaluable measurements. Data of individual participants cannot be reported due to risk of re-identification of participants.

Complete source fields

classes

categories
measurements
group Id
OG000
spread
42
value
21.16
denoms
counts
group Id
OG000
value
4
units
Participants
title
Cycle 0 Day 1
categories
measurements
comment
It was planned that data would not be summarized when there were less than 3 evaluable measurements. Data of individual participants cannot be reported due to risk of re-identification of participants.
group Id
OG000
spread
NA
value
NA
denoms
counts
group Id
OG000
value
2
units
Participants
title
Cycle 1 Day 1

denoms

counts
group Id
OG000
value
4
units
Participants

description

Area under the concentration-time profile from time zero to the time tau where the dosing interval (tau = 1 week). AUCtau was determined using the linear/log trapezoidal method.

dispersion Type

Geometric Coefficient of Variation

groups

description
Participants received an initial priming dose of 600 microgram per kilogram elranatamab subcutaneously on Cycle 0 Day 1 (7 days prior to Cycle 1 Day 1). During treatment cycle, participants were administered 1000 microgram per kilogram elranatamab weekly during each cycle (each cycle was of 3 weeks).
id
OG000
title
Elranatamab

param Type

GEOMETRIC_MEAN

population Description

Pharmacokinetic parameter analysis population was defined as all enrolled participants treated who did not have protocol deviations influencing PK assessment, and had sufficient information to estimate at least 1 of the PK parameters of interest. Here, 'Number Analyzed' signifies participants evaluable at specified rows.

reporting Status

POSTED

time Frame

Cycle 0: from Cycle 0 Day 1 (pre dose to the next dose of study intervention) [maximum of 9 days]; Cycle 1: from Cycle 1 Day 1 (pre dose to the next dose of study intervention) [maximum of 9 days]

title

Area Under the Concentration-time Profile From Time Zero to the Time Tau (AUCtau) of Elranatamab

type

SECONDARY

unit Of Measure

Microgram*day per milliliter

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

Preserved source evidence · Not medical advice