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NCT04798586 · OUTCOME

Maximum Observed Serum Concentration (Cmax) 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
Micrograms 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]

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.

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

GroupSource count
Elranatamab4

Reported measurements

Cycle 0 Day1
Values in Micrograms per milliliter · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Elranatamab4.38233Not reportedNot reportedNot reported
Cycle 1 Day 1
Values in Micrograms per milliliter · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Elranatamab8.84639Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        33
        value
        4.382
    title
    Cycle 0 Day1
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        39
        value
        8.846
    title
    Cycle 1 Day 1
denoms
  1. counts
    1. group Id
      OG000
      value
      4
    units
    Participants
dispersion Type
Geometric Coefficient of Variation
groups
  1. 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.
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
Maximum Observed Serum Concentration (Cmax) of Elranatamab
type
SECONDARY
unit Of Measure
Micrograms per milliliter

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

Preserved source evidence · Not medical advice