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NCT04798586 · OUTCOME

Pre-dose Trough Serum Concentrations After Multiple Doses 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 per milliliter
Interval / dispersion
Geometric Coefficient of Variation
Time frame
At pre-dose on Day 1 of Cycle 0, 3, 4, 5, 6, 7, 8, 12, 16; at pre-dose on Days 1, 8, 15 of Cycle 1 and 2

Analysis population: Pharmacokinetic concentration population was defined as all enrolled participants who were treated and had at least 1 analyte concentration. Here, 'Number Analyzed' signifies participants evaluable at specific timepoints.

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: Predose

Analysis denominator · Participants

GroupSource count
Elranatamab4
Values in Microgram per milliliter · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
ElranatamabNANANot reportedNot reportedSummary statistics are not presented if Number of observations Above Lower limit of Quantification (NALQ) = 0 or more than 50% of the concentration data were missing at a particular time point.
Cycle 1 Day1: Predose

Analysis denominator · Participants

GroupSource count
Elranatamab4
Values in Microgram per milliliter · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Elranatamab4.26718Not reportedNot reportedNot reported
Cycle 1 Day8: Predose

Analysis denominator · Participants

GroupSource count
Elranatamab4
Values in Microgram per milliliter · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Elranatamab8.32628Not reportedNot reportedNot reported
Cycle 1 Day15: Predose

Analysis denominator · Participants

GroupSource count
Elranatamab4
Values in Microgram per milliliter · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Elranatamab12.3234Not reportedNot reportedNot reported
Cycle 2 Day1: Predose

Analysis denominator · Participants

GroupSource count
Elranatamab4
Values in Microgram per milliliter · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Elranatamab13.4027Not reportedNot reportedNot reported
Cycle 2 Day8: Predose

Analysis denominator · Participants

GroupSource count
Elranatamab4
Values in Microgram per milliliter · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Elranatamab16.2643Not reportedNot reportedNot reported
Cycle 2 Day15: Predose

Analysis denominator · Participants

GroupSource count
Elranatamab4
Values in Microgram per milliliter · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Elranatamab17.8345Not reportedNot reportedNot reported
Cycle 3 Day1: Predose

Analysis denominator · Participants

GroupSource count
Elranatamab4
Values in Microgram per milliliter · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Elranatamab19.7549Not reportedNot reportedNot reported
Cycle 4 Day1: Predose

Analysis denominator · Participants

GroupSource count
Elranatamab4
Values in Microgram per milliliter · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Elranatamab21.6835Not reportedNot reportedNot reported
Cycle 5 Day1: Predose

Analysis denominator · Participants

GroupSource count
Elranatamab4
Values in Microgram per milliliter · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Elranatamab21.7143Not reportedNot reportedNot reported
Cycle 6 Day1: Predose

Analysis denominator · Participants

GroupSource count
Elranatamab4
Values in Microgram per milliliter · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Elranatamab23.9934Not reportedNot reportedNot reported
Cycle 7 Day1: Predose

Analysis denominator · Participants

GroupSource count
Elranatamab4
Values in Microgram per milliliter · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Elranatamab18.0387Not reportedNot reportedNot reported
Cycle 8 Day1: Predose

Analysis denominator · Participants

GroupSource count
Elranatamab4
Values in Microgram per milliliter · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Elranatamab24.2751Not reportedNot reportedNot reported
Cycle 12 Day1: Predose

Analysis denominator · Participants

GroupSource count
Elranatamab3
Values in Microgram per milliliter · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Elranatamab21.3041Not reportedNot reportedNot reported
Cycle 16 Day1: Predose

Analysis denominator · Participants

GroupSource count
Elranatamab1
Values in Microgram per milliliter · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
ElranatamabNANANot reportedNot reportedSummary statistics are not presented if NALQ = 0 or more than 50% of the concentration data were missing at a particular time point.
Complete source fields
classes
  1. categories
    1. measurements
      1. comment
        Summary statistics are not presented if Number of observations Above Lower limit of Quantification (NALQ) = 0 or more than 50% of the concentration data were missing at a particular time point.
        group Id
        OG000
        spread
        NA
        value
        NA
    denoms
    1. counts
      1. group Id
        OG000
        value
        4
      units
      Participants
    title
    Cycle 0 Day1: Predose
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        18
        value
        4.267
    denoms
    1. counts
      1. group Id
        OG000
        value
        4
      units
      Participants
    title
    Cycle 1 Day1: Predose
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        28
        value
        8.326
    denoms
    1. counts
      1. group Id
        OG000
        value
        4
      units
      Participants
    title
    Cycle 1 Day8: Predose
  4. categories
    1. measurements
      1. group Id
        OG000
        spread
        34
        value
        12.32
    denoms
    1. counts
      1. group Id
        OG000
        value
        4
      units
      Participants
    title
    Cycle 1 Day15: Predose
  5. categories
    1. measurements
      1. group Id
        OG000
        spread
        27
        value
        13.40
    denoms
    1. counts
      1. group Id
        OG000
        value
        4
      units
      Participants
    title
    Cycle 2 Day1: Predose
  6. categories
    1. measurements
      1. group Id
        OG000
        spread
        43
        value
        16.26
    denoms
    1. counts
      1. group Id
        OG000
        value
        4
      units
      Participants
    title
    Cycle 2 Day8: Predose
  7. categories
    1. measurements
      1. group Id
        OG000
        spread
        45
        value
        17.83
    denoms
    1. counts
      1. group Id
        OG000
        value
        4
      units
      Participants
    title
    Cycle 2 Day15: Predose
  8. categories
    1. measurements
      1. group Id
        OG000
        spread
        49
        value
        19.75
    denoms
    1. counts
      1. group Id
        OG000
        value
        4
      units
      Participants
    title
    Cycle 3 Day1: Predose
  9. categories
    1. measurements
      1. group Id
        OG000
        spread
        35
        value
        21.68
    denoms
    1. counts
      1. group Id
        OG000
        value
        4
      units
      Participants
    title
    Cycle 4 Day1: Predose
  10. categories
    1. measurements
      1. group Id
        OG000
        spread
        43
        value
        21.71
    denoms
    1. counts
      1. group Id
        OG000
        value
        4
      units
      Participants
    title
    Cycle 5 Day1: Predose
  11. categories
    1. measurements
      1. group Id
        OG000
        spread
        34
        value
        23.99
    denoms
    1. counts
      1. group Id
        OG000
        value
        4
      units
      Participants
    title
    Cycle 6 Day1: Predose
  12. categories
    1. measurements
      1. group Id
        OG000
        spread
        87
        value
        18.03
    denoms
    1. counts
      1. group Id
        OG000
        value
        4
      units
      Participants
    title
    Cycle 7 Day1: Predose
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 concentration population was defined as all enrolled participants who were treated and had at least 1 analyte concentration. Here, 'Number Analyzed' signifies participants evaluable at specific timepoints.
reporting Status
POSTED
time Frame
At pre-dose on Day 1 of Cycle 0, 3, 4, 5, 6, 7, 8, 12, 16; at pre-dose on Days 1, 8, 15 of Cycle 1 and 2
title
Pre-dose Trough Serum Concentrations After Multiple Doses of Elranatamab
type
SECONDARY
unit Of Measure
Microgram per milliliter

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

Preserved source evidence · Not medical advice