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NCT01556438 · OUTCOME

Pharmacokinetics (PK): Maximum Plasma Concentration (Cmax) for Tabalumab (LY2127399)

Study of Tabalumab (LY2127399) in Japanese Participants With Relapsed or Refactory Multiple Myeloma · Source last updated 2019-03-20

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 (μg/mL)
Interval / dispersion
Geometric Coefficient of Variation
Time frame
Cycle 1, Day 1: 6 + or - hours after bortezomib (BTZ); Cycle 7, Day 1: immediately post BTZ dose and 2 hours after tabalumab

Analysis population: All participants who received at least 1 dose of any study drug and had evaluable PK data.

Groups in this outcome

100 mg Tabalumab+BTZ IV+Dex

Cohort 1. 100 mg tabalumab (LY2127399) intravenously (IV) on day 1 of each cycle. Bortezomib (BTZ), 1.3 milligram per square meter (mg/m\^2), IV on days 1, 4, 8, 11 of Cycle 1-8, then on days 1, 8, 15, 22 from Cycle 9 onward. Oral dexamethasone (Dex), 20 mg/day, on day of and day after BTZ.

300 mg Tabalumab+ IV BTZ +Dex

Cohort 2. 300 mg tabalumab (LY2127399) IV on day 1 of each cycle. BTZ, 1.3 mg/m\^2, IV on days 1, 4, 8, 11 of Cycle 1-8, then on days 1, 8, 15, 22 from Cycle 9 onward. Oral dex, 20 mg/day, on day of and day after BTZ IV.

300 mg Tabalumab+ SC BTZ +Dex

Cohort 2. 300 mg tabalumab (LY2127399) IV on day 1 of each cycle. BTZ, 1.3 mg/m\^2, IV on days 1, 4, 8, 11 of Cycle 1-8, then on days 1, 8, 15, 22 from Cycle 9 onward. Oral dex, 20 mg/day, on day of and day after BTZ SC.

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
100 mg Tabalumab+BTZ IV+Dex4
300 mg Tabalumab+ IV BTZ +Dex4
300 mg Tabalumab+ SC BTZ +Dex8

Reported measurements

Cycle 1 Day 1

Analysis denominator · Participants

GroupSource count
100 mg Tabalumab+BTZ IV+Dex4
300 mg Tabalumab+ IV BTZ +Dex4
300 mg Tabalumab+ SC BTZ +Dex8
Values in microgram per milliliter (μg/mL) · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
100 mg Tabalumab+BTZ IV+Dex38.512Not reportedNot reportedNot reported
300 mg Tabalumab+ IV BTZ +Dex15421Not reportedNot reportedNot reported
300 mg Tabalumab+ SC BTZ +Dex13914Not reportedNot reportedNot reported
Cycle 7 Day 1

Analysis denominator · Participants

GroupSource count
100 mg Tabalumab+BTZ IV+Dex1
300 mg Tabalumab+ IV BTZ +Dex1
300 mg Tabalumab+ SC BTZ +Dex3
Values in microgram per milliliter (μg/mL) · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
100 mg Tabalumab+BTZ IV+Dex70.5NANot reportedNot reportedN of 1, Individual data presented, no CV value.
300 mg Tabalumab+ IV BTZ +Dex179NANot reportedNot reportedN of 1, Individual data presented, no CV value.
300 mg Tabalumab+ SC BTZ +Dex22025Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        12
        value
        38.5
      2. group Id
        OG001
        spread
        21
        value
        154
      3. group Id
        OG002
        spread
        14
        value
        139
    denoms
    1. counts
      1. group Id
        OG000
        value
        4
      2. group Id
        OG001
        value
        4
      3. group Id
        OG002
        value
        8
      units
      Participants
    title
    Cycle 1 Day 1
  2. categories
    1. measurements
      1. comment
        N of 1, Individual data presented, no CV value.
        group Id
        OG000
        spread
        NA
        value
        70.5
      2. comment
        N of 1, Individual data presented, no CV value.
        group Id
        OG001
        spread
        NA
        value
        179
      3. group Id
        OG002
        spread
        25
        value
        220
    denoms
    1. counts
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        1
      3. group Id
        OG002
        value
        3
      units
      Participants
    title
    Cycle 7 Day 1
denoms
  1. counts
    1. group Id
      OG000
      value
      4
    2. group Id
      OG001
      value
      4
    3. group Id
      OG002
      value
      8
    units
    Participants
dispersion Type
Geometric Coefficient of Variation
groups
  1. description
    Cohort 1. 100 mg tabalumab (LY2127399) intravenously (IV) on day 1 of each cycle. Bortezomib (BTZ), 1.3 milligram per square meter (mg/m\^2), IV on days 1, 4, 8, 11 of Cycle 1-8, then on days 1, 8, 15, 22 from Cycle 9 onward. Oral dexamethasone (Dex), 20 mg/day, on day of and day after BTZ.
    id
    OG000
    title
    100 mg Tabalumab+BTZ IV+Dex
  2. description
    Cohort 2. 300 mg tabalumab (LY2127399) IV on day 1 of each cycle. BTZ, 1.3 mg/m\^2, IV on days 1, 4, 8, 11 of Cycle 1-8, then on days 1, 8, 15, 22 from Cycle 9 onward. Oral dex, 20 mg/day, on day of and day after BTZ IV.
    id
    OG001
    title
    300 mg Tabalumab+ IV BTZ +Dex
  3. description
    Cohort 2. 300 mg tabalumab (LY2127399) IV on day 1 of each cycle. BTZ, 1.3 mg/m\^2, IV on days 1, 4, 8, 11 of Cycle 1-8, then on days 1, 8, 15, 22 from Cycle 9 onward. Oral dex, 20 mg/day, on day of and day after BTZ SC.
    id
    OG002
    title
    300 mg Tabalumab+ SC BTZ +Dex
param Type
GEOMETRIC_MEAN
population Description
All participants who received at least 1 dose of any study drug and had evaluable PK data.
reporting Status
POSTED
time Frame
Cycle 1, Day 1: 6 + or - hours after bortezomib (BTZ); Cycle 7, Day 1: immediately post BTZ dose and 2 hours after tabalumab
title
Pharmacokinetics (PK): Maximum Plasma Concentration (Cmax) for Tabalumab (LY2127399)
type
SECONDARY
unit Of Measure
microgram per milliliter (μg/mL)

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Preserved source evidence · Not medical advice