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NCT01556438 · OUTCOME

Pharmacodynamics (PD): Change From Baseline in B-cell Subset Fractions

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
MEAN
Unit
percentage of b-cell change
Interval / dispersion
Standard Deviation
Time frame
Baseline, Cycle 1 and Cycle 7: prior to first tabalumab dose.

What was measured

CD19+ peripheral B-cells counts are based on the percentage of total leukocyte population and absolute cell counts.

Analysis population: All participants who received at least 1 dose of study drug and had evaluable PD. 300 mg tabalumab IV and SC dose were analyzed together.

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+BTZ IV+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 subcutaneously or intravenously (SC, IV respectively).

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+BTZ IV+Dex12

Reported measurements

Baseline

Analysis denominator · Participants

GroupSource count
100 mg Tabalumab+BTZ IV+Dex4
300 mg Tabalumab+BTZ IV+Dex12
Values in percentage of b-cell change · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
100 mg Tabalumab+BTZ IV+Dex9.38.1Not reportedNot reportedNot reported
300 mg Tabalumab+BTZ IV+Dex12.510.7Not reportedNot reportedNot reported
Cycle 1, Day 1

Analysis denominator · Participants

GroupSource count
100 mg Tabalumab+BTZ IV+Dex4
300 mg Tabalumab+BTZ IV+Dex12
Values in percentage of b-cell change · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
100 mg Tabalumab+BTZ IV+Dex1.11.6Not reportedNot reportedNot reported
300 mg Tabalumab+BTZ IV+Dex0.36.7Not reportedNot reportedNot reported
Cycle 7, Day 1

Analysis denominator · Participants

GroupSource count
100 mg Tabalumab+BTZ IV+Dex1
300 mg Tabalumab+BTZ IV+Dex4
Values in percentage of b-cell change · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
100 mg Tabalumab+BTZ IV+DexNANANot reportedNot reportedN of 1, pd data not collected from participant
300 mg Tabalumab+BTZ IV+Dex-14.47.5Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        8.1
        value
        9.3
      2. group Id
        OG001
        spread
        10.7
        value
        12.5
    denoms
    1. counts
      1. group Id
        OG000
        value
        4
      2. group Id
        OG001
        value
        12
      units
      Participants
    title
    Baseline
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        1.6
        value
        1.1
      2. group Id
        OG001
        spread
        6.7
        value
        0.3
    denoms
    1. counts
      1. group Id
        OG000
        value
        4
      2. group Id
        OG001
        value
        12
      units
      Participants
    title
    Cycle 1, Day 1
  3. categories
    1. measurements
      1. comment
        N of 1, pd data not collected from participant
        group Id
        OG000
        spread
        NA
        value
        NA
      2. group Id
        OG001
        spread
        7.5
        value
        -14.4
    denoms
    1. counts
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        4
      units
      Participants
    title
    Cycle 7, Day 1
denoms
  1. counts
    1. group Id
      OG000
      value
      4
    2. group Id
      OG001
      value
      12
    units
    Participants
description
CD19+ peripheral B-cells counts are based on the percentage of total leukocyte population and absolute cell counts.
dispersion Type
Standard Deviation
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 subcutaneously or intravenously (SC, IV respectively).
    id
    OG001
    title
    300 mg Tabalumab+BTZ IV+Dex
param Type
MEAN
population Description
All participants who received at least 1 dose of study drug and had evaluable PD. 300 mg tabalumab IV and SC dose were analyzed together.
reporting Status
POSTED
time Frame
Baseline, Cycle 1 and Cycle 7: prior to first tabalumab dose.
title
Pharmacodynamics (PD): Change From Baseline in B-cell Subset Fractions
type
SECONDARY
unit Of Measure
percentage of b-cell change

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

Preserved source evidence · Not medical advice