NCT01556438 · OUTCOME

Pharmacodynamics (PD): Change From Baseline in Absolute B-cell Count

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: Not reported
Unit: Not reported
Interval / dispersion: Not reported
Time frame: Baseline through study completion (up to 455 days)

Analysis population: Zero participants analyzed as no post baseline data collected.

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. Bortezomib IV: Administered IV Dexamethasone: Administered orally

300 mg Tabalumab+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 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

Group	Source count
100 mg Tabalumab+BTZ IV+Dex	0
300 mg Tabalumab+BTZ +Dex	0

Reported measurements

No numerical measurement classes were posted for this outcome. Missing is not zero.

Complete source fields

denoms

counts
group Id
OG000
value
0
group Id
OG001
value
0
units
Participants

groups

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. Bortezomib IV: Administered IV Dexamethasone: Administered orally
id
OG000
title
100 mg Tabalumab+BTZ IV+Dex
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 +Dex

population Description

Zero participants analyzed as no post baseline data collected.

reporting Status

POSTED

time Frame

Baseline through study completion (up to 455 days)

title

Pharmacodynamics (PD): Change From Baseline in Absolute B-cell Count

type

SECONDARY

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

Preserved source evidence · Not medical advice