NCT01602224 · OUTCOME

PK: Area Under the Curve Over the Dosing Interval (AUC-T) for Tabalumab

A Study of Tabalumab (LY2127399) in Participants With Previously Treated Multiple Myeloma (MM) · Source last updated 2019-10-08

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure: GEOMETRIC_MEAN
Unit: micrograms times hour per milliliter
Interval / dispersion: Geometric Coefficient of Variation
Time frame: C1 D1: Predose, 3O minutes, 2 hours Postdose; C1 D4, 8, 11: Predose, (D11 only, 30 minutes Postdose); C2 and C6-C10 D1: Predose and immediately Postdose; C2 D 4, 8, 11: Anytime

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

Groups in this outcome

100 mg Tabalumab+Dexamethasone+Bortezomib

Tabalumab 100 milligram (mg) administered once intravenously (IV) over 30 minutes on Day 1 every 21 days for 8 cycles. Dexamethasone 20 mg administered once orally on Days 1, 2, 4, 5, 8, 9, 11 and 12 every 21 days for 8 cycles. Bortezomib 1.3 milligram per square meter (mg/m\^2) administered once subcutaneously (SQ) on Days 1, 4, 8 and 11 every 21 days for 8 cycles.

300 mg Tabalumab+Dexamethasone+Bortezomib

Tabalumab 300 mg administered once IV over 30 minutes on Day 1 every 21 days for 8 cycles. Dexamethasone 20 mg administered orally on Days 1, 2, 4, 5, 8, 9, 11 and 12 every 21 days for 8 cycles. Bortezomib 1.3 mg/m\^2 administered once SQ on Days 1, 4, 8 and 11 every 21 days for 8 cycles.

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+Dexamethasone+Bortezomib	68
300 mg Tabalumab+Dexamethasone+Bortezomib	71

Reported measurements

Cycle 1

Analysis denominator · Participants

Group	Source count
100 mg Tabalumab+Dexamethasone+Bortezomib	68
300 mg Tabalumab+Dexamethasone+Bortezomib	71

Values in micrograms times hour per milliliter · Interval/dispersion: Geometric Coefficient of Variation
Group	Value	Spread	Lower	Upper	Comment
100 mg Tabalumab+Dexamethasone+Bortezomib	7790	42	Not reported	Not reported	Not reported
300 mg Tabalumab+Dexamethasone+Bortezomib	2220	44	Not reported	Not reported	Not reported

Cycle 2

Analysis denominator · Participants

Group	Source count
100 mg Tabalumab+Dexamethasone+Bortezomib	63
300 mg Tabalumab+Dexamethasone+Bortezomib	68

Values in micrograms times hour per milliliter · Interval/dispersion: Geometric Coefficient of Variation
Group	Value	Spread	Lower	Upper	Comment
100 mg Tabalumab+Dexamethasone+Bortezomib	11600	36	Not reported	Not reported	Not reported
300 mg Tabalumab+Dexamethasone+Bortezomib	35400	49	Not reported	Not reported	Not reported

Steady State (Cycle 6-10)

Analysis denominator · Participants

Group	Source count
100 mg Tabalumab+Dexamethasone+Bortezomib	47
300 mg Tabalumab+Dexamethasone+Bortezomib	38

Values in micrograms times hour per milliliter · Interval/dispersion: Geometric Coefficient of Variation
Group	Value	Spread	Lower	Upper	Comment
100 mg Tabalumab+Dexamethasone+Bortezomib	25300	57	Not reported	Not reported	Not reported
300 mg Tabalumab+Dexamethasone+Bortezomib	70100	52	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
spread
42
value
7790
group Id
OG001
spread
44
value
2220
denoms
counts
group Id
OG000
value
68
group Id
OG001
value
71
units
Participants
title
Cycle 1
categories
measurements
group Id
OG000
spread
36
value
11600
group Id
OG001
spread
49
value
35400
denoms
counts
group Id
OG000
value
63
group Id
OG001
value
68
units
Participants
title
Cycle 2
categories
measurements
group Id
OG000
spread
57
value
25300
group Id
OG001
spread
52
value
70100
denoms
counts
group Id
OG000
value
47
group Id
OG001
value
38
units
Participants
title
Steady State (Cycle 6-10)

denoms

counts
group Id
OG000
value
68
group Id
OG001
value
71
units
Participants

dispersion Type

Geometric Coefficient of Variation

groups

description
Tabalumab 100 milligram (mg) administered once intravenously (IV) over 30 minutes on Day 1 every 21 days for 8 cycles. Dexamethasone 20 mg administered once orally on Days 1, 2, 4, 5, 8, 9, 11 and 12 every 21 days for 8 cycles. Bortezomib 1.3 milligram per square meter (mg/m\^2) administered once subcutaneously (SQ) on Days 1, 4, 8 and 11 every 21 days for 8 cycles.
id
OG000
title
100 mg Tabalumab+Dexamethasone+Bortezomib
description
Tabalumab 300 mg administered once IV over 30 minutes on Day 1 every 21 days for 8 cycles. Dexamethasone 20 mg administered orally on Days 1, 2, 4, 5, 8, 9, 11 and 12 every 21 days for 8 cycles. Bortezomib 1.3 mg/m\^2 administered once SQ on Days 1, 4, 8 and 11 every 21 days for 8 cycles.
id
OG001
title
300 mg Tabalumab+Dexamethasone+Bortezomib

param Type

GEOMETRIC_MEAN

population Description

All randomized participants who received at least 1 dose of study drug and had evaluable PK parameters.

reporting Status

POSTED

time Frame

C1 D1: Predose, 3O minutes, 2 hours Postdose; C1 D4, 8, 11: Predose, (D11 only, 30 minutes Postdose); C2 and C6-C10 D1: Predose and immediately Postdose; C2 D 4, 8, 11: Anytime

title

PK: Area Under the Curve Over the Dosing Interval (AUC-T) for Tabalumab

type

SECONDARY

unit Of Measure

micrograms times hour per milliliter

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

Preserved source evidence · Not medical advice