NCT00366106 · OUTCOME

Relative Dose Intensity of Bortezomib

Alternative Schedule of Velcade/Dexamethasone Plus Doxil for Patients With Multiple Myeloma · Source last updated 2012-04-06

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

Measure: MEAN
Unit: Relative dose intensity
Interval / dispersion: Standard Deviation
Time frame: Each dose of bortezomib (days 1, 4, 15, and 18 every 28 days)

What was measured

Relative dose intensity is defined as actual dose/scheduled dose. Bortezomib is administered on Days 1, 4, 15, and 18 every 28 days.

Analysis population: Note that the sample sized varied at each dose and ranged from 32 patients to 1 patient.

Groups in this outcome

Treatment Group

All subjects received bortezomib 1.3mg/m\^2 on Days 1, 4, 15, and 18 every 28 days and dexamethasone 20mg daily on Days 1, 2, 4, 5, 15, 16, 18, and 19 every 28 days. Following US FDA approval of doxorubicin HCl liposome injection in combination with bortezomib in May 2007, the study was amended to allow combination treatment with both bortezomib and doxorubicin HCl liposome injection 30 mg/m\^2 on Day 4 every 28 days with dexamethasone. The target goal was 8 cycles of treatment.

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
Treatment Group	32

Reported measurements

Cycle 1 / Week 1

Values in Relative dose intensity · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Treatment Group	0.97	0.158	Not reported	Not reported	Not reported

Cycle 1 / Week 1 Day 4

Values in Relative dose intensity · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Treatment Group	0.98	0.159	Not reported	Not reported	Not reported

Cycle 1 / Week 3

Values in Relative dose intensity · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Treatment Group	0.97	0.158	Not reported	Not reported	Not reported

Cycle 1 / Week 3 Day 18

Values in Relative dose intensity · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Treatment Group	0.97	0.154	Not reported	Not reported	Not reported

Cycle 2 / Week 5

Values in Relative dose intensity · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Treatment Group	0.95	0.144	Not reported	Not reported	Not reported

Cycle 2 / Week 5 Day 4

Values in Relative dose intensity · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Treatment Group	0.96	0.148	Not reported	Not reported	Not reported

Cycle 2 / Week 7

Values in Relative dose intensity · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Treatment Group	0.95	0.140	Not reported	Not reported	Not reported

Cycle 2 / Week 7 Day 18

Values in Relative dose intensity · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Treatment Group	0.96	0.146	Not reported	Not reported	Not reported

Cycle 3 / Week 9

Values in Relative dose intensity · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Treatment Group	0.99	0.147	Not reported	Not reported	Not reported

Cycle 3 / Week 9 Day 4

Values in Relative dose intensity · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Treatment Group	0.97	0.121	Not reported	Not reported	Not reported

Cycle 3 / Week 11

Values in Relative dose intensity · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Treatment Group	0.97	0.142	Not reported	Not reported	Not reported

Cycle 3 / Week 11 Day 18

Values in Relative dose intensity · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Treatment Group	0.95	0.104	Not reported	Not reported	Not reported

Cycle 4 / Week 13

Values in Relative dose intensity · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Treatment Group	0.99	0.152	Not reported	Not reported	Not reported

Cycle 4 / Week 13 Day 4

Values in Relative dose intensity · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Treatment Group	0.96	0.111	Not reported	Not reported	Not reported

Cycle 4 / Week 15

Values in Relative dose intensity · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Treatment Group	0.99	0.154	Not reported	Not reported	Not reported

Cycle 4 / Week 15 Day 18

Values in Relative dose intensity · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Treatment Group	0.96	0.111	Not reported	Not reported	Not reported

Cycle 5 / Week 17

Values in Relative dose intensity · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Treatment Group	0.98	0.151	Not reported	Not reported	Not reported

Cycle 5 / Week 17 Day 4

Values in Relative dose intensity · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Treatment Group	0.96	0.110	Not reported	Not reported	Not reported

Cycle 5 / Week 19

Values in Relative dose intensity · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Treatment Group	1.00	0.157	Not reported	Not reported	Not reported

Cycle 5 / Week 19 Day 18

Values in Relative dose intensity · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Treatment Group	0.97	0.111	Not reported	Not reported	Not reported

Cycle 6 / Week 21

Values in Relative dose intensity · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Treatment Group	1.01	0.162	Not reported	Not reported	Not reported

Cycle 6 / Week 21 Day 4

Values in Relative dose intensity · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Treatment Group	0.98	0.114	Not reported	Not reported	Not reported

Cycle 6 / Week 23

Values in Relative dose intensity · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Treatment Group	1.01	0.169	Not reported	Not reported	Not reported

Cycle 6 / Week 23 Day 18

Values in Relative dose intensity · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Treatment Group	0.99	0.115	Not reported	Not reported	Not reported

Cycle 7 / Week 25

Values in Relative dose intensity · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Treatment Group	1.11	0.154	Not reported	Not reported	Not reported

Cycle 7 / Week 25 Day 4

Values in Relative dose intensity · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Treatment Group	1.03	0.148	Not reported	Not reported	Not reported

Cycle 7 / Week 27

Values in Relative dose intensity · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Treatment Group	1.08	0.198	Not reported	Not reported	Not reported

Cycle 7 / Week 27 Day 18

Values in Relative dose intensity · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Treatment Group	1.03	0.148	Not reported	Not reported	Not reported

Cycle 8 / Week 29

Values in Relative dose intensity · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Treatment Group	1.05	0.213	Not reported	Not reported	Not reported

Cycle 8 / Week 29 Day 4

Values in Relative dose intensity · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Treatment Group	0.99	0.140	Not reported	Not reported	Not reported

Cycle 8 / Week 31

Values in Relative dose intensity · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Treatment Group	1.05	0.213	Not reported	Not reported	Not reported

Cycle 8 / Week 31 Day 18

Values in Relative dose intensity · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Treatment Group	1.04	0.085	Not reported	Not reported	Not reported

Cycle 9 / Week 33

Values in Relative dose intensity · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Treatment Group	1.10	0.488	Not reported	Not reported	Not reported

Cycle 9 / Week 33 Day 4

Values in Relative dose intensity · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Treatment Group	0.75	NA	Not reported	Not reported	Only 1 patient was dosed.

Cycle 9 / Week 35

Values in Relative dose intensity · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Treatment Group	1.15	0.417	Not reported	Not reported	Not reported

Cycle 10 / Week 37

Values in Relative dose intensity · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Treatment Group	1.22	0.311	Not reported	Not reported	Not reported

Cycle 10 / Week 37 Day 4

Values in Relative dose intensity · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Treatment Group	1.00	NA	Not reported	Not reported	Only 1 patient was dosed.

Cycle 10 / Week 39

Values in Relative dose intensity · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Treatment Group	1.22	0.311	Not reported	Not reported	Not reported

Cycle 10 / Week 39 Day 18

Values in Relative dose intensity · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Treatment Group	1.00	NA	Not reported	Not reported	Only 1 patient was dosed.

Cycle 11 / Week 41

Values in Relative dose intensity · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Treatment Group	1.22	0.311	Not reported	Not reported	Not reported

Cycle 11 / Week 41 Day 4

Values in Relative dose intensity · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Treatment Group	1.00	NA	Not reported	Not reported	Only 1 patient was dosed.

Cycle 11 / Week 43

Values in Relative dose intensity · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Treatment Group	1.44	NA	Not reported	Not reported	Only 1 patient was dosed.

Cycle 11 / Week 43 Day 18

Values in Relative dose intensity · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Treatment Group	1.00	NA	Not reported	Not reported	Only 1 patient was dosed.

Complete source fields

classes

categories
measurements
group Id
OG000
spread
0.158
value
0.97
title
Cycle 1 / Week 1
categories
measurements
group Id
OG000
spread
0.159
value
0.98
title
Cycle 1 / Week 1 Day 4
categories
measurements
group Id
OG000
spread
0.158
value
0.97
title
Cycle 1 / Week 3
categories
measurements
group Id
OG000
spread
0.154
value
0.97
title
Cycle 1 / Week 3 Day 18
categories
measurements
group Id
OG000
spread
0.144
value
0.95
title
Cycle 2 / Week 5
categories
measurements
group Id
OG000
spread
0.148
value
0.96
title
Cycle 2 / Week 5 Day 4
categories
measurements
group Id
OG000
spread
0.140
value
0.95
title
Cycle 2 / Week 7
categories
measurements
group Id
OG000
spread
0.146
value
0.96
title
Cycle 2 / Week 7 Day 18
categories
measurements
group Id
OG000
spread
0.147
value
0.99
title
Cycle 3 / Week 9
categories
measurements
group Id
OG000
spread
0.121
value
0.97
title
Cycle 3 / Week 9 Day 4
categories
measurements
group Id
OG000
spread
0.142
value
0.97
title
Cycle 3 / Week 11
categories
measurements
group Id
OG000
spread
0.104
value
0.95
title
Cycle 3 / Week 11 Day 18

denoms

counts
group Id
OG000
value
32
units
Participants

description

Relative dose intensity is defined as actual dose/scheduled dose. Bortezomib is administered on Days 1, 4, 15, and 18 every 28 days.

dispersion Type

Standard Deviation

groups

description
All subjects received bortezomib 1.3mg/m\^2 on Days 1, 4, 15, and 18 every 28 days and dexamethasone 20mg daily on Days 1, 2, 4, 5, 15, 16, 18, and 19 every 28 days. Following US FDA approval of doxorubicin HCl liposome injection in combination with bortezomib in May 2007, the study was amended to allow combination treatment with both bortezomib and doxorubicin HCl liposome injection 30 mg/m\^2 on Day 4 every 28 days with dexamethasone. The target goal was 8 cycles of treatment.
id
OG000
title
Treatment Group

param Type

MEAN

population Description

Note that the sample sized varied at each dose and ranged from 32 patients to 1 patient.

reporting Status

POSTED

time Frame

Each dose of bortezomib (days 1, 4, 15, and 18 every 28 days)

title

Relative Dose Intensity of Bortezomib

type

SECONDARY

unit Of Measure

Relative dose intensity

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

Preserved source evidence · Not medical advice