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NCT02755597 · OUTCOME

Mean Change From Baseline in Patient Reported Outcomes Measurement Information System [PROMIS] Cancer Fatigue Short Form [SF] Score

A Study Evaluating Venetoclax (ABT-199) in Multiple Myeloma Subjects Who Are Receiving Bortezomib and Dexamethasone as Standard Therapy · Source last updated 2023-08-22

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

Measure: MEAN
Unit: T-score
Interval / dispersion: Standard Deviation
Time frame: Baseline; Cycle 3 (Cycles 1 - 8 are 21 days, Cycles 9 and beyond are 35 days) through Cycle 47, collected on Day 1 of every other cycle and at the Treatment Completion Visit (TCV) while participant is on treatment

What was measured

PROMIS Cancer Fatigue SF is a seven item questionnaire that assesses the impact and experience of fatigue over the past 7 days. All questions employ the following five response options: 1 = Not at all, 2 = A little bit, 3 = Somewhat, 4 = Quite a bit, and 5 = Very much. The total raw score is the sum of the responses to each question and is converted to a T-score. The T-score re-scales the total raw score to a standardized score with a mean of 50 and a standard deviation of 10. The \[PROMIS\] Cancer Fatigue Short Form \[SF\] 7a T-Scores range from 29.4 to 83.2, with higher scores indicating more fatigue. Negative changes from baseline indicate improvement.

Analysis population: Intent-To-Treat (ITT) analysis set: all randomized participants, analyzed by treatment group assignment given at the time of randomization; participants who have both baseline and post-baseline values are included in the analysis at each visit

Groups in this outcome

Venetoclax + Bortezomib and Dexamethasone

Cycles 1-8: Venetoclax 800 mg orally every day (QD) on Days 1 - 21 plus bortezomib 1.3 mg/m\^2 subcutaneously or IV on Days 1, 4, 8 \& 11 and dexamethasone 20 mg orally on Days 1, 2, 4, 5, 8, 9, 11 \& 12; Cycles 9 and beyond: Venetoclax 800 mg orally every day (QD) on Days 1 - 35 plus bortezomib 1.3 mg/m\^2 subcutaneously or IV on Days 1, 8, 15 and 22 and dexamethasone 20 mg orally on Days 1, 2, 8, 9, 15, 16, 22 and 23

Placebo + Bortezomib and Dexamethasone

Cycles 1-8: Placebo (to match venetoclax 100 mg tablet) 800 mg orally every day (QD) on Days 1 - 21 plus bortezomib 1.3 mg/m\^2 subcutaneously or IV on Days 1, 4, 8 \& 11 and dexamethasone 20 mg orally on Days 1, 2, 4, 5, 8, 9, 11 \& 12; Cycles 9 and beyond: Placebo (to match venetoclax 100 mg tablet) 800 mg orally every day (QD) on Days 1 - 35 plus bortezomib 1.3 mg/m\^2 subcutaneously or IV on Days 1, 8, 15 and 22 and dexamethasone 20 mg orally on Days 1, 2, 8, 9, 15, 16, 22 \& 23

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
Venetoclax + Bortezomib and Dexamethasone	185
Placebo + Bortezomib and Dexamethasone	92

Reported measurements

Cycle 3, Day 1

Analysis denominator · Participants

Group	Source count
Venetoclax + Bortezomib and Dexamethasone	163
Placebo + Bortezomib and Dexamethasone	79

Values in T-score · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Venetoclax + Bortezomib and Dexamethasone	2.2	9.54	Not reported	Not reported	Not reported
Placebo + Bortezomib and Dexamethasone	1.8	8.12	Not reported	Not reported	Not reported

Cycle 5, Day 1

Analysis denominator · Participants

Group	Source count
Venetoclax + Bortezomib and Dexamethasone	141
Placebo + Bortezomib and Dexamethasone	70

Values in T-score · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Venetoclax + Bortezomib and Dexamethasone	3.3	9.25	Not reported	Not reported	Not reported
Placebo + Bortezomib and Dexamethasone	2.4	10.34	Not reported	Not reported	Not reported

Cycle 7, Day 1

Analysis denominator · Participants

Group	Source count
Venetoclax + Bortezomib and Dexamethasone	126
Placebo + Bortezomib and Dexamethasone	70

Values in T-score · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Venetoclax + Bortezomib and Dexamethasone	3.2	9.28	Not reported	Not reported	Not reported
Placebo + Bortezomib and Dexamethasone	2.6	9.70	Not reported	Not reported	Not reported

Cycle 9, Day 1

Analysis denominator · Participants

Group	Source count
Venetoclax + Bortezomib and Dexamethasone	114
Placebo + Bortezomib and Dexamethasone	65

Values in T-score · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Venetoclax + Bortezomib and Dexamethasone	2.3	8.90	Not reported	Not reported	Not reported
Placebo + Bortezomib and Dexamethasone	2.6	8.67	Not reported	Not reported	Not reported

Cycle 11, Day 1

Analysis denominator · Participants

Group	Source count
Venetoclax + Bortezomib and Dexamethasone	99
Placebo + Bortezomib and Dexamethasone	55

Values in T-score · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Venetoclax + Bortezomib and Dexamethasone	0.6	8.54	Not reported	Not reported	Not reported
Placebo + Bortezomib and Dexamethasone	3.1	8.98	Not reported	Not reported	Not reported

Cycle 13, Day 1

Analysis denominator · Participants

Group	Source count
Venetoclax + Bortezomib and Dexamethasone	83
Placebo + Bortezomib and Dexamethasone	43

Values in T-score · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Venetoclax + Bortezomib and Dexamethasone	1.8	8.03	Not reported	Not reported	Not reported
Placebo + Bortezomib and Dexamethasone	2.3	6.97	Not reported	Not reported	Not reported

Cycle 15, Day 1

Analysis denominator · Participants

Group	Source count
Venetoclax + Bortezomib and Dexamethasone	77
Placebo + Bortezomib and Dexamethasone	31

Values in T-score · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Venetoclax + Bortezomib and Dexamethasone	1.5	8.84	Not reported	Not reported	Not reported
Placebo + Bortezomib and Dexamethasone	2.1	7.66	Not reported	Not reported	Not reported

Cycle 17, Day 1

Analysis denominator · Participants

Group	Source count
Venetoclax + Bortezomib and Dexamethasone	67
Placebo + Bortezomib and Dexamethasone	27

Values in T-score · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Venetoclax + Bortezomib and Dexamethasone	1.2	8.11	Not reported	Not reported	Not reported
Placebo + Bortezomib and Dexamethasone	2.6	8.05	Not reported	Not reported	Not reported

Cycle 19, Day 1

Analysis denominator · Participants

Group	Source count
Venetoclax + Bortezomib and Dexamethasone	68
Placebo + Bortezomib and Dexamethasone	22

Values in T-score · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Venetoclax + Bortezomib and Dexamethasone	0.7	8.52	Not reported	Not reported	Not reported
Placebo + Bortezomib and Dexamethasone	0.9	9.32	Not reported	Not reported	Not reported

Cycle 21, Day 1

Analysis denominator · Participants

Group	Source count
Venetoclax + Bortezomib and Dexamethasone	59
Placebo + Bortezomib and Dexamethasone	18

Values in T-score · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Venetoclax + Bortezomib and Dexamethasone	1.6	8.58	Not reported	Not reported	Not reported
Placebo + Bortezomib and Dexamethasone	1.2	7.66	Not reported	Not reported	Not reported

Cycle 23, Day 1

Analysis denominator · Participants

Group	Source count
Venetoclax + Bortezomib and Dexamethasone	55
Placebo + Bortezomib and Dexamethasone	17

Values in T-score · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Venetoclax + Bortezomib and Dexamethasone	2.0	8.08	Not reported	Not reported	Not reported
Placebo + Bortezomib and Dexamethasone	1.5	8.83	Not reported	Not reported	Not reported

Cycle 25, Day 1

Analysis denominator · Participants

Group	Source count
Venetoclax + Bortezomib and Dexamethasone	48
Placebo + Bortezomib and Dexamethasone	13

Values in T-score · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Venetoclax + Bortezomib and Dexamethasone	2.0	8.59	Not reported	Not reported	Not reported
Placebo + Bortezomib and Dexamethasone	-0.1	8.73	Not reported	Not reported	Not reported

Cycle 27, Day 1

Analysis denominator · Participants

Group	Source count
Venetoclax + Bortezomib and Dexamethasone	38
Placebo + Bortezomib and Dexamethasone	14

Values in T-score · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Venetoclax + Bortezomib and Dexamethasone	3.4	8.19	Not reported	Not reported	Not reported
Placebo + Bortezomib and Dexamethasone	-0.1	9.59	Not reported	Not reported	Not reported

Cycle 29, Day 1

Analysis denominator · Participants

Group	Source count
Venetoclax + Bortezomib and Dexamethasone	40
Placebo + Bortezomib and Dexamethasone	15

Values in T-score · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Venetoclax + Bortezomib and Dexamethasone	3.9	8.07	Not reported	Not reported	Not reported
Placebo + Bortezomib and Dexamethasone	0.8	8.51	Not reported	Not reported	Not reported

Cycle 31, Day 1

Analysis denominator · Participants

Group	Source count
Venetoclax + Bortezomib and Dexamethasone	40
Placebo + Bortezomib and Dexamethasone	9

Values in T-score · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Venetoclax + Bortezomib and Dexamethasone	2.8	8.43	Not reported	Not reported	Not reported
Placebo + Bortezomib and Dexamethasone	-0.3	9.15	Not reported	Not reported	Not reported

Cycle 33, Day 1

Analysis denominator · Participants

Group	Source count
Venetoclax + Bortezomib and Dexamethasone	38
Placebo + Bortezomib and Dexamethasone	7

Values in T-score · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Venetoclax + Bortezomib and Dexamethasone	2.0	8.93	Not reported	Not reported	Not reported
Placebo + Bortezomib and Dexamethasone	3.7	9.17	Not reported	Not reported	Not reported

Cycle 35, Day 1

Analysis denominator · Participants

Group	Source count
Venetoclax + Bortezomib and Dexamethasone	35
Placebo + Bortezomib and Dexamethasone	6

Values in T-score · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Venetoclax + Bortezomib and Dexamethasone	3.4	9.27	Not reported	Not reported	Not reported
Placebo + Bortezomib and Dexamethasone	1.1	7.22	Not reported	Not reported	Not reported

Cycle 37, Day 1

Analysis denominator · Participants

Group	Source count
Venetoclax + Bortezomib and Dexamethasone	31
Placebo + Bortezomib and Dexamethasone	4

Values in T-score · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Venetoclax + Bortezomib and Dexamethasone	4.1	9.72	Not reported	Not reported	Not reported
Placebo + Bortezomib and Dexamethasone	-3.0	11.72	Not reported	Not reported	Not reported

Cycle 39, Day 1

Analysis denominator · Participants

Group	Source count
Venetoclax + Bortezomib and Dexamethasone	27
Placebo + Bortezomib and Dexamethasone	3

Values in T-score · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Venetoclax + Bortezomib and Dexamethasone	3.6	8.12	Not reported	Not reported	Not reported
Placebo + Bortezomib and Dexamethasone	4.1	2.82	Not reported	Not reported	Not reported

Cycle 41, Day 1

Analysis denominator · Participants

Group	Source count
Venetoclax + Bortezomib and Dexamethasone	22
Placebo + Bortezomib and Dexamethasone	3

Values in T-score · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Venetoclax + Bortezomib and Dexamethasone	3.3	8.69	Not reported	Not reported	Not reported
Placebo + Bortezomib and Dexamethasone	-0.7	6.90	Not reported	Not reported	Not reported

Cycle 43, Day 1

Analysis denominator · Participants

Group	Source count
Venetoclax + Bortezomib and Dexamethasone	17
Placebo + Bortezomib and Dexamethasone	2

Values in T-score · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Venetoclax + Bortezomib and Dexamethasone	5.3	9.28	Not reported	Not reported	Not reported
Placebo + Bortezomib and Dexamethasone	4.4	1.91	Not reported	Not reported	Not reported

Cycle 45, Day 1

Analysis denominator · Participants

Group	Source count
Venetoclax + Bortezomib and Dexamethasone	10
Placebo + Bortezomib and Dexamethasone	2

Values in T-score · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Venetoclax + Bortezomib and Dexamethasone	-0.3	7.99	Not reported	Not reported	Not reported
Placebo + Bortezomib and Dexamethasone	1.8	0.28	Not reported	Not reported	Not reported

Cycle 47, Day 1

Analysis denominator · Participants

Group	Source count
Venetoclax + Bortezomib and Dexamethasone	4
Placebo + Bortezomib and Dexamethasone	1

Values in T-score · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Venetoclax + Bortezomib and Dexamethasone	-2.5	6.30	Not reported	Not reported	Not reported
Placebo + Bortezomib and Dexamethasone	0.0	Not reported	Not reported	Not reported	Not reported

Final visit

Analysis denominator · Participants

Group	Source count
Venetoclax + Bortezomib and Dexamethasone	176
Placebo + Bortezomib and Dexamethasone	87

Values in T-score · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Venetoclax + Bortezomib and Dexamethasone	5.0	10.95	Not reported	Not reported	Not reported
Placebo + Bortezomib and Dexamethasone	2.9	9.96	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
spread
9.54
value
2.2
group Id
OG001
spread
8.12
value
1.8
denoms
counts
group Id
OG000
value
163
group Id
OG001
value
79
units
Participants
title
Cycle 3, Day 1
categories
measurements
group Id
OG000
spread
9.25
value
3.3
group Id
OG001
spread
10.34
value
2.4
denoms
counts
group Id
OG000
value
141
group Id
OG001
value
70
units
Participants
title
Cycle 5, Day 1
categories
measurements
group Id
OG000
spread
9.28
value
3.2
group Id
OG001
spread
9.70
value
2.6
denoms
counts
group Id
OG000
value
126
group Id
OG001
value
70
units
Participants
title
Cycle 7, Day 1
categories
measurements
group Id
OG000
spread
8.90
value
2.3
group Id
OG001
spread
8.67
value
2.6
denoms
counts
group Id
OG000
value
114
group Id
OG001
value
65
units
Participants
title
Cycle 9, Day 1
categories
measurements
group Id
OG000
spread
8.54
value
0.6
group Id
OG001
spread
8.98
value
3.1
denoms
counts
group Id
OG000
value
99
group Id
OG001
value
55
units
Participants
title
Cycle 11, Day 1
categories
measurements
group Id
OG000
spread
8.03
value
1.8
group Id
OG001
spread
6.97
value
2.3
denoms
counts
group Id
OG000
value
83
group Id
OG001
value
43
units
Participants
title
Cycle 13, Day 1
categories
measurements
group Id
OG000
spread
8.84
value
1.5
group Id
OG001
spread
7.66
value
2.1
denoms
counts
group Id
OG000
value
77
group Id
OG001
value
31
units
Participants
title
Cycle 15, Day 1
categories
measurements
group Id
OG000
spread
8.11
value
1.2
group Id
OG001
spread
8.05
value
2.6
denoms
counts
group Id
OG000
value
67
group Id
OG001
value
27
units
Participants
title
Cycle 17, Day 1
categories
measurements
group Id
OG000
spread
8.52
value
0.7
group Id
OG001
spread
9.32
value
0.9
denoms
counts
group Id
OG000
value
68
group Id
OG001
value
22
units
Participants
title
Cycle 19, Day 1
categories
measurements
group Id
OG000
spread
8.58
value
1.6
group Id
OG001
spread
7.66
value
1.2
denoms
counts
group Id
OG000
value
59
group Id
OG001
value
18
units
Participants
title
Cycle 21, Day 1
categories
measurements
group Id
OG000
spread
8.08
value
2.0
group Id
OG001
spread
8.83
value
1.5
denoms
counts
group Id
OG000
value
55
group Id
OG001
value
17
units
Participants
title
Cycle 23, Day 1
categories
measurements
group Id
OG000
spread
8.59
value
2.0
group Id
OG001
spread
8.73
value
-0.1
denoms
counts
group Id
OG000
value
48
group Id
OG001
value
13
units
Participants
title
Cycle 25, Day 1

denoms

counts
group Id
OG000
value
185
group Id
OG001
value
92
units
Participants

description

PROMIS Cancer Fatigue SF is a seven item questionnaire that assesses the impact and experience of fatigue over the past 7 days. All questions employ the following five response options: 1 = Not at all, 2 = A little bit, 3 = Somewhat, 4 = Quite a bit, and 5 = Very much. The total raw score is the sum of the responses to each question and is converted to a T-score. The T-score re-scales the total raw score to a standardized score with a mean of 50 and a standard deviation of 10. The \[PROMIS\] Cancer Fatigue Short Form \[SF\] 7a T-Scores range from 29.4 to 83.2, with higher scores indicating more fatigue. Negative changes from baseline indicate improvement.

dispersion Type

Standard Deviation

groups

description
Cycles 1-8: Venetoclax 800 mg orally every day (QD) on Days 1 - 21 plus bortezomib 1.3 mg/m\^2 subcutaneously or IV on Days 1, 4, 8 \& 11 and dexamethasone 20 mg orally on Days 1, 2, 4, 5, 8, 9, 11 \& 12; Cycles 9 and beyond: Venetoclax 800 mg orally every day (QD) on Days 1 - 35 plus bortezomib 1.3 mg/m\^2 subcutaneously or IV on Days 1, 8, 15 and 22 and dexamethasone 20 mg orally on Days 1, 2, 8, 9, 15, 16, 22 and 23
id
OG000
title
Venetoclax + Bortezomib and Dexamethasone
description
Cycles 1-8: Placebo (to match venetoclax 100 mg tablet) 800 mg orally every day (QD) on Days 1 - 21 plus bortezomib 1.3 mg/m\^2 subcutaneously or IV on Days 1, 4, 8 \& 11 and dexamethasone 20 mg orally on Days 1, 2, 4, 5, 8, 9, 11 \& 12; Cycles 9 and beyond: Placebo (to match venetoclax 100 mg tablet) 800 mg orally every day (QD) on Days 1 - 35 plus bortezomib 1.3 mg/m\^2 subcutaneously or IV on Days 1, 8, 15 and 22 and dexamethasone 20 mg orally on Days 1, 2, 8, 9, 15, 16, 22 \& 23
id
OG001
title
Placebo + Bortezomib and Dexamethasone

param Type

MEAN

population Description

Intent-To-Treat (ITT) analysis set: all randomized participants, analyzed by treatment group assignment given at the time of randomization; participants who have both baseline and post-baseline values are included in the analysis at each visit

reporting Status

POSTED

time Frame

Baseline; Cycle 3 (Cycles 1 - 8 are 21 days, Cycles 9 and beyond are 35 days) through Cycle 47, collected on Day 1 of every other cycle and at the Treatment Completion Visit (TCV) while participant is on treatment

title

Mean Change From Baseline in Patient Reported Outcomes Measurement Information System [PROMIS] Cancer Fatigue Short Form [SF] Score

type

SECONDARY

unit Of Measure

T-score

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice