Part 2: Change From Baseline in Health-related Quality of Life (HRQL) Score Based on Functional Assessment of Cancer Therapy - Multiple Myeloma (FACT-MM) Questionnaire
Selinexor Treatment of Refractory Myeloma · Source last updated 2023-01-26
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
Measure
MEAN
Unit
Score on a Scale
Interval / dispersion
Standard Deviation
Time frame
Baseline, Day 1 of Cycle 2 to Cycle 20 (up to a maximum of 17 months)
What was measured
FACT-MM combines the general version of the FACT (FACT-G) with a MM-specific sub-scale (14 items). The sub-scales for the FACT-G are Physical Well-Being (7 items), Social/Family Well-Being (7 items), Emotional Well-Being (6 items), and Functional Well-Being (7 items). The trial outcomes index (TOI); total of 41 items) is the primary measurement of interest, comprised of the Physical and Functional sub-scales plus the MM-specific sub-scale. Each item is rated on a 5-point Likert scale, ranging from 0 ("Not at all") to 4 ("Very much"), therefore the TOI has a score ranging from 0 to 120. Higher scores indicated improvement in well being.
Analysis population: mITT population set. Here, "Number of participants analyzed" signifies those participants who were evaluable for this outcome measure at given time points. Data was not planned to be collected and analyzed for Part 1.
Groups in this outcome
Part 2
Participants who previously had received more than 3 anti-MM regimens and had penta-exposed, triple class-refractory MM (i.e. previously treated with lenalidomide, pomalidomide, bortezomib, carfilzomib, and daratumumab, and refractory to prior treatment with glucocorticoids, an IMiD, a PI, and the anti-CD38 mAb daratumumab) received, selinexor 80 mg PO plus low-dose dexamethasone 20 mg Sd twice-weekly on Days 1 and 3 until disease progression, death, or unacceptable toxicity (maximum duration of approximately 17 months).
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
Part 2
107
Reported measurements
Trial Outcomes Index Score: Baseline
Analysis denominator · Participants
Group
Source count
Part 2
107
Values in Score on a Scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Part 2
67.5
19.20
Not reported
Not reported
Not reported
Trial Outcomes Index Score: Change at C2D1
Analysis denominator · Participants
Group
Source count
Part 2
76
Values in Score on a Scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Part 2
-6.1
18.43
Not reported
Not reported
Not reported
Trial Outcomes Index Score: Change at C3D1
Analysis denominator · Participants
Group
Source count
Part 2
50
Values in Score on a Scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Part 2
-8.5
15.50
Not reported
Not reported
Not reported
Trial Outcomes Index Score: Change at C4D1
Analysis denominator · Participants
Group
Source count
Part 2
31
Values in Score on a Scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Part 2
-9.1
16.79
Not reported
Not reported
Not reported
Trial Outcomes Index Score: Change at C5D1
Analysis denominator · Participants
Group
Source count
Part 2
26
Values in Score on a Scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Part 2
-6.9
12.06
Not reported
Not reported
Not reported
Trial Outcomes Index Score: Change at C6D1
Analysis denominator · Participants
Group
Source count
Part 2
19
Values in Score on a Scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Part 2
-8.3
15.07
Not reported
Not reported
Not reported
Trial Outcomes Index Score: Change at C7D1
Analysis denominator · Participants
Group
Source count
Part 2
13
Values in Score on a Scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Part 2
-7.5
19.26
Not reported
Not reported
Not reported
Trial Outcomes Index Score: Change at C8D1
Analysis denominator · Participants
Group
Source count
Part 2
5
Values in Score on a Scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Part 2
-15.4
24.59
Not reported
Not reported
Not reported
Trial Outcomes Index Score: Change at C9D1
Analysis denominator · Participants
Group
Source count
Part 2
3
Values in Score on a Scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Part 2
-4.7
14.84
Not reported
Not reported
Not reported
Trial Outcomes Index Score: Change at C10D1
Analysis denominator · Participants
Group
Source count
Part 2
3
Values in Score on a Scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Part 2
-4.0
5.29
Not reported
Not reported
Not reported
Trial Outcomes Index Score: Change at C11D1
Analysis denominator · Participants
Group
Source count
Part 2
1
Values in Score on a Scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Part 2
3.0
NA
Not reported
Not reported
Standard deviation was not estimated due to single participant.
Trial Outcomes Index Score: Change at C12D1
Analysis denominator · Participants
Group
Source count
Part 2
1
Values in Score on a Scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Part 2
3.0
NA
Not reported
Not reported
Standard deviation was not estimated due to single participant.
Trial Outcomes Index Score: Change at C13D1
Analysis denominator · Participants
Group
Source count
Part 2
1
Values in Score on a Scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Part 2
-23.0
NA
Not reported
Not reported
Standard deviation was not estimated due to single participant.
Trial Outcomes Index Score: Change at C14D1
Analysis denominator · Participants
Group
Source count
Part 2
1
Values in Score on a Scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Part 2
14.0
NA
Not reported
Not reported
Standard deviation was not estimated due to single participant.
Trial Outcomes Index Score: Change at C15D1
Analysis denominator · Participants
Group
Source count
Part 2
1
Values in Score on a Scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Part 2
1.0
NA
Not reported
Not reported
Standard deviation was not estimated due to single participant.
Trial Outcomes Index Score: Change at C16D1
Analysis denominator · Participants
Group
Source count
Part 2
1
Values in Score on a Scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Part 2
4.0
NA
Not reported
Not reported
Standard deviation was not estimated due to single participant.
Trial Outcomes Index Score: Change at C17D1
Analysis denominator · Participants
Group
Source count
Part 2
0
Trial Outcomes Index Score: Change at C18D1
Analysis denominator · Participants
Group
Source count
Part 2
0
Trial Outcomes Index Score: Change at C19D1
Analysis denominator · Participants
Group
Source count
Part 2
0
Trial Outcomes Index Score: Change at C20D1
Analysis denominator · Participants
Group
Source count
Part 2
0
Complete source fields
classes
categories
measurements
group Id
OG000
spread
19.20
value
67.5
denoms
counts
group Id
OG000
value
107
units
Participants
title
Trial Outcomes Index Score: Baseline
categories
measurements
group Id
OG000
spread
18.43
value
-6.1
denoms
counts
group Id
OG000
value
76
units
Participants
title
Trial Outcomes Index Score: Change at C2D1
categories
measurements
group Id
OG000
spread
15.50
value
-8.5
denoms
counts
group Id
OG000
value
50
units
Participants
title
Trial Outcomes Index Score: Change at C3D1
categories
measurements
group Id
OG000
spread
16.79
value
-9.1
denoms
counts
group Id
OG000
value
31
units
Participants
title
Trial Outcomes Index Score: Change at C4D1
categories
measurements
group Id
OG000
spread
12.06
value
-6.9
denoms
counts
group Id
OG000
value
26
units
Participants
title
Trial Outcomes Index Score: Change at C5D1
categories
measurements
group Id
OG000
spread
15.07
value
-8.3
denoms
counts
group Id
OG000
value
19
units
Participants
title
Trial Outcomes Index Score: Change at C6D1
categories
measurements
group Id
OG000
spread
19.26
value
-7.5
denoms
counts
group Id
OG000
value
13
units
Participants
title
Trial Outcomes Index Score: Change at C7D1
categories
measurements
group Id
OG000
spread
24.59
value
-15.4
denoms
counts
group Id
OG000
value
5
units
Participants
title
Trial Outcomes Index Score: Change at C8D1
categories
measurements
group Id
OG000
spread
14.84
value
-4.7
denoms
counts
group Id
OG000
value
3
units
Participants
title
Trial Outcomes Index Score: Change at C9D1
categories
measurements
group Id
OG000
spread
5.29
value
-4.0
denoms
counts
group Id
OG000
value
3
units
Participants
title
Trial Outcomes Index Score: Change at C10D1
categories
measurements
comment
Standard deviation was not estimated due to single participant.
group Id
OG000
spread
NA
value
3.0
denoms
counts
group Id
OG000
value
1
units
Participants
title
Trial Outcomes Index Score: Change at C11D1
categories
measurements
comment
Standard deviation was not estimated due to single participant.
group Id
OG000
spread
NA
value
3.0
denoms
counts
group Id
OG000
value
1
units
Participants
title
Trial Outcomes Index Score: Change at C12D1
denoms
counts
group Id
OG000
value
107
units
Participants
description
FACT-MM combines the general version of the FACT (FACT-G) with a MM-specific sub-scale (14 items). The sub-scales for the FACT-G are Physical Well-Being (7 items), Social/Family Well-Being (7 items), Emotional Well-Being (6 items), and Functional Well-Being (7 items). The trial outcomes index (TOI); total of 41 items) is the primary measurement of interest, comprised of the Physical and Functional sub-scales plus the MM-specific sub-scale. Each item is rated on a 5-point Likert scale, ranging from 0 ("Not at all") to 4 ("Very much"), therefore the TOI has a score ranging from 0 to 120. Higher scores indicated improvement in well being.
dispersion Type
Standard Deviation
groups
description
Participants who previously had received more than 3 anti-MM regimens and had penta-exposed, triple class-refractory MM (i.e. previously treated with lenalidomide, pomalidomide, bortezomib, carfilzomib, and daratumumab, and refractory to prior treatment with glucocorticoids, an IMiD, a PI, and the anti-CD38 mAb daratumumab) received, selinexor 80 mg PO plus low-dose dexamethasone 20 mg Sd twice-weekly on Days 1 and 3 until disease progression, death, or unacceptable toxicity (maximum duration of approximately 17 months).
id
OG000
title
Part 2
param Type
MEAN
population Description
mITT population set. Here, "Number of participants analyzed" signifies those participants who were evaluable for this outcome measure at given time points. Data was not planned to be collected and analyzed for Part 1.
reporting Status
POSTED
time Frame
Baseline, Day 1 of Cycle 2 to Cycle 20 (up to a maximum of 17 months)
title
Part 2: Change From Baseline in Health-related Quality of Life (HRQL) Score Based on Functional Assessment of Cancer Therapy - Multiple Myeloma (FACT-MM) Questionnaire
Triangle