Percentage of Participants With Response to 'Patient Expectation Questionnaire at Baseline (PEQ-BL)'
SC Versus IV Isatuximab in Combination With Pomalidomide and Dexamethasone in RRMM · Source last updated 2026-09-02
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
Measure
NUMBER
Unit
percentage of participants
Interval / dispersion
Not reported
Time frame
Baseline (Cycle 1 Day 1)
What was measured
Percentage of participants who responded that they strongly agree or agree at baseline with expectations of pain, discomfort and side effects from the injection method, the injection method would save time, study medication may result in side effects and would be worth taking are reported. PEQ-BL consisted of 7 items. Percentage of participants who ever received medication through IV and/or SC administration are also reported. Percentages are rounded off to the tenth decimal place. The baseline value was defined as the last non-missing value collected on or before the start date of study medication.
Analysis population: The ITT population included all randomized population. Only those participants with data collected at Baseline are reported.
Groups in this outcome
Isa-IV + Pd
Participants received isatuximab 10 mg/kg IV infusion QW (i.e. on Days 1, 8, 15 and 22) in Cycle 1 (28 days) and then 10 mg/kg Q2W (i.e. on Days 1 and 15) of each subsequent 28-day cycle along with pomalidomide 4 mg orally on Days 1 to 21 of each 28-day cycle and dexamethasone 40 mg (or 20 mg for participant \>=75 years) orally on Days 1, 8, 15, and 22 of each cycle until disease progression, unacceptable AEs, participant request to discontinue treatment, or any other reason, whichever came first.
Isa-SC + Pd
Participants received isatuximab 1400 mg SC injection administered via an OBDS which is an investigational device injector QW (i.e on Days 1, 8, 15 and 22) in Cycle 1 (28 days) and then 1400 mg Q2W (i.e. on Days 1 and 15) of each subsequent 28-day cycle along with pomalidomide 4 mg orally on Days 1 to 21 of each 28-day cycle and dexamethasone 40 mg (or 20 mg for participant \>=75 years) orally on Days 1, 8, 15, and 22 of each cycle until disease progression, unacceptable AEs, participant request to discontinue treatment, or any other reason, whichever came first.
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
Isa-IV + Pd
217
Isa-SC + Pd
228
Reported measurements
Injection method may be painful: strongly agree
Values in percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Isa-IV + Pd
6.0
Not reported
Not reported
Not reported
Not reported
Isa-SC + Pd
7.9
Not reported
Not reported
Not reported
Not reported
Injection method may be painful: agree
Values in percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Isa-IV + Pd
33.6
Not reported
Not reported
Not reported
Not reported
Isa-SC + Pd
33.3
Not reported
Not reported
Not reported
Not reported
Injection method may be uncomfortable: strongly agree
Values in percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Isa-IV + Pd
11.1
Not reported
Not reported
Not reported
Not reported
Isa-SC + Pd
9.6
Not reported
Not reported
Not reported
Not reported
Injection method may be uncomfortable: agree
Values in percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Isa-IV + Pd
37.8
Not reported
Not reported
Not reported
Not reported
Isa-SC + Pd
25.9
Not reported
Not reported
Not reported
Not reported
Injection method may result in side effects: strongly agree
Values in percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Isa-IV + Pd
9.2
Not reported
Not reported
Not reported
Not reported
Isa-SC + Pd
4.8
Not reported
Not reported
Not reported
Not reported
Injection method may result in side effects: agree
Values in percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Isa-IV + Pd
42.9
Not reported
Not reported
Not reported
Not reported
Isa-SC + Pd
45.2
Not reported
Not reported
Not reported
Not reported
Injection method will save me time: strongly agree
Values in percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Isa-IV + Pd
9.2
Not reported
Not reported
Not reported
Not reported
Isa-SC + Pd
21.1
Not reported
Not reported
Not reported
Not reported
Injection method will save me time: agree
Values in percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Isa-IV + Pd
31.8
Not reported
Not reported
Not reported
Not reported
Isa-SC + Pd
51.8
Not reported
Not reported
Not reported
Not reported
Study medication may result in side effects: strongly agree
Values in percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Isa-IV + Pd
12.9
Not reported
Not reported
Not reported
Not reported
Isa-SC + Pd
7.9
Not reported
Not reported
Not reported
Not reported
Study medication may result in side effects: agree
Values in percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Isa-IV + Pd
47.5
Not reported
Not reported
Not reported
Not reported
Isa-SC + Pd
44.3
Not reported
Not reported
Not reported
Not reported
Study medication would be worth taking: strongly agree
Values in percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Isa-IV + Pd
26.7
Not reported
Not reported
Not reported
Not reported
Isa-SC + Pd
26.8
Not reported
Not reported
Not reported
Not reported
Study medication would be worth taking: agree
Values in percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Isa-IV + Pd
47.0
Not reported
Not reported
Not reported
Not reported
Isa-SC + Pd
47.8
Not reported
Not reported
Not reported
Not reported
Ever received medication through IV
Values in percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Isa-IV + Pd
74.2
Not reported
Not reported
Not reported
Not reported
Isa-SC + Pd
62.3
Not reported
Not reported
Not reported
Not reported
Ever received medication through SC
Values in percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Isa-IV + Pd
48.8
Not reported
Not reported
Not reported
Not reported
Isa-SC + Pd
61.4
Not reported
Not reported
Not reported
Not reported
Neither received medication ever via IV or SC
Values in percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Isa-IV + Pd
9.2
Not reported
Not reported
Not reported
Not reported
Isa-SC + Pd
6.1
Not reported
Not reported
Not reported
Not reported
Complete source fields
classes
categories
measurements
group Id
OG000
value
6.0
group Id
OG001
value
7.9
title
Injection method may be painful: strongly agree
categories
measurements
group Id
OG000
value
33.6
group Id
OG001
value
33.3
title
Injection method may be painful: agree
categories
measurements
group Id
OG000
value
11.1
group Id
OG001
value
9.6
title
Injection method may be uncomfortable: strongly agree
categories
measurements
group Id
OG000
value
37.8
group Id
OG001
value
25.9
title
Injection method may be uncomfortable: agree
categories
measurements
group Id
OG000
value
9.2
group Id
OG001
value
4.8
title
Injection method may result in side effects: strongly agree
categories
measurements
group Id
OG000
value
42.9
group Id
OG001
value
45.2
title
Injection method may result in side effects: agree
categories
measurements
group Id
OG000
value
9.2
group Id
OG001
value
21.1
title
Injection method will save me time: strongly agree
categories
measurements
group Id
OG000
value
31.8
group Id
OG001
value
51.8
title
Injection method will save me time: agree
categories
measurements
group Id
OG000
value
12.9
group Id
OG001
value
7.9
title
Study medication may result in side effects: strongly agree
categories
measurements
group Id
OG000
value
47.5
group Id
OG001
value
44.3
title
Study medication may result in side effects: agree
categories
measurements
group Id
OG000
value
26.7
group Id
OG001
value
26.8
title
Study medication would be worth taking: strongly agree
categories
measurements
group Id
OG000
value
47.0
group Id
OG001
value
47.8
title
Study medication would be worth taking: agree
denoms
counts
group Id
OG000
value
217
group Id
OG001
value
228
units
Participants
description
Percentage of participants who responded that they strongly agree or agree at baseline with expectations of pain, discomfort and side effects from the injection method, the injection method would save time, study medication may result in side effects and would be worth taking are reported. PEQ-BL consisted of 7 items. Percentage of participants who ever received medication through IV and/or SC administration are also reported. Percentages are rounded off to the tenth decimal place. The baseline value was defined as the last non-missing value collected on or before the start date of study medication.
groups
description
Participants received isatuximab 10 mg/kg IV infusion QW (i.e. on Days 1, 8, 15 and 22) in Cycle 1 (28 days) and then 10 mg/kg Q2W (i.e. on Days 1 and 15) of each subsequent 28-day cycle along with pomalidomide 4 mg orally on Days 1 to 21 of each 28-day cycle and dexamethasone 40 mg (or 20 mg for participant \>=75 years) orally on Days 1, 8, 15, and 22 of each cycle until disease progression, unacceptable AEs, participant request to discontinue treatment, or any other reason, whichever came first.
id
OG000
title
Isa-IV + Pd
description
Participants received isatuximab 1400 mg SC injection administered via an OBDS which is an investigational device injector QW (i.e on Days 1, 8, 15 and 22) in Cycle 1 (28 days) and then 1400 mg Q2W (i.e. on Days 1 and 15) of each subsequent 28-day cycle along with pomalidomide 4 mg orally on Days 1 to 21 of each 28-day cycle and dexamethasone 40 mg (or 20 mg for participant \>=75 years) orally on Days 1, 8, 15, and 22 of each cycle until disease progression, unacceptable AEs, participant request to discontinue treatment, or any other reason, whichever came first.
id
OG001
title
Isa-SC + Pd
param Type
NUMBER
population Description
The ITT population included all randomized population. Only those participants with data collected at Baseline are reported.
reporting Status
POSTED
time Frame
Baseline (Cycle 1 Day 1)
title
Percentage of Participants With Response to 'Patient Expectation Questionnaire at Baseline (PEQ-BL)'
Triangle