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NCT05405166 · OUTCOME

Percentage of Participants Who Visited Healthcare Professional for Non-trial-related Health Issues Based on HRUPQ

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: Cycle 1 Days 8, 15 and 22, Cycle 2 Day 1, Cycles 3 to 29 Day 15 and EOT visit (up to PCD: 06-Nov-2024) (30 days after last drug administration or before further anti myeloma therapy initiation, whichever occurred first, up to approximately 28 months)

What was measured

Medical resource utilization was collected through HRUPQ. Percentage of participants with healthcare professional visit not required by clinical trial since last isatuximab administration was recorded. Percentages are rounded off to the tenth decimal place.

Analysis population: The ITT population included all randomized population. Only those participants with data collected at specified timepoints 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	224
Isa-SC + Pd	208

Reported measurements

Cycle 1 Day 8

Analysis denominator · Participants

Group	Source count
Isa-IV + Pd	210
Isa-SC + Pd	208

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Isa-IV + Pd	11.4	Not reported	Not reported	Not reported	Not reported
Isa-SC + Pd	14.9	Not reported	Not reported	Not reported	Not reported

Cycle 1 Day 15

Analysis denominator · Participants

Group	Source count
Isa-IV + Pd	201
Isa-SC + Pd	195

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Isa-IV + Pd	10.0	Not reported	Not reported	Not reported	Not reported
Isa-SC + Pd	9.2	Not reported	Not reported	Not reported	Not reported

Cycle 1 Day 22

Analysis denominator · Participants

Group	Source count
Isa-IV + Pd	206
Isa-SC + Pd	193

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Isa-IV + Pd	11.7	Not reported	Not reported	Not reported	Not reported
Isa-SC + Pd	9.8	Not reported	Not reported	Not reported	Not reported

Cycle 2 Day 1

Analysis denominator · Participants

Group	Source count
Isa-IV + Pd	224
Isa-SC + Pd	204

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Isa-IV + Pd	12.5	Not reported	Not reported	Not reported	Not reported
Isa-SC + Pd	10.8	Not reported	Not reported	Not reported	Not reported

Cycle 3 Day 15

Analysis denominator · Participants

Group	Source count
Isa-IV + Pd	190
Isa-SC + Pd	182

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Isa-IV + Pd	13.2	Not reported	Not reported	Not reported	Not reported
Isa-SC + Pd	11.5	Not reported	Not reported	Not reported	Not reported

Cycle 4 Day 15

Analysis denominator · Participants

Group	Source count
Isa-IV + Pd	175
Isa-SC + Pd	176

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Isa-IV + Pd	13.1	Not reported	Not reported	Not reported	Not reported
Isa-SC + Pd	8.5	Not reported	Not reported	Not reported	Not reported

Cycle 5 Day 15

Analysis denominator · Participants

Group	Source count
Isa-IV + Pd	192
Isa-SC + Pd	178

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Isa-IV + Pd	8.9	Not reported	Not reported	Not reported	Not reported
Isa-SC + Pd	7.3	Not reported	Not reported	Not reported	Not reported

Cycle 6 Day 15

Analysis denominator · Participants

Group	Source count
Isa-IV + Pd	165
Isa-SC + Pd	163

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Isa-IV + Pd	9.7	Not reported	Not reported	Not reported	Not reported
Isa-SC + Pd	9.2	Not reported	Not reported	Not reported	Not reported

Cycle 7 Day 15

Analysis denominator · Participants

Group	Source count
Isa-IV + Pd	151
Isa-SC + Pd	141

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Isa-IV + Pd	13.2	Not reported	Not reported	Not reported	Not reported
Isa-SC + Pd	9.2	Not reported	Not reported	Not reported	Not reported

Cycle 8 Day 15

Analysis denominator · Participants

Group	Source count
Isa-IV + Pd	132
Isa-SC + Pd	123

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Isa-IV + Pd	16.7	Not reported	Not reported	Not reported	Not reported
Isa-SC + Pd	14.6	Not reported	Not reported	Not reported	Not reported

Cycle 9 Day 15

Analysis denominator · Participants

Group	Source count
Isa-IV + Pd	112
Isa-SC + Pd	99

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Isa-IV + Pd	11.6	Not reported	Not reported	Not reported	Not reported
Isa-SC + Pd	14.1	Not reported	Not reported	Not reported	Not reported

Cycle 10 Day 15

Analysis denominator · Participants

Group	Source count
Isa-IV + Pd	92
Isa-SC + Pd	92

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Isa-IV + Pd	10.9	Not reported	Not reported	Not reported	Not reported
Isa-SC + Pd	14.1	Not reported	Not reported	Not reported	Not reported

Cycle 11 Day 15

Analysis denominator · Participants

Group	Source count
Isa-IV + Pd	92
Isa-SC + Pd	77

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Isa-IV + Pd	13.0	Not reported	Not reported	Not reported	Not reported
Isa-SC + Pd	10.4	Not reported	Not reported	Not reported	Not reported

Cycle 12 Day 15

Analysis denominator · Participants

Group	Source count
Isa-IV + Pd	73
Isa-SC + Pd	64

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Isa-IV + Pd	6.8	Not reported	Not reported	Not reported	Not reported
Isa-SC + Pd	10.9	Not reported	Not reported	Not reported	Not reported

Cycle 13 Day 15

Analysis denominator · Participants

Group	Source count
Isa-IV + Pd	65
Isa-SC + Pd	57

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Isa-IV + Pd	16.9	Not reported	Not reported	Not reported	Not reported
Isa-SC + Pd	12.3	Not reported	Not reported	Not reported	Not reported

Cycle 14 Day 15

Analysis denominator · Participants

Group	Source count
Isa-IV + Pd	56
Isa-SC + Pd	52

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Isa-IV + Pd	12.5	Not reported	Not reported	Not reported	Not reported
Isa-SC + Pd	5.8	Not reported	Not reported	Not reported	Not reported

Cycle 15 Day 15

Analysis denominator · Participants

Group	Source count
Isa-IV + Pd	48
Isa-SC + Pd	48

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Isa-IV + Pd	18.8	Not reported	Not reported	Not reported	Not reported
Isa-SC + Pd	12.5	Not reported	Not reported	Not reported	Not reported

Cycle 16 Day 15

Analysis denominator · Participants

Group	Source count
Isa-IV + Pd	40
Isa-SC + Pd	36

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Isa-IV + Pd	7.5	Not reported	Not reported	Not reported	Not reported
Isa-SC + Pd	13.9	Not reported	Not reported	Not reported	Not reported

Cycle 17 Day 15

Analysis denominator · Participants

Group	Source count
Isa-IV + Pd	33
Isa-SC + Pd	30

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Isa-IV + Pd	15.2	Not reported	Not reported	Not reported	Not reported
Isa-SC + Pd	16.7	Not reported	Not reported	Not reported	Not reported

Cycle 18 Day 15

Analysis denominator · Participants

Group	Source count
Isa-IV + Pd	23
Isa-SC + Pd	25

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Isa-IV + Pd	13.0	Not reported	Not reported	Not reported	Not reported
Isa-SC + Pd	12.0	Not reported	Not reported	Not reported	Not reported

Cycle 19 Day 15

Analysis denominator · Participants

Group	Source count
Isa-IV + Pd	24
Isa-SC + Pd	22

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Isa-IV + Pd	8.3	Not reported	Not reported	Not reported	Not reported
Isa-SC + Pd	13.6	Not reported	Not reported	Not reported	Not reported

Cycle 20 Day 15

Analysis denominator · Participants

Group	Source count
Isa-IV + Pd	16
Isa-SC + Pd	19

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Isa-IV + Pd	12.5	Not reported	Not reported	Not reported	Not reported
Isa-SC + Pd	15.8	Not reported	Not reported	Not reported	Not reported

Cycle 21 Day 15

Analysis denominator · Participants

Group	Source count
Isa-IV + Pd	12
Isa-SC + Pd	10

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Isa-IV + Pd	25.0	Not reported	Not reported	Not reported	Not reported
Isa-SC + Pd	0	Not reported	Not reported	Not reported	Not reported

Cycle 22 Day 15

Analysis denominator · Participants

Group	Source count
Isa-IV + Pd	9
Isa-SC + Pd	9

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Isa-IV + Pd	44.4	Not reported	Not reported	Not reported	Not reported
Isa-SC + Pd	11.1	Not reported	Not reported	Not reported	Not reported

Cycle 23 Day 15

Analysis denominator · Participants

Group	Source count
Isa-IV + Pd	4
Isa-SC + Pd	9

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Isa-IV + Pd	0	Not reported	Not reported	Not reported	Not reported
Isa-SC + Pd	22.2	Not reported	Not reported	Not reported	Not reported

Cycle 24 Day 15

Analysis denominator · Participants

Group	Source count
Isa-IV + Pd	5
Isa-SC + Pd	4

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Isa-IV + Pd	20.0	Not reported	Not reported	Not reported	Not reported
Isa-SC + Pd	0	Not reported	Not reported	Not reported	Not reported

Cycle 25 Day 15

Analysis denominator · Participants

Group	Source count
Isa-IV + Pd	3
Isa-SC + Pd	4

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Isa-IV + Pd	0	Not reported	Not reported	Not reported	Not reported
Isa-SC + Pd	25.0	Not reported	Not reported	Not reported	Not reported

Cycle 26 Day 15

Analysis denominator · Participants

Group	Source count
Isa-IV + Pd	2
Isa-SC + Pd	4

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Isa-IV + Pd	0	Not reported	Not reported	Not reported	Not reported
Isa-SC + Pd	0	Not reported	Not reported	Not reported	Not reported

Cycle 27 Day 15

Analysis denominator · Participants

Group	Source count
Isa-IV + Pd	1
Isa-SC + Pd	3

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Isa-IV + Pd	0	Not reported	Not reported	Not reported	Not reported
Isa-SC + Pd	0	Not reported	Not reported	Not reported	Not reported

Cycle 28 Day 15

Analysis denominator · Participants

Group	Source count
Isa-IV + Pd	0
Isa-SC + Pd	2

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Isa-SC + Pd	50.0	Not reported	Not reported	Not reported	Not reported

Cycle 29 Day 15

Analysis denominator · Participants

Group	Source count
Isa-IV + Pd	0
Isa-SC + Pd	1

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Isa-SC + Pd	0	Not reported	Not reported	Not reported	Not reported

EOT visit

Analysis denominator · Participants

Group	Source count
Isa-IV + Pd	68
Isa-SC + Pd	76

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Isa-IV + Pd	25.0	Not reported	Not reported	Not reported	Not reported
Isa-SC + Pd	17.1	Not reported	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
value
11.4
group Id
OG001
value
14.9
denoms
counts
group Id
OG000
value
210
group Id
OG001
value
208
units
Participants
title
Cycle 1 Day 8
categories
measurements
group Id
OG000
value
10.0
group Id
OG001
value
9.2
denoms
counts
group Id
OG000
value
201
group Id
OG001
value
195
units
Participants
title
Cycle 1 Day 15
categories
measurements
group Id
OG000
value
11.7
group Id
OG001
value
9.8
denoms
counts
group Id
OG000
value
206
group Id
OG001
value
193
units
Participants
title
Cycle 1 Day 22
categories
measurements
group Id
OG000
value
12.5
group Id
OG001
value
10.8
denoms
counts
group Id
OG000
value
224
group Id
OG001
value
204
units
Participants
title
Cycle 2 Day 1
categories
measurements
group Id
OG000
value
13.2
group Id
OG001
value
11.5
denoms
counts
group Id
OG000
value
190
group Id
OG001
value
182
units
Participants
title
Cycle 3 Day 15
categories
measurements
group Id
OG000
value
13.1
group Id
OG001
value
8.5
denoms
counts
group Id
OG000
value
175
group Id
OG001
value
176
units
Participants
title
Cycle 4 Day 15
categories
measurements
group Id
OG000
value
8.9
group Id
OG001
value
7.3
denoms
counts
group Id
OG000
value
192
group Id
OG001
value
178
units
Participants
title
Cycle 5 Day 15
categories
measurements
group Id
OG000
value
9.7
group Id
OG001
value
9.2
denoms
counts
group Id
OG000
value
165
group Id
OG001
value
163
units
Participants
title
Cycle 6 Day 15
categories
measurements
group Id
OG000
value
13.2
group Id
OG001
value
9.2
denoms
counts
group Id
OG000
value
151
group Id
OG001
value
141
units
Participants
title
Cycle 7 Day 15
categories
measurements
group Id
OG000
value
16.7
group Id
OG001
value
14.6
denoms
counts
group Id
OG000
value
132
group Id
OG001
value
123
units
Participants
title
Cycle 8 Day 15
categories
measurements
group Id
OG000
value
11.6
group Id
OG001
value
14.1
denoms
counts
group Id
OG000
value
112
group Id
OG001
value
99
units
Participants
title
Cycle 9 Day 15
categories
measurements
group Id
OG000
value
10.9
group Id
OG001
value
14.1
denoms
counts
group Id
OG000
value
92
group Id
OG001
value
92
units
Participants
title
Cycle 10 Day 15

denoms

counts
group Id
OG000
value
224
group Id
OG001
value
208
units
Participants

description

Medical resource utilization was collected through HRUPQ. Percentage of participants with healthcare professional visit not required by clinical trial since last isatuximab administration was recorded. Percentages are rounded off to the tenth decimal place.

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 specified timepoints are reported.

reporting Status

POSTED

time Frame

Cycle 1 Days 8, 15 and 22, Cycle 2 Day 1, Cycles 3 to 29 Day 15 and EOT visit (up to PCD: 06-Nov-2024) (30 days after last drug administration or before further anti myeloma therapy initiation, whichever occurred first, up to approximately 28 months)

title

Percentage of Participants Who Visited Healthcare Professional for Non-trial-related Health Issues Based on HRUPQ

type

SECONDARY

unit Of Measure

percentage of participants

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

Preserved source evidence · Not medical advice