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NCT05405166 · OUTCOME

Ctrough of Isatuximab

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: MEAN
Unit: mcg/mL
Interval / dispersion: Standard Deviation
Time frame: Pre-dose on Cycle 1 Days 8, 15 and 22, Cycles 2 to 5 Days 1 and 15, Cycles 6, 7, 8, 9, 12, 15, 18, 21, 24 and 27 Day 1

What was measured

Plasma samples were collected at specified timepoints for the assessment of Ctrough.

Analysis population: The PK population included all participants with at least 1 available isatuximab concentration post-baseline (whatever the cycle and even if dosing was incomplete) with adequate documentation of dosing and sampling dates and times. 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	209
Isa-SC + Pd	210

Reported measurements

Cycle 1 Day 8

Analysis denominator · Participants

Group	Source count
Isa-IV + Pd	204
Isa-SC + Pd	210

Values in mcg/mL · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Isa-IV + Pd	92	47	Not reported	Not reported	Not reported
Isa-SC + Pd	129	66	Not reported	Not reported	Not reported

Cycle 1 Day 15

Analysis denominator · Participants

Group	Source count
Isa-IV + Pd	179
Isa-SC + Pd	187

Values in mcg/mL · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Isa-IV + Pd	171	84	Not reported	Not reported	Not reported
Isa-SC + Pd	249	115	Not reported	Not reported	Not reported

Cycle 1 Day 22

Analysis denominator · Participants

Group	Source count
Isa-IV + Pd	160
Isa-SC + Pd	163

Values in mcg/mL · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Isa-IV + Pd	227	99	Not reported	Not reported	Not reported
Isa-SC + Pd	321	144	Not reported	Not reported	Not reported

Cycle 2 Day 1

Analysis denominator · Participants

Group	Source count
Isa-IV + Pd	140
Isa-SC + Pd	147

Values in mcg/mL · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Isa-IV + Pd	293	117	Not reported	Not reported	Not reported
Isa-SC + Pd	407	211	Not reported	Not reported	Not reported

Cycle 2 Day 15

Analysis denominator · Participants

Group	Source count
Isa-IV + Pd	209
Isa-SC + Pd	202

Values in mcg/mL · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Isa-IV + Pd	243	130	Not reported	Not reported	Not reported
Isa-SC + Pd	363	228	Not reported	Not reported	Not reported

Cycle 3 Day 1

Analysis denominator · Participants

Group	Source count
Isa-IV + Pd	179
Isa-SC + Pd	160

Values in mcg/mL · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Isa-IV + Pd	268	133	Not reported	Not reported	Not reported
Isa-SC + Pd	381	192	Not reported	Not reported	Not reported

Cycle 3 Day 15

Analysis denominator · Participants

Group	Source count
Isa-IV + Pd	188
Isa-SC + Pd	206

Values in mcg/mL · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Isa-IV + Pd	256	138	Not reported	Not reported	Not reported
Isa-SC + Pd	392	245	Not reported	Not reported	Not reported

Cycle 4 Day 1

Analysis denominator · Participants

Group	Source count
Isa-IV + Pd	167
Isa-SC + Pd	167

Values in mcg/mL · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Isa-IV + Pd	277	151	Not reported	Not reported	Not reported
Isa-SC + Pd	477	424	Not reported	Not reported	Not reported

Cycle 4 Day 15

Analysis denominator · Participants

Group	Source count
Isa-IV + Pd	182
Isa-SC + Pd	185

Values in mcg/mL · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Isa-IV + Pd	285	139	Not reported	Not reported	Not reported
Isa-SC + Pd	452	400	Not reported	Not reported	Not reported

Cycle 5 Day 1

Analysis denominator · Participants

Group	Source count
Isa-IV + Pd	156
Isa-SC + Pd	153

Values in mcg/mL · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Isa-IV + Pd	366	568	Not reported	Not reported	Not reported
Isa-SC + Pd	470	264	Not reported	Not reported	Not reported

Cycle 5 Day 15

Analysis denominator · Participants

Group	Source count
Isa-IV + Pd	190
Isa-SC + Pd	180

Values in mcg/mL · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Isa-IV + Pd	306	168	Not reported	Not reported	Not reported
Isa-SC + Pd	463	275	Not reported	Not reported	Not reported

Cycle 6 Day 1

Analysis denominator · Participants

Group	Source count
Isa-IV + Pd	158
Isa-SC + Pd	145

Values in mcg/mL · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Isa-IV + Pd	330	165	Not reported	Not reported	Not reported
Isa-SC + Pd	491	256	Not reported	Not reported	Not reported

Cycle 7 Day 1

Analysis denominator · Participants

Group	Source count
Isa-IV + Pd	128
Isa-SC + Pd	123

Values in mcg/mL · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Isa-IV + Pd	339	189	Not reported	Not reported	Not reported
Isa-SC + Pd	523	336	Not reported	Not reported	Not reported

Cycle 8 Day 1

Analysis denominator · Participants

Group	Source count
Isa-IV + Pd	116
Isa-SC + Pd	100

Values in mcg/mL · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Isa-IV + Pd	348	172	Not reported	Not reported	Not reported
Isa-SC + Pd	569	336	Not reported	Not reported	Not reported

Cycle 9 Day 1

Analysis denominator · Participants

Group	Source count
Isa-IV + Pd	101
Isa-SC + Pd	96

Values in mcg/mL · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Isa-IV + Pd	365	193	Not reported	Not reported	Not reported
Isa-SC + Pd	598	369	Not reported	Not reported	Not reported

Cycle 12 Day 1

Analysis denominator · Participants

Group	Source count
Isa-IV + Pd	63
Isa-SC + Pd	63

Values in mcg/mL · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Isa-IV + Pd	380	214	Not reported	Not reported	Not reported
Isa-SC + Pd	593	404	Not reported	Not reported	Not reported

Cycle 15 Day 1

Analysis denominator · Participants

Group	Source count
Isa-IV + Pd	45
Isa-SC + Pd	39

Values in mcg/mL · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Isa-IV + Pd	354	158	Not reported	Not reported	Not reported
Isa-SC + Pd	651	361	Not reported	Not reported	Not reported

Cycle 18 Day 1

Analysis denominator · Participants

Group	Source count
Isa-IV + Pd	18
Isa-SC + Pd	23

Values in mcg/mL · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Isa-IV + Pd	367	140	Not reported	Not reported	Not reported
Isa-SC + Pd	645	343	Not reported	Not reported	Not reported

Cycle 21 Day 1

Analysis denominator · Participants

Group	Source count
Isa-IV + Pd	10
Isa-SC + Pd	9

Values in mcg/mL · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Isa-IV + Pd	388	174	Not reported	Not reported	Not reported
Isa-SC + Pd	668	213	Not reported	Not reported	Not reported

Cycle 24 Day 1

Analysis denominator · Participants

Group	Source count
Isa-IV + Pd	2
Isa-SC + Pd	3

Values in mcg/mL · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Isa-IV + Pd	525	455	Not reported	Not reported	Not reported
Isa-SC + Pd	651	424	Not reported	Not reported	Not reported

Cycle 27 Day 1

Analysis denominator · Participants

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

Values in mcg/mL · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Isa-SC + Pd	566	200	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
spread
47
value
92
group Id
OG001
spread
66
value
129
denoms
counts
group Id
OG000
value
204
group Id
OG001
value
210
units
Participants
title
Cycle 1 Day 8
categories
measurements
group Id
OG000
spread
84
value
171
group Id
OG001
spread
115
value
249
denoms
counts
group Id
OG000
value
179
group Id
OG001
value
187
units
Participants
title
Cycle 1 Day 15
categories
measurements
group Id
OG000
spread
99
value
227
group Id
OG001
spread
144
value
321
denoms
counts
group Id
OG000
value
160
group Id
OG001
value
163
units
Participants
title
Cycle 1 Day 22
categories
measurements
group Id
OG000
spread
117
value
293
group Id
OG001
spread
211
value
407
denoms
counts
group Id
OG000
value
140
group Id
OG001
value
147
units
Participants
title
Cycle 2 Day 1
categories
measurements
group Id
OG000
spread
130
value
243
group Id
OG001
spread
228
value
363
denoms
counts
group Id
OG000
value
209
group Id
OG001
value
202
units
Participants
title
Cycle 2 Day 15
categories
measurements
group Id
OG000
spread
133
value
268
group Id
OG001
spread
192
value
381
denoms
counts
group Id
OG000
value
179
group Id
OG001
value
160
units
Participants
title
Cycle 3 Day 1
categories
measurements
group Id
OG000
spread
138
value
256
group Id
OG001
spread
245
value
392
denoms
counts
group Id
OG000
value
188
group Id
OG001
value
206
units
Participants
title
Cycle 3 Day 15
categories
measurements
group Id
OG000
spread
151
value
277
group Id
OG001
spread
424
value
477
denoms
counts
group Id
OG000
value
167
group Id
OG001
value
167
units
Participants
title
Cycle 4 Day 1
categories
measurements
group Id
OG000
spread
139
value
285
group Id
OG001
spread
400
value
452
denoms
counts
group Id
OG000
value
182
group Id
OG001
value
185
units
Participants
title
Cycle 4 Day 15
categories
measurements
group Id
OG000
spread
568
value
366
group Id
OG001
spread
264
value
470
denoms
counts
group Id
OG000
value
156
group Id
OG001
value
153
units
Participants
title
Cycle 5 Day 1
categories
measurements
group Id
OG000
spread
168
value
306
group Id
OG001
spread
275
value
463
denoms
counts
group Id
OG000
value
190
group Id
OG001
value
180
units
Participants
title
Cycle 5 Day 15
categories
measurements
group Id
OG000
spread
165
value
330
group Id
OG001
spread
256
value
491
denoms
counts
group Id
OG000
value
158
group Id
OG001
value
145
units
Participants
title
Cycle 6 Day 1

denoms

counts
group Id
OG000
value
209
group Id
OG001
value
210
units
Participants

description

Plasma samples were collected at specified timepoints for the assessment of Ctrough.

dispersion Type

Standard Deviation

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

MEAN

population Description

The PK population included all participants with at least 1 available isatuximab concentration post-baseline (whatever the cycle and even if dosing was incomplete) with adequate documentation of dosing and sampling dates and times. Only those participants with data collected at specified timepoints are reported.

reporting Status

POSTED

time Frame

Pre-dose on Cycle 1 Days 8, 15 and 22, Cycles 2 to 5 Days 1 and 15, Cycles 6, 7, 8, 9, 12, 15, 18, 21, 24 and 27 Day 1

title

Ctrough of Isatuximab

type

SECONDARY

unit Of Measure

mcg/mL

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

Preserved source evidence · Not medical advice