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NCT02990338 · OUTCOME

PK Parameter: Plasma Concentration of Isatuximab at Ctrough

Multinational Clinical Study Comparing Isatuximab, Pomalidomide, and Dexamethasone to Pomalidomide and Dexamethasone in Refractory or Relapsed and Refractory Multiple Myeloma Patients · Source last updated 2025-01-17

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

Measure: GEOMETRIC_MEAN
Unit: mcg/mL
Interval / dispersion: Geometric Coefficient of Variation
Time frame: Pre-infusion on C1D1, C1D8, C1D15, C1D22, C2D1, C2D15, C3D1, C3D15, C4D1, C4D15, C5D1, C6D1, C7D1, C8D1, C9D1, C10D1, C11D1, C12D1, C13D1, C14D1, C15D1, C16D1, C17D1, C18D1, C19D1, C20D1; End of treatment (EOT [30 days after last drug administration])

What was measured

Trough Concentration (Ctrough) is the concentration prior to study drug administration.

Analysis population: Analysis was performed on PK population. Here, 'Number analyzed' = participants with available data for each specified category. Data for this OM was not planned to be collected and analyzed for Pd arm.

Groups in this outcome

IPd (Isatuximab + Pomalidomide + Dexamethasone)

Participants received isatuximab 10 mg/kg IV infusion on Days 1, 8, 15, and 22 at Cycle 1, and then on Days 1 and 15 of subsequent cycles plus pomalidomide 4 mg PO on Days 1 to 21 of each 28-day treatment cycle and dexamethasone 40 mg (participants \>= 75 years of age received 20 mg dexamethasone), PO or IV on Day 1, 8, 15, 22 of each 28-day treatment cycle until disease progression or unacceptable toxicity or participant's wish to discontinue study treatment, or any other reason, whichever comes first (maximum exposure: 76.7 weeks).

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
IPd (Isatuximab + Pomalidomide + Dexamethasone)	149

Reported measurements

C1D1

Analysis denominator · Participants

Group	Source count
IPd (Isatuximab + Pomalidomide + Dexamethasone)	144

Values in mcg/mL · Interval/dispersion: Geometric Coefficient of Variation
Group	Value	Spread	Lower	Upper	Comment
IPd (Isatuximab + Pomalidomide + Dexamethasone)	0.00	1194.973	Not reported	Not reported	Not reported

C1D8

Analysis denominator · Participants

Group	Source count
IPd (Isatuximab + Pomalidomide + Dexamethasone)	135

Values in mcg/mL · Interval/dispersion: Geometric Coefficient of Variation
Group	Value	Spread	Lower	Upper	Comment
IPd (Isatuximab + Pomalidomide + Dexamethasone)	31.49	53.602	Not reported	Not reported	Not reported

C1D15

Analysis denominator · Participants

Group	Source count
IPd (Isatuximab + Pomalidomide + Dexamethasone)	126

Values in mcg/mL · Interval/dispersion: Geometric Coefficient of Variation
Group	Value	Spread	Lower	Upper	Comment
IPd (Isatuximab + Pomalidomide + Dexamethasone)	57.89	54.764	Not reported	Not reported	Not reported

C1D22

Analysis denominator · Participants

Group	Source count
IPd (Isatuximab + Pomalidomide + Dexamethasone)	126

Values in mcg/mL · Interval/dispersion: Geometric Coefficient of Variation
Group	Value	Spread	Lower	Upper	Comment
IPd (Isatuximab + Pomalidomide + Dexamethasone)	84.82	57.666	Not reported	Not reported	Not reported

C2D1

Analysis denominator · Participants

Group	Source count
IPd (Isatuximab + Pomalidomide + Dexamethasone)	138

Values in mcg/mL · Interval/dispersion: Geometric Coefficient of Variation
Group	Value	Spread	Lower	Upper	Comment
IPd (Isatuximab + Pomalidomide + Dexamethasone)	89.09	60.155	Not reported	Not reported	Not reported

C2D15

Analysis denominator · Participants

Group	Source count
IPd (Isatuximab + Pomalidomide + Dexamethasone)	121

Values in mcg/mL · Interval/dispersion: Geometric Coefficient of Variation
Group	Value	Spread	Lower	Upper	Comment
IPd (Isatuximab + Pomalidomide + Dexamethasone)	89.35	61.167	Not reported	Not reported	Not reported

C3D1

Analysis denominator · Participants

Group	Source count
IPd (Isatuximab + Pomalidomide + Dexamethasone)	131

Values in mcg/mL · Interval/dispersion: Geometric Coefficient of Variation
Group	Value	Spread	Lower	Upper	Comment
IPd (Isatuximab + Pomalidomide + Dexamethasone)	64.15	76.469	Not reported	Not reported	Not reported

C3D15

Analysis denominator · Participants

Group	Source count
IPd (Isatuximab + Pomalidomide + Dexamethasone)	109

Values in mcg/mL · Interval/dispersion: Geometric Coefficient of Variation
Group	Value	Spread	Lower	Upper	Comment
IPd (Isatuximab + Pomalidomide + Dexamethasone)	91.73	78.406	Not reported	Not reported	Not reported

C4D1

Analysis denominator · Participants

Group	Source count
IPd (Isatuximab + Pomalidomide + Dexamethasone)	118

Values in mcg/mL · Interval/dispersion: Geometric Coefficient of Variation
Group	Value	Spread	Lower	Upper	Comment
IPd (Isatuximab + Pomalidomide + Dexamethasone)	86.05	70.062	Not reported	Not reported	Not reported

C4D15

Analysis denominator · Participants

Group	Source count
IPd (Isatuximab + Pomalidomide + Dexamethasone)	108

Values in mcg/mL · Interval/dispersion: Geometric Coefficient of Variation
Group	Value	Spread	Lower	Upper	Comment
IPd (Isatuximab + Pomalidomide + Dexamethasone)	105.42	68.035	Not reported	Not reported	Not reported

C5D1

Analysis denominator · Participants

Group	Source count
IPd (Isatuximab + Pomalidomide + Dexamethasone)	108

Values in mcg/mL · Interval/dispersion: Geometric Coefficient of Variation
Group	Value	Spread	Lower	Upper	Comment
IPd (Isatuximab + Pomalidomide + Dexamethasone)	106.08	65.275	Not reported	Not reported	Not reported

C6D1

Analysis denominator · Participants

Group	Source count
IPd (Isatuximab + Pomalidomide + Dexamethasone)	107

Values in mcg/mL · Interval/dispersion: Geometric Coefficient of Variation
Group	Value	Spread	Lower	Upper	Comment
IPd (Isatuximab + Pomalidomide + Dexamethasone)	111.33	64.985	Not reported	Not reported	Not reported

C7D1

Analysis denominator · Participants

Group	Source count
IPd (Isatuximab + Pomalidomide + Dexamethasone)	96

Values in mcg/mL · Interval/dispersion: Geometric Coefficient of Variation
Group	Value	Spread	Lower	Upper	Comment
IPd (Isatuximab + Pomalidomide + Dexamethasone)	134.14	60.017	Not reported	Not reported	Not reported

C8D1

Analysis denominator · Participants

Group	Source count
IPd (Isatuximab + Pomalidomide + Dexamethasone)	86

Values in mcg/mL · Interval/dispersion: Geometric Coefficient of Variation
Group	Value	Spread	Lower	Upper	Comment
IPd (Isatuximab + Pomalidomide + Dexamethasone)	146.15	55.946	Not reported	Not reported	Not reported

C9D1

Analysis denominator · Participants

Group	Source count
IPd (Isatuximab + Pomalidomide + Dexamethasone)	82

Values in mcg/mL · Interval/dispersion: Geometric Coefficient of Variation
Group	Value	Spread	Lower	Upper	Comment
IPd (Isatuximab + Pomalidomide + Dexamethasone)	162.84	65.193	Not reported	Not reported	Not reported

C10D1

Analysis denominator · Participants

Group	Source count
IPd (Isatuximab + Pomalidomide + Dexamethasone)	73

Values in mcg/mL · Interval/dispersion: Geometric Coefficient of Variation
Group	Value	Spread	Lower	Upper	Comment
IPd (Isatuximab + Pomalidomide + Dexamethasone)	145.86	60.719	Not reported	Not reported	Not reported

C11D1

Analysis denominator · Participants

Group	Source count
IPd (Isatuximab + Pomalidomide + Dexamethasone)	71

Values in mcg/mL · Interval/dispersion: Geometric Coefficient of Variation
Group	Value	Spread	Lower	Upper	Comment
IPd (Isatuximab + Pomalidomide + Dexamethasone)	169.39	56.078	Not reported	Not reported	Not reported

C12D1

Analysis denominator · Participants

Group	Source count
IPd (Isatuximab + Pomalidomide + Dexamethasone)	63

Values in mcg/mL · Interval/dispersion: Geometric Coefficient of Variation
Group	Value	Spread	Lower	Upper	Comment
IPd (Isatuximab + Pomalidomide + Dexamethasone)	182.32	56.814	Not reported	Not reported	Not reported

C13D1

Analysis denominator · Participants

Group	Source count
IPd (Isatuximab + Pomalidomide + Dexamethasone)	49

Values in mcg/mL · Interval/dispersion: Geometric Coefficient of Variation
Group	Value	Spread	Lower	Upper	Comment
IPd (Isatuximab + Pomalidomide + Dexamethasone)	215.85	54.667	Not reported	Not reported	Not reported

C14D1

Analysis denominator · Participants

Group	Source count
IPd (Isatuximab + Pomalidomide + Dexamethasone)	35

Values in mcg/mL · Interval/dispersion: Geometric Coefficient of Variation
Group	Value	Spread	Lower	Upper	Comment
IPd (Isatuximab + Pomalidomide + Dexamethasone)	214.88	55.172	Not reported	Not reported	Not reported

C15D1

Analysis denominator · Participants

Group	Source count
IPd (Isatuximab + Pomalidomide + Dexamethasone)	24

Values in mcg/mL · Interval/dispersion: Geometric Coefficient of Variation
Group	Value	Spread	Lower	Upper	Comment
IPd (Isatuximab + Pomalidomide + Dexamethasone)	253.61	58.885	Not reported	Not reported	Not reported

C16D1

Analysis denominator · Participants

Group	Source count
IPd (Isatuximab + Pomalidomide + Dexamethasone)	19

Values in mcg/mL · Interval/dispersion: Geometric Coefficient of Variation
Group	Value	Spread	Lower	Upper	Comment
IPd (Isatuximab + Pomalidomide + Dexamethasone)	206.60	50.965	Not reported	Not reported	Not reported

C17D1

Analysis denominator · Participants

Group	Source count
IPd (Isatuximab + Pomalidomide + Dexamethasone)	13

Values in mcg/mL · Interval/dispersion: Geometric Coefficient of Variation
Group	Value	Spread	Lower	Upper	Comment
IPd (Isatuximab + Pomalidomide + Dexamethasone)	242.79	45.364	Not reported	Not reported	Not reported

C18D1

Analysis denominator · Participants

Group	Source count
IPd (Isatuximab + Pomalidomide + Dexamethasone)	8

Values in mcg/mL · Interval/dispersion: Geometric Coefficient of Variation
Group	Value	Spread	Lower	Upper	Comment
IPd (Isatuximab + Pomalidomide + Dexamethasone)	216.70	58.273	Not reported	Not reported	Not reported

C19D1

Analysis denominator · Participants

Group	Source count
IPd (Isatuximab + Pomalidomide + Dexamethasone)	5

Values in mcg/mL · Interval/dispersion: Geometric Coefficient of Variation
Group	Value	Spread	Lower	Upper	Comment
IPd (Isatuximab + Pomalidomide + Dexamethasone)	240.36	42.099	Not reported	Not reported	Not reported

C20D1

Analysis denominator · Participants

Group	Source count
IPd (Isatuximab + Pomalidomide + Dexamethasone)	1

Values in mcg/mL · Interval/dispersion: Geometric Coefficient of Variation
Group	Value	Spread	Lower	Upper	Comment
IPd (Isatuximab + Pomalidomide + Dexamethasone)	164.07	Not reported	Not reported	Not reported	Not reported

EOT

Analysis denominator · Participants

Group	Source count
IPd (Isatuximab + Pomalidomide + Dexamethasone)	60

Values in mcg/mL · Interval/dispersion: Geometric Coefficient of Variation
Group	Value	Spread	Lower	Upper	Comment
IPd (Isatuximab + Pomalidomide + Dexamethasone)	9.51	136.883	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
spread
1194.973
value
0.00
denoms
counts
group Id
OG000
value
144
units
Participants
title
C1D1
categories
measurements
group Id
OG000
spread
53.602
value
31.49
denoms
counts
group Id
OG000
value
135
units
Participants
title
C1D8
categories
measurements
group Id
OG000
spread
54.764
value
57.89
denoms
counts
group Id
OG000
value
126
units
Participants
title
C1D15
categories
measurements
group Id
OG000
spread
57.666
value
84.82
denoms
counts
group Id
OG000
value
126
units
Participants
title
C1D22
categories
measurements
group Id
OG000
spread
60.155
value
89.09
denoms
counts
group Id
OG000
value
138
units
Participants
title
C2D1
categories
measurements
group Id
OG000
spread
61.167
value
89.35
denoms
counts
group Id
OG000
value
121
units
Participants
title
C2D15
categories
measurements
group Id
OG000
spread
76.469
value
64.15
denoms
counts
group Id
OG000
value
131
units
Participants
title
C3D1
categories
measurements
group Id
OG000
spread
78.406
value
91.73
denoms
counts
group Id
OG000
value
109
units
Participants
title
C3D15
categories
measurements
group Id
OG000
spread
70.062
value
86.05
denoms
counts
group Id
OG000
value
118
units
Participants
title
C4D1
categories
measurements
group Id
OG000
spread
68.035
value
105.42
denoms
counts
group Id
OG000
value
108
units
Participants
title
C4D15
categories
measurements
group Id
OG000
spread
65.275
value
106.08
denoms
counts
group Id
OG000
value
108
units
Participants
title
C5D1
categories
measurements
group Id
OG000
spread
64.985
value
111.33
denoms
counts
group Id
OG000
value
107
units
Participants
title
C6D1

denoms

counts
group Id
OG000
value
149
units
Participants

description

Trough Concentration (Ctrough) is the concentration prior to study drug administration.

dispersion Type

Geometric Coefficient of Variation

groups

description
Participants received isatuximab 10 mg/kg IV infusion on Days 1, 8, 15, and 22 at Cycle 1, and then on Days 1 and 15 of subsequent cycles plus pomalidomide 4 mg PO on Days 1 to 21 of each 28-day treatment cycle and dexamethasone 40 mg (participants \>= 75 years of age received 20 mg dexamethasone), PO or IV on Day 1, 8, 15, 22 of each 28-day treatment cycle until disease progression or unacceptable toxicity or participant's wish to discontinue study treatment, or any other reason, whichever comes first (maximum exposure: 76.7 weeks).
id
OG000
title
IPd (Isatuximab + Pomalidomide + Dexamethasone)

param Type

GEOMETRIC_MEAN

population Description

Analysis was performed on PK population. Here, 'Number analyzed' = participants with available data for each specified category. Data for this OM was not planned to be collected and analyzed for Pd arm.

reporting Status

POSTED

time Frame

Pre-infusion on C1D1, C1D8, C1D15, C1D22, C2D1, C2D15, C3D1, C3D15, C4D1, C4D15, C5D1, C6D1, C7D1, C8D1, C9D1, C10D1, C11D1, C12D1, C13D1, C14D1, C15D1, C16D1, C17D1, C18D1, C19D1, C20D1; End of treatment (EOT [30 days after last drug administration])

title

PK Parameter: Plasma Concentration of Isatuximab at Ctrough

type

SECONDARY

unit Of Measure

mcg/mL

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

Preserved source evidence · Not medical advice