NCT01677858 · OUTCOME

Maximum Plasma Concentration of Carfilzomib

A Study of Weekly Carfilzomib in Combination With Dexamethasone for Progressive Multiple Myeloma · Source last updated 2022-09-23

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

Measure: GEOMETRIC_MEAN
Unit: ng/mL
Interval / dispersion: Geometric Coefficient of Variation
Time frame: Day 1 cycle 1 (20 mg/m² carfilzomib), cycle 1 day 15 (phase 1 70 and 88 mg/m² carfilzomib), and cycle 2 day 15 (phase 2 70 mg/m² carfilzomib) from predose to 4 hours after the end of the infusion.

Analysis population: Pharmacokinetic (PK) analyses were conducted for participants assigned to cohorts 3 and 4 in phase 1 (70 and 88 mg/m² carfilzomib) and a subset of participants in phase 2; only participants for whom PK parameters could be calculated were included in the analyses.

Groups in this outcome

Carfilzomib 20 mg/m²

Participants in phase 1 and phase 2 received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on day 1 cycle 1.

Carfilzomib 70 mg/m²

Participants in phase 1 and phase 2 received carfilzomib 70 mg/m² administered by intravenous (IV) infusion from day 8 cycle 1 onwards.

Carfilzomib 88 mg/m²

Participants in phase 1 received carfilzomib 88 mg/m² administered by intravenous (IV) infusion from day 8 cycle 1 onwards.

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
Carfilzomib 20 mg/m²	26
Carfilzomib 70 mg/m²	21
Carfilzomib 88 mg/m²	5

Reported measurements

Source class 1

Values in ng/mL · Interval/dispersion: Geometric Coefficient of Variation
Group	Value	Spread	Lower	Upper	Comment
Carfilzomib 20 mg/m²	789	65.5	Not reported	Not reported	Not reported
Carfilzomib 70 mg/m²	2390	30.7	Not reported	Not reported	Not reported
Carfilzomib 88 mg/m²	3090	27.3	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
spread
65.5
value
789
group Id
OG001
spread
30.7
value
2390
group Id
OG002
spread
27.3
value
3090

denoms

counts
group Id
OG000
value
26
group Id
OG001
value
21
group Id
OG002
value
5
units
Participants

dispersion Type

Geometric Coefficient of Variation

groups

description
Participants in phase 1 and phase 2 received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on day 1 cycle 1.
id
OG000
title
Carfilzomib 20 mg/m²
description
Participants in phase 1 and phase 2 received carfilzomib 70 mg/m² administered by intravenous (IV) infusion from day 8 cycle 1 onwards.
id
OG001
title
Carfilzomib 70 mg/m²
description
Participants in phase 1 received carfilzomib 88 mg/m² administered by intravenous (IV) infusion from day 8 cycle 1 onwards.
id
OG002
title
Carfilzomib 88 mg/m²

param Type

GEOMETRIC_MEAN

population Description

Pharmacokinetic (PK) analyses were conducted for participants assigned to cohorts 3 and 4 in phase 1 (70 and 88 mg/m² carfilzomib) and a subset of participants in phase 2; only participants for whom PK parameters could be calculated were included in the analyses.

reporting Status

POSTED

time Frame

Day 1 cycle 1 (20 mg/m² carfilzomib), cycle 1 day 15 (phase 1 70 and 88 mg/m² carfilzomib), and cycle 2 day 15 (phase 2 70 mg/m² carfilzomib) from predose to 4 hours after the end of the infusion.

title

Maximum Plasma Concentration of Carfilzomib

type

SECONDARY

unit Of Measure

ng/mL

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice