NCT01217957 · OUTCOME

Phase 1: Cmax: Maximum Observed Plasma Concentration for Ixazomib

A Study of Ixazomib Administered in Combination With Lenalidomide and Low-Dose Dexamethasone in Patients With Newly Diagnosed Multiple Myeloma · Source last updated 2018-03-14

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: Standard Deviation
Time frame: Cycle 1, Days 1 and 15

What was measured

Cmax: Maximum Observed Plasma Concentration (Cmax) is the peak plasma concentration of ixazomib obtained directly from the plasma concentration-time curve.

Analysis population: The Pharmacokinetic (PK) analysis population, defined as all patients enrolled in the phase 1 portion of the study who had sufficient dosing data and ixazomib concentration-time data to permit calculation of ixazomib pharmacokinetic parameters, with available data.

Groups in this outcome

Phase 1: Ixazomib 1.68 mg/m^2 + Lenalidomide + Dexamethasone

In phase 1, ixazomib 1.68 mg/m\^2, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once on Days 1 through 21 of a 28-day cycle for up to 12 cycles. Cycle 13 and beyond, single agent ixazomib 1.68 mg/m\^2, capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity.

Phase 1: Ixazomib 2.23 mg/m^2 + Lenalidomide + Dexamethasone

In phase 1, ixazomib 2.23 mg/m\^2, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once on Days 1 through 21 of a 28-day cycle for up to 12 cycles. Cycle 13 and beyond, single agent ixazomib 2.23 mg/m\^2, capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity.

Phase 1: Ixazomib 2.97 mg/m^2 + Lenalidomide + Dexamethasone

In phase 1, ixazomib 2.97 mg/m\^2, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once on Days 1 through 21 of a 28-day cycle for up to 12 cycles. Cycle 13 and beyond, single agent ixazomib 2.97 mg/m\^2, capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity.

Phase 1: Ixazomib 3.95 mg/m^2 + Lenalidomide + Dexamethasone

In phase 1, ixazomib 3.95 mg/m\^2, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once on Days 1 through 21 of a 28-day cycle for up to 12 cycles. Cycle 13 and beyond, single agent ixazomib 3.95 mg/m\^2, capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity.

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
Phase 1: Ixazomib 1.68 mg/m^2 + Lenalidomide + Dexamethasone	2
Phase 1: Ixazomib 2.23 mg/m^2 + Lenalidomide + Dexamethasone	3
Phase 1: Ixazomib 2.97 mg/m^2 + Lenalidomide + Dexamethasone	4
Phase 1: Ixazomib 3.95 mg/m^2 + Lenalidomide + Dexamethasone	2

Reported measurements

Day 1 (n=1, 3, 4, 1)

Values in ng/mL · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Phase 1: Ixazomib 1.68 mg/m^2 + Lenalidomide + Dexamethasone	NA	NA	Not reported	Not reported	Not calculated for 1 participant.
Phase 1: Ixazomib 2.23 mg/m^2 + Lenalidomide + Dexamethasone	22.303	13.0184	Not reported	Not reported	Not reported
Phase 1: Ixazomib 2.97 mg/m^2 + Lenalidomide + Dexamethasone	94.779	34.5442	Not reported	Not reported	Not reported
Phase 1: Ixazomib 3.95 mg/m^2 + Lenalidomide + Dexamethasone	NA	NA	Not reported	Not reported	Not calculated for 1 participant.

Day 15 (n=2, 3, 4, 1)

Values in ng/mL · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Phase 1: Ixazomib 1.68 mg/m^2 + Lenalidomide + Dexamethasone	11.999	NA	Not reported	Not reported	Not calculated for 2 participants.
Phase 1: Ixazomib 2.23 mg/m^2 + Lenalidomide + Dexamethasone	31.368	31.9963	Not reported	Not reported	Not reported
Phase 1: Ixazomib 2.97 mg/m^2 + Lenalidomide + Dexamethasone	53.517	22.1412	Not reported	Not reported	Not reported
Phase 1: Ixazomib 3.95 mg/m^2 + Lenalidomide + Dexamethasone	NA	NA	Not reported	Not reported	Not calculated for 1 participant.

Complete source fields

classes

categories
measurements
comment
Not calculated for 1 participant.
group Id
OG000
spread
NA
value
NA
group Id
OG001
spread
13.0184
value
22.303
group Id
OG002
spread
34.5442
value
94.779
comment
Not calculated for 1 participant.
group Id
OG003
spread
NA
value
NA
title
Day 1 (n=1, 3, 4, 1)
categories
measurements
comment
Not calculated for 2 participants.
group Id
OG000
spread
NA
value
11.999
group Id
OG001
spread
31.9963
value
31.368
group Id
OG002
spread
22.1412
value
53.517
comment
Not calculated for 1 participant.
group Id
OG003
spread
NA
value
NA
title
Day 15 (n=2, 3, 4, 1)

denoms

counts
group Id
OG000
value
2
group Id
OG001
value
3
group Id
OG002
value
4
group Id
OG003
value
2
units
Participants

description

Cmax: Maximum Observed Plasma Concentration (Cmax) is the peak plasma concentration of ixazomib obtained directly from the plasma concentration-time curve.

dispersion Type

Standard Deviation

groups

description
In phase 1, ixazomib 1.68 mg/m\^2, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once on Days 1 through 21 of a 28-day cycle for up to 12 cycles. Cycle 13 and beyond, single agent ixazomib 1.68 mg/m\^2, capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity.
id
OG000
title
Phase 1: Ixazomib 1.68 mg/m^2 + Lenalidomide + Dexamethasone
description
In phase 1, ixazomib 2.23 mg/m\^2, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once on Days 1 through 21 of a 28-day cycle for up to 12 cycles. Cycle 13 and beyond, single agent ixazomib 2.23 mg/m\^2, capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity.
id
OG001
title
Phase 1: Ixazomib 2.23 mg/m^2 + Lenalidomide + Dexamethasone
description
In phase 1, ixazomib 2.97 mg/m\^2, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once on Days 1 through 21 of a 28-day cycle for up to 12 cycles. Cycle 13 and beyond, single agent ixazomib 2.97 mg/m\^2, capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity.
id
OG002
title
Phase 1: Ixazomib 2.97 mg/m^2 + Lenalidomide + Dexamethasone
description
In phase 1, ixazomib 3.95 mg/m\^2, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once on Days 1 through 21 of a 28-day cycle for up to 12 cycles. Cycle 13 and beyond, single agent ixazomib 3.95 mg/m\^2, capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity.
id
OG003
title
Phase 1: Ixazomib 3.95 mg/m^2 + Lenalidomide + Dexamethasone

param Type

GEOMETRIC_MEAN

population Description

The Pharmacokinetic (PK) analysis population, defined as all patients enrolled in the phase 1 portion of the study who had sufficient dosing data and ixazomib concentration-time data to permit calculation of ixazomib pharmacokinetic parameters, with available data.

reporting Status

POSTED

time Frame

Cycle 1, Days 1 and 15

title

Phase 1: Cmax: Maximum Observed Plasma Concentration for Ixazomib

type

SECONDARY

unit Of Measure

ng/mL

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Preserved source evidence · Not medical advice