NCT01217957 · OUTCOME

Phase 1: Rac: Accumulation Ratio of 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: Ratio
Interval / dispersion: Standard Deviation
Time frame: Cycle 1, Day 15

What was measured

The accumulation ratio (Rac) was estimated as the ratio of AUC(0-168) on Day 15 to the AUC(0-168) on Day 1. AUC(0-168) is the area under the plasma concentration-time curve from time 0 to 168 hours postdose for ixazomib.

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	1
Phase 1: Ixazomib 2.23 mg/m^2 + Lenalidomide + Dexamethasone	3
Phase 1: Ixazomib 2.97 mg/m^2 + Lenalidomide + Dexamethasone	3
Phase 1: Ixazomib 3.95 mg/m^2 + Lenalidomide + Dexamethasone	0

Reported measurements

Source class 1

Values in Ratio · 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	1.849	0.8359	Not reported	Not reported	Not reported
Phase 1: Ixazomib 2.97 mg/m^2 + Lenalidomide + Dexamethasone	2.051	0.6469	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
comment
Not calculated for 1 participant
group Id
OG000
spread
NA
value
NA
group Id
OG001
spread
0.8359
value
1.849
group Id
OG002
spread
0.6469
value
2.051

denoms

counts
group Id
OG000
value
1
group Id
OG001
value
3
group Id
OG002
value
3
group Id
OG003
value
0
units
Participants

description

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, Day 15

title

Phase 1: Rac: Accumulation Ratio of Ixazomib

type

SECONDARY

unit Of Measure

Ratio

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Preserved source evidence · Not medical advice