NCT00925782 · OUTCOME

Concentration-Max (Cmax)

PK Study of Melphalan HCL & Alkeran for Injection of MA Conditioning in MM Patients of Autologous Transplantation · Source last updated 2019-12-17

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: Day -3 and Day -2

What was measured

Cmax was one of the pharmacokinetic endpoints to confirm pharmacokinetic similarity between Melphalan HCl for Injection (Propylene Glycol-Free) and Alkeran for Injection in patients with multiple myeloma. Pharmacokinetic similarity was defined as a difference of 20% or less in the 90% confidence intervals (CIs) for the ratios of the pharmacokinetic parameters (calculated using log-transformed data) for the two formulations. The Cmax results provided is the summary of Melphalan PK following Melphalan-Alkeran injection in Sequence 1 and Alkeran-melphalan injection in Sequence 2.

Analysis population: The pharmacokinetic-evaluable population was defined as all patients who completed dosing and adequate subsequent pharmacokinetic blood draws for the calculation of area under the plasma concentration-time curve (AUC) and maximum plasma concentration (Cmax) for both Melphalan HCl for Injection and Alkeran for Injection.

Groups in this outcome

Melphalan

Open-label, randomized, cross-over design study where Propylene Glycol Free Melphalan and Alkeran were assessed in the same multiple myeloma patients. This group includes all patients with Melphalan dose administration regardless of cross over sequence

Alkeran

Open-label, randomized, cross-over design study where Propylene Glycol Free Melphalan and Alkeran were assessed in the same multiple myeloma patients. This group includes all patients with Alkeran dose administration regardless of cross over sequence

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
Melphalan	24
Alkeran	24

Reported measurements

Source class 1

Values in ng/mL · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Melphalan	4374	1050	105	117	Not reported
Alkeran	3931	1034	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
lower Limit
105
spread
1050
upper Limit
117
value
4374
group Id
OG001
spread
1034
value
3931

denoms

counts
group Id
OG000
value
24
group Id
OG001
value
24
units
Participants

description

dispersion Type

Standard Deviation

groups

description
Open-label, randomized, cross-over design study where Propylene Glycol Free Melphalan and Alkeran were assessed in the same multiple myeloma patients. This group includes all patients with Melphalan dose administration regardless of cross over sequence
id
OG000
title
Melphalan
description
Open-label, randomized, cross-over design study where Propylene Glycol Free Melphalan and Alkeran were assessed in the same multiple myeloma patients. This group includes all patients with Alkeran dose administration regardless of cross over sequence
id
OG001
title
Alkeran

param Type

GEOMETRIC_MEAN

population Description

The pharmacokinetic-evaluable population was defined as all patients who completed dosing and adequate subsequent pharmacokinetic blood draws for the calculation of area under the plasma concentration-time curve (AUC) and maximum plasma concentration (Cmax) for both Melphalan HCl for Injection and Alkeran for Injection.

reporting Status

POSTED

time Frame

Day -3 and Day -2

title

Concentration-Max (Cmax)

type

PRIMARY

unit Of Measure

ng/mL

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

Preserved source evidence · Not medical advice