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NCT02669615 · OUTCOME

AUC0-t (Pharmacokinetics)

Pharmacokinetic Study of Propylene Glycol-Free Melphalan HCl for Myeloablative Conditioning in Multiple Myeloma Patients Undergoing Autologous Transplantation · Source last updated 2018-10-10

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

Measure
MEDIAN
Unit
ng*min/ml
Interval / dispersion
Full Range
Time frame
Day -2

What was measured

Area under the plasma concentration-time curve to the last measurable time point (AUC0-t) calculated by the trapezoidal rule. The area under the concentration-time curve (AUC) is calculated to determine the total drug exposure over a period of time.

Groups in this outcome

Melphalan HCl for Injection (Propylene Glycol Free)

Patients will receive 200 mg/m\^2 of Melphalan HCl for injection (propylene glycol free) as a one-time infusion on day 2. Blood samples for the pharmacokinetic (PK) evaluation of melphalan will be collected after melphalan dosing (day -2). Following one day of rest after the myeloablative Melphalan conditioning (day -1), patients will receive an autologous graft with a minimum cell dose of 2 × 106 CD34+ cells/kg of patient body weight (day 0). Melphalan HCl for injection (propylene glycol free): During the study period, patients will receive 200 mg/m2 of Melphalan HCl for injection (propylene glycol free) as a one-time infusion on day 2.

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Melphalan HCl for Injection (Propylene Glycol Free)24

Reported measurements

Source class 1
Values in ng*min/ml · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Melphalan HCl for Injection (Propylene Glycol Free)533552Not reported253780770538Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        253780
        upper Limit
        770538
        value
        533552
denoms
  1. counts
    1. group Id
      OG000
      value
      24
    units
    Participants
description
Area under the plasma concentration-time curve to the last measurable time point (AUC0-t) calculated by the trapezoidal rule. The area under the concentration-time curve (AUC) is calculated to determine the total drug exposure over a period of time.
dispersion Type
Full Range
groups
  1. description
    Patients will receive 200 mg/m\^2 of Melphalan HCl for injection (propylene glycol free) as a one-time infusion on day 2. Blood samples for the pharmacokinetic (PK) evaluation of melphalan will be collected after melphalan dosing (day -2). Following one day of rest after the myeloablative Melphalan conditioning (day -1), patients will receive an autologous graft with a minimum cell dose of 2 × 106 CD34+ cells/kg of patient body weight (day 0). Melphalan HCl for injection (propylene glycol free): During the study period, patients will receive 200 mg/m2 of Melphalan HCl for injection (propylene glycol free) as a one-time infusion on day 2.
    id
    OG000
    title
    Melphalan HCl for Injection (Propylene Glycol Free)
param Type
MEDIAN
reporting Status
POSTED
time Frame
Day -2
title
AUC0-t (Pharmacokinetics)
type
PRIMARY
unit Of Measure
ng*min/ml

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

Preserved source evidence · Not medical advice