NCT00925782 · FLOW

Participant flow

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.

groups

description
Randomized group of Melphalan - Alkeran sequence Melphalan HCl for Injection (Propylene Glycol-Free) (single-use glass vial containing melphalan HCl 56 mg powder \[equivalent to 50 mg of melphalan free base\] and 2700 mg sulfobutylether-beta-cyclodextrin Captisol) reconstituted with normal saline solution, 100 mg/m2 melphalan HCl diluted with normal saline to concentration no greater than 0.45 mg/mL, infused over 30 minutes via a central venous catheter. Alkeran for Injection (single-use glass vial containing melphalan HCl powder \[equivalent to 50 mg melphalan\] and 20 mg povidone) reconstituted with sterile diluent (containing sodium citrate, propylene glycol, ethanol, and Water for Injection), 100 mg/m2 melphalan HCl diluted with normal saline to concentration no greater than 0.45 mg/mL, infused over 30 minutes via a central venous catheter.
id
FG000
title
Melphalan - Alkeran
description
Randomized group of Alkeran-Melphalan Alkeran for Injection (single-use glass vial containing melphalan HCl powder \[equivalent to 50 mg melphalan\] and 20 mg povidone) reconstituted with sterile diluent (containing sodium citrate, propylene glycol, ethanol, and Water for Injection), 100 mg/m2 melphalan HCl diluted with normal saline to concentration no greater than 0.45 mg/mL, infused over 30 minutes via a central venous catheter. Melphalan HCl for Injection (Propylene Glycol-Free) (single-use glass vial containing melphalan HCl 56 mg powder \[equivalent to 50 mg of melphalan free base\] and 2700 mg sulfobutylether-beta-cyclodextrin Captisol) reconstituted with normal saline solution, 100 mg/m2 melphalan HCl diluted with normal saline to concentration no greater than 0.45 mg/mL, infused over 30 minutes via a central venous catheter.
id
FG001
title
Alkeran - Melphalan

periods

milestones
achievements
group Id
FG000
num Subjects
12
group Id
FG001
num Subjects
12
type
STARTED
achievements
group Id
FG000
num Subjects
12
group Id
FG001
num Subjects
12
type
COMPLETED
achievements
group Id
FG000
num Subjects
0
group Id
FG001
num Subjects
0
type
NOT COMPLETED
title
Pretreatment (Day -30 to Day -3)
milestones
achievements
group Id
FG000
num Subjects
12
group Id
FG001
num Subjects
12
type
STARTED
achievements
group Id
FG000
num Subjects
12
group Id
FG001
num Subjects
12
type
COMPLETED
achievements
group Id
FG000
num Subjects
0
group Id
FG001
num Subjects
0
type
NOT COMPLETED
title
Study Period (Day -3 to Day 0)
milestones
achievements
group Id
FG000
num Subjects
12
group Id
FG001
num Subjects
12
type
STARTED
achievements
group Id
FG000
num Subjects
12
group Id
FG001
num Subjects
12
type
COMPLETED
achievements
group Id
FG000
num Subjects
0
group Id
FG001
num Subjects
0
type
NOT COMPLETED
title
Follow-up(Day +1 to Date of Engraftment)

pre Assignment Details

No patients that were enrolled in the study were excluded from the trial prior to assignment to groups.

recruitment Details

The study was conducted at a single study center (University of Kansas Medical Center -two facilities) in the United States under the direction of the investigator, Omar S. Aljitawi, M.D.

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