High Dose Melphalan: A pilot study to evaluate pharmacokinetic-based dose determination in patients with multiple myeloma scheduled to undergo autologous stem cell transplantation

Phase 4

Active, not recruiting

• Conditions: Multiple Myeloma; Cancer - Myeloma

• Registration Number: ACTRN12613000487718
• Lead Sponsor: The Children's Hospital at Westmead

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-05-01
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Active, not recruiting
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

1. Patients of any age scheduled to receive single agent high dose melphalan and autologous stem cell rescue for multiple myeloma.
2. Written informed consent

Exclusion Criteria

Those for whom written informed consent cannot be obtained.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To evaluate the feasibility of real-time pharmacokinetics in a multi-centre setting using a test dose of melphalan, followed by therapeutic drug monitoring (measuring the drug levels in repeated blood samples after it is infused) of a targeted dose of melphalan in patients with multiple myeloma[Blood sampling occurs at 5 min, 15 min, 30 min, 40 min, 1h 15 min and 2h 30 min after the end of the melphalan infusions for the test and full doses, which are administered between Day -4 and Day -1 before autologous stem cell transplantation.]