Studying Common Genetic Mutations Related to Mucositis in Patients With Multiple Myeloma Receiving High-Dose Melphalan

Terminated

• Conditions: Mucositis; Multiple Myeloma and Plasma Cell Neoplasm
• Interventions: Other: laboratory biomarker analysis

• Registration Number: NCT00602147
• Lead Sponsor: Vanderbilt-Ingram Cancer Center

Brief Summary

RATIONALE: Studying blood or mouthwash samples in the laboratory from patients receiving melphalan for cancer may help doctors learn more about changes that occur in DNA, identify biomarkers related to cancer, and help predict how patients will respond to treatment.

PURPOSE: This clinical trial is studying common genetic mutations related to mucositis in patients with multiple myeloma receiving high-dose melphalan.

Detailed Description

OBJECTIVES:

* To determine whether single nucleotide polymorphisms (SNPs) in genes that encode the melphalan transporters are associated with the development and/or severity of mucositis in patients with multiple myeloma receiving high-dose melphalan.

* To determine whether SNPs in genes that influence melphalan metabolism are associated with the development and/or severity of mucositis in these patients.

OUTLINE: This is a multicenter study.

Blood or mouthwash samples are collected and DNA isolated from these specimens is analyzed for single nucleotide polymorphisms (SNPs) in LAT1 or other candidate genes. Public databases (i.e., dbSNP and HapMap) are reviewed to select representative SNPs for genotype analysis.

Study Timeline

• Study Start: 2007-07
• Study First Submitted: 2008-01-22
• Study First Submitted QC: 2008-01-22
• Study First Posted: 2008-01-28
• Primary Completion: 2009-01
• Study Completion: 2010-04
• Status Verified: 2013-03
• Last Update Submitted: 2013-03-12
• Last Update Posted: 2013-03-14

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 95

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Prospective sample	laboratory biomarker analysis	People who have been diagnosed with multiple myeloma and will be receiving high-dose melphalan.
Retrospective sample	laboratory biomarker analysis	People who have been diagnosed with multiple myeloma and have received high-dose melphalan.

Primary Outcome Measures

Name	Time	Method
Association between SNPs in genes that influence melphalan metabolism and development and/or severity of mucositis	4 weeks
Association between single nucleotide polymorphisms (SNPs) in genes that encode the melphalan transporters and development and/or severity of mucositis	4 weeks

Trial Locations

Locations (3)

Veterans Affairs Medical Center - Nashville; 🇺🇸 Nashville, Tennessee, United States

Vanderbilt-Ingram Cancer Center at Franklin; 🇺🇸 Nashville, Tennessee, United States

Vanderbilt-Ingram Cancer Center; 🇺🇸 Nashville, Tennessee, United States