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

Genetic Analysis of Toxicity Associated With High-Dose Melphalan

Status

Terminated

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00602147

Enrollment

Registered

2008-01-28

Start date

2007-07-31

Completion date

2010-04-30

Last updated

2013-03-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mucositis, Multiple Myeloma and Plasma Cell Neoplasm

Keywords

mucositis, stage I multiple myeloma, stage II multiple myeloma, stage III multiple myeloma, refractory multiple myeloma

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.

Interventions

OTHERlaboratory biomarker analysis

Blood or cheek cells wil be collected.

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

DISEASE CHARACTERISTICS: * Diagnosis of multiple myeloma * Receiving treatment with high-dose melphalan for an autologous stem cell transplantation at any of these facilities: * Vanderbilt University Medical Center * Nashville Veteran's Administration Medical Center (VAMC) * Seattle VAMC * San Antonio VAMC PATIENT CHARACTERISTICS: * Not pregnant PRIOR CONCURRENT THERAPY: * See Disease Characteristics * No palifermin

Design outcomes

Primary

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026