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

Vanderbilt University Medical Center

Status: Terminated

Conditions: Multiple Myeloma and Plasma Cell Neoplasm; Mucositis

Treatments: Other: laboratory biomarker analysis

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT00602147

VU-VICC-HEM-0750

VU-VICC-070644

VICC HEM 0750

Details and patient eligibility

About

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.

Full 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.

Enrollment: 95 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

95 participants in 2 patient groups

Retrospective sample

Description:

People who have been diagnosed with multiple myeloma and have received high-dose melphalan.

Treatment:

Other: laboratory biomarker analysis

Prospective sample

Description:

People who have been diagnosed with multiple myeloma and will be receiving high-dose melphalan.

Treatment:

Other: laboratory biomarker analysis