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

Multiple Myeloma and Plasma Cell Neoplasm Clinical Trial

Official title:

Genetic Analysis of Toxicity Associated With High-Dose Melphalan

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00602147
• Other study ID #: VICC HEM 0750
• Secondary ID: VU-VICC-HEM-0750
• Status: Terminated
• Phase: N/A
• First received: January 22, 2008
• Last updated: March 12, 2013
• Start date: July 2007
• Est. completion date: April 2010

Study information

• Verified date: March 2013
• Source: Vanderbilt-Ingram Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 95
• Est. completion date: April 2010
• Est. primary completion date: January 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Mucositis
• Multiple Myeloma
• Multiple Myeloma and Plasma Cell Neoplasm
• Neoplasms, Plasma Cell
• Plasmacytoma

Intervention

Other:
• laboratory biomarker analysis
Blood or cheek cells wil be collected.

Locations

Country	Name	City	State
United States	Vanderbilt-Ingram Cancer Center	Nashville	Tennessee
United States	Vanderbilt-Ingram Cancer Center at Franklin	Nashville	Tennessee
United States	Veterans Affairs Medical Center - Nashville	Nashville	Tennessee

Sponsors (2)

Lead Sponsor	Collaborator
Vanderbilt-Ingram Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Association between single nucleotide polymorphisms (SNPs) in genes that encode the melphalan transporters and development and/or severity of mucositis		4 weeks	No
Primary	Association between SNPs in genes that influence melphalan metabolism and development and/or severity of mucositis		4 weeks	No