Clinical trial NCT00602147: Studying Common Genetic Mutations Related to Mucositis in Patients With Multiple Myeloma Receiving High-Dose Melphalan
Official title: Genetic Analysis of Toxicity Associated With High-Dose Melphalan
Study type: OBSERVATIONAL
Overall status: TERMINATED
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
Lead sponsor: Vanderbilt-Ingram Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2008-01-28
Enrollment: 95
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: People who have been diagnosed with multiple myeloma and have received or will be receiving high-dose melphalan.

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.

Eligibility 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

Primary outcomes:
measure: Association between single nucleotide polymorphisms (SNPs) in genes that encode the melphalan transporters and development and/or severity of mucositis
timeFrame: 4 weeks
measure: Association between SNPs in genes that influence melphalan metabolism and development and/or severity of mucositis
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt-Ingram Cancer Center at Franklin
state: Tennessee
city: Nashville
country: United States
facility: Veterans Affairs Medical Center - Nashville
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt-Ingram Cancer Center
state: Tennessee
Study officials:
affiliation: Vanderbilt-Ingram Cancer Center
name: Stephen Brandt, MD
role: PRINCIPAL_INVESTIGATOR
References: