Studying Common Genetic Mutations Related to Mucositis in Patients With Multiple Myeloma Receiving High-Dose Melphalan
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Detailed Description
OBJECTIVES:
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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.
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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 Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Retrospective sample People who have been diagnosed with multiple myeloma and have received high-dose melphalan. |
Other: laboratory biomarker analysis
Blood or cheek cells wil be collected.
|
| Prospective sample People who have been diagnosed with multiple myeloma and will be receiving high-dose melphalan. |
Other: laboratory biomarker analysis
Blood or cheek cells wil be collected.
|
Outcome Measures
Primary Outcome Measures
- 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]
Eligibility Criteria
Criteria
DISEASE CHARACTERISTICS:
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Diagnosis of multiple myeloma
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Receiving treatment with high-dose melphalan for an autologous stem cell transplantation at any of these facilities:
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Vanderbilt University Medical Center
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Nashville Veteran's Administration Medical Center (VAMC)
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Seattle VAMC
-
San Antonio VAMC
PATIENT CHARACTERISTICS:
- Not pregnant
PRIOR CONCURRENT THERAPY:
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See Disease Characteristics
-
No palifermin
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Vanderbilt-Ingram Cancer Center at Franklin | Nashville | Tennessee | United States | 37064 |
| 2 | Veterans Affairs Medical Center - Nashville | Nashville | Tennessee | United States | 37212 |
| 3 | Vanderbilt-Ingram Cancer Center | Nashville | Tennessee | United States | 37232-6838 |
Sponsors and Collaborators
- Vanderbilt-Ingram Cancer Center
- National Cancer Institute (NCI)
Investigators
- Principal Investigator: Stephen Brandt, MD, Vanderbilt-Ingram Cancer Center
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- VICC HEM 0750
- VU-VICC-HEM-0750
- VU-VICC-070644