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

Sponsors and Collaborators:	Vanderbilt-Ingram Cancer Center National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00602147

Purpose

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	Intervention
Cancer-Related Problem/Condition Multiple Myeloma and Plasma Cell Neoplasm	Drug: melphalan Procedure: laboratory biomarker analysis Procedure: polymorphism analysis

Genetics Home Reference related topics: aceruloplasminemia hemophilia

MedlinePlus related topics: Cancer Multiple Myeloma

Drug Information available for: Melphalan Melphalan hydrochloride Sarcolysin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Open Label
Official Title:	Genetic Analysis of Toxicity Associated With High-Dose Melphalan

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Association between single nucleotide polymorphisms (SNPs) in genes that encode the melphalan transporters and development and/or severity of mucositis [ Designated as safety issue: No ]
Association between SNPs in genes that influence melphalan metabolism and development and/or severity of mucositis [ Designated as safety issue: No ]

Estimated Enrollment:	432
Study Start Date:	July 2007
Estimated Primary Completion Date:	July 2011 (Final data collection date for primary outcome measure)

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

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00602147

Locations

United States, Tennessee
Vanderbilt-Ingram Cancer Center - Cool Springs	Recruiting
Nashville, Tennessee, United States, 37064
Contact: Stephen J Brandt 615-936-1809
Vanderbilt-Ingram Cancer Center at Franklin	Recruiting
Nashville, Tennessee, United States, 37064
Contact: Stephen J Brandt 615-936-1809
Vanderbilt-Ingram Cancer Center	Recruiting
Nashville, Tennessee, United States, 37232-6838
Contact: Clinical Trials Office - Vanderbilt-Ingram Cancer Center 800-811-8480
Veterans Affairs Medical Center - Nashville	Recruiting
Nashville, Tennessee, United States, 37212
Contact: Clinical Trials Office - Veterans Affairs Medical Center - Nas 615-327-4751

Sponsors and Collaborators

Vanderbilt-Ingram Cancer Center

National Cancer Institute (NCI)

Investigators

Study Chair:

Jennifer Giglia, MD

Vanderbilt-Ingram Cancer Center

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Study ID Numbers:	CDR0000582185, VU-VICC-HEM-0750, VU-VICC-070644
Study First Received:	January 22, 2008
Last Updated:	November 13, 2008
ClinicalTrials.gov Identifier:	NCT00602147
Health Authority:	Unspecified

Keywords provided by National Cancer Institute (NCI):

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

Study placed in the following topic categories:

Melphalan
Immunoproliferative Disorders
Mucositis
Blood Protein Disorders
Hematologic Diseases
Blood Coagulation Disorders
Vascular Diseases

Paraproteinemias
Hemostatic Disorders
Multiple Myeloma
Hemorrhagic Disorders
Multiple myeloma
Lymphoproliferative Disorders
Neoplasms, Plasma Cell

Additional relevant MeSH terms:

Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Immune System Diseases
Immunologic Factors
Antineoplastic Agents
Physiological Effects of Drugs
Immunosuppressive Agents

Pharmacologic Actions
Neoplasms
Therapeutic Uses
Myeloablative Agonists
Cardiovascular Diseases
Antineoplastic Agents, Alkylating
Alkylating Agents

ClinicalTrials.gov processed this record on January 14, 2009