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

This study has been terminated.
(The original PI on this study left VICC, thus study was closed.)
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Stephen Brandt, Vanderbilt-Ingram Cancer Center
ClinicalTrials.gov Identifier:
NCT00602147
First received: January 22, 2008
Last updated: March 12, 2013
Last verified: March 2013
History of Changes
  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
Mucositis
Multiple Myeloma and Plasma Cell Neoplasm
 Other: laboratory biomarker analysis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Genetic Analysis of Toxicity Associated With High-Dose Melphalan

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Vanderbilt-Ingram Cancer Center:

Primary Outcome Measures:
  • Association between single nucleotide polymorphisms (SNPs) in genes that encode the melphalan transporters and development and/or severity of mucositis [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Association between SNPs in genes that influence melphalan metabolism and development and/or severity of mucositis [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Blood sample or cheek cells will be collected.


Enrollment: 95
Study Start Date: July 2007
Study Completion Date: April 2010
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.
Other Name: laboratory biomarker analysis
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.
Other Name: laboratory biomarker analysis

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
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.

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 at Franklin
Nashville, Tennessee, United States, 37064
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States, 37232-6838
Veterans Affairs Medical Center - Nashville
Nashville, Tennessee, United States, 37212
Sponsors and Collaborators
Vanderbilt-Ingram Cancer Center
National Cancer Institute (NCI)
Investigators
Principal Investigator: Stephen Brandt, MD Vanderbilt-Ingram Cancer Center
  More Information

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

No publications provided

Responsible Party: Stephen Brandt, Professor of Medicine, Cell and Developmental Biology, and Cancer Biology, Vanderbilt-Ingram Cancer Center
ClinicalTrials.gov Identifier: NCT00602147     History of Changes
Other Study ID Numbers: VICC HEM 0750, VU-VICC-HEM-0750, VU-VICC-070644
Study First Received: January 22, 2008
Last Updated: March 12, 2013
Health Authority: United States: Federal Government

Keywords provided by Vanderbilt-Ingram Cancer Center:
mucositis
stage I multiple myeloma
stage II multiple myeloma
stage III multiple myeloma
refractory multiple myeloma

Additional relevant MeSH terms:
Neoplasms
Multiple Myeloma
Neoplasms, Plasma Cell
Plasmacytoma
Mucositis
Neoplasms by Histologic Type
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
 Immune System Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Mouth Diseases
Stomatognathic Diseases
Melphalan
Myeloablative Agonists
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Antineoplastic Agents, Alkylating

ClinicalTrials.gov processed this record on May 22, 2013