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Sponsors and Collaborators: |
Vanderbilt-Ingram Cancer Center National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00602147 |
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 |
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Cancer-Related Problem/Condition Multiple Myeloma and Plasma Cell Neoplasm |
Drug: melphalan Procedure: laboratory biomarker analysis Procedure: polymorphism analysis |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | Genetic Analysis of Toxicity Associated With High-Dose Melphalan |
Estimated Enrollment: | 432 |
Study Start Date: | July 2007 |
Estimated Primary Completion Date: | July 2011 (Final data collection date for primary outcome measure) |
OBJECTIVES:
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Receiving treatment with high-dose melphalan for an autologous stem cell transplantation at any of these facilities:
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
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 |
Study Chair: | Jennifer Giglia, MD | Vanderbilt-Ingram Cancer Center |
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 |
mucositis stage I multiple myeloma stage II multiple myeloma stage III multiple myeloma refractory multiple myeloma |
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 |
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 |