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TerminatedNCT00602147Updated Mar 14, 2013

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

An observational study in Mucositis and Multiple Myeloma and Plasma Cell Neoplasm, sponsored by Vanderbilt-Ingram Cancer Center. Terminated at 3 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-03-14.

Sponsored by Vanderbilt-Ingram Cancer Center · Observational

Why this study was terminated
The original PI on this study left VICC, thus study was closed.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
95
Ages
18 Years and older
Sex
All
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Study 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.

Read the 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.

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Conditions studied

  • Mucositis
  • Multiple Myeloma and Plasma Cell Neoplasm

Keywords

  • mucositis
  • stage I multiple myeloma
  • stage II multiple myeloma
  • stage III multiple myeloma
  • refractory multiple myeloma
03

In context

Multiple Myeloma

3,632 studies on the registry are indexed under Multiple Myeloma; 745 are open to participants now.

This study's enrollment of 95 is below the median of 140 across 468 observational studies indexed under Multiple Myeloma.

Browse Multiple Myeloma studies →

Lead sponsor

Vanderbilt-Ingram Cancer Center is the lead sponsor of 220 studies on the registry; 32 are open to participants now.

Of its 23 completed or terminated interventional studies of FDA-regulated products, 18 (78%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
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.

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
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
95 participants (actual)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • Retrospective sample

    People who have been diagnosed with multiple myeloma and have received high-dose melphalan.

    Other: laboratory biomarker analysis

  • Prospective sample

    People who have been diagnosed with multiple myeloma and will be receiving high-dose melphalan.

    Other: laboratory biomarker analysis

Interventions

  • Otherlaboratory biomarker analysis

    Blood or cheek cells wil be collected.

06

What researchers measure

Primary outcomes

  1. Association between single nucleotide polymorphisms (SNPs) in genes that encode the melphalan transporters and development and/or severity of mucositis

    Time frame: 4 weeks

  2. Association between SNPs in genes that influence melphalan metabolism and development and/or severity of mucositis

    Time frame: 4 weeks

07

Study locations

3 sites
  • Vanderbilt-Ingram Cancer Center at Franklin
    Nashville, Tennessee 37064, United States
  • Veterans Affairs Medical Center - Nashville
    Nashville, Tennessee 37212, United States
  • Vanderbilt-Ingram Cancer Center
    Nashville, Tennessee 37232-6838, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 14, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00602147
Lead sponsor
Vanderbilt-Ingram Cancer Center
Collaborators
National Cancer Institute (NCI)
Responsible party
Stephen Brandt (Professor of Medicine, Cell and Developmental Biology, and Cancer Biology, Vanderbilt-Ingram Cancer Center) — Principal investigator
First posted
Jan 28, 2008
Start date
Jul 2007
Primary completion
Jan 2009
Completion
Apr 2010
Last update
Mar 14, 2013

Study contacts

Stephen Brandt, MD
principal investigator · Vanderbilt-Ingram Cancer Center

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Mar 2013. You cannot join it, but the record below documents what was studied.

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