Study Stopped
The original PI on this study left VICC, thus study was closed.
Studying Common Genetic Mutations Related to Mucositis in Patients With Multiple Myeloma Receiving High-Dose Melphalan
Genetic Analysis of Toxicity Associated With High-Dose Melphalan
3 other identifiers
observational
95
1 country
3
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jul 2007
Typical duration for all trials
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2007
CompletedFirst Submitted
Initial submission to the registry
January 22, 2008
CompletedFirst Posted
Study publicly available on registry
January 28, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2010
CompletedMarch 14, 2013
March 1, 2013
1.5 years
January 22, 2008
March 12, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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
Study Arms (2)
Retrospective sample
People who have been diagnosed with multiple myeloma and have received high-dose melphalan.
Prospective sample
People who have been diagnosed with multiple myeloma and will be receiving high-dose melphalan.
Interventions
Blood or cheek cells wil be collected.
Eligibility Criteria
People who have been diagnosed with multiple myeloma and have received or will be receiving high-dose melphalan.
Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.
Sponsors & Collaborators
- Vanderbilt-Ingram Cancer Centerlead
- National Cancer Institute (NCI)collaborator
Study Sites (3)
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
Biospecimen
Blood sample or cheek cells will be collected.
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Stephen Brandt, MD
Vanderbilt-Ingram Cancer Center
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor of Medicine, Cell and Developmental Biology, and Cancer Biology
Study Record Dates
First Submitted
January 22, 2008
First Posted
January 28, 2008
Study Start
July 1, 2007
Primary Completion
January 1, 2009
Study Completion
April 1, 2010
Last Updated
March 14, 2013
Record last verified: 2013-03