This date has not been verified as actual or estimated.
Primary Completion
January 2009
Actual (reported)
Study Completion
April 2010
Actual (reported)
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.
Registry Overview
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
Recruitment status
terminated
Actual enrollment (reported)
95 participants
Study completion date
April 2010
Actual (reported)
Listed locations
1 countries · 3 sites
Trial Relationships
Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Related Scientific Literature
Loading related publications...
Study Timeline
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
Study Start
July 2007
Date type not reported
This date has not been verified as actual or estimated.
mucositisstage I multiple myelomastage II multiple myelomastage III multiple myelomarefractory multiple myeloma
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.
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
laboratory biomarker analysisOther
Blood or cheek cells wil be collected.
Prospective sampleRetrospective sample
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Eligibility Criteria
Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population
People who have been diagnosed with multiple myeloma and have received or will be receiving high-dose melphalan.
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
Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.
GastroenteritisGastrointestinal DiseasesDigestive System DiseasesMouth DiseasesStomatognathic DiseasesNeoplasms by Histologic TypeNeoplasmsHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein Disorders
Study Officials
Stephen Brandt, MD
Vanderbilt-Ingram Cancer Center
PRINCIPAL INVESTIGATOR
Enrollment
95 participants (actual enrollment reported by the registry).
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 2007
Date type not reported
This date has not been verified as actual or estimated.
NCT00907920
Studying Tumor Samples From Young Patients With Neuroblastoma
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.