MucositisNCT00602147
Studying Common Genetic Mutations Related to Mucositis in Patients With Multiple Myeloma Receiving High-Dose Melphalan
An observational study of Mucositis and Multiple Myeloma and Plasma Cell Neoplasm, run by Vanderbilt-Ingram Cancer Center at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mucositis, Multiple Myeloma and Plasma Cell Neoplasm
- What is being tested?
- laboratory biomarker analysis
- How many people
- 95 participants
- Where
- 3 sitesUnited States
- Study dates
- Jul 2007to Apr 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Vanderbilt-Ingram Cancer Center at Franklin
Nashville, Tennessee, 37064
Veterans Affairs Medical Center - Nashville
Nashville, Tennessee, 37212
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, 37232-6838
About this study
Official title: Genetic Analysis of Toxicity Associated With High-Dose Melphalan
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.
- Being tested
- laboratory biomarker analysis
- Keywords
- mucositis, stage I multiple myeloma, stage II multiple myeloma, stage III multiple myeloma, refractory multiple myeloma
- Medical subject headings
- Mucositis, Multiple Myeloma, Neoplasms, Plasma Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
laboratory biomarker analysisOther
Blood or cheek cells wil be collected.
| Study group | Role | What they receive |
|---|---|---|
| Retrospective sample | People who have been diagnosed with multiple myeloma and have received high-dose melphalan. Receives: Other: laboratory biomarker analysis | |
| Prospective sample | People who have been diagnosed with multiple myeloma and will be receiving high-dose melphalan. Receives: Other: laboratory biomarker analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Association between single nucleotide polymorphisms (SNPs) in genes that encode the melphalan transporters and development and/or severity of mucositis
Measured: 4 weeks
Association between SNPs in genes that influence melphalan metabolism and development and/or severity of mucositis
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2008 (estimated)
- Study startJul 2007
- Primary completionJan 2009
- Study completionApr 2010
Why it stopped: The original PI on this study left VICC, thus study was closed.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MucositisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 95 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt-Ingram Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Stephen Brandt, Vanderbilt-Ingram Cancer Center
- Investigators
- Stephen Brandt, MD, Principal investigator, Vanderbilt-Ingram Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00602147
- Sponsor's protocol ID
- VICC HEM 0750
- Other IDs
- VU-VICC-HEM-0750, VU-VICC-070644
- Status last verified
- Mar 2013
- First submitted
- 22 Jan 2008
- Last updated
- 14 Mar 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Genetic Analysis of Toxicity Associated With High-Dose Melphalan
- ClinicalTrials.gov ID
- NCT00602147
- Acronym / sponsor ID
- VICC HEM 0750
- Keywords
- mucositis, stage I multiple myeloma, stage II multiple myeloma, stage III multiple myeloma, refractory multiple myeloma
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: The original PI on this study left VICC, thus study was closed.
- Enrolment
- 95 participants (actual)
- Lead sponsor
- Vanderbilt-Ingram Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Jul 2007
- Primary completion
- Jan 2009 (actual)
- Study completion
- Apr 2010 (actual)
- First posted
- 28 Jan 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Retrospective sample | – | Other: laboratory biomarker analysisPeople who have been diagnosed with multiple myeloma and have received high-dose melphalan. |
| Prospective sample | – | Other: laboratory biomarker analysisPeople who have been diagnosed with multiple myeloma and will be receiving high-dose melphalan. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- People who have been diagnosed with multiple myeloma and have received or will be receiving high-dose melphalan.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| laboratory biomarker analysisBlood or cheek cells wil be collected. | Other | Prospective sample, Retrospective sample |
Primary outcome
Association between single nucleotide polymorphisms (SNPs) in genes that encode the melphalan transporters and development and/or severity of mucositis
Time frame: 4 weeks
Association between SNPs in genes that influence melphalan metabolism and development and/or severity of mucositis
Time frame: 4 weeks
Results and safety
The study was stopped early (reason given: The original PI on this study left VICC, thus study was closed.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2013.
Related trials for Mucositis
RecruitingPhase 2
Traditional Chinese Medicine Preparation Alleviates Radiotherapy-induced Oral Mucositis in Head and Neck Cancer Patients.
Radiotherapy-induced Oral Mucositis
RecruitingPhase 3
High-dose Prophylactic Gabapentin (HOPE) vs. Placebo to Prevent Opioid Use for Oral Mucositis Pain During Concurrent Chemoradiation for Head and Neck Cancer
Head and Neck Squamous Cell Carcinoma, Stage I Head and Neck Cutaneous Squamous Cell Carcinoma AJCC v8
RecruitingObservational study
Evaluation of 25(OH)D3 and LL-37 Levels in Periimplant Sulcus Fluid
Peri Implantitis, Peri Implant Mucositis
RecruitingPhase 2
Taurine for the Prevention and Treatment of Radiation-induced Oral Mucositis in Patients With Nasopharyngeal Carcinoma
Oral Mucositis (Ulcerative) Due to Radiation, Nasopharyngeal Carcinoma (NPC)
Recruiting
Home-Use Dual-Light Antibacterial Photodynamic Therapy for Peri-Implant Mucositis in Full-Arch Implant Prostheses
Peri Implant Mucositis, Dental Implant Rehabilitation
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stephen Brandt, MD principal investigator
Vanderbilt-Ingram Cancer Center
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mucositis and Multiple Myeloma and Plasma Cell Neoplasm, run by Vanderbilt-Ingram Cancer Center at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 14 Mar 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: The original PI on this study left VICC, thus study was closed.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Association between single nucleotide polymorphisms (SNPs) in genes that encode the melphalan transporters and development and/or severity of mucositis (time frame: 4 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Mar 2013.