Study Stopped
No accrual
Analysis of Oral Mucositis in Patient's Undergoing Melphalan Conditioning and Autologous Stem Cell Transplant
A Pilot Study: Gene Expression and Bacterial Analysis of Oral Mucositis in Patient's Undergoing Melphalan Conditioning and Autologous Stem Cell Transplant
1 other identifier
observational
N/A
1 country
2
Brief Summary
This is a pilot study to explore and identify changes in molecular processes within the oral mucosa that are associated with the development of oral mucositis (OM) in patients treated with Melphalan who undergo autologous peripheral blood stem cell transplantation.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Oct 2015
Longer than P75 for all trials
2 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
First Submitted
Initial submission to the registry
October 26, 2015
CompletedFirst Posted
Study publicly available on registry
October 28, 2015
CompletedStudy Start
First participant enrolled
October 30, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 23, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
March 23, 2020
CompletedJanuary 10, 2022
January 1, 2022
4.4 years
October 26, 2015
January 6, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Gene expression
RNA sequencing from oral buccal mucosal cells
30 days
Bacterial colonization
DNA sequencing of bacteria in oral buccal mucosal cells
30 days
Melphalan exposure
Concentration of Melphalan in plasma samples
30 days
Interventions
Concentration of Melphalan in plasma samples
DNA from oral buccal mucosal cells will be sequenced for bacterial composition
RNA from oral buccal mucosal cells will be analyzed to compare gene expression
Eligibility Criteria
Patients treated with Melphalan who undergo autologous stem cell transplant at the Indiana University Health Melvin and Bren Simon Cancer Center.
You may qualify if:
- Patients with multiple myeloma (MM) or systemic light-chain amyloidosis who are receiving high-dose Melphalan (HDM) and autologous peripheral blood stem cell transplantation (ASCT).
- Age is greater than 18 years old
- Patients receiving a total Melphalan dose of 140-200 mg/m2 as the preparative regimen
- No prior history of allogeneic stem cell transplantation
- Patients otherwise meeting all standard institutional criteria for ASCT
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Sherif S. Faraglead
Study Sites (2)
Indiana University Health Hospital
Indianapolis, Indiana, 46202, United States
Indiana University Melvin and Bren Simon Cancer Center
Indianapolis, Indiana, 46202, United States
Biospecimen
Cells collected from oral mucosal samples
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sheriff Farag, M.D., Ph.D.
Indiana University School of Medicine, Indiana University Simon Cancer Center
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Professor of Medicine and Medical and Molecular Genetics
Study Record Dates
First Submitted
October 26, 2015
First Posted
October 28, 2015
Study Start
October 30, 2015
Primary Completion
March 23, 2020
Study Completion
March 23, 2020
Last Updated
January 10, 2022
Record last verified: 2022-01