MucositisNCT02589860
Analysis of Oral Mucositis in Patient's Undergoing Melphalan Conditioning and Autologous Stem Cell Transplant
An observational study of Mucositis and Multiple Myeloma, run by Sherif S. Farag at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mucositis, Multiple Myeloma, Amyloidosis
- What is being tested?
- Melphalan kinetic study, Oral bacterial study and Gene expression study
- Type of treatment
- Pill or oral medicine
- How many people
- 0 participants
- Where
- 2 sitesUnited States
- Study dates
- 30 Oct 2015to 23 Mar 2020
- 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: Patients treated with Melphalan who undergo autologous stem cell transplant at the Indiana University Health Melvin and Bren Simon Cancer Center.
Who may be able to join
- 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
Who cannot join
- 1. Patients who do not meet inclusion criteria
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Indiana University Health Hospital
Indianapolis, Indiana, 46202
Indiana University Melvin and Bren Simon Cancer Center
Indianapolis, Indiana, 46202
About this study
Official title: A Pilot Study: Gene Expression and Bacterial Analysis of Oral Mucositis in Patient's Undergoing Melphalan Conditioning and Autologous Stem Cell Transplant
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.
Read the detailed description
This is an exploratory observational (non-therapeutic) study to collect blood and buccal mucosal samples to evaluate RNA expression, assess bacterial colonization, and plasma Melphalan concentrations in approximately 50 eligible patients.
All study samples will be collected from participants while they are hospitalized to receive standard of care high-dose Melphalan (HDM) chemotherapy and autologous peripheral blood stem cell transplantation (ASCT). Patients who receive this treatment are typically admitted the day before HDM. The day after HDM, patients receive ASCT and remain hospitalized for approximately 21 days, or until their absolute neutrophil count increases to at least 500 cells per mm3 and they are no longer considered neutropenic.
Patients will have blood samples collected for pharmacokinetic analysis at approximately 0 minutes (before infusion begins), 15 minutes (during the infusion), 30 minutes (at the end of infusion), 60 minutes, 90 minutes, 120 minutes, and 180 minutes after the start of Melphalan infusion.
A buccal swab will be done to collect mucosal bacterial samples using paper strips (Periopaper) or a sterile cotton tipped swab brushed against the right and left buccal mucosa for approximately 15-30 seconds at the following time points:
- Within 24 hours PRIOR to administration of Melphalan
- Day +3 AFTER transplantation
- Upon development of OM (approximately on days +7-10)
- Upon recovery of absolute neutrophil count (ANC) to greater than 500/mm3, or on discharge, whichever occurs first, in patients who developed OM
A buccal scraping will be done for gene expression using a dermatologic curette taken from the right and left buccal mucosa at the following time points:
- Within 24 hours PRIOR to administration of Melphalan
- Day +3 AFTER transplantation Note: Patients' mouths will be rinsed with Mary's Magic mouthwash prior to the procedure for 15 seconds, which will allow for removal of food particles, colonized bacteria and anesthetization of oral mucosa. During procedure, any signs of patient discomfort will be monitored. If patient expresses discomfort, additional oral topical anesthetic will be utilized to de-sensitive buccal mucosa.
- Conditions
- Mucositis, Multiple Myeloma, Amyloidosis, Oral Mucositis
- Being tested
- Melphalan kinetic study, Oral bacterial study, Gene expression study
- Keywords
- Stem Cell Transplantation
- Medical subject headings
- Mucositis, Multiple Myeloma, Amyloidosis, Stomatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Melphalan kinetic studyOther
Concentration of Melphalan in plasma samples
Oral bacterial studyGenetic
DNA from oral buccal mucosal cells will be sequenced for bacterial composition
Gene expression studyGenetic
RNA from oral buccal mucosal cells will be analyzed to compare gene expression
What is being measured
The primary outcome is the main question the study is designed to answer.
Gene expression
RNA sequencing from oral buccal mucosal cells
Measured: 30 days
Bacterial colonization
DNA sequencing of bacteria in oral buccal mucosal cells
Measured: 30 days
Melphalan exposure
Concentration of Melphalan in plasma samples
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2015 (estimated)
- Study start30 Oct 2015
- Primary completion23 Mar 2020
- Study completion23 Mar 2020
Why it stopped: No accrual
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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sherif S. Farag
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Sherif S. Farag, Indiana University
- Investigators
- Sheriff Farag, M.D., Ph.D., Principal investigator, Indiana University School of Medicine, Indiana University Simon Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02589860
- Sponsor's protocol ID
- IUSCC-0536
- Status last verified
- Jan 2022
- First submitted
- 26 Oct 2015
- Last updated
- 10 Jan 2022
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study: Gene Expression and Bacterial Analysis of Oral Mucositis in Patient's Undergoing Melphalan Conditioning and Autologous Stem Cell Transplant
- ClinicalTrials.gov ID
- NCT02589860
- Acronym / sponsor ID
- IUSCC-0536
- Conditions
- Mucositis, Multiple Myeloma, Amyloidosis, Oral Mucositis
- Keywords
- Stem Cell Transplantation
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: No accrual
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Sherif S. FaragUniversity, hospital or other
- Study start
- 30 Oct 2015 (actual)
- Primary completion
- 23 Mar 2020 (actual)
- Study completion
- 23 Mar 2020 (actual)
- First posted
- 28 Oct 2015 (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.
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.
Detailed description
This is an exploratory observational (non-therapeutic) study to collect blood and buccal mucosal samples to evaluate RNA expression, assess bacterial colonization, and plasma Melphalan concentrations in approximately 50 eligible patients.
All study samples will be collected from participants while they are hospitalized to receive standard of care high-dose Melphalan (HDM) chemotherapy and autologous peripheral blood stem cell transplantation (ASCT). Patients who receive this treatment are typically admitted the day before HDM. The day after HDM, patients receive ASCT and remain hospitalized for approximately 21 days, or until their absolute neutrophil count increases to at least 500 cells per mm3 and they are no longer considered neutropenic.
Patients will have blood samples collected for pharmacokinetic analysis at approximately 0 minutes (before infusion begins), 15 minutes (during the infusion), 30 minutes (at the end of infusion), 60 minutes, 90 minutes, 120 minutes, and 180 minutes after the start of Melphalan infusion.
A buccal swab will be done to collect mucosal bacterial samples using paper strips (Periopaper) or a sterile cotton tipped swab brushed against the right and left buccal mucosa for approximately 15-30 seconds at the following time points:
- Within 24 hours PRIOR to administration of Melphalan
- Day +3 AFTER transplantation
- Upon development of OM (approximately on days +7-10)
- Upon recovery of absolute neutrophil count (ANC) to greater than 500/mm3, or on discharge, whichever occurs first, in patients who developed OM
A buccal scraping will be done for gene expression using a dermatologic curette taken from the right and left buccal mucosa at the following time points:
- Within 24 hours PRIOR to administration of Melphalan
- Day +3 AFTER transplantation Note: Patients' mouths will be rinsed with Mary's Magic mouthwash prior to the procedure for 15 seconds, which will allow for removal of food particles, colonized bacteria and anesthetization of oral mucosa. During procedure, any signs of patient discomfort will be monitored. If patient expresses discomfort, additional oral topical anesthetic will be utilized to de-sensitive buccal mucosa.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients treated with Melphalan who undergo autologous stem cell transplant at the Indiana University Health Melvin and Bren Simon Cancer Center.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (1 listed)
- 1. Patients who do not meet inclusion criteria
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 |
|---|---|---|
| Melphalan kinetic studyConcentration of Melphalan in plasma samples | Other | – |
| Oral bacterial studyDNA from oral buccal mucosal cells will be sequenced for bacterial composition | Genetic | – |
| Gene expression studyRNA from oral buccal mucosal cells will be analyzed to compare gene expression | Genetic | – |
Primary outcome
Gene expression
Time frame: 30 days
RNA sequencing from oral buccal mucosal cells
Bacterial colonization
Time frame: 30 days
DNA sequencing of bacteria in oral buccal mucosal cells
Melphalan exposure
Time frame: 30 days
Concentration of Melphalan in plasma samples
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2022.
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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.
Sheriff Farag, M.D., Ph.D. principal investigator
Indiana University School of Medicine, Indiana University Simon Cancer Center
2 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, run by Sherif S. Farag at 2 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?
The sponsor lists 5 inclusion and 1 exclusion criteria. 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: withdrawn, as of the sponsor's last update on 10 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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 withdrawn before enrolling participants, so there are no results.
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?
Gene expression (time frame: 30 days). The study lists 3 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 10 Jan 2022.