Analysis of Oral Mucositis in Patient's Undergoing Melphalan Conditioning and Autologous Stem Cell Transplant

January 6, 2022 updated by: Sherif S. Farag

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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:

  1. Within 24 hours PRIOR to administration of Melphalan
  2. Day +3 AFTER transplantation
  3. Upon development of OM (approximately on days +7-10)
  4. 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:

  1. Within 24 hours PRIOR to administration of Melphalan
  2. 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 Type

Observational

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Indiana University Melvin and Bren Simon Cancer Center
      • Indianapolis, Indiana, United States, 46202
        • Indiana University Health Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients treated with Melphalan who undergo autologous stem cell transplant at the Indiana University Health Melvin and Bren Simon Cancer Center.

Description

Inclusion Criteria:

  1. 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).
  2. Age is greater than 18 years old
  3. Patients receiving a total Melphalan dose of 140-200 mg/m2 as the preparative regimen
  4. No prior history of allogeneic stem cell transplantation
  5. Patients otherwise meeting all standard institutional criteria for ASCT

Exclusion Criteria:

1. Patients who do not meet inclusion criteria

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Gene expression
Time Frame: 30 days
RNA sequencing from oral buccal mucosal cells
30 days
Bacterial colonization
Time Frame: 30 days
DNA sequencing of bacteria in oral buccal mucosal cells
30 days
Melphalan exposure
Time Frame: 30 days
Concentration of Melphalan in plasma samples
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sherif S. Farag

Investigators

  • Principal Investigator: Sheriff Farag, M.D., Ph.D., Indiana University School of Medicine, Indiana University Simon Cancer Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 30, 2015

Primary Completion (Actual)

March 23, 2020

Study Completion (Actual)

March 23, 2020

Study Registration Dates

First Submitted

October 26, 2015

First Submitted That Met QC Criteria

October 26, 2015

First Posted (Estimate)

October 28, 2015

Study Record Updates

Last Update Posted (Actual)

January 10, 2022

Last Update Submitted That Met QC Criteria

January 6, 2022

Last Verified

January 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IUSCC-0536

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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