Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02589860
Recruitment Status : Withdrawn (No accrual)
First Posted : October 28, 2015
Last Update Posted : November 13, 2020
Sponsor:
Information provided by (Responsible Party):
Sherif S. Farag, Indiana University School of Medicine

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.

Condition or disease Intervention/treatment
Mucositis Multiple Myeloma Amyloidosis Oral Mucositis Other: Melphalan kinetic study Genetic: Oral bacterial study Genetic: Gene expression study

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.

Layout table for study information
Study Type : Observational
Actual Enrollment : 0 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Pilot Study: Gene Expression and Bacterial Analysis of Oral Mucositis in Patient's Undergoing Melphalan Conditioning and Autologous Stem Cell Transplant
Actual Study Start Date : October 30, 2015
Estimated Primary Completion Date : September 2018
Actual Study Completion Date : March 23, 2020



Intervention Details:
  • Other: Melphalan kinetic study
    Concentration of Melphalan in plasma samples
  • Genetic: Oral bacterial study
    DNA from oral buccal mucosal cells will be sequenced for bacterial composition
  • Genetic: Gene expression study
    RNA from oral buccal mucosal cells will be analyzed to compare gene expression


Primary Outcome Measures :
  1. Gene expression [ Time Frame: 30 days ]
    RNA sequencing from oral buccal mucosal cells

  2. Bacterial colonization [ Time Frame: 30 days ]
    DNA sequencing of bacteria in oral buccal mucosal cells

  3. Melphalan exposure [ Time Frame: 30 days ]
    Concentration of Melphalan in plasma samples


Biospecimen Retention:   Samples With DNA
Cells collected from oral mucosal samples


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02589860


Locations
Layout table for location information
United States, Indiana
Indiana University Health Hospital
Indianapolis, Indiana, United States, 46202
Indiana University Melvin and Bren Simon Cancer Center
Indianapolis, Indiana, United States, 46202
Sponsors and Collaborators
Sherif S. Farag
Investigators
Layout table for investigator information
Principal Investigator: Sheriff Farag, M.D., Ph.D. Indiana University School of Medicine, Indiana University Simon Cancer Center
Layout table for additonal information
Responsible Party: Sherif S. Farag, Professor of Medicine and Medical and Molecular Genetics, Indiana University School of Medicine
ClinicalTrials.gov Identifier: NCT02589860    
Other Study ID Numbers: IUSCC-0536
First Posted: October 28, 2015    Key Record Dates
Last Update Posted: November 13, 2020
Last Verified: October 2020
Keywords provided by Sherif S. Farag, Indiana University School of Medicine:
Stem Cell Transplantation
Additional relevant MeSH terms:
Layout table for MeSH terms
Multiple Myeloma
Mucositis
Stomatitis
Amyloidosis
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Proteostasis Deficiencies
Metabolic Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Mouth Diseases
Stomatognathic Diseases
Melphalan
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists