Ignite Creation Date:
2025-12-25 @ 2:08 AM
Ignite Modification Date:
2026-03-01 @ 1:26 PM
Study NCT ID:
NCT02589860
Status:
WITHDRAWN
Last Update Posted:
2022-01-10
First Post:
2015-10-26
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Analysis of Oral Mucositis in Patient's Undergoing Melphalan Conditioning and Autologous Stem Cell Transplant
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D052016', 'term': 'Mucositis'}, {'id': 'D009101', 'term': 'Multiple Myeloma'}, {'id': 'D000686', 'term': 'Amyloidosis'}, {'id': 'D013280', 'term': 'Stomatitis'}], 'ancestors': [{'id': 'D005759', 'term': 'Gastroenteritis'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D054219', 'term': 'Neoplasms, Plasma Cell'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D020141', 'term': 'Hemostatic Disorders'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D010265', 'term': 'Paraproteinemias'}, {'id': 'D001796', 'term': 'Blood Protein Disorders'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D006474', 'term': 'Hemorrhagic Disorders'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D057165', 'term': 'Proteostasis Deficiencies'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Cells collected from oral mucosal samples'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'No accrual', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2015-10-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-01', 'completionDateStruct': {'date': '2020-03-23', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-01-06', 'studyFirstSubmitDate': '2015-10-26', 'studyFirstSubmitQcDate': '2015-10-26', 'lastUpdatePostDateStruct': {'date': '2022-01-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-10-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2020-03-23', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Gene expression', 'timeFrame': '30 days', 'description': 'RNA sequencing from oral buccal mucosal cells'}, {'measure': 'Bacterial colonization', 'timeFrame': '30 days', 'description': 'DNA sequencing of bacteria in oral buccal mucosal cells'}, {'measure': 'Melphalan exposure', 'timeFrame': '30 days', 'description': 'Concentration of Melphalan in plasma samples'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Stem Cell Transplantation'], 'conditions': ['Mucositis', 'Multiple Myeloma', 'Amyloidosis', 'Oral Mucositis']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': "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.\n\nAll 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.\n\nPatients 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.\n\nA 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:\n\n1. Within 24 hours PRIOR to administration of Melphalan\n2. Day +3 AFTER transplantation\n3. Upon development of OM (approximately on days +7-10)\n4. Upon recovery of absolute neutrophil count (ANC) to greater than 500/mm3, or on discharge, whichever occurs first, in patients who developed OM\n\nA 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:\n\n1. Within 24 hours PRIOR to administration of Melphalan\n2. 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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients treated with Melphalan who undergo autologous stem cell transplant at the Indiana University Health Melvin and Bren Simon Cancer Center.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. 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).\n2. Age is greater than 18 years old\n3. Patients receiving a total Melphalan dose of 140-200 mg/m2 as the preparative regimen\n4. No prior history of allogeneic stem cell transplantation\n5. Patients otherwise meeting all standard institutional criteria for ASCT\n\nExclusion Criteria:\n\n1\\. Patients who do not meet inclusion criteria'}, 'identificationModule': {'nctId': 'NCT02589860', 'briefTitle': "Analysis of Oral Mucositis in Patient's Undergoing Melphalan Conditioning and Autologous Stem Cell Transplant", 'organization': {'class': 'OTHER', 'fullName': 'Indiana University'}, 'officialTitle': "A Pilot Study: Gene Expression and Bacterial Analysis of Oral Mucositis in Patient's Undergoing Melphalan Conditioning and Autologous Stem Cell Transplant", 'orgStudyIdInfo': {'id': 'IUSCC-0536'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Melphalan kinetic study', 'type': 'OTHER', 'description': 'Concentration of Melphalan in plasma samples'}, {'name': 'Oral bacterial study', 'type': 'GENETIC', 'description': 'DNA from oral buccal mucosal cells will be sequenced for bacterial composition'}, {'name': 'Gene expression study', 'type': 'GENETIC', 'description': 'RNA from oral buccal mucosal cells will be analyzed to compare gene expression'}]}, 'contactsLocationsModule': {'locations': [{'zip': '46202', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'Indiana University Health Hospital', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '46202', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'Indiana University Melvin and Bren Simon Cancer Center', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}], 'overallOfficials': [{'name': 'Sheriff Farag, M.D., Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Indiana University School of Medicine, Indiana University Simon Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sherif S. Farag', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Professor of Medicine and Medical and Molecular Genetics', 'investigatorFullName': 'Sherif S. Farag', 'investigatorAffiliation': 'Indiana University School of Medicine'}}}}