Clinical Trials Logo

Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT02589860
Other study ID # IUSCC-0536
Secondary ID
Status Withdrawn
Phase
First received
Last updated
Start date October 30, 2015
Est. completion date March 23, 2020

Study information

Verified date January 2022
Source Indiana University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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.


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.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date March 23, 2020
Est. primary completion date March 23, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Intervention

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
Gene expression study
RNA from oral buccal mucosal cells will be analyzed to compare gene expression

Locations

Country Name City State
United States Indiana University Health Hospital Indianapolis Indiana
United States Indiana University Melvin and Bren Simon Cancer Center Indianapolis Indiana

Sponsors (1)

Lead Sponsor Collaborator
Sherif S. Farag

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Gene expression RNA sequencing from oral buccal mucosal cells 30 days
Primary Bacterial colonization DNA sequencing of bacteria in oral buccal mucosal cells 30 days
Primary Melphalan exposure Concentration of Melphalan in plasma samples 30 days
See also
  Status Clinical Trial Phase
Recruiting NCT05027594 - Ph I Study in Adult Patients With Relapsed or Refractory Multiple Myeloma Phase 1
Completed NCT02412878 - Once-weekly Versus Twice-weekly Carfilzomib in Combination With Dexamethasone in Adults With Relapsed and Refractory Multiple Myeloma Phase 3
Completed NCT01947140 - Pralatrexate + Romidepsin in Relapsed/Refractory Lymphoid Malignancies Phase 1/Phase 2
Recruiting NCT05971056 - Providing Cancer Care Closer to Home for Patients With Multiple Myeloma N/A
Recruiting NCT05243797 - Phase 3 Study of Teclistamab in Combination With Lenalidomide and Teclistamab Alone Versus Lenalidomide Alone in Participants With Newly Diagnosed Multiple Myeloma as Maintenance Therapy Following Autologous Stem Cell Transplantation Phase 3
Active, not recruiting NCT04555551 - MCARH109 Chimeric Antigen Receptor (CAR) Modified T Cells for the Treatment of Multiple Myeloma Phase 1
Recruiting NCT05618041 - The Safety and Efficay Investigation of CAR-T Cell Therapy for Patients With Hematological Malignancies N/A
Active, not recruiting NCT03844048 - An Extension Study of Venetoclax for Subjects Who Have Completed a Prior Venetoclax Clinical Trial Phase 3
Recruiting NCT03412877 - Administration of Autologous T-Cells Genetically Engineered to Express T-Cell Receptors Reactive Against Neoantigens in People With Metastatic Cancer Phase 2
Completed NCT02916979 - Myeloid-Derived Suppressor Cells and Checkpoint Immune Regulators' Expression in Allogeneic SCT Using FluBuATG Phase 1
Recruiting NCT03570983 - A Trial Comparing Single Agent Melphalan to Carmustine, Etoposide, Cytarabine, and Melphalan (BEAM) as a Preparative Regimen for Patients With Multiple Myeloma Undergoing High Dose Therapy Followed by Autologous Stem Cell Reinfusion Phase 2
Terminated NCT03399448 - NY-ESO-1-redirected CRISPR (TCRendo and PD1) Edited T Cells (NYCE T Cells) Phase 1
Completed NCT03665155 - First-in- Human Imaging of Multiple Myeloma Using 89Zr-DFO-daratumumab, a CD38-targeting Monoclonal Antibody Phase 1/Phase 2
Completed NCT02812706 - Isatuximab Single Agent Study in Japanese Relapsed AND Refractory Multiple Myeloma Patients Phase 1/Phase 2
Active, not recruiting NCT05024045 - Study of Oral LOXO-338 in Patients With Advanced Blood Cancers Phase 1
Active, not recruiting NCT03792763 - Denosumab for High Risk SMM and SLiM CRAB Positive, Early Myeloma Patients Phase 2
Active, not recruiting NCT03989414 - A Study to Determine the Recommended Dose and Regimen and to Evaluate the Safety and Preliminary Efficacy of CC-92480 in Combination With Standard Treatments in Participants With Relapsed or Refractory Multiple Myeloma (RRMM) and Newly Diagnosed Multiple Myeloma (NDMM) Phase 1/Phase 2
Withdrawn NCT03608501 - A Study of Ixazomib, Thalidomide and Dexamethasone in Newly Diagnosed and Treatment-naive Multiple Myeloma (MM) Participants Non-eligible for Autologous Stem-cell Transplantation Phase 2
Recruiting NCT04537442 - Clinical Study to Evaluate the Safety and Efficacy of IM21 CAR-T Cells in the Treatment of Elderly Patients With Relapsed or Refractory Multiple Myeloma Phase 1
Completed NCT02546167 - CART-BCMA Cells for Multiple Myeloma Phase 1