Clinical trial · Observational
Analysis of Oral Mucositis in Patient's Undergoing Melphalan Conditioning and Autologous Stem Cell Transplant
A Pilot Study: Gene Expression and Bacterial Analysis of Oral Mucositis in Patient's Undergoing Melphalan Conditioning and Autologous Stem Cell Transplant
NCT02589860CI-TRIAL-00055838withdrawnClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): No accrual
Summary
Brief summary (as posted)
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.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Amyloidosis | Amyloidosis | ONTOLOGY_EXACT | 0.98 |
| Mucositis | — | UNRESOLVED | — |
| Multiple Myeloma | Multiple Myeloma | CURATED_EXACT | 0.92 |
| Oral Mucositis | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Gene expression study | Genetic | — | UNRESOLVED |
| Melphalan kinetic study | Other | — | UNRESOLVED |
| Oral bacterial study | Genetic | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (3)
- 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
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.