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NCT06313502 · ClinicalTrials.gov registry record · Phase 1
High Dose Ascorbic Acid (HDAA) in Patients With Plasma Cell Disorders
A Phase 1 study of Plasma Cell Disorder, sponsored by University of Arkansas.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 18
- Enrollment target
- 1
- Study location
NCT06313502: Recruiting Phase 1 study of Plasma Cell Disorder, sponsored by University of Arkansas.
NCT06313502 is a Phase 1 study of Plasma Cell Disorder that is actively recruiting participants, run by University of Arkansas. The registered enrollment target is 18 participants, below the 107-participant average among 4 other Plasma Cell Disorder trials with a reported enrollment target (83% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06313502, a Phase 1 study of Plasma Cell Disorder, is actively recruiting participants, sponsored by University of Arkansas.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 18 participants
- Enrollment target
- 1
- Study location
Study Summary
The purpose of this research is to evaluate whether HDAA in combination with a single dose of 100 mg/m2 IV melphalan followed by autologous stem cell transplantation (ASCT) is safe and effective for subjects with relapsed refractory multiple myeloma. The proposed melphalan dose is 50% of the current standard myeloablative dose (200 mg/m2). Based on our preclinical data, the investigator hypothesize that the combination of reduced dose melphalan with IV HDAA will have high efficacy and tolerability Primary Objective To determine tumor response using International Myeloma Working Group (IMWG) criteria (see Appendix B). Secondary Objectives Objectives: 1. Determine the safety and tolerability of HDAA in combination with reduced dose melphalan conditioning and autologous stem cell transplantation (ASCT) in relapsed refractory multiple myeloma subjects. 2. Determine the rate of Minimal Residual Disease (MRD) negativity at time point of response assessment using 8 color flow cytometry on BM sample. Functional imaging, such as positron emission tomography (PET) scan and magnetic resonance imaging (MRI), will also be performed to assess the disease status. 3. Categorize and quantify adverse events compared to historical control. 4. Determine quality of life parameters using standardized health-related quality of life measures 5. Determine oxidative stress parameters in plasma during treatment.
Primary Outcome
To determine tumor response using International Myeloma Working Group (IMWG) criteria
Conditions Studied
Interventions
- DRUG 75gm HDAA
- DRUG 100gm HDAA
- DRUG 125gm HDAA
Study Locations (1)
Arkansas
- University of Arkansas for Medical Sciences - Little Rock
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 18 participants |
| Start Date | 2024-07-19 |
| Est. Completion | 2028-04 |
| Phase | Phase 1 |
What NCT06313502 shows while recruiting
NCT06313502 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 18 participants, a relatively small participant target, below the 107-participant average among 4 other Plasma Cell Disorder trials with a reported enrollment target (83% lower).
The record links to 1 condition, with Plasma Cell Disorder appearing as the primary indexed condition, and to 3 interventions - of which 75gm HDAA is the first listed.
NCT06313502 reports a single indexed study location in Arkansas.
Frequently Asked Questions
What is clinical trial NCT06313502 about?
NCT06313502 is a clinical study titled "High Dose Ascorbic Acid (HDAA) in Patients With Plasma Cell Disorders". The purpose of this research is to evaluate whether HDAA in combination with a single dose of 100 mg/m2 IV melphalan followed by autologous stem cell transplantation (ASCT) is safe and effective for subjects with relapsed refractory multiple myeloma. The proposed melphalan dose is 50% of the current...
What is the current status of trial NCT06313502?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 18 participants. The study started on 2024-07-19. Estimated completion is 2028-04.
What conditions does trial NCT06313502 study?
This clinical trial studies the following conditions: Plasma Cell Disorder.
What interventions are being tested in trial NCT06313502?
The interventions under investigation include: 75gm HDAA (DRUG), 100gm HDAA (DRUG), 125gm HDAA (DRUG).
Who is sponsoring clinical trial NCT06313502?
This trial is sponsored by University of Arkansas, which has 318 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06313502 being conducted?
This trial has 1 study location across Arkansas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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