Actively Recruiting
High Dose Ascorbic Acid (HDAA) in Patients With Plasma Cell Disorders
Led by University of Arkansas · Updated on 2025-06-15
18
Participants Needed
1
Research Sites
193 weeks
Total Duration
On this page
Sponsors
U
University of Arkansas
Lead Sponsor
U
University of Iowa
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
High Dose Ascorbic Acid (HDAA) in Patients With Plasma Cell Disorders
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Subject has provided informed consent.
- Participants who are 18 years of age or older.
- Previously treated with 3 or more lines of therapy including proteasome inhibitors, immunomodulatory agents, and monoclonal antibodies, with disease progression in past 6 months.
- Have at least 1x10^6/kg CD34 stem cells in storage.
- Have measurable disease by defined criteria including M-protein levels, urine protein, serum-free light chain levels, IgA levels, bone marrow plasmacytosis, or lesions on MRI/PET scans.
- Adequate organ function including specific blood counts, liver enzymes, kidney function, coagulation, heart ejection fraction, and pulmonary function.
- Performance status of 0-2 on ECOG scale or 3-4 if due to bone pain with documentation.
- Negative pregnancy test at screening.
You will not qualify if you...
- Prior allogeneic transplant.
- Known allergy or severe reaction to ascorbic acid or melphalan or grade 3+ adverse event from test dose.
- Concurrent malignancy requiring chemotherapy within past year or life expectancy under 5 years.
- Life-threatening comorbidities.
- History or evidence of multiple myeloma associated immunodeficiency states or known HIV infection.
- Evidence of central nervous system myeloma.
- Uncontrolled infections, recent heart attack, unstable heart conditions, or psychiatric/social conditions limiting compliance.
- Use of warfarin (coumadin).
- Glucose-6-phosphate dehydrogenase deficiency.
- Pre-existing kidney issues including insufficiency, stones, or dialysis.
- Insulin-dependent diabetes.
- Any other condition that may interfere with study safety or conduct.
AI-Screening
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Trial Site Locations
Total: 1 location
1
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States, 72205
Actively Recruiting
Research Team
A
Aaron Holley
CONTACT
B
Beth Scanlan
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
3
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