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High Dose Ascorbic Acid for Plasma Cell Disorders

This study is testing if high doses of ascorbic acid (HDAA), also known as Vitamin C, combined with a lower dose of melphalan (a chemotherapy drug) and a stem cell transplant, is safe and effective for people with plasma cell disorders (like multiple myeloma) that have returned or not responded to previous treatments. Researchers believe this combination might work well and be easier to tolerate than standard treatments. You would receive a test dose of HDAA, then different doses (75gm, 100gm, or 125gm) along with melphalan and a stem cell transplant. The study aims to see how well tumors respond to this treatment. This study is currently recruiting up to 18 participants aged 18 to 100 years old.

Study design
This is a single-arm Phase 1 study, meaning all 18 participants will receive the study treatment. It is designed to evaluate the safety, tolerability, and effectiveness of the treatment.
What's involved
You would receive a test dose of HDAA, then HDAA combined with melphalan and a stem cell transplant. You would then receive additional HDAA doses over several weeks, with lab tests, vital sign checks, and scans performed at scheduled times.
Compensation
Not stated in the trial record.
Follow-up
Tumor response will be measured at the end of treatment, which is approximately 24 months from the beginning of enrollment.

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NCT06313502

High Dose Ascorbic Acid (HDAA) in Patients With Plasma Cell Disorders

Recruiting
PHASE1Ages 18+InterventionalTreatment
University of Arkansas
~18 participants
Updated 2026-06-04 on ClinicalTrials.gov
What's tested:75gm HDAA100gm HDAA125gm HDAA

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Tumor Response measured by IMWG criteria
Measured over End of Treatment (approx. 24 months from beginning of enrollment)

Conditions

Plasma Cell Disorder

Explore related trials

Multiple Myeloma

Where it's being run

1 sites across 1 states
Arkansas1

Study leadership

  • Carolina Schinke, MD · PRINCIPAL_INVESTIGATOR · University of Arkansas

Who to contact

Aaron Holley
[email protected]
501-686-8274
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

M-protein quantities ≥ 0.5 gm/dl by SPEP
≥ 200 mg/24-hour urine collection by UPEP
serum-free light chain levels \> 100 mg/L (milligrams/liter involved light chain) and an abnormal kappa/lambda (κ/λ) ratio in subjects without detectable serum or urine m-protein
a serum IgA level ≥ 500 mg/dL for subjects with immunoglobulin class A (IgA) myeloma whose disease can only be reliably measured by quantitative immunoglobulin measurement
Non-secretory subjects are eligible provided the subject has \> 20% BM plasmacytosis, OR multiple plasmacytomas or lesions (≥3) on MRI at the time of diagnosis or study enrollment, OR the presence of lesions (≥ 3) on PET/Computerized Tomography (CT) scan. 6. Adequate organ function reflects the following:
Absolute neutrophil count (ANC) ≥ 0.5 x 109/L without growth factor support for 7 days (14 days if pegfilgastrim).
Platelets ≥ 25 x 109/L without transfusion for 7 days. However, subject can be enrolled if the ANC and platelets are low due to disease
Potassium within normal limits or correctable with supplements
Aspartate aminotransferase and alanine aminotransferase ≤ 2.5 x upper limit of normal (ULN)
Serum bilirubin ≤ 1.5 x ULN
Estimated serum creatinine clearance of ≥ 45 mL/min using the Cockcroft-Gault equation or directly calculated from the 24-hour urine collection method
International normalized ratio (INR) \< 1.5 x ULN and partial thromboplastin time \< 1.5 x ULN
Ejection fraction by ECHO or MUGA of ≥ 40% performed
Subjects must have adequate pulmonary function studies (PFTs) \> 50% of predicted on mechanical aspects (forced expiratory volume, forced vital capacity) and \> 50% of predicted (adjusted for hemoglobin) on diffusion capacity. If the participant is unable to complete PFTs due to disease-related pain or other circumstances that make it difficult to reliably perform PFTs, documentation of pulmonary function adequate for transplant will occur via a CT scan without evidence of major pulmonary disease and arterial blood gas results. 7. Subjects must have a performance status of 0-2 based on ECOG performance criteria. Subjects with poor performance status (3-4) based solely on bone pain will be eligible if there is documentation to verify this. 8. Negative serum or urine pregnancy test (sensitivity of at least 25 mIU/mL) at screening.

What this trial measures

  • Tumor Response measured by IMWG criteriaEnd of Treatment (approx. 24 months from beginning of enrollment)

    To determine tumor response using International Myeloma Working Group (IMWG) criteria