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

Part of paid clinical trials in Little Rock, Arkansas.

Sponsor
University of Arkansas
Study ID
NCT06313502
Phase
PHASE1
Status
Recruiting
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Conditions

  • Plasma Cell Disorder

Eligibility Criteria

Sex
ALL
Age
18 Years - 100 Years
Healthy Volunteers
Not accepted

Interventions

  • 75gm HDAA — DRUG
    Initiation: Subjects will receive a test dose of ascorbate (15 gm), during screening period, prior to starting therapy. Dose: After successfully completing the test dose, subjects will receive 75gm of ascorbate infusion. Dose modifications will not be made for weight or body surface area. Administration: Infusion time is set to occur at 120 minutes +/-10 minutes but may be adjusted for subject comfort. The infusion rate should not exceed 500 mL/hour without consulting with PI. Changes in infusion rates should be recorded.
  • 100gm HDAA — DRUG
    Initiation: Subjects will receive a test dose of ascorbate (15 gm), during screening period, prior to starting therapy. Dose: After successfully completing the test dose, subjects will receive 100gm of ascorbate infusion. Dose modifications will not be made for weight or body surface area. Administration: Infusion time is set to occur at 180 minutes +/-10 minutes but may be adjusted for subject comfort. The infusion rate should not exceed 500 mL/hour without consulting with PI. Changes in infusion rates should be recorded.
  • 125gm HDAA — DRUG
    Initiation: Subjects will receive a test dose of ascorbate (15 gm), during screening period, prior to starting therapy. Dose: After successfully completing the test dose, subjects will receive 125gm of ascorbate infusion. Dose modifications will not be made for weight or body surface area. Administration: Infusion time is set to occur at 240 minutes +/-10 minutes but may be adjusted for subject comfort. The infusion rate should not exceed 500 mL/hour without consulting with PI. Changes in infusion rates should be recorded.

Study Details

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.

Key Dates

Start date
Jul 19, 2024
Status verified
Jun 2026
Primary completion
Apr 30, 2027
Completion
Apr 30, 2028

Study Design

Enrollment
18 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: 75gm HDAA + Melphalan 100mg/m2
    Subjects will receive HDAA alone (75gm) on day -4, HDAA combined with melphalan 100 mg/m2 on day -1, and ASCT on day 0. Four additional HDAA doses (75gm) will then be administered 3 days apart on D+2, D+5, D+8 and D+11, followed by weekly doses of the corresponding dose of HDAA for four additional weeks. On day, D-1, when both drugs are given, melphalan should be given first
  • Experimental: 100gm HDAA + Melphalan 100mg/m2
    Subjects will receive HDAA alone (100gm) on day -4, HDAA combined with melphalan 100 mg/m2 on day -1, and ASCT on day 0. Four additional HDAA doses (100gm) will then be administered 3 days apart on D+2, D+5, D+8 and D+11, followed by weekly doses of the corresponding dose of HDAA for four additional weeks. On day, D-1, when both drugs are given, melphalan should be given first
  • Experimental: 125gm HDAA + Melphalan 100mg/m2
    Subjects will receive HDAA alone (125gm) on day -4, HDAA combined with melphalan 100 mg/m2 on day -1, and ASCT on day 0. Four additional HDAA doses (125gm) will then be administered 3 days apart on D+2, D+5, D+8 and D+11, followed by weekly doses of the corresponding dose of HDAA for four additional weeks. On day, D-1, when both drugs are given, melphalan should be given first

Primary Outcome Measure

Tumor Response measured by IMWG criteria [ Time Frame: End of Treatment (approx. 24 months from beginning of enrollment) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Arkansas for Medical SciencesLittle RockArkansas72205
Carolina Schinke, MD
501-686-8230

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