High Dose Ascorbic Acid for Plasma Cell Disorders HIGH-DOSE ASCORBIC ACID

What's the purpose of this trial?

This is a Phase I single-arm open-label clinical study primarily assessing the safety and secondarily, the relative efficacy of low dose melphalan + high dose ascorbate acid (HDAA) in relapsed refractory patients with multiple myeloma.

This trial is currently open and accepting patients.

What will happen during the trial?

This is a phase 1 study for patients with relapsed refractory multiple myeloma. Patients will receive a 15-gram test dose, and a maximum of 3 cycles, each composed of 4 doses of high-dose ascorbic acid (HDAA) and 2 doses of melphalan. This study will enroll 9 patients with relapsed refractory multiple myeloma. The starting dose of ascorbic acid will be 50 grams. Using a 3+3 dose escalation, the dose will potentially increase to 75 grams then 100 grams.

You may be able to join this trial if you:

The following criteria is a partial list of reasons why patients may be eligible to participate in this clinical trial. Further evaluation with a medical professional is required.

Inclusion Criteria:

  • Subject has provided informed consent.
  • Diagnosis of multiple myeloma per IMWG criteria(26)
  • Patients must have progressive disease following 3 or more prior lines of therapy.
    • Prior treatment must include a proteasome inhibitor, an immunomodulatory agent (IMiD), and an anti-CD38 monoclonal antibody.
    • Patients must not be candidates for regimens known to provide clinical benefit in relapsed or refractory multiple myeloma based on the investigator's judgement.
    • If a patient declines such therapy, this must be recorded in the study files. 4. Subjects must have measurable disease, including at least one of the criteria below:
    • SPEP demonstrating M-protein quantities ≥ 0.5 g/dl
    • UPEP demonstrating monoclonal protein ≥ 200 mg/24hr
    • Involved serum free light chain levels > 100 mg/L and an abnormal kappa/lambda (κ/λ)ratio
    • For patients with immunoglobulin class A (IgA) myeloma whose disease can only be reliably measured by quantitative immunoglobulin measurement, a serum IgA level ≥ 500 mg/dl will qualify as measurable disease
    • Non-secretory participants are eligible provided the participant has > 20% bone marrow plasmacytosis
  • Adequate organ function:
    • Absolute neutrophil count (ANC) ≥ 1.0 x 10^9/L without growth factor support for 7 days
    • Platelets (plt) ≥ 50 x 10^9/L without transfusion for 7 days.
    • Hemoglobin ≥ 8.0 g/dl, transfusion support permitted
    • Aspartate aminotransferase (AST/SGOT) and alanine aminotransferase (ALT/SGPT) ≤ 3.0x 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 (PTT) < 1.5 x ULN
    • Left Ventricular Ejection Fraction by ECHO or MUGA of ≥ 40%.
    • Participants must have a performance status of 0-2 based on ECOG criteria.
    • For women of child bearing potential negative serum or urine pregnancy test (sensitivity of at least 25 mIU/mL) at screening

Exclusion Criteria

  • Known hypersensitivity or allergy to ascorbic acid or melphalan
  • Participants must not have a concurrent malignancy unless it can be adequately treated by non- chemotherapeutic intervention. Participants may have a history of prior malignancy, provided they have not had any chemotherapy within 365 days of study entry AND their life expectancy exceeds 5 years with respect to the concurrent malignancy at the time of study entry.
  • Participants must not have life-threatening comorbidities.
  • Known human immunodeficiency virus(HIV) disease (requires negative test for clinically suspected HIV infection).
  • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, recent (within 6 months) myocardial infarction, uncontrolled or symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, uncontrolled hypertension on appropriate therapy or psychiatric illness/social situations that would limit compliance with study requirements.
  • Concurrent use of Coumadin (warfarin)
  • Patients with G6PD deficiency
  • Patients with a history of oxalate renal stones or a known history of multiple renal stones
  • Diabetic patients who rely on a glucometer to dose insulin as ascorbate can interfere with glucometer readings


Additional Trial Information

Phase 1

Enrollment: 9 patients (estimated)

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