OncoMatch/Clinical Trials/NCT06313502
High Dose Ascorbic Acid (HDAA) in Patients With Plasma Cell Disorders
Is NCT06313502 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies multiple treatments including 75gm HDAA and 100gm HDAA for plasma cell disorder.
Treatment: 75gm HDAA · 100gm HDAA · 125gm HDAA — 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.
Check if I qualifyExtracted eligibility criteria
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: proteasome inhibitor
Must have received: immunomodulatory agent (lenalidomide)
Must have received: monoclonal antibody (daratumumab)
Cannot have received: allogeneic transplant
Lab requirements
Blood counts
Absolute neutrophil count (ANC) ≥ 0.5 x 10^9/L without growth factor support for 7 days (14 days if pegfilgastrim); Platelets ≥ 25 x 10^9/L without transfusion for 7 days (unless low due to disease)
Kidney function
Estimated serum creatinine clearance of ≥ 45 mL/min using the Cockcroft-Gault equation or directly calculated from the 24-hour urine collection method
Liver function
Aspartate aminotransferase and alanine aminotransferase ≤ 2.5 x upper limit of normal (ULN); Serum bilirubin ≤ 1.5 x ULN
Cardiac function
Ejection fraction by ECHO or MUGA of ≥ 40% performed; INR < 1.5 x ULN and partial thromboplastin time < 1.5 x ULN
Adequate organ function reflects the following: ANC ≥ 0.5 x 10^9/L without growth factor support for 7 days (14 days if pegfilgastrim). Platelets ≥ 25 x 10^9/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.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- University of Arkansas for Medical Sciences · Little Rock, Arkansas
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