Study Summary
This trial is testing if a low dose of melphalan combined with high doses of ascorbate acid is safe and effective in treating patients who have multiple myeloma that has returned or does not respond to treatment.
Treatment Effectiveness
Effectiveness Progress
Study Objectives
1 Primary · 4 Secondary · Reporting Duration: Through 28 days after the end of treatment
Day 28
Number of treatment related adverse events as defined by National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 4.03
Month 24
Overall response rate based on International Myeloma Working Group (IMWG) criteria
Oxidative stress parameters in plasma through blood testing
Day 28
Rate of minimal residual disease (MRD) negativity through bone marrow testing and imaging
Month 24
Categorize and quantify adverse events compared to historical control
Trial Safety
Safety Progress
Trial Design
1 Treatment Group
Low dose melphalan + high dose ascorbate acid (HDAA)
1 of 1
Experimental Treatment
9 Total Participants · 1 Treatment Group
Primary Treatment: Ascorbate · No Placebo Group · Phase 1
Low dose melphalan + high dose ascorbate acid (HDAA)Experimental Group · 2 Interventions: Ascorbate, Melphalan · Intervention Types: Other, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ascorbic acid
FDA approved
Trial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: through 28 days after the end of treatment
Who is running the clinical trial?
Michael TomassonLead Sponsor
University of IowaOTHER
407 Previous Clinical Trials
794,405 Total Patients Enrolled
3 Trials studying Multiple Myeloma
123 Patients Enrolled for Multiple Myeloma
Michael Tomasson, MDPrincipal Investigator - University of Iowa
University of Iowa Chemical Dependency Center, University of Iowa Hospitals & Clinics
Stanford University School Of Medicine (Medical School)
Mass Gen Hospital (Residency)
Eligibility Criteria
Age 18+ · All Participants · 10 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:People who have been treated with three or more different types of therapies, such as proteasome inhibitors, immuno-modulatory agents, and monoclonal antibodies, and have seen their disease progress within the last six months are eligible to participate in this study
People with levels of M-protein that are 0.5 g/dl or more by SPEP test or 200 mg/24 hour urine collection by UPEP test, or serum free light chain levels that are 100 mg/L or more (involved light chain), and an abnormal kappa/lambda ratio, do not have detectable serum or urine M-protein, but still have myeloma
The participant must have a bone marrow plasmacytosis percentage of more than 20% OR multiple plasmacytomas or lesions on an MRI at the time of diagnosis or study enrollment, OR the presence of lesions on a PET/CT scan.
The patient must have an absolute neutrophil count of at least 1.0 x 109/L and platelets of at least 50 x 109/L without transfusion for 7 days in order to be enrolled in the study
The enzymes aspartate aminotransferase (AST/SGOT) and alanine aminotransferase (ALT/SGPT) are present at levels that are ≤ 2.5 times the upper limit of normal.
If your international normalized ratio (INR) is less than 1.5 times the upper limit of normal (ULN) and your partial thromboplastin time (PTT) is less than 1.5 times the ULN, you may have a low risk of bleeding.
Patients with serum creatinine clearance ≥ 45 mL/min using the Cockcroft-Gault equation or directly calculated from the 24-hour urine collection method or ≥30 mL allowed if renal insufficiency is attributed to myeloma are eligible for study therapy.
Potassium is a mineral that is found in certain foods and also in supplements
The subject has agreed to the experiment and has been informed of the risks and benefits.
You have a serum bilirubin level of ≤ 1.5 x ULN.
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Conditions
Cancer Related
Treatments