Vitamin c and chemo combo tested in Hard-to-Treat myeloma
NCT ID NCT03602235
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early-phase study tested a combination of high dose vitamin C and a low dose of the chemotherapy drug melphalan in 6 patients with multiple myeloma that had stopped responding to other treatments. The main goal was to check safety, and researchers also looked for signs that the treatment was working. The study is complete, but results are not yet reported.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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6 people
The number who actually took part.
- Started
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Mar 2019
- Finished
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Sep 2025
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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 people 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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Bispecific antibody combo aims to deepen myeloma responses
- Can a stronger drug cocktail give older myeloma patients a better start?
- Cheap blood count ratios eyed as window into Myeloma's inflammatory grip
- Can a t-cell engager rescue myeloma that outsmarted CAR-T?
- Can myeloma treatment work without steroids?
- Double-Drug attack on Hard-to-Treat lymphomas