Plasma Cell DisorderPhase 1NCT06313502

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

A Phase 1 study testing 75gm HDAA, 100gm HDAA and 125gm HDAA in people with Plasma Cell Disorder, run by University of Arkansas at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 to 100 years
Conditions the study is for: Plasma Cell Disorder
What is being tested?: 75gm HDAA, 100gm HDAA and 125gm HDAA
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 18 participants
Where: 1 siteUnited States
Study dates: 19 Jul 2024to Apr 2028
Phase: Phase 1
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 100 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Subject has provided informed consent.
Participants who are 18 years of age or older
Subjects who have been previously treated with 3 or more lines of therapy (i.e., proteasome inhibitors, immunomodulatory agents such as lenalidomide, and monoclonal antibodies such as daratumumab) and have progressed within past 6 months.
Subjects who have at least 1x106/kg CD34 stem cells in storage
Subjects must have measurable disease (as determined by the UAMS clinical lab), including at least one of the criteria below. Tests performed as SOC within 30 days of the first dose may be utilized:
M-protein quantities ≥ 0.5 gm/dl by SPEP

Show all 22Show fewer

≥ 200 mg/24-hour urine collection by UPEP
serum-free light chain levels > 100 mg/L (milligrams/liter involved light chain) and an abnormal kappa/lambda (κ/λ) ratio in subjects without detectable serum or urine m-protein
a serum IgA level ≥ 500 mg/dL for subjects with immunoglobulin class A (IgA) myeloma whose disease can only be reliably measured by quantitative immunoglobulin measurement
Non-secretory subjects are eligible provided the subject has > 20% BM plasmacytosis, OR multiple plasmacytomas or lesions (≥3) on MRI at the time of diagnosis or study enrollment, OR the presence of lesions (≥ 3) on PET/Computerized Tomography (CT) scan.
Adequate organ function reflects the following:
Absolute neutrophil count (ANC) ≥ 0.5 x 109/L without growth factor support for 7 days (14 days if pegfilgastrim).
Platelets ≥ 25 x 109/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.
Subjects must have a performance status of 0-2 based on ECOG performance criteria. Subjects with poor performance status (3-4) based solely on bone pain will be eligible if there is documentation to verify this.
Negative serum or urine pregnancy test (sensitivity of at least 25 mIU/mL) at screening.

Who cannot join

Prior allogeneic transplant.
Known hypersensitivity or allergy to ascorbic acid or melphalan, or any Grade 3 or higher AE as a result of test dose given during screening (15 gm).
Subjects must not have a concurrent malignancy unless it can be adequately treated by non-chemotherapeutic intervention. Participants may have a history of prior malignancy without any chemotherapy within 365 days of study entry AND life expectancy exceeding 5 years at the time of study entry.
Subjects must not have life-threatening comorbidities as assessed by the investigator.
History or evidence of MM associated with immunodeficiency states (e.g., hereditary immune deficiency, human immunodeficiency virus (HIV), organ transplant, or leukemia).
Known HIV disease (requires negative test for clinically suspected HIV infection).

Show all 13Show fewer

Evidence of CNS myeloma.
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).
Glucose-6-phosphate dehydrogenase deficiency as defined by blood test at screening visit.
Pre-existing renal insufficiency or renal failure, a known history of renal stones, or who are undergoing dialysis.
Diabetic subjects who are insulin dependent.
Any other condition that, in the opinion of the investigator, might interfere with the safe conduct of the study.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Aaron Holley contact

Beth Scanlan contact

United States1 site, 1 recruiting

University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205
Carolina Schinke, MD, 501-686-8230
Recruiting

Other trials in United States

About this study

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:

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.
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.
Categorize and quantify adverse events compared to historical control.
Determine quality of life parameters using standardized health-related quality of life measures
Determine oxidative stress parameters in plasma during treatment.

Read the detailed description

This is a single arm Phase I trial evaluating safety, tolerability, and efficacy of High Dose Ascorbic Acid (HDAA) in patients with plasma cell disorders. This is a single arm study. Subjects will receive a test dose of HDAA alone at screening (15gm), then proceed to either 75, 100, or 125 gm, depending upon the cohort) on day -4, HDAA combined with melphalan 100 mg/m2 on day -1, and ASCT on day 0. Four additional HDAA doses (each of which is either 75, 100, or 125 gm, depending upon the cohort) 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.Lab tests, vitals, and scans will be performed to assess tolerability, safety, and efficacy at each scheduled infusion timepoint.

Conditions: Plasma Cell Disorder
Being tested: 75gm HDAA, 100gm HDAA, 125gm HDAA
Medical subject headings: Neoplasms, Plasma Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

75gm HDAADrug
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 HDAADrug
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 HDAADrug
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 groups in NCT06313502
Study group	Role	What they receive
75gm HDAA + Melphalan 100mg/m2	Experimental	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 Receives: Drug: 75gm HDAA
100gm HDAA + Melphalan 100mg/m2	Experimental	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 Receives: Drug: 100gm HDAA
125gm HDAA + Melphalan 100mg/m2	Experimental	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 Receives: Drug: 125gm HDAA

What is being measured

The primary outcome is the main question the study is designed to answer.

Tumor Response measured by IMWG criteria
To determine tumor response using International Myeloma Working Group (IMWG) criteria
Measured: End of Treatment (approx. 24 months from beginning of enrollment)

Secondary outcomes (4)

Safety and Tolerability of HDAA with reduced dose melphalan measured using number and severity of AEs
The number and severity of all AEs will be summarized by simple descriptive statistics and compared to a historical control.
Measured: End of Treatment (approx. 24 months from beginning of enrollment)
Rate of Minimal Residual Disease (MRD) negativity using 8 color flow cytometry
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.
Measured: End of Treatment (approx. 24 months from beginning of enrollment)
Determine quality of life parameter using QLQ-C30
Determined using standardized health-related quality of life measures.
Measured: End of Treatment (approx. 24 months from beginning of enrollment)
Determine quality of life parameter using EQ-5D-5L
Determined using standardized health-related quality of life measures.
Measured: End of Treatment (approx. 24 months from beginning of enrollment)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

19 Jul 2024Apr 2028

First posted15 Mar 2024
Study start19 Jul 2024
Primary completionApr 2027 (estimated)
Study completionApr 2028 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Plasma Cell DisorderStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Sequential
Masking: None (open label)
Enrolment: 18 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06313502
Sponsor's protocol ID: 274271
Status last verified: Jun 2026
First submitted: 8 Mar 2024
Last updated: 4 Jun 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No

Study at a glance

From the registry record, last updated by the sponsor on 4 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: High Dose Ascorbic Acid (HDAA) in Patients With Plasma Cell Disorders
ClinicalTrials.gov ID: NCT06313502
Acronym / sponsor ID: 274271
Conditions: Plasma Cell Disorder
Phase: Phase 1
Study type: Interventional
Recruitment status: Recruiting
Enrolment: 18 participants (estimated)
Lead sponsor: University of ArkansasUniversity, hospital or other
Collaborators: University of Iowa
Study start: 19 Jul 2024 (actual)
Primary completion: Apr 2027 (estimated)
Study completion: Apr 2028 (estimated)
First posted: 15 Mar 2024 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Primary Objective To determine tumor response using International Myeloma Working Group (IMWG) criteria (see Appendix B).

Secondary Objectives

Objectives:

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.
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.
Categorize and quantify adverse events compared to historical control.
Determine quality of life parameters using standardized health-related quality of life measures
Determine oxidative stress parameters in plasma during treatment.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Sequential
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
75gm HDAA + Melphalan 100mg/m2	Experimental	Drug: 75gm HDAASubjects 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
100gm HDAA + Melphalan 100mg/m2	Experimental	Drug: 100gm HDAASubjects 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
125gm HDAA + Melphalan 100mg/m2	Experimental	Drug: 125gm HDAASubjects 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

Who may qualify

Ages: 18 to 100 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (22 listed)

Subject has provided informed consent.
Participants who are 18 years of age or older
Subjects who have been previously treated with 3 or more lines of therapy (i.e., proteasome inhibitors, immunomodulatory agents such as lenalidomide, and monoclonal antibodies such as daratumumab) and have progressed within past 6 months.
Subjects who have at least 1x106/kg CD34 stem cells in storage
Subjects must have measurable disease (as determined by the UAMS clinical lab), including at least one of the criteria below. Tests performed as SOC within 30 days of the first dose may be utilized:

Key exclusion criteria (13 listed)

Prior allogeneic transplant.
Known hypersensitivity or allergy to ascorbic acid or melphalan, or any Grade 3 or higher AE as a result of test dose given during screening (15 gm).
Subjects must not have a concurrent malignancy unless it can be adequately treated by non-chemotherapeutic intervention. Participants may have a history of prior malignancy without any chemotherapy within 365 days of study entry AND life expectancy exceeding 5 years at the time of study entry.
Subjects must not have life-threatening comorbidities as assessed by the investigator.
History or evidence of MM associated with immunodeficiency states (e.g., hereditary immune deficiency, human immunodeficiency virus (HIV), organ transplant, or leukemia).

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
75gm HDAAInitiation: 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.	Drug	75gm HDAA + Melphalan 100mg/m2
100gm HDAAInitiation: 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.	Drug	100gm HDAA + Melphalan 100mg/m2
125gm HDAAInitiation: 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.	Drug	125gm HDAA + Melphalan 100mg/m2

Primary outcome

Tumor Response measured by IMWG criteria
Time frame: End of Treatment (approx. 24 months from beginning of enrollment)
To determine tumor response using International Myeloma Working Group (IMWG) criteria

4 secondary outcomes

Safety and Tolerability of HDAA with reduced dose melphalan measured using number and severity of AEs
Time frame: End of Treatment (approx. 24 months from beginning of enrollment)
Rate of Minimal Residual Disease (MRD) negativity using 8 color flow cytometry
Time frame: End of Treatment (approx. 24 months from beginning of enrollment)
Determine quality of life parameter using QLQ-C30
Time frame: End of Treatment (approx. 24 months from beginning of enrollment)
Determine quality of life parameter using EQ-5D-5L
Time frame: End of Treatment (approx. 24 months from beginning of enrollment)

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2026.

Related trials for Plasma Cell Disorder

RecruitingPhase 1/2
A Phase 1b/2 Study of Sonrotoclax (BGB-11417) as Monotherapy and in Various Combinations With Dexamethasone Plus Carfilzomib, Dexamethasone Plus Daratumumab, and Dexamethasone Plus Pomalidomide in Multiple Myeloma
Relapsed/Refractory Multiple Myeloma
RecruitingPhase 2
Testing the Combination of Venetoclax and Rituximab, in Comparison to the Usual Treatment (Ibrutinib Plus Rituximab or Zanubrutinib Alone) for Waldenstrom's Macroglobulinemia/Lymphoplasmacytic Lymphoma
Lymphoplasmacytic Lymphoma, Waldenstrom Macroglobulinemia
RecruitingPhase 1
Autologous T Cells Transduced With Retroviral Vectors Expressing TCRs for Participant-specific Neoantigens in Patients With Hematologic Malignancies
Malignancy, Hematologic, Neoplasms, Hematologic
RecruitingObservational study
Natural History Study of Monoclonal B Cell Lymphocytosis (MBL), Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL), Lymphoplasmacytic Lymphoma (LPL)/Waldenstrom Macroglobulinemia (WM), and Splenic Marginal Zone Lymphoma (SMZL)
Waldenstrom Macroglobulinemia, Lymphoplasmacytic Lymphoma
RecruitingObservational study
Leukapheresis Procedures to Obtain Plasma and Lymphocytes for Research Studies on Antiretroviral Naive HIV-1 Research Participants
HIV

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.

Aaron Holley contact

Beth Scanlan contact

Carolina Schinke, MD principal investigator

University of Arkansas

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing 75gm HDAA, 100gm HDAA and 125gm HDAA in people with Plasma Cell Disorder, run by University of Arkansas at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 22 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 4 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Aaron Holley (501-686-8274, jaholley@uams.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Tumor Response measured by IMWG criteria (time frame: End of Treatment (approx. 24 months from beginning of enrollment)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06313502.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2026.