Multiple MyelomaPhase 1NCT03602235
High Dose Ascorbic Acid for Plasma Cell Disorders
A Phase 1 study testing Ascorbate and Melphalan in people with Multiple Myeloma, run by Christopher Strouse at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Myeloma
- What is being tested?
- Ascorbate and Melphalan
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Mar 2019to 3 Sep 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
Show all 22Show fewer
- 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
Who cannot join
- 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)
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242
About this study
Official title: High Dose Ascorbic Acid (HDAA) in Patients With Plasma Cell Disorders
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.
Read the detailed description
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.
- Conditions
- Multiple Myeloma
- Being tested
- Ascorbate, Melphalan
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AscorbateOther
Also called Ascorbate Acid; Ascorbic Acid for Injection, USP
Ascorbate is in the vitamin drug class
MelphalanDrug
Also called L-phenylamine mustard; L-PAM; L-Sarcolysin
Melphalan is an alkylating agent coupled to an amino acid
| Study group | Role | What they receive |
|---|---|---|
| Low dose melphalan + high dose ascorbate acid (HDAA) | Experimental | Patients will receive a test dose of 15g of HDAA prior to starting treatment dose. This will be mainly to rule out allergic reactions.
HDAA + Melphalan:
HDAA on day 1 and day 4 in combination with melphalan 12.5 mg/m2, followed by 2 additional doses of HDAA on day 2 and day 5.
A 3 + 3 cohort method will be used for this study. After successfully completing the test dose, subjects will receive 50gms, 75gms and 100gms of ascorbate per infusion in 3 different cohorts. Dose modifications are not made for weight or body surface area. Receives: Other: Ascorbate; Drug: Melphalan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of treatment related adverse events as defined by National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 4.03
Adverse events occuring within the DLT assessment window which do not resolve in less than 72 hours and are not clearly and incontrovertibly due to extraneous causes.
Measured: First day of treatment through 28 days
Secondary outcomes (4)
Rate of minimal residual disease (MRD) negativity through bone marrow testing and imaging
MRD will be determined by highly sensitive, eight color flow on bone marrow sample. Functional imaging, such as PET scan and MRI will also be performed to assess the disease status.
Measured: Through 28 days after the end of treatment
Overall response rate based on International Myeloma Working Group (IMWG) criteria
Response to treatment will be assessed by IMWG criteria.
Measured: Through 24 months after the end of treatment
Categorize and quantify adverse events compared to historical control
The number and severity of all adverse events will be summarized by simple descriptive statistics and compared to a historical control.
Measured: Up to 24 months following the end of treatment for the last patient
Oxidative stress parameters in plasma through blood testing
Blood will be drawn and serum iron, TIBC, serum ferritin and transferrin saturation levels tested.
Measured: Through 24 months after the end of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2018
- Study start5 Mar 2019
- Primary completion1 Jul 2024
- Study completion3 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple MyelomaStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Christopher Strouse
- Sponsor type
- University, hospital or other
- Collaborators
- University of Iowa
- Responsible party
- Sponsor-investigator, Christopher Strouse, University of Iowa
- Investigators
- Christopher Strouse, MD, Principal investigator, University of Iowa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03602235
- Sponsor's protocol ID
- 201804754
- Status last verified
- Oct 2025
- First submitted
- 17 Jul 2018
- Last updated
- 21 Oct 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2025. 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
- NCT03602235
- Acronym / sponsor ID
- 201804754
- Conditions
- Multiple Myeloma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Christopher StrouseUniversity, hospital or other
- Collaborators
- University of Iowa
- Study start
- 5 Mar 2019 (actual)
- Primary completion
- 1 Jul 2024 (actual)
- Study completion
- 3 Sep 2025 (actual)
- First posted
- 26 Jul 2018 (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.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Low dose melphalan + high dose ascorbate acid (HDAA) | Experimental | Other: Ascorbate, Drug: MelphalanPatients will receive a test dose of 15g of HDAA prior to starting treatment dose. This will be mainly to rule out allergic reactions. HDAA + Melphalan: HDAA on day 1 and day 4 in combination with melphalan 12.5 mg/m2, followed by 2 additional doses of HDAA on day 2 and day 5. A 3 + 3 cohort method will be used for this study. After successfully completing the test dose, subjects will receive 50gms, 75gms and 100gms of ascorbate per infusion in 3 different cohorts. Dose modifications are not made for weight or body surface area. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (22 listed)
- 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.
- Adequate organ function:
Key exclusion criteria (9 listed)
- 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.
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 |
|---|---|---|
| AscorbateAlso: Ascorbate Acid; Ascorbic Acid for Injection, USPAscorbate is in the vitamin drug class | Other | Low dose melphalan + high dose ascorbate acid (HDAA) |
| MelphalanAlso: L-phenylamine mustard; L-PAM; L-SarcolysinMelphalan is an alkylating agent coupled to an amino acid | Drug | Low dose melphalan + high dose ascorbate acid (HDAA) |
Primary outcome
Number of treatment related adverse events as defined by National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 4.03
Time frame: First day of treatment through 28 days
Adverse events occuring within the DLT assessment window which do not resolve in less than 72 hours and are not clearly and incontrovertibly due to extraneous causes.
4 secondary outcomes
Rate of minimal residual disease (MRD) negativity through bone marrow testing and imaging
Time frame: Through 28 days after the end of treatment
Overall response rate based on International Myeloma Working Group (IMWG) criteria
Time frame: Through 24 months after the end of treatment
Categorize and quantify adverse events compared to historical control
Time frame: Up to 24 months following the end of treatment for the last patient
Oxidative stress parameters in plasma through blood testing
Time frame: Through 24 months after the end of treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2025.
- Individual participant dataSharing planned: No
Related trials for Multiple Myeloma
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 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
Screening for AL Amyloidosis in Smoldering Multiple Myeloma
Smoldering Multiple Myeloma
RecruitingPhase 1/2
Study of Carfilzomib, Lenalidomide, Dexamethasone and Belantamab Mafodotin in Multiple Myeloma
Multiple Myeloma
RecruitingObservational study
Biospecimen Procurement for Center for Immuno-Oncology Immunotherapy Protocols
Multiple Myeloma, Lymphoma, Non-Hodgkin
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. This study is not recruiting at the moment.
Christopher Strouse, MD principal investigator
University of Iowa
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 Ascorbate and Melphalan in people with Multiple Myeloma, run by Christopher Strouse 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 9 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: finished, as of the sponsor's last update on 21 Oct 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of treatment related adverse events as defined by National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 4.03 (time frame: First day of treatment through 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Oct 2025.