Multiple Myeloma Clinical Trial

High Dose Ascorbic Acid for Plasma Cell Disorders

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.

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Full 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.

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Eligibility Criteria

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

Study is for people with:

Multiple Myeloma

Phase:

Phase 1

Estimated Enrollment:

9

Study ID:

NCT03602235

Recruitment Status:

Recruiting

Sponsor:

Christopher Strouse

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There is 1 Location for this study

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University of Iowa Hospitals and Clinics
Iowa City Iowa, 52242, United States More Info
Christopher Strouse, MD
Contact
319-356-0489
[email protected]

How clear is this clinincal trial information?

Study is for people with:

Multiple Myeloma

Phase:

Phase 1

Estimated Enrollment:

9

Study ID:

NCT03602235

Recruitment Status:

Recruiting

Sponsor:


Christopher Strouse

How clear is this clinincal trial information?

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