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.
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 Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
6
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States
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.
Time frame: First day of treatment through 28 days
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Through 24 months after the end of treatment
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