High Dose Ascorbic Acid (HDAA) in Patients With Plasma Cell Disorders
ConditionPlasma Cell Disorder
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-100
SponsorUniversity of Arkansas
About this trial
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:
1. 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. 2. 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. 3. Categorize and quantify adverse events compared to historical control. 4. Determine quality of life parameters using standardized health-related quality of life measures 5. Determine oxidative stress parameters in plasma during treatment.
Eligibility criteria
Qualifiers
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
Disqualifiers
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.
Trial design
Treatments tested in this trial
- 75gm HDAA
- 100gm HDAA
- 125gm HDAA
Treatment groups
18 Participants
are divided into 3 treatment groupsSponsors and collaborators
University of Arkansas
Lead sponsor
University of Iowa
Collaborator
Source ClinicalTrials.gov