Ignite Creation Date:
2025-12-25 @ 3:45 AM
Ignite Modification Date:
2025-12-26 @ 2:32 AM
Study NCT ID:
NCT06313502
Status:
RECRUITING
Last Update Posted:
2025-06-15
First Post:
2024-03-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
High Dose Ascorbic Acid (HDAA) in Patients With Plasma Cell Disorders
Sponsor:
University of Arkansas
Organization:
Study Overview
Official Title:
High Dose Ascorbic Acid (HDAA) in Patients With Plasma Cell Disorders
Status:
RECRUITING
Status Verified Date:
2025-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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.
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: