Ignite Creation Date:
2024-05-06 @ 8:15 PM
Last Modification Date:
2024-10-26 @ 3:23 PM
Study NCT ID:
NCT06313502
Status:
RECRUITING
Last Update Posted:
2024-05-08
First Post:
2024-03-08
Brief Title:
High Dose Ascorbic Acid HDAA in Patients With Plasma Cell Disorders
Sponsor:
University of Arkansas
Organization:
University of Arkansas
Study Overview
Official Title:
High Dose Ascorbic Acid HDAA in Patients With Plasma Cell Disorders
Status:
RECRUITING
Status Verified Date:
2024-07
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 mgm2 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 mgm2 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 mgm2 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 D2 D5 D8 and D11 followed by weekly doses of the corresponding dose of HDAA for four additional weeksLab tests vitals and scans will be performed to assess tolerability safety and efficacy at each scheduled infusion timepoint
Study Oversight
Has Oversight DMC:
None
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?:
None