High Dose Ascorbic Acid for Plasma Cell Disorders
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03602235|
Recruitment Status : Recruiting
First Posted : July 26, 2018
Last Update Posted : April 8, 2019
|Condition or disease||Intervention/treatment||Phase|
|Multiple Myeloma||Other: Ascorbate Drug: Melphalan||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||9 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||High Dose Ascorbic Acid (HDAA) in Patients With Plasma Cell Disorders|
|Actual Study Start Date :||March 5, 2019|
|Estimated Primary Completion Date :||May 11, 2020|
|Estimated Study Completion Date :||May 11, 2021|
Experimental: Low dose melphalan + high dose ascorbate acid (HDAA)
Patients will receive a test dose of 15g of HDAA prior to starting treatment dose. This will be mainly to rule out allergic reactions.
HDAA + Melphalan:
HDAA on day 1 and day 4 in combination with melphalan 12.5 mg/m2, followed by 2 additional doses of HDAA on day 2 and day 5.
A 3 + 3 cohort method will be used for this study. After successfully completing the test dose, subjects will receive 50gms, 75gms and 100gms of ascorbate per infusion in 3 different cohorts. Dose modifications are not made for weight or body surface area.
Ascorbate is in the vitamin drug class
Other Name: Ascorbate Acid; Ascorbic Acid for Injection, USP
Melphalan is an alkylating agent coupled to an amino acid
Other Name: L-phenylamine mustard; L-PAM; L-Sarcolysin
- Number of treatment related adverse events as defined by National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 4.03 [ Time Frame: First day of treatment through 28 days ]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.
- Rate of minimal residual disease (MRD) negativity through bone marrow testing and imaging [ Time Frame: Through 28 days after the end of treatment ]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.
- Overall response rate based on International Myeloma Working Group (IMWG) criteria [ Time Frame: Through 24 months after the end of treatment ]Response to treatment will be assessed by IMWG criteria.
- Categorize and quantify adverse events compared to historical control [ Time Frame: Up to 24 months following the end of treatment for the last patient ]The number and severity of all adverse events will be summarized by simple descriptive statistics and compared to a historical control.
- Oxidative stress parameters in plasma through blood testing [ Time Frame: Through 24 months after the end of treatment ]Blood will be drawn and serum iron, TIBC, serum ferritin and transferrin saturation levels tested.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03602235
|Contact: Yogesh Jethava, MDfirstname.lastname@example.org|
|United States, Iowa|
|University of Iowa Hospitals and Clinics||Recruiting|
|Iowa City, Iowa, United States, 52242|
|Contact: Yogesh Jethava, MD 319-384-9067 email@example.com|
|Principal Investigator:||Yogesh Jethava, MD||University of Iowa|