Spots Global Cancer Trial Database for High Dose Ascorbic Acid for Plasma Cell Disorders
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Trial Identification
Brief Title: High Dose Ascorbic Acid for Plasma Cell Disorders
Official Title: High Dose Ascorbic Acid (HDAA) in Patients With Plasma Cell Disorders
Study ID: NCT03602235
Conditions
Study Description
Brief Summary: 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.
Detailed Description: 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.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
University of Iowa Hospitals and Clinics, Iowa City, Iowa, United States
Contact Details
Name: Christopher Strouse, MD
Affiliation: University of Iowa
Role: PRINCIPAL_INVESTIGATOR
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