Ignite Creation Date:
2025-12-24 @ 10:13 PM
Ignite Modification Date:
2025-12-25 @ 7:48 PM
Study NCT ID:
NCT03602235
Status:
COMPLETED
Last Update Posted:
2025-10-21
First Post:
2018-07-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
High Dose Ascorbic Acid for Plasma Cell Disorders
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009101', 'term': 'Multiple Myeloma'}], 'ancestors': [{'id': 'D054219', 'term': 'Neoplasms, Plasma Cell'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D020141', 'term': 'Hemostatic Disorders'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D010265', 'term': 'Paraproteinemias'}, {'id': 'D001796', 'term': 'Blood Protein Disorders'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D006474', 'term': 'Hemorrhagic Disorders'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001205', 'term': 'Ascorbic Acid'}, {'id': 'D007267', 'term': 'Injections'}, {'id': 'D008558', 'term': 'Melphalan'}], 'ancestors': [{'id': 'D013400', 'term': 'Sugar Acids'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D006880', 'term': 'Hydroxy Acids'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D004333', 'term': 'Drug Administration Routes'}, {'id': 'D004358', 'term': 'Drug Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D009588', 'term': 'Nitrogen Mustard Compounds'}, {'id': 'D009150', 'term': 'Mustard Compounds'}, {'id': 'D006846', 'term': 'Hydrocarbons, Halogenated'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D010649', 'term': 'Phenylalanine'}, {'id': 'D024322', 'term': 'Amino Acids, Aromatic'}, {'id': 'D000598', 'term': 'Amino Acids, Cyclic'}, {'id': 'D000596', 'term': 'Amino Acids'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 6}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-03-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2025-09-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-10-17', 'studyFirstSubmitDate': '2018-07-17', 'studyFirstSubmitQcDate': '2018-07-17', 'lastUpdatePostDateStruct': {'date': '2025-10-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2018-07-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-07-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of treatment related adverse events as defined by National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 4.03', 'timeFrame': 'First day of treatment through 28 days', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Rate of minimal residual disease (MRD) negativity through bone marrow testing and imaging', 'timeFrame': 'Through 28 days after the end of treatment', 'description': '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.'}, {'measure': 'Overall response rate based on International Myeloma Working Group (IMWG) criteria', 'timeFrame': 'Through 24 months after the end of treatment', 'description': 'Response to treatment will be assessed by IMWG criteria.'}, {'measure': 'Categorize and quantify adverse events compared to historical control', 'timeFrame': 'Up to 24 months following the end of treatment for the last patient', 'description': 'The number and severity of all adverse events will be summarized by simple descriptive statistics and compared to a historical control.'}, {'measure': 'Oxidative stress parameters in plasma through blood testing', 'timeFrame': 'Through 24 months after the end of treatment', 'description': 'Blood will be drawn and serum iron, TIBC, serum ferritin and transferrin saturation levels tested.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Multiple Myeloma']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Subject has provided informed consent.\n* Diagnosis of multiple myeloma per IMWG criteria(26)\n* Patients must have progressive disease following 3 or more prior lines of therapy.\n\n * Prior treatment must include a proteasome inhibitor, an immunomodulatory agent (IMiD), and an anti-CD38 monoclonal antibody.\n * Patients must not be candidates for regimens known to provide clinical benefit in relapsed or refractory multiple myeloma based on the investigator's judgement.\n * If a patient declines such therapy, this must be recorded in the study files. 4. Subjects must have measurable disease, including at least one of the criteria below:\n * SPEP demonstrating M-protein quantities ≥ 0.5 g/dl\n * UPEP demonstrating monoclonal protein ≥ 200 mg/24hr\n * Involved serum free light chain levels \\> 100 mg/L and an abnormal kappa/lambda (κ/λ)ratio\n * For patients with immunoglobulin class A (IgA) myeloma whose disease can only be reliably measured by quantitative immunoglobulin measurement, a serum IgA level ≥ 500 mg/dl will qualify as measurable disease\n * Non-secretory participants are eligible provided the participant has \\> 20% bone marrow plasmacytosis\n* Adequate organ function:\n\n * Absolute neutrophil count (ANC) ≥ 1.0 x 10\\^9/L without growth factor support for 7 days\n * Platelets (plt) ≥ 50 x 10\\^9/L without transfusion for 7 days.\n * Hemoglobin ≥ 8.0 g/dl, transfusion support permitted\n * Aspartate aminotransferase (AST/SGOT) and alanine aminotransferase (ALT/SGPT) ≤ 3.0x upper limit of normal (ULN)\n * Serum bilirubin ≤ 1.5 x ULN\n * Estimated serum creatinine clearance of ≥ 45 mL/min using the Cockcroft-Gault equation or directly calculated from the 24-hour urine collection method.\n * International normalized ratio (INR) \\< 1.5 x ULN and partial thromboplastin time (PTT) \\< 1.5 x ULN\n * Left Ventricular Ejection Fraction by ECHO or MUGA of ≥ 40%.\n * Participants must have a performance status of 0-2 based on ECOG criteria.\n * For people of child bearing potential negative serum or urine pregnancy test (sensitivity of at least 25 mIU/mL) at screening\n\nExclusion Criteria\n\n* Known hypersensitivity or allergy to ascorbic acid or melphalan\n* Participants must not have a concurrent malignancy unless it can be adequately treated by non- chemotherapeutic intervention. Participants may have a history of prior malignancy, provided they have not had any chemotherapy within 365 days of study entry AND their life expectancy exceeds 5 years with respect to the concurrent malignancy at the time of study entry.\n* Participants must not have life-threatening comorbidities.\n* Known human immunodeficiency virus(HIV) disease (requires negative test for clinically suspected HIV infection).\n* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, recent (within 6 months) myocardial infarction, uncontrolled or symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, uncontrolled hypertension on appropriate therapy or psychiatric illness/social situations that would limit compliance with study requirements.\n* Concurrent use of Coumadin (warfarin)\n* Patients with G6PD deficiency\n* Patients with a history of oxalate renal stones or a known history of multiple renal stones\n* Diabetic patients who rely on a glucometer to dose insulin as ascorbate can interfere with glucometer readings"}, 'identificationModule': {'nctId': 'NCT03602235', 'briefTitle': 'High Dose Ascorbic Acid for Plasma Cell Disorders', 'organization': {'class': 'OTHER', 'fullName': 'University of Iowa'}, 'officialTitle': 'High Dose Ascorbic Acid (HDAA) in Patients With Plasma Cell Disorders', 'orgStudyIdInfo': {'id': '201804754'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Low dose melphalan + high dose ascorbate acid (HDAA)', 'description': 'Patients will receive a test dose of 15g of HDAA prior to starting treatment dose. This will be mainly to rule out allergic reactions.\n\nHDAA + Melphalan:\n\nHDAA 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.\n\nA 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.', 'interventionNames': ['Other: Ascorbate', 'Drug: Melphalan']}], 'interventions': [{'name': 'Ascorbate', 'type': 'OTHER', 'otherNames': ['Ascorbate Acid; Ascorbic Acid for Injection, USP'], 'description': 'Ascorbate is in the vitamin drug class', 'armGroupLabels': ['Low dose melphalan + high dose ascorbate acid (HDAA)']}, {'name': 'Melphalan', 'type': 'DRUG', 'otherNames': ['L-phenylamine mustard; L-PAM; L-Sarcolysin'], 'description': 'Melphalan is an alkylating agent coupled to an amino acid', 'armGroupLabels': ['Low dose melphalan + high dose ascorbate acid (HDAA)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '52242', 'city': 'Iowa City', 'state': 'Iowa', 'country': 'United States', 'facility': 'University of Iowa Hospitals and Clinics', 'geoPoint': {'lat': 41.66113, 'lon': -91.53017}}], 'overallOfficials': [{'name': 'Christopher Strouse, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Iowa'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Christopher Strouse', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Iowa', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Clinical Assistant Professor', 'investigatorFullName': 'Christopher Strouse', 'investigatorAffiliation': 'University of Iowa'}}}}