Suspended

Phase II Study of Melphalan, Arsenic Trioxide, and Ascorbic Acid in Patients With Relapsed or Refractory Multiple Myeloma

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What is being tested

Data Collection

Who is being recruted

Blood Protein Disorders
+12

+ Cardiovascular Diseases
+ Hematologic Diseases
Over 18 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 2
Interventional
See protocol details

Summary

Principal SponsorOncotherapeutics
Last updated: January 14, 2026
Sourced from a government-validated database.Claim as a partner

OBJECTIVES: Primary * Determine the time to progression in patients with relapsed or refractory multiple myeloma (MM) treated with melphalan, arsenic trioxide, and ascorbic acid. * Determine the response rate (combined complete response, partial response, and minimal response) in patients treated with this regimen. * Determine the safety and tolerability of this regimen in these patients. Secondary * Determine the time to response and overall survival of patients treated with this regimen. * Determine the effects of this regimen on renal failure associated with MM in these patients. OUTLINE: This is an open-label, non-randomized, multicenter study. Patients receive oral melphalan once daily on days 1-4 of week 1 and arsenic trioxide (ATO) IV over 1-2 hours and ascorbic acid IV over 15 minutes on days 1-4 of week 1 and then twice weekly during weeks 2-5. Treatment repeats every 6 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients with disease progression any time after course 1 also receive oral prednisone once daily on days 1-4 and 22-25 of each course. Patients achieving a complete response after 6 courses of therapy undergo bone marrow biopsy and receive no further therapy. Patients achieving stable disease or a partial response after 6 courses of therapy continue to receive ATO and ascorbic acid once weekly. Patients are followed every 3 months. PROJECTED ACCRUAL: A total of 65 patients will be accrued for this study.

Official TitlePhase II Study of Melphalan, Arsenic Trioxide, and Ascorbic Acid in Patients With Relapsed or Refractory Multiple Myeloma 
NCT00085345
Principal SponsorOncotherapeutics
Last updated: January 14, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
Over 18 YearsRange of ages for which participants are eligible to join.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Blood Protein Disorders
Cardiovascular Diseases
Hematologic Diseases
Hemorrhagic Disorders
Immune System Diseases
Immunoproliferative Disorders
Lymphoproliferative Disorders
Multiple Myeloma
Neoplasms
Neoplasms by Histologic Type
Paraproteinemias
Plasmacytoma
Vascular Diseases
Hemostatic Disorders
Neoplasms, Plasma Cell
Criteria

DISEASE CHARACTERISTICS: * Diagnosis of multiple myeloma meeting at least 1 of the following criteria: * Relapsed disease after a response to standard first-line chemotherapy (e.g., vincristine, doxorubicin, and dexamethasone \[VAD\] OR melphalan and prednisone) or first-line high-dose chemotherapy * Refractory disease (failed to achieve at least stable disease) to most recent chemotherapy with or without systemic corticosteroids * Measurable disease, defined as a monoclonal immunoglobulin spike on serum electrophoresis of ≥ 1 g/dL AND/OR urine monoclonal immunoglobulin spike of ≥ 200 mg/24 hours * No non-secretory myeloma * No plasma cell leukemia PATIENT CHARACTERISTICS: Age * 18 and over Performance status * Karnofsky 60-100% Life expectancy * More than 3 months Hematopoietic * Platelet count ≥ 50,000/mm\^3 (30,000/mm\^3 if bone marrow is extensively infiltrated) * Hemoglobin ≥ 8.0 g/dL * Absolute neutrophil count ≥ 1,000/mm\^3 * Pancytopenia secondary to multiple myeloma or hypersplenism allowed Hepatic * AST and ALT ≤ 3 times upper limit of normal (ULN) * Bilirubin ≤ 2 times ULN (unless clearly related to disease) * No known active hepatitis B or C infection Renal * Calcium \< 14 mg/dL Cardiovascular * No evidence of acute ischemia or new conduction system abnormality by electrocardiogram * No myocardial infarction within the past 6 months * No New York Heart Association class III or IV heart failure * No poorly controlled hypertension * No prolonged corrected QT interval (\> 460 ms) with potassium \> 4 mmol/L and magnesium ≥ 1.8 mmol/L Other * No active infection * No POEMS syndrome (plasma cell dyscrasia with polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes) * No diabetes mellitus * No other serious medical or psychiatric illness that would preclude study participation * No known allergic reaction attributable to compounds of similar chemical or biological composition to study drugs * No history of grand mal seizures * HIV negative * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy * More than 4 weeks since prior immunotherapy or antibody therapy Chemotherapy * See Disease Characteristics * More than 3 weeks since prior chemotherapy (6 weeks for nitrosoureas) Endocrine therapy * See Disease Characteristics * No other concurrent corticosteroids Radiotherapy * More than 4 weeks since prior radiotherapy Surgery * More than 4 weeks since prior major surgery Other * No other concurrent investigational agents



Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has 18 locations
Suspended
Palo Verde Hematology OncologyGlendale, United StatesSee the location
Suspended
Comprehensive Blood and Cancer CenterBakersfield, United States
Suspended
Southbay Oncology / Hematology Medical GroupCampbell, United States
Suspended
Hematology-Oncology Medical Group of Fresno, IncorporatedFresno, United States

Suspended18 Study Centers
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