Clinical trial · Interventional
Arsenic Trioxide Plus Vitamin C in Treating Patients With Recurrent or Refractory Multiple Myeloma
Phase I/II Trial of Arsenic Trioxide (As2O3) With Ascorbic Acid in the Treatment of Relapsed/Refractory Multiple Myeloma
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Vitamin C may increase the effectiveness of arsenic trioxide by making cancer cells more sensitive to the drug. PURPOSE: Phase I/II trial to determine the effectiveness of arsenic trioxide plus vitamin C in treating patients who have recurrent or refractory multiple myeloma.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Multiple Myeloma and Plasma Cell Neoplasm | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| arsenic trioxide | Drug | Arsenic Trioxide | ALIAS |
| ascorbic acid | Dietary Supplement | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Disease response as measured by M protein quantitation and the percentage of plasma cell infiltration in bone marrow biopsies after every course
Secondary outcomes (1)
- measure
- Toxicity as measured by CTCAE criteria
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 120 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* Histologically confirmed multiple myeloma
* M-protein by serum protein electrophoresis or urine protein electrophoresis
* Quantitative determination of immunoglobulin
* Bone marrow biopsy and aspirate with a plasma cell count greater than 10%
* Refractory or chemoresistant disease defined as failure to respond (less than 50% reduction in M protein level) or progression within 2 months after receiving at least 2 chemotherapy regimens including:
* Alkylating based regimen (melphalan) in combination with steroids (prednisone) or other chemotherapy regimens (e.g., vincristine, bleomycin, melphalan, cyclophosphamide, and prednisone or vincristine, carmustine, doxorubicin, and prednisone)
* Vincristine, doxorubicin, and dexamethasone (VAD) regimen
* Pulse therapy with high dose steroids alone
* High dose alkylating agent and autologous stem cell transplantation
* Allogeneic bone marrow transplantation
* Plateau phase defined as M protein in the serum or urine for more than 6 weeks despite response to prior therapy
* Must have received at least 2 of the chemotherapy regimens listed above or equivalent regimens
* Recurrent disease defined as progression more than 2 months after initial therapy and failure to respond (less than 50% reduction or progression in M protein levels) to 1 chemotherapy regimen listed above or other salvage regimens (e.g., high-dose cyclophosphamide or topotecan)
* Must have received VAD or other equivalent chemotherapy regimen
* Should be considered for autologous or allogenic transplantation
* Prior local radiotherapy allowed
PATIENT CHARACTERISTICS:
Age:
* Over 18
Performance status:
* Karnofsky 60-100%
Life expectancy:
* Not specified
Hematopoietic:
* WBC at least 2,000/mm\^3\*
* Platelet count at least 50,000/mm\^3\* NOTE: \*Unless attributable to bone marrow infiltration by multiple myeloma
Hepatic:
* Bilirubin less than 3 mg/dL
* Transaminases less than 2.5 times upper limit of normal (ULN)
Renal:
* Creatinine less than 1.5 times ULN OR
* Creatinine clearance at least 60 mL/min
Cardiovascular:
* No cardiac arrhythmias including recurrent supraventricular arrhythmia, any type of sustained ventricular arrhythmia, or conduction block (atrioventricular block grade II or III, left bundle branch block)
* Ejection fraction at least 30%
* No uncontrolled ischemic heart disease
Other:
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective barrier contraception during and for 4 months after study
* HIV negative
* No grade 3 or higher neurological disorder, including seizure disorders
* No underlying medical condition that would preclude study
* No other active malignancy except adequately treated basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervix
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* See Disease Characteristics
Chemotherapy:
* See Disease Characteristics
* At least 2 weeks since prior chemotherapy
Endocrine therapy:
* See Disease Characteristics
* Concurrent steroid treatment allowed except for primary treatment of myeloma
Radiotherapy:
* See Disease Characteristics
* Concurrent local radiotherapy for pain or symptom control allowed provided the pain or symptom is not related to disease progression
Surgery:
* Not specified
Other:
* No other concurrent ascorbic acid supplements
* No other concurrent investigational drug or therapy
* Concurrent bisphosphonates allowedReferences
Publications (1)
- RESULTBahlis NJ, McCafferty-Grad J, Jordan-McMurry I, Neil J, Reis I, Kharfan-Dabaja M, Eckman J, Goodman M, Fernandez HF, Boise LH, Lee KP. Feasibility and correlates of arsenic trioxide combined with ascorbic acid-mediated depletion of intracellular glutathione for the treatment of relapsed/refractory multiple myeloma. Clin Cancer Res. 2002 Dec;8(12):3658-68. PMID 12473574