Clinical trial · Interventional
Arsenic Trioxide and Ascorbic Acid Combined With Bortezomib, Thalidomide, and Dexamethasone in Treating Patients With Relapsed or Refractory Multiple Myeloma or Plasma Cell Leukemia
A Phase I Study of Arsenic Trioxide and Ascorbic Acid (ATO/AA) in Combination With Low Dose Velcade-Thalidomide-Dexamethasone (VTD) in Relapsed/Refractory Multiple Myeloma (MM)
- 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, such as arsenic trioxide and dexamethasone, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Ascorbic acid may help arsenic trioxide work better by making cancer cells more sensitive to the drug. Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Thalidomide may stop the growth of cancer cells by stopping blood flow to the cancer. Giving arsenic trioxide and ascorbic acid together with bortezomib, thalidomide, and dexamethasone may stop the growth of and kill more cancer cells. PURPOSE: This phase I trial is studying the side effects and best dose of arsenic trioxide when given together with ascorbic acid, bortezomib, thalidomide, and dexamethasone in treating patients with relapsed or refractory multiple myeloma or plasma cell leukemia.
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 (6)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| arsenic trioxide | Drug | Arsenic Trioxide | ALIAS |
| ascorbic acid | Dietary Supplement | — | UNRESOLVED |
| Aspirin | Drug | Aspirin | ALIAS |
| bortezomib | Drug | Bortezomib | ALIAS |
| dexamethasone | Drug | Dexamethasone | ALIAS |
| thalidomide | Drug | Thalidomide | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Bortezomib, AT, Thalidomide, Dexamethasone, Vit C, ASA
- description
- Bortezomib (Velcade)- 0.7→1.0 mg/m2 IVP d 1, 4, 8, 11; Arsenic Trioxide \[AT\] (Trisenox)- 0.10→0.15→0.25 mg/kg/dose IVPB days 1, 4, 8, 11; Thalidomide (Thalomid)- 50 mg/day by mouth (PO); Dexamethasone (Decadron)- 40 mg/d IVPB or by mouth (PO) d 1, 4, 8, 11; Ascorbic Acid (Vit C)- 1000 mg IVPB p Arsenic Trioxide (ATO) days 1, 4, 8, 11; Aspirin (ASA)- 325 mg by mouth (PO) every day
- interventionNames
- Dietary Supplement: ascorbic acid
- Drug: arsenic trioxide
- Drug: bortezomib
- Drug: dexamethasone
- Drug: thalidomide
- Drug: Aspirin
Primary outcomes (1)
- measure
- To determine if arsenic trioxide and ascorbic acid at doses up to 0.25 mg/mg/dose can be given in combination with reduced-dose dexamethasone, bortezomib and thalidomide without dose limiting toxicity, especially sensory neuropathies.
- timeFrame
- Days 1, 4, 8 & 11 of each 21 day cycle
Secondary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed multiple myeloma (MM) or plasma cell leukemia meeting 1 of the following criteria: * Relapsed or refractory disease after treatment with prior effective therapy * Exhibited \< a partial response to the last therapy * Measurable disease, defined by 1 of the following: * Serum M protein ≥ 1.0 g/dL * Urine M-protein ≥ 500 mg/24 hours * Plasmacytoma with bidimensional measurements on CT scan or MRI (each axis ≥ 1 cm) * Previously treated with ≥ 1 induction chemotherapy regimen for MM * No known CNS involvement by multiple myeloma PATIENT CHARACTERISTICS: Age * 18 and over Performance status * Zubrod or SWOG 0-2 OR * Karnofsky 60-100% Life expectancy * More than 12 weeks Hematopoietic * WBC ≥ 1,500/mm\^3 * Absolute neutrophil count ≥ 1,000/mm\^3 * Platelet count ≥ 80,000/mm\^3 * Hemoglobin ≥ 8.5 g/dL * No history of heparin-induced thrombocytopenia * Low blood counts allowed if marrow is heavily infiltrated by multiple myeloma Hepatic * Bilirubin ≤ 1.5 times upper limit normal (ULN) * AST and ALT ≤ 2.5 times ULN Renal * Creatinine ≤ 2.5 mg/dL Cardiovascular * QTc \< 480 msec on EKG in the presence of serum potassium ≥ 4.0 mEq/dL and serum magnesium ≥ 1.8 mg/dL * LVEF ≥ 55% by ECHO or MUGA * No prior deep vein thrombosis, unless on concurrent anticoagulation * No symptomatic congestive heart failure * No unstable angina pectoris * No history of ventricular arrhythmia Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception during and for 6 months after completion of study treatment * No history of allergic reactions or severe adverse reactions attributed to compounds of similar chemical or biological composition to study drugs * No other malignancy in the past 2 years except adequately treated nonmelanoma skin cancer or carcinoma in situ of the cervix * No peripheral neuropathy ≥ grade 2 * No ongoing or active infection requiring IV antibiotics * No psychiatric illness or social situation that would preclude study compliance * No other uncontrolled illness * Controlled HIV disease allowed as long as there are no associated comorbid complications * No active peptic ulcer disease * No other condition that would confer a high risk of bleeding complications PRIOR CONCURRENT THERAPY: Biologic therapy * More than 4 weeks since prior thalidomide or lenalidomide for MM * Prior autologous or allogeneic stem cell transplant for MM allowed * Concurrent hematopoietic growth factors (e.g., epoetin alfa, filgrastim \[G-CSF\]) for MM allowed Chemotherapy * See Disease Characteristics * More than 4 weeks since prior arsenic trioxide for MM Endocrine therapy * More than 4 weeks since prior corticosteroids for MM Radiotherapy * More than 4 weeks since prior therapeutic radiotherapy (e.g., to plasmacytomas) * Palliative radiotherapy for painful symptomatic lytic skeletal lesions allowed within the past 4 weeks Surgery * Not specified Other * More than 4 weeks since prior cytotoxic agents or other therapy (e.g., bortezomib) for MM * More than 30 days (or 5 half-lives) since prior investigational agents * Concurrent bisphosphonates for MM allowed * No other concurrent anticancer therapy * No other concurrent investigational agents
References
Publications (0)
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