Clinical trial · Interventional
Arsenic Trioxide, Thalidomide, Dexamethasone, and Ascorbic Acid in Treating Patients With Relapsed or Refractory Multiple Myeloma
A Phase II Study of Arsenic Trioxide in Combination With Thalidomide, Dexamethasone, and Ascorbic Acid
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Terminated early due to funding suspension by grant sponsor.
Summary
Brief summary (as posted)
RATIONALE: Drugs used in chemotherapy, such as arsenic trioxide, dexamethasone, and ascorbic acid, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more cancer cells. Sometimes when chemotherapy is given, it does not stop the growth of cancer cells. The cancer is said to be resistant to chemotherapy. Giving arsenic trioxide together with chemotherapy may reduce drug resistance and allow the cancer cells to be killed. Thalidomide may stop the growth of multiple myeloma by blocking blood flow to the cancer. Giving arsenic trioxide together with thalidomide, dexamethasone, and ascorbic acid may kill more cancer cells. PURPOSE: This phase II trial is studying how well giving arsenic trioxide together with thalidomide, dexamethasone, and ascorbic acid works in treating patients with relapsed 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 (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| arsenic trioxide | Drug | Arsenic Trioxide | ALIAS |
| ascorbic acid | Dietary Supplement | — | UNRESOLVED |
| dexamethasone | Drug | Dexamethasone | ALIAS |
| thalidomide | Drug | Thalidomide | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Arsenic Trioxide
- description
- Arsenic Trioxide in Combination With Thalidomide, Dexamethasone, and Ascorbic Acid
- interventionNames
- Dietary Supplement: ascorbic acid
- Drug: arsenic trioxide
- Drug: dexamethasone
- Drug: thalidomide
Primary outcomes (1)
- measure
- Response rate (complete response, partial response, and minimal response) as measured by bone marrow aspirate, biopsy, cytogenetic analysis, serum, urine, and immunofixation skeletal survey at 6 months and end of study treatment
Secondary outcomes (1)
- measure
- Safety and tolerability as measured by physical exams, blood tests, and adverse events reports weekly
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Diagnosis of multiple myeloma (MM) * Relapsed or refractory disease * Monoclonal immunoglobulin spike by serum electrophoresis of ≥ 1 gm/dL AND/OR urine monoclonal immunoglobulin spike of ≥ 200 mg/24 hours * Has received ≥ 2 prior treatment regimens for MM * None of the following are allowed: * Non-secretory MM * Plasma cell leukemia * Polyneuropathy, organomegaly, endocrinopathy, monoclonal gammopathy, and skin changes (POEMS) syndrome PATIENT CHARACTERISTICS: Age * Over 18 Performance status * ECOG 0-2 Life expectancy * More than 3 months Hematopoietic * Platelet count ≥ 50,000/mm\^3 (30,000/mm\^3 if the bone marrow is extensively infiltrated) * Hemoglobin ≥ 8.0 g/dL * Absolute neutrophil count ≥ 1,000/mm\^3 Hepatic * AST and ALT \< 3.0 times upper limit of normal (ULN) * Bilirubin \< 2.0 times ULN Renal * Not specified Cardiovascular * No cardiac disease, including any of the following conditions: * History of recurrent supraventricular arrhythmia * History of sustained ventricular tachycardia * History of second or third degree AV block * History of left bundle branch block * Cardiomyopathy with LVEF \< 40% * Uncontrolled ischemic heart disease * No myocardial infarction within the past 6 months * No prolonged QT interval \> 500 ms Other * Not pregnant or nursing * Negative pregnancy test * No HIV positivity * No neuropathy \> grade 3 * Potassium ≥ 4 mEq/L * Magnesium ≥ 1.8 mg/dL PRIOR CONCURRENT THERAPY: Biologic therapy * Not specified Chemotherapy * Not specified Endocrine therapy * Not specified Radiotherapy * Not specified Surgery * Not specified Other * More than 30 days since prior investigational drugs
References
Publications (0)
Data not yet available