Clinical trial · Interventional
Arsenic Trioxide and Dexamethasone in Treating Patients With Recurrent or Refractory Stage II or Stage III Multiple Myeloma
CTI 1060: A Phase II Clinical Trial of Arsenic Trioxide and Dexamethasone as Therapy for Relapsed or Refractory Multiple Myeloma
NCT00017069CI-TRIAL-00047487terminatedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- 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. Combining more than one drug may kill more cancer cells. PURPOSE: Phase II trial to study the effectiveness of combining arsenic trioxide and dexamethasone in treating patients who have recurrent or refractory stage II or stage III 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 |
| dexamethasone | Drug | Dexamethasone | ALIAS |
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 120 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Diagnosis of stage II or III multiple myeloma * Refractory myeloma defined as progressive disease (more than 25% increase in M protein or in radiographic findings of nonsecretory myeloma) despite up to 3 courses of prior cytotoxic chemotherapy * No more than 3 prior cytotoxic regimens * No more than 1 prior high-dose cytotoxic regimen with stem cell transplantation * History of disease progression after prior steroid antimyeloma therapy * No smoldering myeloma * Measurable disease based on presence of serum and urine M protein and/or measurable plasmacytoma PATIENT CHARACTERISTICS: Age: * Over 18 Performance status: * Karnofsky 70-100% Life expectancy: * At least 3 months Hematopoietic: * Absolute granulocyte count greater than 1,200/mm\^3\* * Platelet count greater than 75,000/mm\^3\* * Hemoglobin greater than 10 g/dL\* NOTE: \*Unless due to multiple myeloma Hepatic: * Bilirubin no greater than 2 times upper limit of normal (ULN) * SGOT and SGPT no greater than 2 times ULN Renal: * Creatinine no greater than 1.5 times ULN Cardiovascular: * Absolute QT interval less than 460 msec in the presence of normal potassium and magnesium levels * No significant underlying cardiac dysfunction * No conduction defects * No unstable angina * No congestive heart failure * No New York Heart Association class II-IV cardiac disease * No myocardial infarction within the past 6 months Other: * No preexisting grade 2 or greater neurotoxicity/neuropathy * No other malignancy within the past 5 years except curatively treated carcinoma in situ of the cervix or nonmelanoma skin cancer * No uncontrolled diabetes mellitus * No active serious infection uncontrolled by antibiotics * No history of grand mal seizures (other than infantile febrile seizures) * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: * See Disease Characteristics * See Chemotherapy * At least 28 days since prior biologic therapy Chemotherapy: * See Disease Characteristics * At least 28 days since prior cytotoxic chemotherapy, including high-dose cytotoxic regimen with stem cell transplantation * No other concurrent cytotoxic chemotherapy Endocrine therapy: * See Disease Characteristics Radiotherapy: * At least 28 days since prior radiotherapy except for focal radiation for symptom control Surgery: * Not specified
References
Publications (0)
Data not yet available
No reference posted for this study.