NCT00112879WithdrawnPhase 2
Phase II Study of Arsenic Trioxide, Ascorbic Acid, Dexamethasone, and Thalidomide in Patients With Previously Untreated High-Risk or Relapsed or Refractory Multiple Myeloma
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Withdrawn
- Sponsor
- The Cleveland Clinic
- Locations
- 2
Study Overview
Brief Summary
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. Thalidomide may stop the growth of multiple myeloma by blocking blood flow to the cancer. Giving arsenic trioxide together with ascorbic acid, dexamethasone, and thalidomide may kill more cancer cells.
PURPOSE: This phase II trial is studying how well giving arsenic trioxide together with ascorbic acid, dexamethasone, and thalidomide work in treating patients with multiple myeloma.
Detailed Description
OBJECTIVES:
Primary
- Determine the response rate in patients with previously untreated high-risk or relapsed or refractory multiple myeloma (MM) treated with arsenic trioxide, ascorbic acid, dexamethasone, and thalidomide.
- Determine the safety of this regimen in these patients.
Secondary
- Determine the duration of response, progression-free survival, and overall survival of patients with previously untreated high-risk MM treated with this regimen.
Study Design
- Study Type
- Interventional
- Primary Purpose
- Treatment
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •DISEASE CHARACTERISTICS:
- •Diagnosis of multiple myeloma (MM), meeting 1 of the following criteria:
- •Previously untreated disease with poor prognosis, meeting 1 of the following criteria:
- •Active disease with β2 microglobulin ≥ 5.5 mg/dL
- •Inactive disease with peripheral plasma cells OR chromosome 13 or 14 abnormalities by fluorescent in situ hybridization
- •Relapsed or refractory disease
- •Measurable disease by serum and urine M-protein and/or measurable plasmacytoma
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status
- •ECOG 0-2* NOTE: *ECOG 3 allowed for patients with bone pain due to MM
- •Life expectancy
- •At least 3 months
- •Hematopoietic
- •Platelet count ≥ 75,000/mm^3 unless plasma cells > 50% in bone marrow
- •Any WBC allowed provided plasma cells > 50% in bone marrow
- •SGOT and SGPT ≤ 2.5 times upper limit of normal (ULN)
- •Bilirubin ≤ 2.5 times ULN
- •Creatinine ≤ 6.0 mg/dL
- •Cardiovascular
- •Absolute QT interval ≤ 460 msec with potassium ≥ 4.0 mEq/L AND magnesium ≥ 1.8 mg/dL
- •No conduction defects
- •No unstable angina
- •No myocardial infarction within the past 6 months
- •No congestive heart failure
- •No New York Heart Association class II-IV heart disease
- •No other significant underlying cardiac dysfunction
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective double-method contraception for ≥ 4 weeks before, during, and for ≥ 4 weeks after completion of study therapy
- •No blood, ova, or sperm donation during study participation
- •No history of grand mal seizures except infantile febrile seizures
- •No pre-existing neurotoxicity or neuropathy ≥ grade 2
- •No uncontrolled diabetes mellitus
- •No active serious infection that cannot be controlled with antibiotics
- •No other malignancy within the past 5 years except curatively treated carcinoma in situ of the cervix or nonmelanoma skin cancer
- •No other condition that would preclude study compliance or follow up
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- •Prior thalidomide allowed (in patients with relapsed or refractory MM)
- •No prior thalidomide in combination with arsenic trioxide
- •Prior epoetin alfa allowed
- •Chemotherapy
- •See Biologic therapy
- •Prior arsenic trioxide allowed (for patients with relapsed or refractory MM)
- •No concurrent cytotoxic chemotherapy
- •No chemotherapy within 2 weeks after completion of study treatment
- •Endocrine therapy
- •Prior steroid therapy allowed (for patients with relapsed or refractory MM)
- •Radiotherapy
- +4 more not shown
Exclusion Criteria
- Not provided
Investigators
Study Sites (2)
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