Arsenic Trioxide, Thalidomide, Dexamethasone, and Ascorbic Acid in Treating Patients With Relapsed or Refractory Multiple Myeloma

• Status: Terminated
• Trial end date: 2006-02-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: OHSU Knight Cancer Institute
• Collaborator: National Cancer Institute (NCI)
• Treatments: Arsenic Trioxide; Ascorbic Acid; BB 1101; Dexamethasone; Dexamethasone 21-phosphate; Dexamethasone acetate; Thalidomide

Criteria

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