Dexamethasone and Chemotherapy With or Without Plasma Exchange in Patients With Newly Diagnosed Multiple Myeloma and Acute Kidney Failure

• Status: Completed
• Trial end date: 2008-12-01
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Dexamethasone is used to treat multiple myeloma. Drugs used in chemotherapy may stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Plasma exchange is a process in which certain cells are separated from the plasma in the blood by a machine and then only the cells are returned to the patient. Dexamethasone and plasma exchange may be an effective treatment for acute kidney failure caused by multiple myeloma. It is not yet known whether giving dexamethasone and chemotherapy together with plasma exchange is more effective than giving dexamethasone and chemotherapy alone in treating patients with multiple myeloma and acute kidney failure.

PURPOSE: This randomized phase III trial is studying dexamethasone, chemotherapy, and plasma exchange to see how well they work compared with dexamethasone and chemotherapy alone in treating patients with newly diagnosed multiple myeloma and acute kidney failure.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Glasgow
• Treatments: BB 1101; Dexamethasone; Dexamethasone 21-phosphate; Dexamethasone acetate

Criteria

DISEASE CHARACTERISTICS:

• Newly diagnosed multiple myeloma (MM), meeting ≥ 2 of the following criteria:

• Serum or urine* paraprotein

• Bone marrow showing > 10% plasma cells

• Lytic bone lesions NOTE: *The presence of typical myeloma kidney on renal biopsy is considered equivalent to the demonstration of urine paraprotein by electrophoresis

• Acute renal failure attributable to MM, meeting both of the following criteria:

• Creatinine > 5.65 mg/dL OR urine output < 400 mL/day OR requires dialysis

• Unresponsive to treatment with fluids and/or treatment of hypercalcemia with bisphosphonates

• No significant intrinsic renal disease unrelated to MM

PATIENT CHARACTERISTICS:

• Platelet count ≥ 50,000/mm³

• Bilirubin ≤ 1.5 times upper limit of normal (ULN)

• ALT and AST ≤ 2.5 times ULN

• No contraindications to study medication, including the following:

• Active or recent peptic ulcer

• Known significant cardiac insufficiency

• Allergy to study medications

• Not pregnant or nursing

• Fertile patients must use effective contraception

• No known HIV positivity

PRIOR CONCURRENT THERAPY:

• No prior chemotherapy for MM

• Prior steroid therapy of ≤ 3 days duration for MM allowed