Dexamethasone With or Without Thalidomide in Treating Patients With Newly Diagnosed Multiple Myeloma

• Status: Completed
• Trial end date: 2006-06-01
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Thalidomide may stop the growth of cancer by stopping blood flow to the tumor. Combining dexamethasone and thalidomide may kill more cancer cells. It is not yet known whether dexamethasone is more effective with or without thalidomide in treating multiple myeloma.

PURPOSE: Randomized phase III trial to determine the effectiveness of dexamethasone with or without thalidomide in treating patients who have multiple myeloma.

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

Details

• Lead Sponsor: National Cancer Institute (NCI)
• Treatments: BB 1101; Dexamethasone; Dexamethasone 21-phosphate; Dexamethasone acetate; Pamidronate; Thalidomide; Zoledronic Acid

Criteria

DISEASE CHARACTERISTICS:

• Newly diagnosed symptomatic multiple myeloma confirmed by the following:

• Bone marrow plasmacytosis with at least 10% plasma cells or sheets of plasma cells or biopsy-proven plasmacytosis

• Monoclonal protein (M protein) at least 1.0 g/dL on serum protein electrophoresis or at least 200 mg of monoclonal light chain on a 24-hour urine protein electrophoresis

• No smoldering myeloma or monoclonal gammopathy of undetermined significance

PATIENT CHARACTERISTICS:

Age:

• 18 and over

Performance status:

• ECOG 0-2

Life expectancy:

• Not specified

Hematopoietic:

• Absolute neutrophil count greater than 1,000/mm^3

• Platelet count greater than 50,000/mm^3

• Hemoglobin greater than 7 g/dL

Hepatic:

• Bilirubin no greater than 1.5 mg/dL

• ALT and AST no greater than 2.5 times upper limit of normal

Renal:

• Creatinine less than 3 mg/dL

Cardiovascular:

• No prior or concurrent deep venous thrombosis

Other:

• Prior malignancy allowed provided the following criteria are met:

• Received prior treatment with curative intent

• Free of disease for the time period appropriate for cure of the specific cancer

• No grade 2 or greater peripheral neuropathy due to other medical conditions

• No active infection

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use 1 highly effective method and 1 additional method of contraception for 1 month before, during, and for 4 weeks after study for women and effective barrier contraception for men during and for 4 weeks after study participation

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• No prior biologic therapy for multiple myeloma

• No other concurrent biologic therapy for multiple myeloma

Chemotherapy:

• No prior chemotherapy for multiple myeloma

• No other concurrent chemotherapy for multiple myeloma

Endocrine therapy:

• More than 6 months since prior systemic dexamethasone or glucocorticoids

• No concurrent corticosteroids

Radiotherapy:

• At least 4 weeks since prior palliative, localized radiotherapy

• Concurrent palliative, localized radiotherapy allowed at the physician's discretion

Surgery:

• Not specified

Other:

• No prior systemic therapy for multiple myeloma, except bisphosphonates

• No concurrent anticoagulant therapy for deep vein thrombosis

• No concurrent barbiturates or alcohol (thalidomide arm)