Chemotherapy Plus Steroid Therapy in Treating Patients With Multiple Myeloma

• Status: Unknown status
• Trial end date: 1969-12-31
• 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. Combining more than one drug may kill more cancer cells. Steroids, such as dexamethasone or prednisolone, may help relieve some of the side effects of chemotherapy. It is not yet known which regimen of chemotherapy plus steroid therapy is more effective in treating patients with multiple myeloma.

PURPOSE: Randomized phase III trial to compare the effectiveness of two different regimens of chemotherapy plus steroid therapy in treating patients with multiple myeloma that has recurred for the first time.

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

Details

• Lead Sponsor: Riverside Haematology Group
• Treatments: BB 1101; Cyclophosphamide; Dexamethasone; Dexamethasone 21-phosphate; Dexamethasone acetate; Idarubicin; Lomustine; Melphalan; Methylprednisolone; Methylprednisolone acetate; Methylprednisolone Hemisuccinate; Prednisolone; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate

Criteria

DISEASE CHARACTERISTICS:

• Diagnosis of multiple myeloma based on at least two of the following:

• Paraprotein in serum and/or urine

• Greater than 10% plasma cells in bone marrow

• Lytic bone lesions

• Measurable serum and/or urine paraprotein

• Progression from first or second stable plateau phase

• No non-secretory myeloma or plasma cell leukemia (greater than 2,000/mm^3 circulating plasma cells)

• No primary refractory disease or second or later relapse

PATIENT CHARACTERISTICS:

Age:

• 18 and over

Performance status:

• 0-3

Life expectancy:

• Not specified

Hematopoietic:

• Neutrophil count at least 1,000/mm^3

• Platelet count at least 75,000/mm^3

Hepatic:

• Bilirubin no greater than 1.5 times upper limit of normal (ULN)

• ALT/AST no greater than 2.5 times ULN

Renal:

• Creatinine less than 3.4 mg/dL

Cardiovascular:

• No clinically significant cardiac insufficiency

• No uncontrolled hypertension

Other:

• No uncontrolled diabetes mellitus

• No recent history of peptic ulceration

• HIV-1 and HIV-2 negative

• Fertile patients must use effective contraception during and for 6 months after study participation

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• No prior allogeneic peripheral blood stem cell or bone marrow transplantation

• No planned future autologous transplantation unless sufficient stored stem cells available

• Prior interferon allowed if administered as maintenance of stable plateau phase

• No concurrent epoetin alfa

Chemotherapy:

• At least 3 months since prior chemotherapy

Endocrine therapy:

• Not specified

Radiotherapy:

• Concurrent radiotherapy for pain or to treat localized tumors allowed

Surgery:

• Not specified

Other:

• No prior participation in any clinical trial with an unlicensed product