Combination Chemotherapy in Treating Patients With Stage II or Stage III Multiple Myeloma

OBJECTIVES:

• Compare the partial and complete response rates in patients with multiple myeloma treated with induction therapy comprising idarubicin and dexamethasone vs vincristine, doxorubicin, and dexamethasone.
• Compare the disease progression, time to achieve maximal response, and duration of response in patients treated with these 2 regimens.
• Compare the quality of life of patients treated with these 2 regimens.

OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 2 treatment arms.

• Arm I: Patients receive oral idarubicin and oral dexamethasone daily on days 1-4. Treatment continues every 3 weeks for 4 courses in the absence of disease progression or unacceptable toxicity. Patients also receive oral dexamethasone daily on days 8-11 during course 1 only.
• Arm II: Patients receive oral dexamethasone daily, doxorubicin IV continuously, and vincristine IV continuously on days 1-4. Courses repeat as in arm I. Patients receive additional dexamethasone as in arm I.

Patients without a maximal response after completion of course 4 may receive up to 2 additional courses.

Quality of life is assessed at baseline and then prior to each study course.

Patients are followed for survival.

PROJECTED ACCRUAL: A total of 200 patients (100 per arm) will be accrued for this study within 2 years.

DISEASE CHARACTERISTICS:

• Diagnosis of stage II or III multiple myeloma

• No prior therapy except local radiotherapy to bone lesions
• No indolent multiple myeloma
• No monoclonal gammopathy of unknown significance

PATIENT CHARACTERISTICS:

Age:

• 75 and under

Performance status:

• Not specified

Life expectancy:

• Not specified

Hematopoietic:

• Not specified

Hepatic:

• Bilirubin no greater than 2.34 mg/dL

Renal:

• No end stage renal failure (creatinine greater than 5.65 mg/dL after rehydration)
• No requirement for dialysis

Other:

• No other medical condition that would preclude intensive treatment
• Not pregnant or nursing
• Fertile patients must use effective contraception
• No other prior malignancy

PRIOR CONCURRENT THERAPY:

Biologic therapy

• See Disease Characteristics

Chemotherapy

• See Disease Characteristics

Endocrine therapy

• See Disease Characteristics

Radiotherapy

• Concurrent local radiotherapy allowed for painful lesions or lesions that appear likely to lead to an imminent fracture

Surgery

• See Disease Characteristics