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

West of Scotland Lymphoma Group

Status and phase: Completed; Phase 3

Conditions: Multiple Myeloma and Plasma Cell Neoplasm

Treatments: Drug: vincristine sulfate; Drug: idarubicin; Drug: doxorubicin hydrochloride; Drug: dexamethasone

Study type: Interventional

Funder types: Other

Identifiers

NCT00006232

WSLG-H31

CDR0000068156 (Registry Identifier)

ISRCTN65684689

EU-20032

Details and patient eligibility

About

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known which combination chemotherapy regimen is more effective for multiple myeloma.

PURPOSE: This randomized phase III trial is comparing two combination chemotherapy regimens to see how well they work in treating patients with stage II or stage III multiple myeloma.

Full description

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.

Enrollment: 200 estimated patients

Sex: All

Ages: Under 75 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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