Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Objectives

1. 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.
2. Compare the disease progression, time to achieve maximal response, and duration of response in patients treated with these 2 regimens.
3. Compare the quality of life of patients treated with these 2 regimens.

Entry 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

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

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

Expected Enrollment

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

Outcomes

Comparison of response rates

Time to achieve a maximal response
Duration of response

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.

Trial Contact Information

Trial Lead Organizations

West of Scotland Lymphoma Group

Gordon Cook, MD, PhD, Protocol chair		Ph: 44-113-206-7940

Registry Information
Official Title		A Randomized Trial Comparing Z-Dex with VAD as Induction Therapy for Patients with Multiple Myeloma
Trial Start Date		1996-10-18
Registered in ClinicalTrials.gov		NCT00006232
Date Submitted to PDQ		2000-06-23
Information Last Verified		2007-03-27

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