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: Randomized phase III trial to compare the effectiveness of two combination chemotherapy regimens in treating patients who have stage II or stage III multiple myeloma.

Condition	Treatment or Intervention	Phase
stage II multiple myeloma stage III multiple myeloma	Drug: dexamethasone  Drug: doxorubicin  Drug: idarubicin  Drug: vincristine  Procedure: biological response modifier therapy  Procedure: chemotherapy  Procedure: non-specific immune-modulator therapy	Phase III

Further Study Details: 

OBJECTIVES:

• Compare the partial and complete response rates in patients with multiple myeloma treated with induction therapy comprised of 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.

Ages Eligible for Study:  up to  75 Years,  Genders Eligible for Study:  Both

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

United Kingdom, England
      Addenbrooke's Hospital at Cambridge University Hospitals NHS Foundation Trust, Cambridge,  England,  CB2 2QQ,  United Kingdom; Recruiting
      Birmingham Heartlands and Solihull NHS Trust -Teaching, Birmingham,  England,  B9 5SS,  United Kingdom; Recruiting
      New Cross Hospital, Wolverhampton,  England,  WV10 0QP,  United Kingdom; Recruiting
      Royal Liverpool and Broadgreen Hospitals, Liverpool,  England,  L7 8XP,  United Kingdom; Recruiting
United Kingdom, Northern Ireland
      Belfast City Hospital Trust, Belfast,  Northern Ireland,  BT9 7AB,  United Kingdom; Recruiting
United Kingdom, Scotland
      Aberdeen Royal Infirmary, Aberdeen,  Scotland,  AB25 2ZN,  United Kingdom; Recruiting
      Beatson Oncology Centre, Glasgow,  Scotland,  G11 6NT,  United Kingdom; Recruiting
      Dumfries Royal Infirmary, Dumfries,  Scotland,  DG1 4AP,  United Kingdom; Recruiting
      Monklands General Hospital, Airdrie,  Scotland,  ML6 0JF,  United Kingdom; Recruiting
      Ninewells Hospital and Medical School, Dundee,  Scotland,  DD1 9SY,  United Kingdom; Recruiting
      Royal Alexandra Hospital, Paisley,  Scotland,  United Kingdom; Recruiting
      Royal Infirmary - Castle, Glasgow,  Scotland,  G4 0SF,  United Kingdom; Recruiting
      Vale Of Leven D G Hospital, Alexandria,  Scotland,  G83 0UA,  United Kingdom; Recruiting

Study chairs or principal investigators

Gordon G. Cook, MD, PhD,  Study Chair,  Monklands General Hospital   

Study ID Numbers:  CDR0000068156; WSLG-H31; EU-20032; NCT00006232
Record last reviewed:  September 2000
Last Updated:  April 4, 2005
Record first received:  September 11, 2000
ClinicalTrials.gov Identifier:  NCT00006232
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08