RATIONALE: Thalidomide may stop the growth of multiple myeloma by stopping blood flow to the tumor. It is not yet known whether combining thalidomide with prednisone and giving them after autologous stem cell transplantation may be effective in treating multiple myeloma.

PURPOSE: Randomized phase III trial to determine the effectiveness of combining thalidomide with prednisone in treating patients who have undergone stem cell transplantation for multiple myeloma.

Condition	Treatment or Intervention	Phase
stage I multiple myeloma stage II multiple myeloma stage III multiple myeloma	Drug: prednisone  Drug: thalidomide  Procedure: anti-cytokine therapy  Procedure: antiangiogenesis therapy  Procedure: biological response modifier therapy  Procedure: endocrine therapy  Procedure: growth factor antagonist therapy  Procedure: hormone therapy  Procedure: steroid therapy	Phase III

Further Study Details: 

OBJECTIVES:

• Compare overall survival of patients with multiple myeloma treated with thalidomide and prednisone as maintenance therapy vs observation alone after autologous stem cell transplantation.
• Compare progression-free survival of patients treated with these regimens.
• Compare quality of life of patients treated with these regimens.
• Compare toxic effects of these regimens in these patients.
• Compare the objective venous thromboembolism rate in symptomatic patients treated with these regimens.

OUTLINE: This is a randomized, non-blinded, multicenter study. Patients are stratified according to treatment center, age (under 60 vs 60 and over), and response to prior transplantation (complete vs incomplete). Patients are randomized to 1 of 2 treatment arms.

• Arm I: Patients receive oral thalidomide daily and oral prednisone every other day for 4 years in the absence of disease progression or unacceptable toxicity.
• Arm II: Patients undergo observation. Patients are assessed (including for quality of life) regularly throughout the treatment/observation period: at baseline, every 2 months for 6 months, every 3 months for 3.5 years, every 6 months for 1 year, and then annually thereafter.

After the treatment/observation period, patients are followed every 6 months for 1 year and then annually thereafter.

PROJECTED ACCRUAL: A total of 324 patients will be accrued for this study within 3.5 years.

Ages Eligible for Study:  16 Years and above,  Genders Eligible for Study:  Both

Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed multiple myeloma as evidenced by one of the following:
• Biopsy of an osteolytic lesion or soft tissue tumor composed of plasma cells
• Bone marrow aspirate and/or biopsy demonstrating at least 10% plasmacytosis
• Bone marrow less than 10% plasma cells with at least 1 bony lesion and meets the M-protein criteria as below
• Detectable serum M-component of IgG, IgA, IgD, or IgE at initial diagnosis OR
• Urinary excretion of light chain (Bence Jones) protein at least 1.0 gm/24 hrs if only light chain disease (urine M-protein) was present at initial diagnosis
• Previously treated with autologous stem cell transplantation after high-dose melphalan (200 mg/m
• ) within the past 60-100 days
• Received transplantation within 1 year of the beginning of initial chemotherapy for multiple myeloma
• No evidence of disease progression

PATIENT CHARACTERISTICS: Age

• 16 and over

Performance status

• ECOG 0-2

Life expectancy

• At least 6 months

Hematopoietic

• No prior hereditary hypercoaguable disorder
• Granulocyte count at least 1,000/mm^3
• Platelet count at least 75,000/mm^3

Hepatic

• Bilirubin no greater than 2 times upper limit of normal (ULN)
• AST and/or ALT no greater than 2 times ULN
• Alkaline phosphatase no greater than 2 times ULN

Renal

• Creatinine no greater than 3 times ULN

Cardiovascular

• No prior spontaneous above-knee deep vein thrombosis
• Catheter-associated thrombus allowed
• No uncontrolled hypertension

Pulmonary

• No prior pulmonary embolism

Other

• No other prior malignancy within the past 5 years except adequately treated squamous cell or basal cell skin cancer or carcinoma in situ of the cervix
• No prior gastric ulceration or bleeding within the past 5 years
• No prior documented lupus anti-coagulant or anti-phospholipid antibody
• Not pregnant or nursing
• Negative pregnancy test
• Fertile female patients must use 2 effective methods of contraception for 1 month prior, during, and 1 month after study participation
• Male patients must use effective barrier contraception during and for 1 month after study participation
• No avascular necrosis of the hips or shoulders
• No grade 2 or greater peripheral neuropathy causing symptomatic dysfunction (vincristine-induced sensory symptoms allowed)
• No diabetes with end-organ damage defined as:
• Documented diabetic neuropathy
• Retinal vascular proliferation requiring treatment
• Cardiovascular disease requiring active therapy
• Willing to complete quality of life questionnaires
• Employment does not prohibit the use of sedatives
• No other major medical illness or condition that would preclude study participation

PRIOR CONCURRENT THERAPY: Biologic therapy

• See Disease Characteristics
• No prior thalidomide

Chemotherapy

• See Disease Characteristics

Endocrine therapy

• Not specified

Radiotherapy

• Not specified

Surgery

• Not specified

Other

• No other concurrent anti-cancer therapy
• No other concurrent investigational therapy

Canada, Alberta
      Cross Cancer Institute, Edmonton,  Alberta,  T6G 1Z2,  Canada; Recruiting
      Tom Baker Cancer Centre - Calgary, Calgary,  Alberta,  T2N 4N2,  Canada; Recruiting
Canada, British Columbia
      British Columbia Cancer Agency, Vancouver,  British Columbia,  V5Z 4E6,  Canada; Recruiting
Canada, Manitoba
      CancerCare Manitoba, Winnipeg,  Manitoba,  R3E 0V9,  Canada; Recruiting
Canada, New Brunswick
      Moncton Hospital, Moncton,  New Brunswick,  E1C 4B7,  Canada; Recruiting
Canada, Newfoundland and Labrador
      Newfoundland Cancer Treatment and Research Foundation, St. Johns,  Newfoundland and Labrador,  A1B 3V6,  Canada; Recruiting
Canada, Nova Scotia
      Nova Scotia Cancer Centre at Queen Elizabeth II Health Sciences Centre, Halifax,  Nova Scotia,  B3H 1V7,  Canada; Recruiting
Canada, Ontario
      Cancer Care Ontario - Windsor Regional Cancer Centre, Windsor,  Ontario,  N8W 2X3,  Canada; Recruiting
      Cancer Care Ontario-London Regional Cancer Centre, London,  Ontario,  N6A 4L6,  Canada; Recruiting
      Margaret and Charles Juravinski Cancer Centre, Hamilton,  Ontario,  L8V 5C2,  Canada; Recruiting
      Princess Margaret Hospital, Toronto,  Ontario,  M5G 2C1,  Canada; Recruiting
      Toronto Sunnybrook Regional Cancer Centre, Toronto,  Ontario,  M4N 3M5,  Canada; Recruiting
Canada, Quebec
      CHUS-Hopital Fleurimont, Sherbrooke,  Quebec,  J1H 5N4,  Canada; Recruiting
      Hopital de L'Enfant Jesus, Quebec City,  Quebec,  G1J 1Z4,  Canada; Recruiting
      Hopital Du Sacre-Coeur de Montreal, Montreal,  Quebec,  H4J 1C5,  Canada; Recruiting
      Hopital du Saint-Sacrement, Quebec, Quebec City,  Quebec,  G1S 4L8,  Canada; Recruiting
      Maisonneuve-Rosemont Hospital, Montreal,  Quebec,  H1T 2M4,  Canada; Recruiting
      McGill Cancer Centre, Montreal,  Quebec,  H2W 1S6,  Canada; Recruiting
Canada, Saskatchewan
      Saskatoon Cancer Centre, Saskatoon,  Saskatchewan,  S7N 4H4,  Canada; Recruiting

Study chairs or principal investigators

Keith Stewart, MD,  Study Chair,  Princess Margaret Hospital   

Study ID Numbers:  CDR0000258158; CAN-NCIC-MY10; NCT00049673
Record last reviewed:  September 2004
Last Updated:  April 4, 2005
Record first received:  November 12, 2002
ClinicalTrials.gov Identifier:  NCT00049673
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08