RATIONALE: Thalidomide may stop the growth of multiple myeloma by stopping blood flow to the tumor. Prednisone may be effective in preventing relapse of multiple myeloma. PURPOSE: Randomized phase II trial to compare the effectiveness of two doses of thalidomide combined with prednisone following peripheral stem cell transplantation in treating patients who have multiple myeloma.

Condition	Treatment or Intervention	Phase
stage I multiple myeloma stage II multiple myeloma stage III multiple myeloma refractory plasma cell neoplasm	Drug: prednisone  Drug: thalidomide	Phase II

Further Study Details: 

OBJECTIVES: I. Determine which dose of thalidomide (200 mg vs 400 mg) combined with prednisone is the optimally tolerated dose when used as maintenance therapy following autologous stem cell transplantation in patients with multiple myeloma. II. Compare the response rate in patients treated with these regimens. III. Compare the progression-free and overall survival in patients treated with these regimens.

PROTOCOL OUTLINE: This is a randomized, open-label, multicenter study. Patients are stratified according to age (60 and over vs under 60). Within 60-100 days after autologous stem cell transplantation, patients are randomized to 1 of 2 treatment arms. Arm I: Patients receive lower dose oral thalidomide daily and oral prednisone every other day. Arm II: Patients receive higher dose thalidomide daily and oral prednisone every other day. Treatment continues for 2 years in the absence of disease progression or unacceptable toxicity. Patients are followed monthly for 6 months, every 3 months, and then at time of disease progression.

PROJECTED ACCRUAL: A total of 40-80 patients (20-40 per arm) will be accrued for this study within 17-21 months.

Ages Eligible for Study:  16 Years and above

Criteria

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

• Histologically proven multiple myeloma
• Initial diagnosis must have been confirmed by one of the following prior to initial treatment for multiple myeloma: 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 containing less than 10% plasma cells but with at least 1 bony lesion and the M-protein criteria outlined below
• Measurable serum M-component of IgG, IgA, IgD, or IgE at initial diagnosis OR If only light chain disease (urine M-protein only) present, then the urinary excretion of light chain (Bence Jones) protein must have been at least 1.0 g/24 hours at time of initial diagnosis
• Must have undergone autologous stem cell transplantation within 1 year of beginning initial chemotherapy for multiple myeloma; Must be randomized 60-100 days after autologous stem cell infusion
• No evidence of progressive disease

--Prior/Concurrent Therapy--

• Biologic: See Disease Characteristics; No prior thalidomide
• Chemotherapy: See Disease Characteristics
• Endocrine therapy: Not specified
• Radiotherapy: Not specified
• Surgery: Not specified
• Other: No other concurrent anticancer treatment; No other concurrent investigational therapy

--Patient Characteristics--

• Age: 16 and over
• Performance status: ECOG 0-2
• Life expectancy: At least 6 months
• Hematopoietic: See Disease Characteristics; Granulocyte count at least 1,000/mm3; Platelet count at least 100,000/mm3
• Hepatic: AST and/or ALT no greater than 1.5 times upper limit of normal (ULN); Alkaline phosphatase no greater than 1.5 times ULN
• Renal: Creatinine no greater than 3 times ULN
• Cardiovascular: No uncontrolled hypertension
• Other: Not pregnant or nursing; Negative pregnancy test; Fertile female patients must use 2 effective methods of contraception (1 barrier and 1 hormonal) during and for 1 month after study; Fertile male patients must use effective barrier contraception during and for 1 month after study; No other medical condition that would preclude long term use of prednisone or thalidomide; No other malignancy within the past 5 years except adequately treated squamous cell or basal cell skin cancer or carcinoma in situ of the cervix; No diabetes with end stage organ damage; No history of gastric ulceration or bleeding; No avascular necrosis of the hips; No peripheral neuropathy causing symptomatic dysfunction; Sensory symptoms induced by vincristine allowed; No demonstrated hypersensitivity to thalidomide or its components; No other major medical illness that would increase risk or preclude study; No employment that prohibits the use of sedatives (due to known effect of thalidomide)

Minnesota
      St. Mary's/Duluth Clinic Health System, Duluth,  Minnesota,  55805,  United States
Canada
      Lions Gate Hospital, North Vancouver,  V7L 2P9,  Canada
Canada, Alberta
      Lethbridge Cancer Clinic, Lethbridge,  Alberta,  T1J 1W5,  Canada
      Tom Baker Cancer Center - Calgary, Calgary,  Alberta,  T2N 4N2,  Canada
Canada, British Columbia
      British Columbia Cancer Agency, Vancouver,  British Columbia,  V5Z 4E6,  Canada
      British Columbia Cancer Agency - Fraser Valley Cancer Centre, Surrey,  British Columbia,  V3V 1Z2,  Canada
      Burnaby Hospital Regional Cancer Centre, Burnaby,  British Columbia,  V5H 4C2,  Canada
      G. Steinhoff Clinical Research, Victoria,  British Columbia,  V8V 3N1,  Canada
      Nanaimo Cancer Clinic, Nanaimo,  British Columbia,  V9S 2B7,  Canada
      Penticton Regional Hospital, Penticton,  British Columbia,  V2A 3G6,  Canada
      Prostate Centre at Vancouver General Hospital, Vancouver,  British Columbia,  V5Z 3J5,  Canada
      St. Paul's Hospital - Vancouver, Vancouver,  British Columbia,  V6Z 1Y6,  Canada
Canada, New Brunswick
      Doctor Leon Richard Oncology Centre, Moncton,  New Brunswick,  E1C 8X3,  Canada
      Moncton Hospital, Moncton,  New Brunswick,  E1C 6ZB,  Canada
      Saint John Regional Hospital, Saint John,  New Brunswick,  E2L 4L2,  Canada
Canada, Newfoundland and Labrador
      Newfoundland Cancer Treatment and Research Foundation, St. Johns,  Newfoundland and Labrador,  A1B 3V6,  Canada
Canada, Nova Scotia
      Cape Breton Cancer Centre, Sydney,  Nova Scotia,  B1P 1PS,  Canada
      Nova Scotia Cancer Centre, Halifax,  Nova Scotia,  B3H 1V7,  Canada
Canada, Ontario
      Cancer Care Ontario - Windsor Regional Cancer Centre, Windsor,  Ontario,  N8W 2X3,  Canada
      Cancer Care Ontario-London Regional Cancer Centre, London,  Ontario,  N6A 4L6,  Canada
      Credit Valley Hospital, Mississauga,  Ontario,  L5M 2N1,  Canada
      Hamilton and Disrict Urology Association, Hamilton,  Ontario,  L8N 1T8,  Canada
      Hotel Dieu Health Sciences Hospital - Niagara, St. Catharines,  Ontario,  L2R 5K3,  Canada
      Humber River Regional Hospital, Weston,  Ontario,  M9N 1N8,  Canada
      Lakeridge Health Oshawa, Oshawa,  Ontario,  L1G 2B9,  Canada
      London Health Sciences Centre, London,  Ontario,  N6A 4G5,  Canada
      Male Health Centre/CMX Research Inc., Oakville,  Ontario,  L6H 3PI,  Canada
      Markham Stouffville Hospital, Markham,  Ontario,  L3P 7T3,  Canada
      Mount Sinai Hospital - Toronto, Toronto,  Ontario,  M5G 1X5,  Canada
      North York General Hospital, Ontario, North York,  Ontario,  M2E 1K1,  Canada
      Northeastern Ontario Regional Cancer Centre, Sudbury, Sudbury,  Ontario,  P3E 5J1,  Canada
      Northwestern Ontario Regional Cancer Centre, Thunder Bay, Thunder Bay,  Ontario,  P7A 7T1,  Canada
      Ottawa Regional Cancer Center - General Division, Ottawa,  Ontario,  K1H 8L6,  Canada
      Ottawa Regional Cancer Centre - General Campus, Ottawa,  Ontario,  K1H 1C4,  Canada
      Peterborough Oncology Clinic, Peterborough,  Ontario,  K9H 7B6,  Canada
      Princess Margaret Hospital, Toronto,  Ontario,  M5G 2M9,  Canada
      Royal Victoria Hospital, Barrie, Barrie,  Ontario,  L4M 6M2,  Canada
      Saint Joseph's Health Centre - Toronto, Toronto,  Ontario,  M6R 1B5,  Canada
      Scarborough Hospital - General Site, Scarborough,  Ontario,  M1P 2V5,  Canada
      St. Michael's Hospital - Toronto, Toronto,  Ontario,  M5B 1W8,  Canada
      Toronto East General Hospital, Toronto,  Ontario,  M4C 3E7,  Canada
      Toronto General Hospital, Toronto,  Ontario,  M5G 2C4,  Canada
      Toronto Sunnybrook Regional Cancer Centre, Toronto,  Ontario,  M4N 3M5,  Canada
      Trillium Health Centre, Mississauga,  Ontario,  L5B 1B8,  Canada
      William Osler Health Centre, Brampton,  Ontario,  L6W 2Z8,  Canada
      Women's College Campus, Sunnybrook and Women's College Health Science Center, Toronto,  Ontario,  M5S 1B6,  Canada
      York County Hospital, Newmarket,  Ontario,  L3Y 2P9,  Canada
Canada, Prince Edward Island
      Queen Elizabeth Hospital, PEI, Charlottetown,  Prince Edward Island,  C1A 8T5,  Canada
Canada, Quebec
      Centre Hospitalier de l'Universite' de Montreal, Montreal,  Quebec,  H2W 1T8,  Canada
      Centre Hospitalier Regional de Lanaudiere, Joliette,  Quebec,  J6E 6J2,  Canada
      Centre Hospitalier Regional de Rimouski, Rimouski,  Quebec,  G5L 5T1,  Canada
      CHU de Quebec - L'Hotel-Dieu de Quebec, Quebec City,  Quebec,  G1R 2J6,  Canada
      CHUS-Hopital Fleurimont, Fleurimont,  Quebec,  J1H 5N4,  Canada
      Hopital Charles Lemoyne, Greenfield Park,  Quebec,  J4V 2H1,  Canada
      Hopital Du Sacre-Coeur de Montreal, Montreal,  Quebec,  H4J 1C5,  Canada
      Hopital du Saint-Sacrament, Quebec, Quebec City,  Quebec,  G1S 4L8,  Canada
      Hopital Sainte Justine, Montreal,  Quebec,  H3T 1C5,  Canada
      Hotel Dieu de Montreal, Montreal,  Quebec,  H2W 1T8,  Canada
      Kells Medical Research Group Inc., Pointe-Claire,  Quebec,  H9R 4S3,  Canada
      L'Hopital Laval, Ste Foy,  Quebec,  G1V 4G5,  Canada
      Maisonneuve-Rosemont Hospital, Montreal,  Quebec,  H1T 2M4,  Canada
      McGill University, Montreal,  Quebec,  H2W 1S6,  Canada
Canada, Saskatchewan
      Allan Blair Cancer Centre, Regina,  Saskatchewan,  S4T 7T1,  Canada
      Saskatoon Cancer Centre, Saskatoon,  Saskatchewan,  S7N 4H4,  Canada

Study chairs or principal investigators

Keith Stewart,  Study Chair,  National Cancer Institute of Canada   

Study ID Numbers:  CDR0000068337; CAN-NCIC-MY9; CELGENE-CAN-NCIC-MY9
Record last reviewed:  March 2004
Last Updated:  October 13, 2004
Record first received:  December 6, 2000
ClinicalTrials.gov Identifier:  NCT00006890
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2005-04-08