Thalidomide and Prednisone Following Peripheral Stem Cell Transplantation in Treating Patients With Multiple Myeloma
Multiple Myeloma and Plasma Cell Neoplasm
About this trial
This is an interventional treatment trial for Multiple Myeloma and Plasma Cell Neoplasm focused on measuring refractory multiple myeloma, stage I multiple myeloma, stage II multiple myeloma, stage III multiple myeloma
Eligibility 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 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) PRIOR CONCURRENT THERAPY: Biologic: See Disease Characteristics No prior thalidomide Chemotherapy: See Disease Characteristics Endocrine: Not specified Radiotherapy: Not specified Surgery: Not specified Other: No other concurrent anticancer treatment No other concurrent investigational therapy
Sites / Locations
- St. Mary's/Duluth Clinic Health System
- Tom Baker Cancer Center - Calgary
- Lethbridge Cancer Clinic
- Burnaby Hospital Regional Cancer Centre
- Nanaimo Cancer Clinic
- Penticton Regional Hospital
- British Columbia Cancer Agency - Fraser Valley Cancer Centre
- Prostate Centre at Vancouver General Hospital
- British Columbia Cancer Agency
- St. Paul's Hospital - Vancouver
- G. Steinhoff Clinical Research
- Moncton Hospital
- Doctor Leon Richard Oncology Centre
- Saint John Regional Hospital
- Newfoundland Cancer Treatment and Research Foundation
- Nova Scotia Cancer Centre
- Cape Breton Cancer Centre
- Royal Victoria Hospital, Barrie
- William Osler Health Centre
- Hamilton and Disrict Urology Association
- London Health Sciences Centre
- Cancer Care Ontario-London Regional Cancer Centre
- Markham Stouffville Hospital
- Trillium Health Centre
- Credit Valley Hospital
- York County Hospital
- North York General Hospital, Ontario
- Male Health Centre/CMX Research Inc.
- Lakeridge Health Oshawa
- Ottawa Regional Cancer Centre - General Campus
- Ottawa Regional Cancer Center - General Division
- Peterborough Oncology Clinic
- Scarborough Hospital - General Site
- Hotel Dieu Health Sciences Hospital - Niagara
- Northeastern Ontario Regional Cancer Centre, Sudbury
- Northwestern Ontario Regional Cancer Centre, Thunder Bay
- Toronto East General Hospital
- Toronto Sunnybrook Regional Cancer Centre
- St. Michael's Hospital - Toronto
- Mount Sinai Hospital - Toronto
- Toronto General Hospital
- Princess Margaret Hospital
- Women's College Campus, Sunnybrook and Women's College Health Science Center
- Saint Joseph's Health Centre - Toronto
- Humber River Regional Hospital
- Cancer Care Ontario - Windsor Regional Cancer Centre
- Queen Elizabeth Hospital, PEI
- CHUS-Hopital Fleurimont
- Hopital Charles Lemoyne
- Centre Hospitalier Regional de Lanaudiere
- Maisonneuve-Rosemont Hospital
- McGill University
- Centre Hospitalier de l'Universite' de Montreal
- Hotel Dieu de Montreal
- Hopital Sainte Justine
- Hopital Du Sacre-Coeur de Montreal
- Kells Medical Research Group Inc.
- CHU de Quebec - L'Hotel-Dieu de Quebec
- Hopital du Saint-Sacrament, Quebec
- Centre Hospitalier Regional de Rimouski
- L'Hopital Laval
- Allan Blair Cancer Centre
- Saskatoon Cancer Centre
- Lions Gate Hospital
Arms of the Study
Arm 1
Experimental
Prednisone plus Thalidomide
After Autologous Stem Cell Infusion