Thalidomide and Prednisone After Autologous Stem Cell Transplantation 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 stage I multiple myeloma, stage II multiple myeloma, stage III multiple myeloma
Eligibility 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^2) 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 deep vein thrombosis within the past 5 years Catheter-associated thrombus allowed No uncontrolled hypertension Pulmonary No prior pulmonary embolism within the past 5 years Other No other prior or concurrent malignancy except adequately treated squamous cell or basal cell skin cancer or carcinoma in situ of the cervix or any cancer treated more than 5 years prior to study entry and presumed cured 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 double autologous or allogeneic hematopoietic stem cell transplantation 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
Sites / Locations
- Tom Baker Cancer Centre
- Cross Cancer Institute
- BCCA - Vancouver Cancer Centre
- CancerCare Manitoba
- The Moncton Hospital
- Atlantic Health Sciences Corporation
- Dr. H. Bliss Murphy Cancer Centre
- QEII Health Sciences Center
- Juravinski Cancer Centre at Hamilton Health Sciences
- Cancer Centre of Southeastern Ontario at Kingston
- London Regional Cancer Program
- Odette Cancer Centre
- Univ. Health Network-Princess Margaret Hospital
- Hopital Maisonneuve-Rosemont
- McGill University - Dept. Oncology
- CHA-Hopital Du St-Sacrement
- Centre hospitalier universitaire de Sherbrooke
- Saskatoon Cancer Centre
Arms of the Study
Arm 1
Arm 2
Experimental
No Intervention
Arm I
Arm II
Patients receive oral thalidomide daily and oral prednisone every other day for 4 years in the absence of disease progression or unacceptable toxicity.
Patients undergo observation.