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Home > "T" Clinical Trials Conditions > Thalidomide and Prednisone Following Peripheral Stem Cell Transplantation in Treating Patients With Multiple Myeloma  Thalidomide and Prednisone Following Peripheral Stem Cell Transplantation in Treating Patients With Multiple Myeloma
Thalidomide and Prednisone Following Peripheral Stem Cell Transplantation in Treating Patients With Multiple Myeloma
For Condition: stage 3 multiple myeloma,stage 1 multiple myeloma,refractory plasma cell neoplasm,stage 2 multiple myeloma
Status: No longer recruiting
Sponsor(s): National Cancer Institute of Canada ,
Synopsis: 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.
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.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 16 Years/
Genders:
Protocol Entry 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)
Total Enrollment:
Location and Contact Information:
Overall Study Official:
KeithStewart, Study Chair, National Cancer Institute of Canada
CHU de Quebec - L'Hotel-Dieu de Quebec
Quebec City, Quebec, G1R 2J6
Canada
G. Steinhoff Clinical Research
Victoria, British Columbia, V8V 3N1
Canada
Northeastern Ontario Regional Cancer Centre, Sudbury
Sudbury, Ontario, P3E 5J1
Canada
Nanaimo Cancer Clinic
Nanaimo, British Columbia, V9S 2B7
Canada
Hopital du Saint-Sacrament, Quebec
Quebec City, Quebec, G1S 4L8
Canada
Prostate Centre at Vancouver General Hospital
Vancouver, British Columbia, V5Z 3J5
Canada
Markham Stouffville Hospital
Markham, Ontario, L3P 7T3
Canada
CHUS-Hopital Fleurimont
Fleurimont, Quebec, J1H 5N4
Canada
Women's College Campus, Sunnybrook and Women's College Health Science Center
Toronto, Ontario, M5S 1B6
Canada
Saint John Regional Hospital
Saint John, New Brunswick, E2L 4L2
Canada
Cancer Care Ontario-London Regional Cancer Centre
London, Ontario, N6A 4L6
Canada
William Osler Health Centre
Brampton, Ontario, L6W 2Z8
Canada
Hopital Charles Lemoyne
Greenfield Park, Quebec, J4V 2H1
Canada
St. Michael's Hospital - Toronto
Toronto, Ontario, M5B 1W8
Canada
Centre Hospitalier Regional de Lanaudiere
Joliette, Quebec, J6E 6J2
Canada
Queen Elizabeth Hospital, PEI
Charlottetown, Prince Edward Island, C1A 8T5
Canada
Humber River Regional Hospital
Weston, Ontario, M9N 1N8
Canada
Toronto Sunnybrook Regional Cancer Centre
Toronto, Ontario, M4N 3M5
Canada
Hotel Dieu de Montreal
Montreal, Quebec, H2W 1T8
Canada
Kells Medical Research Group Inc.
Pointe-Claire, Quebec, H9R 4S3
Canada
Lions Gate Hospital
North Vancouver, , V7L 2P9
Canada
Hotel Dieu Health Sciences Hospital - Niagara
St. Catharines, Ontario, L2R 5K3
Canada
Nova Scotia Cancer Centre
Halifax, Nova Scotia, B3H 1V7
Canada
Princess Margaret Hospital
Toronto, Ontario, M5G 2M9
Canada
Centre Hospitalier de l'Universite' de Montreal
Montreal, Quebec, H2W 1T8
Canada
Saskatoon Cancer Centre
Saskatoon, Saskatchewan, S7N 4H4
Canada
Cape Breton Cancer Centre
Sydney, Nova Scotia, B1P 1PS
Canada
Newfoundland Cancer Treatment and Research Foundation
St. Johns, Newfoundland and Labrador, A1B 3V6
Canada
Allan Blair Cancer Centre
Regina, Saskatchewan, S4T 7T1
Canada
Ottawa Regional Cancer Center - General Division
Ottawa, Ontario, K1H 8L6
Canada
London Health Sciences Centre
London, Ontario, N6A 4G5
Canada
Hamilton and Disrict Urology Association
Hamilton, Ontario, L8N 1T8
Canada
North York General Hospital, Ontario
North York, Ontario, M2E 1K1
Canada
Lethbridge Cancer Clinic
Lethbridge, Alberta, T1J 1W5
Canada
Northwestern Ontario Regional Cancer Centre, Thunder Bay
Thunder Bay, Ontario, P7A 7T1
Canada
Hopital Du Sacre-Coeur de Montreal
Montreal, Quebec, H4J 1C5
Canada
Male Health Centre/CMX Research Inc.
Oakville, Ontario, L6H 3PI
Canada
Ottawa Regional Cancer Centre - General Campus
Ottawa, Ontario, K1H 1C4
Canada
Toronto General Hospital
Toronto, Ontario, M5G 2C4
Canada
Saint Joseph's Health Centre - Toronto
Toronto, Ontario, M6R 1B5
Canada
L'Hopital Laval
Ste Foy, Quebec, G1V 4G5
Canada
McGill University
Montreal, Quebec, H2W 1S6
Canada
Cancer Care Ontario - Windsor Regional Cancer Centre
Windsor, Ontario, N8W 2X3
Canada
Hopital Sainte Justine
Montreal, Quebec, H3T 1C5
Canada
Lakeridge Health Oshawa
Oshawa, Ontario, L1G 2B9
Canada
Trillium Health Centre
Mississauga, Ontario, L5B 1B8
Canada
Scarborough Hospital - General Site
Scarborough, Ontario, M1P 2V5
Canada
Tom Baker Cancer Center - Calgary
Calgary, Alberta, T2N 4N2
Canada
Peterborough Oncology Clinic
Peterborough, Ontario, K9H 7B6
Canada
St. Mary's/Duluth Clinic Health System
Duluth, Minnesota, 55805
United States
Royal Victoria Hospital, Barrie
Barrie, Ontario, L4M 6M2
Canada
York County Hospital
Newmarket, Ontario, L3Y 2P9
Canada
Credit Valley Hospital
Mississauga, Ontario, L5M 2N1
Canada
Burnaby Hospital Regional Cancer Centre
Burnaby, British Columbia, V5H 4C2
Canada
British Columbia Cancer Agency - Fraser Valley Cancer Centre
Surrey, British Columbia, V3V 1Z2
Canada
Mount Sinai Hospital - Toronto
Toronto, Ontario, M5G 1X5
Canada
Moncton Hospital
Moncton, New Brunswick, E1C 6ZB
Canada
Centre Hospitalier Regional de Rimouski
Rimouski, Quebec, G5L 5T1
Canada
British Columbia Cancer Agency
Vancouver, British Columbia, V5Z 4E6
Canada
Toronto East General Hospital
Toronto, Ontario, M4C 3E7
Canada
St. Paul's Hospital - Vancouver
Vancouver, British Columbia, V6Z 1Y6
Canada
Penticton Regional Hospital
Penticton, British Columbia, V2A 3G6
Canada
Doctor Leon Richard Oncology Centre
Moncton, New Brunswick, E1C 8X3
Canada
Maisonneuve-Rosemont Hospital
Montreal, Quebec, H1T 2M4
Canada
Additional Information:
Study ID Numbers: CDR0000068337; CELGENE-CAN-NCIC-MY9,CAN-NCIC-MY9
Study Start Date: July 2000
Record last reviewed: March 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00006890
Other Stage 2 Multiple Myeloma Studies:
1. Oblimersen, Thalidomide, and Dexamethasone in Treating Patients With Relapsed or Refractory Multiple Myeloma
2. Melphalan, Peripheral Stem Cell Transplantation, and Interleukin-2 Followed by Interferon alfa in Treating Patients With Advanced Multiple Myeloma
3. Bone Marrow Transplantation in Treating Patients With Multiple Myeloma, Chronic Phase Chronic Myelogenous Leukemia, or Agnogenic Myeloid Metaplasia
4. Chemotherapy, Holmium Ho 166 DOTMP, and Peripheral Stem Cell Transplantation in Treating Patients With Multiple Myeloma
5. Melphalan, Peripheral Stem Cell Transplantation, and Radiation Therapy in Treating Patients With Multiple Myeloma
Related Studies:
Other stage 2 multiple myeloma Clinical Trials
Other Ontario Clinical Trials
Other Toronto Clinical Trials
Thalidomide and Prednisone Following Peripheral Stem Cell Transplantation in Treating Patients With Multiple Myeloma
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