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Thalidomide and Prednisone After Autologous Stem Cell Transplantation in Treating Patients With Multiple Myeloma Clinical Trials Data presented on Clinical Trials Search is not meant to be a substitute for qualified medical advice, visits or professional assistance with a genuine dr.. We are not doctors. Always consult your mD about Thalidomide and Prednisone After Autologous Stem Cell Transplantation in Treating Patients With Multiple Myeloma conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Thalidomide and Prednisone After Autologous Stem Cell Transplantation in Treating Patients With Multiple Myeloma Clinical research trials and Thalidomide and Prednisone After Autologous Stem Cell Transplantation in Treating Patients With Multiple Myeloma medical trials take place in many of places throughout the U.S.A.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually evaluate the effectiveness of new does drugs. The purpose of the studies / projects is to solve specific human healthcare questions. Clinical trials are a popular way for mDs, government agencies, and private sector companies to find cures for all varieties of conditions, like Thalidomide and Prednisone After Autologous Stem Cell Transplantation in Treating Patients With Multiple Myeloma. Thalidomide and Prednisone After Autologous Stem Cell Transplantation in Treating Patients With Multiple Myeloma Clinical Trials and other clinical trials allow for volunteers to have health treatment options before they are available to the masses. Many times the human subjects acquire professional assistance for free of charge, and sometimes they are compensated for their time. Occasionally there is a cost for a Thalidomide and Prednisone After Autologous Stem Cell Transplantation in Treating Patients With Multiple Myeloma clinical trial. Test subjects typically obtain the finest healthcare available for their Thalidomide and Prednisone After Autologous Stem Cell Transplantation in Treating Patients With Multiple Myeloma condition. Dangers are a reality, nevertheless, and might include additional or frequent doctor trips, medical dangers (possibly life-jeopardising), and/or the treatment being ineffectual. Trials are federally regulated with strict guidelines to protect clinical trials patients.
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Home > "T" Clinical Trials Conditions > Thalidomide and Prednisone After Autologous Stem Cell Transplantation in Treating Patients With Multiple Myeloma  Thalidomide and Prednisone After Autologous Stem Cell Transplantation in Treating Patients With Multiple Myeloma
Thalidomide and Prednisone After Autologous Stem Cell Transplantation in Treating Patients With Multiple Myeloma
For Condition: stage 1 multiple myeloma,stage 2 multiple myeloma,stage 3 multiple myeloma
Status: 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. 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: Randomizedphase III trial to determine the effectiveness of combining thalidomide with prednisone in treating patients who have undergone stem cell transplantation for multiple myeloma.
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.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 16 Years/
Genders: Both
Protocol Entry 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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
KeithStewart, Study Chair, Princess Margaret Hospital
Hopital de L'Enfant Jesus *Recruiting*
Quebec City, Quebec, G1J 1Z4
Canada
Recruiting Guy Cantin 418-649-5727
CancerCare Manitoba *Recruiting*
Winnipeg, Manitoba, R3E 0V9
Canada
Recruiting Morel Rubinger 204-787-2113
Tom Baker Cancer Center - Calgary *Recruiting*
Calgary, Alberta, T2N 4N2
Canada
Recruiting Ramakrishman Paramuswaran 403-944-1564
Nova Scotia Cancer Centre *Recruiting*
Halifax, Nova Scotia, B3H 2Y9
Canada
Recruiting Darrell White 902-473-7922
Cancer Care Ontario - Windsor Regional Cancer Centre *Recruiting*
Windsor, Ontario, N8W 2X3
Canada
Recruiting Dolores Sicheri 519-253-3191 ext. 58504
British Columbia Cancer Agency *Recruiting*
Vancouver, British Columbia, V5Z 4E6
Canada
Recruiting Kevin Song 604-875-4863
Maisonneuve-Rosemont Hospital *Recruiting*
Montreal, Quebec, H1T 2M4
Canada
Recruiting Jean Roy 514-252-3404
Margaret and Charles Juravinski Cancer Centre *Recruiting*
Hamilton, Ontario, L8V 5C2
Canada
Recruiting Deborah Marcellus 905-575-9827
Princess Margaret Hospital *Recruiting*
Toronto, Ontario, M5G 2M9
Canada
Recruiting Keith Stewart 416-946-4566
Cancer Care Ontario-London Regional Cancer Centre *Recruiting*
London, Ontario, N6A 4L6
Canada
Recruiting Michael Kovacs 519-685-8500, ext. 55182
Cross Cancer Institute *Recruiting*
Edmonton, Alberta, T6G 1Z2
Canada
Recruiting Andrew Belch 780-432-8757
Newfoundland Cancer Treatment and Research Foundation *Recruiting*
St. Johns, Newfoundland and Labrador, A1B 3V6
Canada
Recruiting Kirsty Tompkins 709-777-8062
Hopital Du Sacre-Coeur de Montreal *Recruiting*
Montreal, Quebec, H4J 1C5
Canada
Recruiting Guylaine Gaudet 514-338-2050
Saskatoon Cancer Centre *Recruiting*
Saskatoon, Saskatchewan, S7N 4H4
Canada
Recruiting Michael Voralia 306-655-2925
Moncton Hospital *Recruiting*
Moncton, New Brunswick, E1C 4B7
Canada
Recruiting Sheldon Rubin 506-857-2881
McGill University *Recruiting*
Montreal, Quebec, H2W 1S6
Canada
Recruiting Chaim Shustik 514-398-1444
Hopital du Saint-Sacrement, Quebec *Recruiting*
Quebec City, Quebec, G1S 4L8
Canada
Recruiting Guy Cantin 418-649-5727
Toronto Sunnybrook Regional Cancer Centre *Recruiting*
Toronto, Ontario, M4N 3M5
Canada
Recruiting Kevin Imrie 416-480-4757
Additional Information:
Study ID Numbers: CDR0000258158; CAN-NCIC-MY10
Study Start Date:
Record last reviewed: March 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00049673
Other Stage 1 Multiple Myeloma Studies:
1. Isotretinoin Plus Dexamethasone in Treating Patients With Multiple Myeloma
2. Dexamethasone With or Without Oblimersen in Treating Patients With Relapsed or Refractory Multiple Myeloma
3. Chemotherapy Plus Steroid Therapy in Treating Patients With Multiple Myeloma
4. Filgrastim Compared With Sargramostim Plus Chemotherapy, Peripheral Stem Cell Transplantation, and Interferon alfa in Treating Patients With Multiple Myeloma
5. Flavopiridol in Treating Patients With Relapsed or Refractory Multiple Myeloma
Related Studies:
Other stage 1 multiple myeloma Clinical Trials
Other Ontario Clinical Trials
Other Toronto Clinical Trials
Thalidomide and Prednisone After Autologous Stem Cell Transplantation in Treating Patients With Multiple Myeloma
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