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Home > "C" Clinical Trials Conditions > Combination Chemotherapy in Treating Patients With Multiple Myeloma  Combination Chemotherapy in Treating Patients With Multiple Myeloma
Combination Chemotherapy in Treating Patients With Multiple Myeloma
For Condition: stage 1 multiple myeloma,stage 2 multiple myeloma,stage 3 multiple myeloma
Status: No longer recruiting
Sponsor(s): National Cancer Institute of Canada ,
Synopsis: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. It is not yet known which combination chemotherapy regimen is most effective in treating patients with multiple myeloma. PURPOSE: Randomized phase III trial to compare the effectiveness of various combination chemotherapy regimens in treating patients with multiple myeloma.
Details: OBJECTIVES: - Compare the overall survival of patients with previously untreated stage I-III multiple myelome treated with melphalan combined with dexamethasone or prednisone as induction therapy. - Compare the overall survival of patients with stable or responding disease after induction treated with dexamethasone vs observation alone as maintenance therapy. - Compare the time to progression, response rate, and quality of life of patients treated with these regimens. - Compare the toxic effects of these regimens in these patients. OUTLINE: This is a randomized, multicenter study. Patients are stratified by center, stage (I or II vs III), creatinine (less than 2.0 mg/dL vs 2.0 mg/dL or greater), and intention to use prophylactic bisphosphonate (yes vs no). - Patients are randomized to 1 of 4 treatment arms. - Arms I and II: Patients receive induction comprising oral prednisone followed by oral melphalan on days 1-4. - Arms III and IV: Patients receive induction comprising oral melphalan and oral dexamethasone (DM) on days 1-4 of all courses and DM on days 15-18 of courses 1-3. Induction for arms I-IV continues every 4 weeks for 12 courses in the absence of disease progression or unacceptable toxicity. Patients with stable or responding disease after induction proceed to maintenance therapy. - Arms I and III: Patients undergo observation. - Arms II and IV: Patients receive oral DM on days 1-4. Maintenance therapy continues every 4 weeks for arms II and IV and every 3 months for arms I and III in the absence of disease progression or unacceptable toxicity. Patients on arms I-IV who develop disease progression proceed to reinduction. - Reinduction: Patients restart induction on the arm to which they were originally randomized. Reinduction continues every 4 weeks in the absence of stable response lasting 16 weeks, disease progression, or unacceptable toxicity. Patients who achieve a stable response lasting 16 weeks restart maintenance therapy. Patients who experience further disease progression during reinduction are taken off study. Quality of life is assessed at baseline, on day 1 of courses 1-3 and then every 3 courses during induction, and then every 3 months during maintenance therapy. Patients are followed every 6 months. PROJECTED ACCRUAL: A maximum of 600 patients will be accrued for this study within 6 years.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically proven previously untreated stage I-III multiple myeloma - Patients with stage I disease must be symptomatic - Must meet at least 1 of the following conditions: - Plasma cells in osteolytic lesion or soft tissue tumor biopsy - At least 10% plasmacytosis in bone marrow aspirate and/or biopsy - Less than 10% plasma cells in bone marrow but at least 1 bony lesion - Detectable serum M-component of IgG, IgA, IgD, or IgE - If only light chain disease (urine M-protein) present, urinary excretion of light chain (Bence Jones) protein must be at least 1.0 g/24 hours PATIENT CHARACTERISTICS: Age: - 18 and over Performance status: - ECOG 0-4 Life expectancy: - Not specified Hematopoietic: - Not specified Hepatic: - Not specified Renal: - Not specified Other: - No other concurrent serious illness - Concurrent diabetes allowed, at the discretion of the treating physician, if changes in insulin requirements can be managed - No other prior or concurrent malignancy except curatively treated nonmelanomatous skin cancer or carcinoma in situ of the cervix PRIOR CONCURRENT THERAPY: Biologic therapy: - No concurrent immunizations - No concurrent filgrastim (G-CSF) or other growth factors as prophylaxis - Concurrent epoetin alfa for anemia allowed Chemotherapy: - No prior chemotherapy Endocrine therapy: - Prior dexamethasone or prednisone with radiotherapy for spinal cord compression allowed if cumulative dexamethasone dose no greater than 120 mg and cumulative prednisone dose no greater than 792 mg - Prior or concurrent corticosteroids for hypercalcemia allowed Radiotherapy: - See Endocrine therapy - Prior focal radiotherapy allowed - Concurrent focal radiotherapy during induction allowed - Concurrent radiotherapy for palliation (e.g., painful osteolytic lesions or spinal cord compression) allowed Surgery: - At least 2 years since prior surgery for radiologic or endoscopic diagnosis of gastric or duodenal ulcer Other: - At least 2 years since prior medication for radiologic or endoscopic diagnosis of gastric or duodenal ulcer - Prior or concurrent bisphosphonates for hypercalcemia allowed
Total Enrollment:
Location and Contact Information:
Overall Study Official:
ChaimShustik, Study Chair, Royal Victoria Hospital - Montreal
Hopital du Saint-Sacrement, Quebec
Quebec City, Quebec, G1S 4L8
Canada
William Osler Health Centre
Brampton, Ontario, L6W 2Z8
Canada
Tom Baker Cancer Center - Calgary
Calgary, Alberta, T2N 4N2
Canada
Toronto East General Hospital
Toronto, Ontario, M4C 3E7
Canada
Northeastern Ontario Regional Cancer Centre, Sudbury
Sudbury, Ontario, P3E 5J1
Canada
Southlake Regional Health Centre
Newmarket, Ontario, L3Y 2P9
Canada
St. Michael's Hospital - Toronto
Toronto, Ontario, M5B 1W8
Canada
Credit Valley Hospital
Mississauga, Ontario, L5M 2N1
Canada
Humber River Regional Hospital
Weston, Ontario, M9N 1N8
Canada
Princess Margaret Hospital
Toronto, Ontario, M5G 2M9
Canada
Cross Cancer Institute
Edmonton, Alberta, T6G 1Z2
Canada
Cancer Care Ontario - Windsor Regional Cancer Centre
Windsor, Ontario, N8W 2X3
Canada
Toronto Sunnybrook Regional Cancer Centre
Toronto, Ontario, M4N 3M5
Canada
British Columbia Cancer Agency
Vancouver, British Columbia, V5Z 4E6
Canada
Cancer Care Ontario-Hamilton Regional Cancer Centre
Hamilton, Ontario, L8V 5C2
Canada
Trillium Health Centre
Mississauga, Ontario, L5B 1B8
Canada
Doctor Leon Richard Oncology Centre
Moncton, New Brunswick, E1C 8X3
Canada
Allan Blair Cancer Centre
Regina, Saskatchewan, S4T 7T1
Canada
Nova Scotia Cancer Centre
Halifax, Nova Scotia, B3H 2Y9
Canada
British Columbia Cancer Agency - Vancouver Island Cancer Centre
Victoria, British Columbia, V8R 6V5
Canada
Hotel Dieu Health Sciences Hospital - Niagara
St. Catharines, Ontario, L2R 5K3
Canada
McGill University
Montreal, Quebec, H2W 1S6
Canada
Cancer Care Ontario-London Regional Cancer Centre
London, Ontario, N6A 4L6
Canada
Hopital de L'Enfant Jesus
Quebec City, Quebec, G1J 1Z4
Canada
Lakeridge Health Oshawa
Oshawa, Ontario, L1G 2B9
Canada
CHUS-Hopital Fleurimont
Fleurimont, Quebec, J1H 5N4
Canada
Saint John Regional Hospital
Saint John, New Brunswick, E2L 4L2
Canada
Hopital Charles Lemoyne
Greenfield Park, Quebec, J4V 2H1
Canada
Moncton Hospital
Moncton, New Brunswick, E1C 6ZB
Canada
Queen Elizabeth Hospital, PEI
Charlottetown, Prince Edward Island, C1A 8T5
Canada
Algoma District Medical Group
Sault Sainte Marie, Ontario, P6B 1Y5
Canada
St. Mary's/Duluth Clinic Health System
Duluth, Minnesota, 55805
United States
Newfoundland Cancer Treatment and Research Foundation
St. Johns, Newfoundland and Labrador, A1B 3V6
Canada
Providence Health Care - Vancouver
Vancouver, British Columbia, V6Z 1Y6
Canada
Kingston Regional Cancer Centre
Kingston, Ontario, K7L 5P9
Canada
British Columbia Cancer Agency - Centre for the Southern Interior
Kelowna, British Columbia, V1Y 5L3
Canada
Toronto General Hospital
Toronto, Ontario, M5G 2C4
Canada
Additional Information:
Study ID Numbers: CDR0000064328; CAN-NCIC-MY7,NCI-V95-0713
Study Start Date:
Record last reviewed: September 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002678
Other Stage 2 Multiple Myeloma Studies:
1. Dexamethasone With or Without CC-5013 in Treating Patients With Newly Diagnosed Multiple Myeloma
2. High-Dose Melphalan Followed by Peripheral Stem Cell Transplantation in Treating Patients With Amyloidosis
3. Chemotherapy, Holmium Ho 166 DOTMP, and Peripheral Stem Cell Transplantation in Treating Patients With Multiple Myeloma
4. Combination Chemotherapy in Treating Patients With Multiple Myeloma
5. Bevacizumab With or Without Thalidomide in Treating Patients With Relapsed or Refractory Multiple Myeloma
Related Studies:
Other stage 2 multiple myeloma Clinical Trials
Other Ontario Clinical Trials
Other Oshawa Clinical Trials
Combination Chemotherapy in Treating Patients With Multiple Myeloma
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