Thalidomide and Prednisone Following Peripheral Stem Cell Transplantation in Treating Patients With Multiple Myeloma
NCT ID: NCT00006890
Last Updated: 2020-04-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
67 participants
INTERVENTIONAL
2000-07-12
2008-12-15
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Prednisone plus Thalidomide
After Autologous Stem Cell Infusion
prednisone
Prednisone 50mg on alternate days
thalidomide
THALIDOMIDE 200 mg qhs
Interventions
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prednisone
Prednisone 50mg on alternate days
thalidomide
THALIDOMIDE 200 mg qhs
Eligibility Criteria
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Inclusion Criteria
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
16 Years
120 Years
ALL
No
Sponsors
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NCIC Clinical Trials Group
NETWORK
Responsible Party
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Principal Investigators
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A. Keith Stewart, MD
Role: STUDY_CHAIR
Princess Margaret Hospital, Canada
Locations
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St. Mary's/Duluth Clinic Health System
Duluth, Minnesota, United States
Tom Baker Cancer Center - Calgary
Calgary, Alberta, Canada
Lethbridge Cancer Clinic
Lethbridge, Alberta, Canada
Burnaby Hospital Regional Cancer Centre
Burnaby, British Columbia, Canada
Nanaimo Cancer Clinic
Nanaimo, British Columbia, Canada
Penticton Regional Hospital
Penticton, British Columbia, Canada
British Columbia Cancer Agency - Fraser Valley Cancer Centre
Surrey, British Columbia, Canada
Prostate Centre at Vancouver General Hospital
Vancouver, British Columbia, Canada
British Columbia Cancer Agency
Vancouver, British Columbia, Canada
St. Paul's Hospital - Vancouver
Vancouver, British Columbia, Canada
G. Steinhoff Clinical Research
Victoria, British Columbia, Canada
Moncton Hospital
Moncton, New Brunswick, Canada
Doctor Leon Richard Oncology Centre
Moncton, New Brunswick, Canada
Saint John Regional Hospital
Saint John, New Brunswick, Canada
Newfoundland Cancer Treatment and Research Foundation
St. John's, Newfoundland and Labrador, Canada
Nova Scotia Cancer Centre
Halifax, Nova Scotia, Canada
Cape Breton Cancer Centre
Sydney, Nova Scotia, Canada
Royal Victoria Hospital, Barrie
Barrie, Ontario, Canada
William Osler Health Centre
Brampton, Ontario, Canada
Northeastern Ontario Regional Cancer Centre, Sudbury
Greater Sudbury, Ontario, Canada
Hamilton and Disrict Urology Association
Hamilton, Ontario, Canada
London Health Sciences Centre
London, Ontario, Canada
Cancer Care Ontario-London Regional Cancer Centre
London, Ontario, Canada
Markham Stouffville Hospital
Markham, Ontario, Canada
Trillium Health Centre
Mississauga, Ontario, Canada
Credit Valley Hospital
Mississauga, Ontario, Canada
York County Hospital
Newmarket, Ontario, Canada
North York General Hospital, Ontario
North York, Ontario, Canada
Male Health Centre/CMX Research Inc.
Oakville, Ontario, Canada
Lakeridge Health Oshawa
Oshawa, Ontario, Canada
Ottawa Regional Cancer Centre - General Campus
Ottawa, Ontario, Canada
Ottawa Regional Cancer Center - General Division
Ottawa, Ontario, Canada
Peterborough Oncology Clinic
Peterborough, Ontario, Canada
Scarborough Hospital - General Site
Scarborough Village, Ontario, Canada
Hotel Dieu Health Sciences Hospital - Niagara
St. Catharines, Ontario, Canada
Northwestern Ontario Regional Cancer Centre, Thunder Bay
Thunder Bay, Ontario, Canada
Toronto East General Hospital
Toronto, Ontario, Canada
Toronto Sunnybrook Regional Cancer Centre
Toronto, Ontario, Canada
St. Michael's Hospital - Toronto
Toronto, Ontario, Canada
Mount Sinai Hospital - Toronto
Toronto, Ontario, Canada
Toronto General Hospital
Toronto, Ontario, Canada
Princess Margaret Hospital
Toronto, Ontario, Canada
Women's College Campus, Sunnybrook and Women's College Health Science Center
Toronto, Ontario, Canada
Saint Joseph's Health Centre - Toronto
Toronto, Ontario, Canada
Humber River Regional Hospital
Weston, Ontario, Canada
Cancer Care Ontario - Windsor Regional Cancer Centre
Windsor, Ontario, Canada
Queen Elizabeth Hospital, PEI
Charlottetown, Prince Edward Island, Canada
CHUS-Hopital Fleurimont
Fleurimont, Quebec, Canada
Hopital Charles Lemoyne
Greenfield Park, Quebec, Canada
Centre Hospitalier Regional de Lanaudiere
Joliette, Quebec, Canada
Maisonneuve-Rosemont Hospital
Montreal, Quebec, Canada
McGill University
Montreal, Quebec, Canada
Centre Hospitalier de l'Universite' de Montreal
Montreal, Quebec, Canada
Hotel Dieu de Montreal
Montreal, Quebec, Canada
Hopital Sainte Justine
Montreal, Quebec, Canada
Hopital Du Sacre-Coeur de Montreal
Montreal, Quebec, Canada
Kells Medical Research Group Inc.
Pointe-Claire, Quebec, Canada
CHU de Quebec - L'Hotel-Dieu de Quebec
Québec, Quebec, Canada
Hopital du Saint-Sacrament, Quebec
Québec, Quebec, Canada
Centre Hospitalier Regional de Rimouski
Rimouski, Quebec, Canada
L'Hopital Laval
Ste-Foy, Quebec, Canada
Allan Blair Cancer Centre
Regina, Saskatchewan, Canada
Saskatoon Cancer Centre
Saskatoon, Saskatchewan, Canada
Lions Gate Hospital
North Vancouver, , Canada
Countries
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References
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Stewart AK, Chen CI, Howson-Jan K, White D, Roy J, Kovacs MJ, Shustik C, Sadura A, Shepherd L, Ding K, Meyer RM, Belch AR. Results of a multicenter randomized phase II trial of thalidomide and prednisone maintenance therapy for multiple myeloma after autologous stem cell transplant. Clin Cancer Res. 2004 Dec 15;10(24):8170-6. doi: 10.1158/1078-0432.CCR-04-1106.
Stewart KA, Chen C, Howson-Jan K, et al.: A randomized phase II dose-finding trial of thalidomide and prednisone as maintenance therapy for myeloma following autologous stem cell transplant. [Abstract] Proceedings of the American Society of Clinical Oncology 21: A-1073, 2002.
Other Identifiers
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CAN-NCIC-MY9
Identifier Type: OTHER
Identifier Source: secondary_id
CELGENE-CAN-NCIC-MY9
Identifier Type: OTHER
Identifier Source: secondary_id
CDR0000068337
Identifier Type: OTHER
Identifier Source: secondary_id
MY9
Identifier Type: -
Identifier Source: org_study_id
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