Thalidomide and Prednisone Following Peripheral Stem Cell Transplantation in Treating Patients With Multiple Myeloma
- Conditions
- Multiple Myeloma and Plasma Cell Neoplasm
- Interventions
- Registration Number
- NCT00006890
- Lead Sponsor
- NCIC Clinical Trials Group
- Brief Summary
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.
- Detailed Description
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.
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 67
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Prednisone plus Thalidomide prednisone After Autologous Stem Cell Infusion Prednisone plus Thalidomide thalidomide After Autologous Stem Cell Infusion
- Primary Outcome Measures
Name Time Method incidence of drop-out or dose reduction 2 years incidence of drop-out or dose reduction due to toxicity within 6 months from the start of treatment.
- Secondary Outcome Measures
Name Time Method Response rate 2 years Time to progression 2 years Overall survival 8 years
Trial Locations
- Locations (64)
St. Mary's/Duluth Clinic Health System
🇺🇸Duluth, Minnesota, United States
Saint John Regional Hospital
🇨🇦Saint John, New Brunswick, Canada
Moncton Hospital
🇨🇦Moncton, New Brunswick, Canada
Markham Stouffville Hospital
🇨🇦Markham, Ontario, Canada
York County Hospital
🇨🇦Newmarket, Ontario, Canada
Lakeridge Health Oshawa
🇨🇦Oshawa, Ontario, Canada
Toronto General Hospital
🇨🇦Toronto, Ontario, Canada
Women's College Campus, Sunnybrook and Women's College Health Science Center
🇨🇦Toronto, Ontario, Canada
Allan Blair Cancer Centre
🇨🇦Regina, Saskatchewan, Canada
Burnaby Hospital Regional Cancer Centre
🇨🇦Burnaby, British Columbia, Canada
British Columbia Cancer Agency - Fraser Valley Cancer Centre
🇨🇦Surrey, British Columbia, Canada
G. Steinhoff Clinical Research
🇨🇦Victoria, British Columbia, Canada
Penticton Regional Hospital
🇨🇦Penticton, British Columbia, Canada
Saskatoon Cancer Centre
🇨🇦Saskatoon, Saskatchewan, Canada
Queen Elizabeth Hospital, PEI
🇨🇦Charlottetown, Prince Edward Island, Canada
Tom Baker Cancer Center - Calgary
🇨🇦Calgary, Alberta, Canada
Lethbridge Cancer Clinic
🇨🇦Lethbridge, Alberta, Canada
Prostate Centre at Vancouver General Hospital
🇨🇦Vancouver, British Columbia, Canada
St. Paul's Hospital - Vancouver
🇨🇦Vancouver, British Columbia, Canada
Nanaimo Cancer Clinic
🇨🇦Nanaimo, British Columbia, Canada
Doctor Leon Richard Oncology Centre
🇨🇦Moncton, New Brunswick, Canada
Nova Scotia Cancer Centre
🇨🇦Halifax, Nova Scotia, Canada
Newfoundland Cancer Treatment and Research Foundation
🇨🇦St. Johns, Newfoundland and Labrador, Canada
William Osler Health Centre
🇨🇦Brampton, Ontario, Canada
Saint Joseph's Health Centre - Toronto
🇨🇦Toronto, Ontario, Canada
London Health Sciences Centre
🇨🇦London, Ontario, Canada
Hamilton and Disrict Urology Association
🇨🇦Hamilton, Ontario, Canada
Northwestern Ontario Regional Cancer Centre, Thunder Bay
🇨🇦Thunder Bay, Ontario, Canada
Scarborough Hospital - General Site
🇨🇦Scarborough, Ontario, Canada
CHUS-Hopital Fleurimont
🇨🇦Fleurimont, Quebec, Canada
Hopital Sainte Justine
🇨🇦Montreal, Quebec, Canada
Centre Hospitalier Regional de Rimouski
🇨🇦Rimouski, Quebec, Canada
L'Hopital Laval
🇨🇦Ste-Foy, Quebec, Canada
Lions Gate Hospital
🇨🇦North Vancouver, Canada
Trillium Health Centre
🇨🇦Mississauga, Ontario, Canada
Cancer Care Ontario-London Regional Cancer Centre
🇨🇦London, Ontario, Canada
Ottawa Regional Cancer Centre - General Campus
🇨🇦Ottawa, Ontario, Canada
Peterborough Oncology Clinic
🇨🇦Peterborough, Ontario, Canada
Toronto East General Hospital
🇨🇦Toronto, Ontario, Canada
Mount Sinai Hospital - Toronto
🇨🇦Toronto, Ontario, Canada
Hopital Charles Lemoyne
🇨🇦Greenfield Park, 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
CHU de Quebec - L'Hotel-Dieu de Quebec
🇨🇦Quebec City, Quebec, Canada
Cape Breton Cancer Centre
🇨🇦Sydney, Nova Scotia, Canada
Royal Victoria Hospital, Barrie
🇨🇦Barrie, Ontario, Canada
Male Health Centre/CMX Research Inc.
🇨🇦Oakville, Ontario, Canada
Toronto Sunnybrook Regional Cancer Centre
🇨🇦Toronto, Ontario, Canada
St. Michael's Hospital - Toronto
🇨🇦Toronto, Ontario, Canada
Humber River Regional Hospital
🇨🇦Weston, Ontario, Canada
Hopital Du Sacre-Coeur de Montreal
🇨🇦Montreal, Quebec, Canada
Kells Medical Research Group Inc.
🇨🇦Pointe Claire, Quebec, Canada
Hopital du Saint-Sacrament, Quebec
🇨🇦Quebec City, Quebec, Canada
Credit Valley Hospital
🇨🇦Mississauga, Ontario, Canada
Ottawa Regional Cancer Center - General Division
🇨🇦Ottawa, Ontario, Canada
Hotel Dieu Health Sciences Hospital - Niagara
🇨🇦St. Catharines, Ontario, Canada
Cancer Care Ontario - Windsor Regional Cancer Centre
🇨🇦Windsor, Ontario, Canada
Centre Hospitalier Regional de Lanaudiere
🇨🇦Joliette, Quebec, Canada
North York General Hospital, Ontario
🇨🇦North York, Ontario, Canada
Northeastern Ontario Regional Cancer Centre, Sudbury
🇨🇦Sudbury, Ontario, Canada
Princess Margaret Hospital
🇨🇦Toronto, Ontario, Canada
British Columbia Cancer Agency
🇨🇦Vancouver, British Columbia, Canada