Thalidomide and Prednisone Following Peripheral Stem Cell Transplantation in Treating Patients With Multiple Myeloma

Condition(s) targeted: Multiple Myeloma and Plasma Cell Neoplasm

Intervention: prednisone (Drug); thalidomide (Drug)

Phase: Phase 2

Status: Active, not recruiting

Sponsored by: National Cancer Institute of Canada

Official(s) and/or principal investigator(s):
A. Keith Stewart, MD, Study Chair, Affiliation: Princess Margaret Hospital, Canada

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.

Official title: A Randomized Phase II Dose Finding Study Of Thalidomide And Prednisone As Maintenance Therapy Following Autologous Stem Cell Transplant In Patients With Multiple Myeloma

Study design: Treatment

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.

Minimum age: 16 Years. Maximum age: N/A. Gender(s): Both.

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

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

Lions Gate Hospital, North Vancouver V7L 2P9, Canada

Lethbridge Cancer Clinic, Lethbridge, Alberta T1J 1W5, Canada

Tom Baker Cancer Center - Calgary, Calgary, Alberta T2N 4N2, Canada

British Columbia Cancer Agency, Vancouver, British Columbia V5Z 4E6, Canada

British Columbia Cancer Agency - Fraser Valley Cancer Centre, Surrey, British Columbia V3V 1Z2, Canada

Burnaby Hospital Regional Cancer Centre, Burnaby, British Columbia V5H 4C2, Canada

G. Steinhoff Clinical Research, Victoria, British Columbia V8V 3N1, Canada

Nanaimo Cancer Clinic, Nanaimo, British Columbia V9S 2B7, Canada

Penticton Regional Hospital, Penticton, British Columbia V2A 3G6, Canada

Prostate Centre at Vancouver General Hospital, Vancouver, British Columbia V5Z 3J5, Canada

St. Paul's Hospital - Vancouver, Vancouver, British Columbia V6Z 1Y6, Canada

St. Mary's/Duluth Clinic Health System, Duluth, Minnesota 55805, United States

Doctor Leon Richard Oncology Centre, Moncton, New Brunswick E1C 8X3, Canada

Moncton Hospital, Moncton, New Brunswick E1C 6ZB, Canada

Saint John Regional Hospital, Saint John, New Brunswick E2L 4L2, Canada

Newfoundland Cancer Treatment and Research Foundation, St. Johns, Newfoundland and Labrador A1B 3V6, Canada

Cape Breton Cancer Centre, Sydney, Nova Scotia B1P 1PS, Canada

Nova Scotia Cancer Centre, Halifax, Nova Scotia B3H 1V7, Canada

Cancer Care Ontario - Windsor Regional Cancer Centre, Windsor, Ontario N8W 2X3, Canada

Cancer Care Ontario-London Regional Cancer Centre, London, Ontario N6A 4L6, Canada

Credit Valley Hospital, Mississauga, Ontario L5M 2N1, Canada

Hamilton and Disrict Urology Association, Hamilton, Ontario L8N 1T8, Canada

Hotel Dieu Health Sciences Hospital - Niagara, St. Catharines, Ontario L2R 5K3, Canada

Humber River Regional Hospital, Weston, Ontario M9N 1N8, Canada

Lakeridge Health Oshawa, Oshawa, Ontario L1G 2B9, Canada

London Health Sciences Centre, London, Ontario N6A 4G5, Canada

Male Health Centre/CMX Research Inc., Oakville, Ontario L6H 3PI, Canada

Markham Stouffville Hospital, Markham, Ontario L3P 7T3, Canada

Mount Sinai Hospital - Toronto, Toronto, Ontario M5G 1X5, Canada

North York General Hospital, Ontario, North York, Ontario M2E 1K1, Canada

Northeastern Ontario Regional Cancer Centre, Sudbury, Sudbury, Ontario P3E 5J1, Canada

Northwestern Ontario Regional Cancer Centre, Thunder Bay, Thunder Bay, Ontario P7A 7T1, Canada

Ottawa Regional Cancer Center - General Division, Ottawa, Ontario K1H 8L6, Canada

Ottawa Regional Cancer Centre - General Campus, Ottawa, Ontario K1H 1C4, Canada

Peterborough Oncology Clinic, Peterborough, Ontario K9H 7B6, Canada

Princess Margaret Hospital, Toronto, Ontario M5G 2M9, Canada

Royal Victoria Hospital, Barrie, Barrie, Ontario L4M 6M2, Canada

Saint Joseph's Health Centre - Toronto, Toronto, Ontario M6R 1B5, Canada

Scarborough Hospital - General Site, Scarborough, Ontario M1P 2V5, Canada

St. Michael's Hospital - Toronto, Toronto, Ontario M5B 1W8, Canada

Toronto East General Hospital, Toronto, Ontario M4C 3E7, Canada

Toronto General Hospital, Toronto, Ontario M5G 2C4, Canada

Toronto Sunnybrook Regional Cancer Centre, Toronto, Ontario M4N 3M5, Canada

Trillium Health Centre, Mississauga, Ontario L5B 1B8, Canada

William Osler Health Centre, Brampton, Ontario L6W 2Z8, Canada

Women's College Campus, Sunnybrook and Women's College Health Science Center, Toronto, Ontario M5S 1B6, Canada

York County Hospital, Newmarket, Ontario L3Y 2P9, Canada

Queen Elizabeth Hospital, PEI, Charlottetown, Prince Edward Island C1A 8T5, Canada

Centre Hospitalier de l'Universite' de Montreal, Montreal, Quebec H2W 1T8, Canada

Centre Hospitalier Regional de Lanaudiere, Joliette, Quebec J6E 6J2, Canada

Centre Hospitalier Regional de Rimouski, Rimouski, Quebec G5L 5T1, Canada

CHU de Quebec - L'Hotel-Dieu de Quebec, Quebec City, Quebec G1R 2J6, Canada

CHUS-Hopital Fleurimont, Fleurimont, Quebec J1H 5N4, Canada

Hopital Charles Lemoyne, Greenfield Park, Quebec J4V 2H1, Canada

Hopital Du Sacre-Coeur de Montreal, Montreal, Quebec H4J 1C5, Canada

Hopital du Saint-Sacrament, Quebec, Quebec City, Quebec G1S 4L8, Canada

Hopital Sainte Justine, Montreal, Quebec H3T 1C5, Canada

Hotel Dieu de Montreal, Montreal, Quebec H2W 1T8, Canada

Kells Medical Research Group Inc., Pointe Claire, Quebec H9R 4S3, Canada

L'Hopital Laval, Ste-Foy, Quebec G1V 4G5, Canada

Maisonneuve-Rosemont Hospital, Montreal, Quebec H1T 2M4, Canada

McGill University, Montreal, Quebec H2W 1S6, Canada

Allan Blair Cancer Centre, Regina, Saskatchewan S4T 7T1, Canada

Saskatoon Cancer Centre, Saskatoon, Saskatchewan S7N 4H4, Canada

Clinical trial summary from the National Cancer Institute's PDQ® database

Starting date: July 2000
Last updated: June 14, 2008