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Thalidomide and Prednisone Following Peripheral Stem Cell Transplantation in Treating Patients With Multiple Myeloma
This study is ongoing, but not recruiting participants.
First Received: December 6, 2000   Last Updated: November 16, 2008   History of Changes
Sponsor: NCIC Clinical Trials Group
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00006890
  Purpose

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.


Condition Intervention Phase
Multiple Myeloma and Plasma Cell Neoplasm
Drug: prednisone
Drug: thalidomide
Phase II

Study Type: Interventional
Study Design: Treatment
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

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Study Start Date: July 2000
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.

  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00006890

  Hide Study Locations
Locations
United States, Minnesota
St. Mary's/Duluth Clinic Health System
Duluth, Minnesota, United States, 55805
Canada
Lions Gate Hospital
North Vancouver, Canada, V7L 2P9
Canada, Alberta
Lethbridge Cancer Clinic
Lethbridge, Alberta, Canada, T1J 1W5
Tom Baker Cancer Center - Calgary
Calgary, Alberta, Canada, T2N 4N2
Canada, British Columbia
G. Steinhoff Clinical Research
Victoria, British Columbia, Canada, V8V 3N1
British Columbia Cancer Agency - Fraser Valley Cancer Centre
Surrey, British Columbia, Canada, V3V 1Z2
Burnaby Hospital Regional Cancer Centre
Burnaby, British Columbia, Canada, V5H 4C2
British Columbia Cancer Agency
Vancouver, British Columbia, Canada, V5Z 4E6
Nanaimo Cancer Clinic
Nanaimo, British Columbia, Canada, V9S 2B7
Penticton Regional Hospital
Penticton, British Columbia, Canada, V2A 3G6
Prostate Centre at Vancouver General Hospital
Vancouver, British Columbia, Canada, V5Z 3J5
St. Paul's Hospital - Vancouver
Vancouver, British Columbia, Canada, V6Z 1Y6
Canada, New Brunswick
Doctor Leon Richard Oncology Centre
Moncton, New Brunswick, Canada, E1C 8X3
Moncton Hospital
Moncton, New Brunswick, Canada, E1C 6ZB
Saint John Regional Hospital
Saint John, New Brunswick, Canada, E2L 4L2
Canada, Newfoundland and Labrador
Newfoundland Cancer Treatment and Research Foundation
St. Johns, Newfoundland and Labrador, Canada, A1B 3V6
Canada, Nova Scotia
Cape Breton Cancer Centre
Sydney, Nova Scotia, Canada, B1P 1PS
Nova Scotia Cancer Centre
Halifax, Nova Scotia, Canada, B3H 1V7
Canada, Ontario
Cancer Care Ontario - Windsor Regional Cancer Centre
Windsor, Ontario, Canada, N8W 2X3
Cancer Care Ontario-London Regional Cancer Centre
London, Ontario, Canada, N6A 4L6
Credit Valley Hospital
Mississauga, Ontario, Canada, L5M 2N1
Hamilton and Disrict Urology Association
Hamilton, Ontario, Canada, L8N 1T8
Hotel Dieu Health Sciences Hospital - Niagara
St. Catharines, Ontario, Canada, L2R 5K3
Humber River Regional Hospital
Weston, Ontario, Canada, M9N 1N8
Northwestern Ontario Regional Cancer Centre, Thunder Bay
Thunder Bay, Ontario, Canada, P7A 7T1
London Health Sciences Centre
London, Ontario, Canada, N6A 4G5
Male Health Centre/CMX Research Inc.
Oakville, Ontario, Canada, L6H 3PI
Markham Stouffville Hospital
Markham, Ontario, Canada, L3P 7T3
Mount Sinai Hospital - Toronto
Toronto, Ontario, Canada, M5G 1X5
North York General Hospital, Ontario
North York, Ontario, Canada, M2E 1K1
Northeastern Ontario Regional Cancer Centre, Sudbury
Sudbury, Ontario, Canada, P3E 5J1
Lakeridge Health Oshawa
Oshawa, Ontario, Canada, L1G 2B9
Ottawa Regional Cancer Center - General Division
Ottawa, Ontario, Canada, K1H 8L6
Ottawa Regional Cancer Centre - General Campus
Ottawa, Ontario, Canada, K1H 1C4
Peterborough Oncology Clinic
Peterborough, Ontario, Canada, K9H 7B6
Princess Margaret Hospital
Toronto, Ontario, Canada, M5G 2M9
St. Michael's Hospital - Toronto
Toronto, Ontario, Canada, M5B 1W8
Saint Joseph's Health Centre - Toronto
Toronto, Ontario, Canada, M6R 1B5
Scarborough Hospital - General Site
Scarborough, Ontario, Canada, M1P 2V5
Royal Victoria Hospital, Barrie
Barrie, Ontario, Canada, L4M 6M2
Toronto East General Hospital
Toronto, Ontario, Canada, M4C 3E7
Toronto General Hospital
Toronto, Ontario, Canada, M5G 2C4
Toronto Sunnybrook Regional Cancer Centre
Toronto, Ontario, Canada, M4N 3M5
Trillium Health Centre
Mississauga, Ontario, Canada, L5B 1B8
William Osler Health Centre
Brampton, Ontario, Canada, L6W 2Z8
Women's College Campus, Sunnybrook and Women's College Health Science Center
Toronto, Ontario, Canada, M5S 1B6
York County Hospital
Newmarket, Ontario, Canada, L3Y 2P9
Canada, Prince Edward Island
Queen Elizabeth Hospital, PEI
Charlottetown, Prince Edward Island, Canada, C1A 8T5
Canada, Quebec
Centre Hospitalier de l'Universite' de Montreal
Montreal, Quebec, Canada, H2W 1T8
Centre Hospitalier Regional de Lanaudiere
Joliette, Quebec, Canada, J6E 6J2
Centre Hospitalier Regional de Rimouski
Rimouski, Quebec, Canada, G5L 5T1
CHU de Quebec - L'Hotel-Dieu de Quebec
Quebec City, Quebec, Canada, G1R 2J6
Hopital du Saint-Sacrament, Quebec
Quebec City, Quebec, Canada, G1S 4L8
Hopital Charles Lemoyne
Greenfield Park, Quebec, Canada, J4V 2H1
Hopital Du Sacre-Coeur de Montreal
Montreal, Quebec, Canada, H4J 1C5
CHUS-Hopital Fleurimont
Fleurimont, Quebec, Canada, J1H 5N4
Hopital Sainte Justine
Montreal, Quebec, Canada, H3T 1C5
Hotel Dieu de Montreal
Montreal, Quebec, Canada, H2W 1T8
Kells Medical Research Group Inc.
Pointe Claire, Quebec, Canada, H9R 4S3
L'Hopital Laval
Ste-Foy, Quebec, Canada, G1V 4G5
Maisonneuve-Rosemont Hospital
Montreal, Quebec, Canada, H1T 2M4
McGill University
Montreal, Quebec, Canada, H2W 1S6
Canada, Saskatchewan
Allan Blair Cancer Centre
Regina, Saskatchewan, Canada, S4T 7T1
Saskatoon Cancer Centre
Saskatoon, Saskatchewan, Canada, S7N 4H4
Sponsors and Collaborators
NCIC Clinical Trials Group
Investigators
Study Chair: A. Keith Stewart, MD Princess Margaret Hospital, Canada
  More Information

Additional Information:
Publications:
Stewart KA, Chen C, Howson-Jan K, et al.: Results of a multi-center randomized phase II trial of thalidomide and prednisone maintenance therapy for multiple myeloma following autologous stem cell transplant. [Abstract] Blood 104 (11 Pt 1): A-335, 2004.
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.

Study ID Numbers: CDR0000068337, CAN-NCIC-MY9, CELGENE-CAN-NCIC-MY9
Study First Received: December 6, 2000
Last Updated: November 16, 2008
ClinicalTrials.gov Identifier: NCT00006890     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
refractory multiple myeloma
stage I multiple myeloma
stage II multiple myeloma
stage III multiple myeloma

Additional relevant MeSH terms:
Anti-Inflammatory Agents
Anti-Infective Agents
Prednisone
Immunologic Factors
Thalidomide
Blood Protein Disorders
Antineoplastic Agents
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Paraproteinemias
Hemostatic Disorders
Hormones
Anti-Bacterial Agents
Hemorrhagic Disorders
Therapeutic Uses
Cardiovascular Diseases
Growth Inhibitors
Angiogenesis Modulating Agents
Immunoproliferative Disorders
Neoplasms by Histologic Type
Immune System Diseases
Antineoplastic Agents, Hormonal
Hematologic Diseases
Growth Substances
Vascular Diseases
Angiogenesis Inhibitors
Immunosuppressive Agents
Glucocorticoids
Pharmacologic Actions
Multiple Myeloma

ClinicalTrials.gov processed this record on November 30, 2009