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| Sponsor: | NCIC Clinical Trials Group |
|---|---|
| Collaborators: |
National Cancer Institute (NCI) Eastern Cooperative Oncology Group |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00049673 |
Purpose
RATIONALE: Thalidomide may stop the growth of multiple myeloma by stopping blood flow to the tumor. It is not yet known whether combining thalidomide with prednisone and giving them after autologous stem cell transplantation may be effective in treating multiple myeloma.
PURPOSE: This randomized phase III trial is studying thalidomide and prednisone to see how well they work compared to observation in treating patients who have undergone stem cell transplantation for multiple myeloma.
| Condition | Intervention | Phase |
|---|---|---|
|
Multiple Myeloma and Plasma Cell Neoplasm |
Drug: prednisone Drug: thalidomide Procedure: observation |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Active Control |
| Official Title: | A Randomized Phase III Study Of Thalidomide And Prednisone As Maintenance Therapy Following Autologous Stem Cell Transplant in Patients With Multiple Myeloma |
| Estimated Enrollment: | 324 |
| Study Start Date: | September 2002 |
| Estimated Primary Completion Date: | July 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Arm I: Experimental
Patients receive oral thalidomide daily and oral prednisone every other day for 4 years in the absence of disease progression or unacceptable toxicity.
|
Drug: prednisone
Given orally
Drug: thalidomide
Given orally
|
|
Arm II: No Intervention
Patients undergo observation.
|
Procedure: observation
No intervention
|
OBJECTIVES:
OUTLINE: This is a randomized, non-blinded, multicenter study. Patients are stratified according to treatment center, age (under 60 vs 60 and over), and response to prior transplantation (complete vs incomplete). Patients are randomized to 1 of 2 treatment arms.
After the treatment/observation period, patients are followed every 6 months for 1 year and then annually thereafter.
PROJECTED ACCRUAL: A total of 324 patients will be accrued for this study within 3.5 years.
Eligibility| Ages Eligible for Study: | 16 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed multiple myeloma as evidenced by one of the following:
Previously treated with autologous stem cell transplantation after high-dose melphalan (200 mg/m^2) within the past 60-100 days
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
No prior spontaneous deep vein thrombosis within the past 5 years
Pulmonary
Other
No diabetes with end-organ damage defined as:
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
Contacts and Locations
Hide Study Locations| United States, Arizona | |
| Mayo Clinic Scottsdale | Recruiting |
| Scottsdale, Arizona, United States, 85259-5499 | |
| Contact: Clinical Trials Office - All Mayo Clinic Locations 507-538-7623 | |
| United States, Florida | |
| Mayo Clinic - Jacksonville | Recruiting |
| Jacksonville, Florida, United States, 32224 | |
| Contact: Clinical Trials Office - All Mayo Clinic Locations 507-538-7623 | |
| United States, Georgia | |
| MBCCOP - Medical College of Georgia Cancer Center | Recruiting |
| Augusta, Georgia, United States, 30912 | |
| Contact: Anand P. Jillella, MD 706-721-2505 | |
| United States, Michigan | |
| CCOP - Michigan Cancer Research Consortium | Recruiting |
| Ann Arbor, Michigan, United States, 48106 | |
| Contact: Philip J. Stella, MD 734-712-1000 | |
| Oakwood Cancer Center at Oakwood Hospital and Medical Center | Recruiting |
| Dearborn, Michigan, United States, 48123-2500 | |
| Contact: Clinical Trials Office - Oakwood Cancer Center at Oakwood Hosp 313-593-8090 | |
| Genesys Hurley Cancer Institute | Recruiting |
| Flint, Michigan, United States, 48503 | |
| Contact: Clinical Trials Office - Genesys Hurley Cancer Institute 810-762-8057 | |
| Hurley Medical Center | Recruiting |
| Flint, Michigan, United States, 48503 | |
| Contact: Clinical Trials Office - Hurley Medical Center 810-762-8057 | |
| Mercy Regional Cancer Center at Mercy Hospital | Recruiting |
| Port Huron, Michigan, United States, 48060 | |
| Contact: Philip J. Stella, MD 734-712-1000 | |
| Foote Memorial Hospital | Recruiting |
| Jackson, Michigan, United States, 49201 | |
| Contact: Philip J. Stella, MD 734-712-1000 | |
| Saint Joseph Mercy Cancer Center | Recruiting |
| Ann Arbor, Michigan, United States, 48106-0995 | |
| Contact: Philip J. Stella, MD 734-712-1000 | |
| Seton Cancer Institute at Saint Mary's - Saginaw | Recruiting |
| Saginaw, Michigan, United States, 48601 | |
| Contact: Clinical Trials Office - Seton Cancer Institute - Saginaw 989-776-8411 | |
| Sparrow Regional Cancer Center | Recruiting |
| Lansing, Michigan, United States, 48912-1811 | |
| Contact: Clinical Trials Office - Sparrow Regional Cancer Center 517-364-2890 | |
| St. John Macomb Hospital | Recruiting |
| Warren, Michigan, United States, 48093 | |
| Contact: Philip J. Stella, MD 734-712-1000 | |
| St. Joseph Mercy Oakland | Recruiting |
| Pontiac, Michigan, United States, 48341-2985 | |
| Contact: Philip J. Stella, MD 734-712-1000 | |
| St. Mary Mercy Hospital | Recruiting |
| Livonia, Michigan, United States, 48154 | |
| Contact: Philip J. Stella, MD 734-712-1000 | |
| Van Elslander Cancer Center at St. John Hospital and Medical Center | Recruiting |
| Grosse Pointe Woods, Michigan, United States, 48236 | |
| Contact: Clincial Trials Office - Van Elslander Cancer Center at St. Jo 313-343-3166 | |
| United States, Minnesota | |
| Mayo Clinic Cancer Center | Recruiting |
| Rochester, Minnesota, United States, 55905 | |
| Contact: Clinical Trials Office - All Mayo Clinic Locations 507-538-7623 | |
| United States, Pennsylvania | |
| Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center | Recruiting |
| Wilkes-Barre, Pennsylvania, United States, 18711 | |
| Contact: Clinical Trials Office - Frank M. and Dorothea Henry Cancer Ce 570-271-5251 | |
| Geisinger Cancer Institute at Geisinger Health | Recruiting |
| Danville, Pennsylvania, United States, 17822-0001 | |
| Contact: Clinical Trials Office - Geisinger Cancer Institute 570-271-5251 | |
| Geisinger Medical Group - Scenery Park | Recruiting |
| State College, Pennsylvania, United States, 16801 | |
| Contact: Adel Z. Makary, MD 570-271-6045 | |
| Canada, Alberta | |
| Cross Cancer Institute at University of Alberta | Recruiting |
| Edmonton, Alberta, Canada, T6G 1Z2 | |
| Contact: Andrew Belch 780-432-8757 | |
| Tom Baker Cancer Centre - Calgary | Recruiting |
| Calgary, Alberta, Canada, T2N 4N2 | |
| Contact: Nizar Jacques Bahlis 403-944-1564 | |
| Canada, British Columbia | |
| British Columbia Cancer Agency - Vancouver Cancer Centre | Recruiting |
| Vancouver, British Columbia, Canada, V5Z 4E6 | |
| Contact: Kevin W.J. Song 604-875-4863 | |
| Canada, Manitoba | |
| CancerCare Manitoba | Recruiting |
| Winnipeg, Manitoba, Canada, R3E 0V9 | |
| Contact: Morel Rubinger 204-787-3594 | |
| Canada, New Brunswick | |
| Moncton Hospital | Recruiting |
| Moncton, New Brunswick, Canada, E1C 6Z8 | |
| Contact: Sheldon Rubin 506-857-2881 | |
| Saint John Regional Hospital | Recruiting |
| Saint John, New Brunswick, Canada, E2L 4L2 | |
| Contact: Margot Burnell 506-648-6884 | |
| Canada, Newfoundland and Labrador | |
| Doctor H. Bliss Murphy Cancer Centre | Recruiting |
| St. John's, Newfoundland and Labrador, Canada, AIB 3V6 | |
| Contact: Kirsty A. Tompkins 709-777-8062 | |
| Canada, Nova Scotia | |
| Nova Scotia Cancer Centre | Recruiting |
| Halifax, Nova Scotia, Canada, B3H 1V7 | |
| Contact: Darrell White 902-473-7922 | |
| Canada, Ontario | |
| Cancer Centre of Southeastern Ontario at Kingston General Hospital | Recruiting |
| Kingston, Ontario, Canada, K7L 5P9 | |
| Contact: John H. Matthews 613-533-6329 | |
| Edmond Odette Cancer Centre at Sunnybrook | Recruiting |
| Toronto, Ontario, Canada, M4N 3M5 | |
| Contact: Kevin R. Imrie 416-480-5000 | |
| London Regional Cancer Program at London Health Sciences Centre | Recruiting |
| London, Ontario, Canada, N6A 4L6 | |
| Contact: Michael J. Kovacs 519-685-8500 | |
| Margaret and Charles Juravinski Cancer Centre | Recruiting |
| Hamilton, Ontario, Canada, L8V 5C2 | |
| Contact: Deborah Marcellus 905-575-9827 | |
| Princess Margaret Hospital | Recruiting |
| Toronto, Ontario, Canada, M5G 2M9 | |
| Contact: Suzanne Marie Trudel 416-946-4566 | |
| Canada, Quebec | |
| CHUS-Hopital Fleurimont | Recruiting |
| Sherbrooke, Quebec, Canada, J1H 5N4 | |
| Contact: Richard Le Blanc 819-346-1110 | |
| Hopital du Saint-Sacrement - Quebec | Recruiting |
| Quebec City, Quebec, Canada, G1S 4L8 | |
| Contact: Guy Cantin 418-682-7511 | |
| Maisonneuve-Rosemont Hospital | Recruiting |
| Montreal, Quebec, Canada, H1T 2M4 | |
| Contact: Jean Roy 514-252-3404 | |
| McGill Cancer Centre at McGill University | Recruiting |
| Montreal, Quebec, Canada, H2W 1S6 | |
| Contact: Chaim Shustik 514-398-1444 | |
| Canada, Saskatchewan | |
| Saskatoon Cancer Centre at the University of Saskatchewan | Recruiting |
| Saskatoon, Saskatchewan, Canada, S7N 4H4 | |
| Contact: Michael Voralia 306-655-2925 | |
| Study Chair: | A. Keith Stewart, MD | Mayo Clinic Scottsdale |
| Study Chair: | Philip R. Greipp, MD | Mayo Clinic |
More Information
| Responsible Party: | NCIC-Clinical Trials Group ( Lois Shepherd ) |
| Study ID Numbers: | CDR0000258158, CAN-NCIC-MY10, CAN-NCIC-JMY10, ECOG-NCIC-JMY10 |
| Study First Received: | November 12, 2002 |
| Last Updated: | April 7, 2009 |
| ClinicalTrials.gov Identifier: | NCT00049673 History of Changes |
| Health Authority: | Unspecified |
|
stage I multiple myeloma stage II multiple myeloma stage III multiple myeloma |
|
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 |