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| Sponsors and Collaborators: |
National Cancer Institute of Canada 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.
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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
Show 38 Study Locations| 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 Prednisone Immunoproliferative Disorders Immunologic Factors Antineoplastic Agents, Hormonal Thalidomide Blood Protein Disorders Hematologic Diseases Hormone Antagonists Blood Coagulation Disorders Hormones, Hormone Substitutes, and Hormone Antagonists Vascular Diseases |
Paraproteinemias Hemostatic Disorders Angiogenesis Inhibitors Immunosuppressive Agents Hormones Glucocorticoids Multiple Myeloma Anti-Bacterial Agents Hemorrhagic Disorders Lymphoproliferative Disorders Neoplasms, Plasma Cell |
|
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 |