Myelodysplastic Syndromes Clinical Trial
| Verified date | May 2004 |
| Source | Celgene |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Food and Drug Administration |
| Study type | Interventional |
The primary objective of the study is to determine the efficacy of thalidomide for the treatment of anemia in patients with myelodysplastic syndromes (MDS).
| Status | Completed |
| Enrollment | 220 |
| Est. completion date | February 2004 |
| Est. primary completion date | |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years to 80 Years |
| Eligibility |
- Eligible patients must have a diagnosis of myelodysplastic syndrome - Life expectancy of at least 6 months. - Patients must be able to adhere to the study visit schedule and other protocol requirements. - Patients must understand and voluntarily sign an informed consent document. - Women of childbearing potential (WCBP) must agree to practice abstinence or to use TWO methods of contraception beginning 4 weeks prior to the start of study medication and throughout the course of treatment. - Males must use barrier contraception when engaging in reproductive sexual activity with women of childbearing potential. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| United States | Northwest Medical Specialists | Arlington Heights | Illinois |
| United States | Roswell Park Cancer Institute | Buffalo | New York |
| United States | Oncology Associates | Cedar Rapids | Iowa |
| United States | Oncology/Hematology Care Inc | Cincinnati | Ohio |
| United States | Texas Oncology PA-BMT Center | Dallas | Texas |
| United States | SMDC Health Systems | Duluth | Minnesota |
| United States | Florida Cancer Specialists | Fort Myers | Florida |
| United States | Southeast Florida Hematology-Oncology | Ft. Lauderdale | Florida |
| United States | Northwestern Carolina Hematology Oncology PA | Hickory | North Carolina |
| United States | Jackson Oncology Associates PLLC | Jackson | Mississippi |
| United States | Medical Oncology Associates | Kingston | Pennsylvania |
| United States | Scripps Cancer Center | La Jolla | California |
| United States | Lancaster Cancer Center LTD | Lancaster | Pennsylvania |
| United States | Southern Nevada Cancer Research Foundation | Las Vegas | Nevada |
| United States | Memorial Sloan Kettering Cancer Ctr | New York | New York |
| United States | VAMC Northport | Northport | New York |
| United States | Whittingham Cancer Center | Norwalk | Connecticut |
| United States | Comprehensive Cancer Centers of the Desert | Palm Springs | California |
| United States | Hematology Oncology Associates of NJ | Paramus | New Jersey |
| United States | MCP Hahnemann University | Philadelphia | Pennsylvania |
| United States | Western Pennsylvania Cancer Institute | Pittsburgh | Pennsylvania |
| United States | Oregon Health & Science University | Portland | Oregon |
| United States | Central Utah Medical Clinic | Provo | Utah |
| United States | Desert Hematology Oncology Medical Group INC | Rancho Mirage | California |
| United States | Mayo Clinic | Rochester | Minnesota |
| United States | University of Rochester Cancer Center | Rochester | New York |
| United States | South Shore Hem-Onc Assoc. PA | Rockville Centre | New York |
| United States | Beaumont Cancer Center | Royal Oak | Michigan |
| United States | InterMountain Hematology/Oncology | Salt Lake City | Utah |
| United States | Swedish Cancer Institute | Seattle | Washington |
| United States | Hematology Oncology Consultants Inc | St. Louis | Missouri |
| United States | Staten Island Unversity Hospital | Staten Island | New York |
| United States | Summit Medical Group/Overlook Oncology Center | Summit | New Jersey |
| United States | Westchester County Medical Center | Valhalla | New York |
| United States | VA Connecticut Healthcare System | West Haven | Connecticut |
| United States | Buffalo Medical Group PC | Williamsville | New York |
| United States | Wake Forest Univ School of Medicine | Winston Salem | North Carolina |
| United States | Yakima Regional CancerCenter | Yakima | Washington |
| Lead Sponsor | Collaborator |
|---|---|
| Celgene Corporation |
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