Status:
COMPLETED
Lenalidomide Versus Placebo in Myelodysplastic Syndromes With a Deletion 5q[31] Abnormality
Lead Sponsor:
Celgene Corporation
Collaborating Sponsors:
ICON Clinical Research
Conditions:
Myelodysplastic Syndromes
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The purpose of this study was to compare 2 doses (10 mg and 5 mg) of lenalidomide to that of placebo in subjects with red blood cell (RBC) transfusion-dependent low- or intermediate-1-risk IPSS MDS as...
Detailed Description
MDS-004 was a multicenter, randomized, double-blind, placebo-controlled, 3-arm study of 2 doses of lenalidomide versus placebo administered to RBC transfusion-dependent adults with low- or intermediat...
Eligibility Criteria
Inclusion
- Must understand and voluntarily sign an informed consent form
- Age 18 years at the time of signing the informed consent form
- Documented diagnosis of myelodysplastic syndromes (MDS) that meets International Prognostic Scoring System (IPSS) criteria for low to intermediate-1-risk disease and has an associated del 5q(31) cytogenetic abnormality
- Red blood cell (RBC) transfusion dependent anaemia defined as not having any 56 days without a RBC transfusion within at least the immediate 112 days
- Must be able to adhere to the study visit schedule and other protocol requirements
- Women of childbearing potential must have a negative pregnancy test prior to inclusion
Exclusion
- Pregnant or lactating females
- Prior therapy with lenalidomide
- Proliferative (white blood cell (WBC)= 12,000/mL) chronic myelomonocytic leukemia (CMML)
- Prior \>= grade-2 (using the National Cancer Institute (NCI)'s Common Terminology Criteria for AEs (CTCAE) (v 3.0)) allergic reaction to thalidomide
- Prior desquamating (blistering) rash while taking thalidomide
- Prior history of malignancy other than MDS (except basal cell or squamous cell carcinoma or carcinoma in situ of the cervix or breast) unless the subject has been free of disease for \>3 years
- Use of cytotoxic chemotherapeutic agents or experimental agents (agents that are not commercially available) for the treatment of MDS within 28 days
- Less than 6 months since prior allogeneic bone marrow transplantation
- Less than 3 months since prior autologous bone marrow or stem cell transplantation
- Less than 28 days since prior myelosuppressive anticancer biologic therapy
- Recombinant human erythropoietin (rHuEPO) therapy received within 28 days
- Known human immunodeficiency virus (HIV-1) positivity
- Any serious medical condition or psychiatric illness that will prevent the subject from signing the informed consent form or will place the subject at unacceptable risk if he or she participates in the study
Key Trial Info
Start Date :
July 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2010
Estimated Enrollment :
205 Patients enrolled
Trial Details
Trial ID
NCT00179621
Start Date
July 1 2005
End Date
June 1 2010
Last Update
April 14 2011
Active Locations (38)
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1
AZ St-Jan Brugge AV
Bruges, Belgium, 8000
2
UZ Gent
Ghent, Belgium, 900
3
UZ Gasthuisberg
Leuven, Belgium, 3000
4
CHU Mont Godine
Yvoir, Belgium, 5530