Lenalidomide Versus Placebo in Myelodysplastic Syndromes With a Deletion 5q[31] Abnormality

• Status: Completed
• Trial end date: 2010-06-01
• Target enrollment: 0
• Participant gender: All

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 associated with a deletion (del) 5q[31] cytogenetic abnormality. Study participants were randomized to one of the two treatment groups or to placebo and took the study drug for 16 weeks. At this timepoint, participants were evaluated for erythroid response. If participants did not achieve at least a minor erythroid response, they were discontinued from the Double-Blind phase and entered into the Open-Label phase. All erythroid responders at Week 16 were to continue in the Double-Blind phase for up to 52 weeks. For participants that were still responding at the end of Double-Blind phase, they could then rollover into the Open-Label phase for an additional two years. Participants could remain on study for up to a total of 3 years. All participants who discontinued from the study were followed every 4 months for overall survival and progression to acute myeloid leukemia (AML).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Celgene Corporation
• Collaborator: ICON Clinical Research
• Treatments: Lenalidomide; Thalidomide

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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