A Study of Lenalidomide Versus Placebo in Subjects With Transfusion Dependent Anemia in Lower Risk Myelodysplastic Syndrome (MDS) Without Del 5q
Condition: Anemia
MeSH terms: Preleukemia; Anemia; Myelodysplastic Syndromes
Intervention: Lenalidomide; Placebo
Intervention description: One 10 mg Lenalidomide capsule + 2 placebo capsules or (3 placebo capsules) once daily for subjects with a creatinine clearance ≥ 60 mL/min. Alternatively-one 5 mg Lenalidomide capsule + 2 placebo capsules (or 3 placebo capsules) once daily for subjects with a creatinine clearance between 40 and 60 mL/min. Subjects may take study drug for at least 168 days unless there are intolerable side effects or disease progresses. Subjects may continue study drug beyond 168 days if they have an erythroid response (increase in their hemoglobin levels and fewer transfusions administered than before starting study drug); 3 placebo capsules once daily. Subjects may take study drug for at least 168 days unless there are intolerable side effects or disease progresses. Subjects may continue study drug beyond 168 days if they have an erythroid response (increase in their hemoglobin levels and fewer transfusions administered than before starting study drug)
Intervention MeSH terms: Lenalidomide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 239.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Myelodysplastic Syndromes; MDS; transfusion dependent anemia; Erythropoiesis stimulating agents; non-del 5q

Summary:

      The purpose of this study is to investigate whether lenalidomide would reduce the number of
      red blood cell transfusions (RBC) needed in anemic (RBC transfusion-dependent) participants
      with low or intermediate-1 risk MDS without a deletion 5q chromosome abnormality. The study
      also investigated the safety of lenalidomide use in these participants. Two-thirds of the
      participants received oral lenalidomide and one-third of the participants received oral
      placebo.
    

Eligibility criteria:

        Inclusion Criteria:

          -  18 years or older

          -  Diagnosis of low or intermediate-1 risk Myelodysplastic (MDS) with any chromosome
             karyotype except del 5q[31]

          -  Anemia that requires red blood cell transfusions

          -  Resistant to erythropoiesis stimulating agents (ESAs) or blood erythropoietin level >
             500 mU/mL

          -  Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) ≤ 2

          -  Must agree to follow pregnancy precautions as required by the protocol.

          -  Must agree to receive counseling related to teratogenic and other risks of
             lenalidomide

          -  Must agree not to donate blood or semen

          -  Must be willing to consent to two or more bone marrow aspirate procedures to be
             completed during study

        Exclusion Criteria:

          -  Subjects previously receiving immunomodulating or immunosuppressive agents, or
             epigenetic or deoxyribonucleic acid (DNA) modulation agents

          -  Allergic reaction to thalidomide

          -  Renal insufficiency creatinine clearance (CrC1)<40 mL/min by Cockcroft-Gault method)

          -  Prior history of cancer, other than MDS, unless the subject has been free of the
             disease for ≥ 5 years. (Basal cell carcinoma of the skin, carcinoma in situ of the
             cervix, or stage Tumor (T) 1a or T1b prostate cancer is allowed)

          -  Absolute neutrophil count (ANC) < 500/uL

          -  Platelets < 50,000/uL

          -  Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 3X upper limit of
             normal

          -  Uncontrolled hyperthyroidism or hypothyroidism

          -  Significant neuropathy

          -  Prior stem cell transplantation

          -  Anemia due to reasons other than MDS

          -  History of deep venous thrombosis (DVT) or pulmonary embolus (PE) within past 3 years

          -  Significant active cardiac disease within the past 6 months

          -  Known Human Immunodeficiency Virus (HIV) infection; known Hepatitis C infection or
             active Hepatitis B infection