Lenalidomide and Prednisone in Low and Int-1 Myelodysplastic Syndrome (MDS) Non 5q MDS
Condition: Myelodysplastic Syndrome; MDS
MeSH terms: Preleukemia; Myelodysplastic Syndromes; Syndrome
Intervention: Prednisone; Lenalidomide
Intervention description: Prednisone therapy for 6 cycles (24 weeks).; Lenalidomide therapy for 6 cycles (24 weeks).
Intervention MeSH terms: Prednisone; Lenalidomide
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 28.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this research is to evaluate the use of lenalidomide and prednisone in people
      with Myelodysplastic Syndrome (MDS).

      Lenalidomide is a drug that alters the immune system and it may also interfere with the
      development of tiny blood vessels that help support tumor growth. Therefore, in theory, it
      may reduce or prevent the growth of cancer cells. Lenalidomide is approved by the U.S. Food
      and Drug Administration (FDA) for the treatment of specific types of myelodysplastic syndrome
      (MDS) and in combination with dexamethasone for people with multiple myeloma (MM) who have
      received at least 1 prior therapy. MDS and MM are cancers of the blood. It is currently being
      tested in a variety of cancer conditions. As it is being used in this study it is considered
      an investigational use. An "investigational use" is a use that is being tested and is not
      approved by the FDA.

      Prednisone is approved by the FDA to treat numerous conditions. In addition, prednisone is
      approved by the FDA to treat Low or Intermediate-1 IPSS Risk, non-del (5q) MDS.

      "Study drug" refers to the combination of lenalidomide and prednisone.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Understand and voluntarily sign an informed consent form

          -  Age ≥ 18 years at the time of signing the informed consent form

          -  Able to adhere to the study visit schedule and other protocol requirements

          -  Documented diagnosis of MDS according Word Health Organization (WHO) that meets
             International Prognostic Scoring System (IPSS) criteria for Low- to
             Intermediate-1-risk disease or non-proliferative (white blood count [WBC] < 13,000/uL)
             chronic myelomonocytic leukemia (CMML) and MDS/myeloproliferative neoplasms (MPN).

          -  Absence of a chromosome 5q deletion by metaphase cytogenetics or fluorescent in situ
             hybridization (FISH) analysis

          -  Red blood cell (RBC) transfusion-dependent anemia defined as having received ≥4
             transfusions of RBCs for hemoglobin (Hgb) ≤ 9.0 g/dl within 56 days of randomization
             or symptomatic anemia (Hgb ≤ 9.0 g/dl)

          -  No response or progression on prior treatment with epoetin alpha (> 40,000 U/wk x 6),
             darbepoetin alpha (≥ 500 mcg q 3 wk x 2) or serum erythropoietin (EPO) concentration ≥
             500 mU/ml

          -  All previous cancer therapy, including radiation, hormonal therapy and surgery, must
             have been discontinued at least 4 weeks prior to treatment in this study.

          -  Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2 at study entry

          -  Laboratory test results within these ranges: Absolute neutrophil count ≥ 500 /mm³;
             Platelet count ≥ 50,000 /mm³; Creatinine Clearance > 60 mL/min by Cockcroft-Gault
             formula; Total bilirubin ≤ 1.5 mg/dl; aspartic transaminase (AST)and alanine
             transaminase (ALT) ≤ 2 x upper limit of normal (ULN).

          -  Disease free of prior malignancies for ≥ 3 years with exception of currently treated
             basal cell, squamous cell carcinoma of the skin, or carcinoma "insitu" of the cervix
             or breast

          -  Must be registered into the mandatory RevAssist® program, and be willing and able to
             comply with the requirements of RevAssist®.

          -  Females of childbearing potential (FCBP)† must have a negative serum or urine
             pregnancy test with a sensitivity of at least 50 milli-international units per
             milliliter (mIU/mL) within 10 - 14 days prior to and again within 24 hours of
             prescribing lenalidomide (prescriptions must be filled within 7 days) and must either
             commit to continued abstinence from heterosexual intercourse or begin TWO acceptable
             methods of birth control, one highly effective method and one additional effective
             method AT THE SAME TIME, at least 28 days before she starts taking lenalidomide. FCBP
             must also agree to ongoing pregnancy testing. Men must agree to use a latex condom
             during sexual contact with a FCBP even if they have had a successful vasectomy.

        Exclusion Criteria:

          -  Any serious medical condition, laboratory abnormality, or psychiatric illness that
             would prevent the patient from signing the informed consent form.

          -  Pregnant or breast feeding. (Lactating females must agree not to breast feed while
             taking lenalidomide).

          -  Any condition, including the presence of laboratory abnormalities, which places the
             subject at unacceptable risk if he/she were to participate in the study or confounds
             the ability to interpret data from the study.

          -  Use of any other experimental drug or therapy within 28 days of baseline

          -  Known hypersensitivity to thalidomide

          -  The development of erythema nodosum if characterized by a desquamating rash while
             taking thalidomide or similar drugs or history of desquamating (blistering) rash while
             taking thalidomide

          -  Any prior use of lenalidomide

          -  Concurrent use of other anti-cancer agents or treatments

          -  Known positive for human immunodeficiency virus (HIV) or infectious hepatitis, type B
             or C

          -  Proliferative CMML (WBC ≥13,000/μL)

          -  MDS secondary to treatment with radiotherapy, chemotherapy, and/or immunotherapy for
             malignant or autoimmune diseases

          -  Prior ≥ grade-2 National Cancer Institute Common Terminology Criteria for Adverse
             Events (NCI CTCAE) allergic reaction to thalidomide

          -  Clinically significant anemia due to factors such as iron, B12 or folate deficiencies,
             autoimmune or hereditary hemolysis or gastrointestinal bleeding

          -  Known HIV-1 positivity

          -  Chromosome 5q deletion

          -  Documented thromboembolic event within the past 3 years