Lenalidomide and Darbepoetin in Low-Intermediate Risk Myelodysplastic Syndrome (MDS)
Condition: Leukemia
MeSH terms: Preleukemia; Myelodysplastic Syndromes
Intervention: Lenalidomide; Darbepoetin alfa
Intervention description: 10 mg/day by mouth on days 1-21 of every 28 day cycle.; 200 mcg subcutaneously every 2 weeks of a 28 cycle.
Intervention MeSH terms: Lenalidomide; Darbepoetin alfa
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 1.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Myelodysplastic Syndrome; Red cell transfusion independence; Darbepoetin alfa; Lenalidomide; CC-5013; Revlimid; Aranesp; Erythropoietin; Erythropoiesis Stimulating Protein

Summary:

      The goal of this clinical research study is to learn if lenalidomide and darbepoetin alfa
      given together will help to control the need for transfusions in patients with low to
      intermediate risk Myelodysplastic Syndrome (MDS). The safety of this combination will also be
      studied.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Understand and voluntarily sign an informed consent form.

          2. Age >/=18 years at the time of signing the informed consent form.

          3. Able to adhere to the study visit schedule and other protocol requirements.

          4. Have low or intermediate-1 IPSS risk category MDS (excluding 5q deletion)

          5. red blood cell (RBC) transfusion-dependent anemia defined as no transfusion free
             interval of >/= 56 consecutive days within the past 112 days.

          6. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 at study entry.

          7. Laboratory test results within these ranges: Serum creatinine </= 1.5 mg/dL ,Total
             bilirubin </= 1.5 mg/dL ,AST (SGOT) and ALT (SGPT) </= 3 x ULN, ANC >/= 500 /uL,
             Platelet count >/= 30,000/uL (untransfused)

          8. Disease free of prior malignancies for >/=2 years with exception of currently treated
             basal cell, squamous cell carcinoma of the skin, or carcinoma "insitu" of the cervix
             or breast

          9. Patients who are on epoetin alfa or darbepoetin prior to enrollment will be allowed to
             enroll if they have failed such therapy, failure defined as transfusion requiring
             despite >/= 6 weeks of epoetin alfa at dose of 40,000 units/week and darbepoetin alfa
             at dose of 150 mcg/ 2 week. No washout period will be necessary. Upon study entry
             patients receiving epoetin alfa will be switched over to darbepoetin.

         10. Females of childbearing potential (FCBP) must have a negative serum or urine pregnancy
             test with a sensitivity of at least 50 mIU/mL within 10-14 days prior to and again
             within 24 hours of prescribing lenalidomide 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 4 weeks before she starts taking lenalidomide. FCBP must also agree to
             ongoing pregnancy testing.

         11. continued from #10 Men must agree to use a latex condom during sexual contact with a
             female of child bearing potential even if they have had a successful vasectomy.

        Exclusion Criteria:

          1. Clinically significant anemia owing to iron, B12, or folate deficiencies.

          2. Any serious medical condition, laboratory abnormality, or psychiatric illness that
             would prevent the subject from signing the informed consent form.

          3. Pregnant or breast feeding females. (Lactating females must agree not to breast feed
             while taking lenalidomide)

          4. Concomitant use of steroids will not be allowed unless used for premedication in
             preparation for transfusions, treatment of hypersensitivity reaction related to
             lenalidomide or any underlying medical condition other than MDS (e.g. Chronic
             Obstructive Pulmonary Disease (COPD)).

          5. 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.

          6. Use of any other experimental drug or therapy within 28 days of baseline.

          7. Known hypersensitivity to thalidomide.

          8. The development of erythema nodosum if characterized by a desquamating rash while
             taking thalidomide or similar drugs.

          9. Any prior use of lenalidomide.

         10. Concurrent use of other anti-cancer agents or treatments.

         11. Known positive for HIV or infectious hepatitis, type A, B or C.

         12. Hypersensitivity to darbepoetin or any component of the formulation (including
             polysorbate 80 and/or albumin);

         13. Uncontrolled hypertension