Revlimid in Transfusion Dependent Patients
Condition: Myelodysplastic Syndrome
MeSH terms: Preleukemia; Myelodysplastic Syndromes; Syndrome
Intervention: Revlimid (Lenalidomide)
Intervention description: The starting dose will be 10 mg days 1-28 with the first dose reduction going to 5 mg days 1-28 of a 28 day cycle. Therapy will cease if there is no response after 12 weeks.
Intervention MeSH terms: Lenalidomide
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 57.0
Sex: All
Minimum age: 21 Years
Healthy volunteers: No

Summary:

      This is a prospective trial of Revlimid for subjects who have a blood cell cancer called
      myelodysplastic syndrome (MDS). Cells in their marrow make proteins through messages that are
      carried from the genes. The amount of the message tells researchers if the protein it is
      going to make is high or low. This is known as expression of genes. The purpose of this study
      is to conduct a prospective trial testing the idea that expression of specific genes can help
      to predict which patients will respond to study drug administration with Revlimid
      (lenalidomide).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Understand and voluntarily sign an informed consent form.

          -  Age ≥ 21 years at the time of signing the informed consent form.

          -  Able to adhere to the study visit schedule and other protocol requirements.

          -  A confirmed diagnosis (using standard FAB criteria) of a myelodysplastic syndrome with
             low/Int-1 risk and with a non-del(5q) karyotype must be established.

          -  Patients must have transfusion dependence (at least 2 units within 8 weeks prior to
             starting therapy).

          -  All transfusion dependent non-del(5q) low/Int-1 risk patients will be eligible for
             treatment with Revlimid®

          -  Newly diagnosed as well as previously treated patients will be eligible

          -  Patients with primary de novo or secondary MDS will be eligible

          -  All previous cancer therapy, including radiation, hormonal therapy and surgery, must
             have been discontinued at least 4 weeks prior to treatment in this study.

          -  ECOG performance status of 0-2 at study entry (see Appendix II).

          -  Laboratory test results within these ranges:

               -  Absolute neutrophil count > 250/uL

               -  Platelet count > 30,000/uL

               -  Serum creatinine ≤ 2.0 mg/dL

               -  Total bilirubin ≤ 1.5 mg/dL

               -  AST (SGOT) and ALT (SGPT) ≤ 3 x ULN

               -  BUN ≤ 2 x ULN

          -  Disease free of prior malignancies for ≥ 2 years with exception of currently treated
             basal cell, squamous cell carcinoma of the skin, or carcinoma "in situ" of the cervix
             or breast.

          -  All study participants 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 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 subject from signing the informed consent form.

          -  Pregnant or breast feeding females. (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.

          -  Any clinically significant cardiac disease, including congestive heart failure

          -  Liver function studies including SGOT/SGPT > 3 x ULN

          -  Clinically significant renal disease.

          -  Any previous chemotherapy, hematopoietic growth factors, erythropoietin, or cytokines
             within 4 weeks of starting treatment. Note: prior therapy with G-CSF within 4 weeks is
             allowed.

          -  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.

          -  Any prior use of lenalidomide. (Patients with prior therapy with thalidomide will be
             eligible as long as at least 4 weeks have elapsed between end of the drug and accrual
             on the present trial)

          -  Concurrent use of other anti-cancer agents or treatments.

          -  Known positive for HIV or infectious hepatitis, type B or C.

          -  Life expectancy < 3 months