Lenalidomide for Patients With Myelofibrosis (MF)
Condition: Myelofibrosis
MeSH terms: Primary Myelofibrosis
Intervention: Lenalidomide; Prednisone
Intervention description: Oral 10 mg daily/days 1-21 of 28 day cycle; Starting dose oral 30 mg/day during cycle 1, 15 mg/day during cycle 2, and 15 mg every other day during cycle 3, and then it will be discontinued.
Intervention MeSH terms: Prednisone; Lenalidomide
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 40.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Combination chemotherapy; Myelofibrosis (MF)

Summary:

      The goal of this clinical research study is to learn if lenalidomide in combination with
      prednisone can help to control myelofibrosis. The safety of lenalidomide and prednisone for
      the treatment of myelofibrosis will also be studied.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Diagnosis of myelofibrosis requiring therapy, including those previously treated and
             relapsed or refractory, or if newly diagnosed, with intermediate or high risk
             according to Lille scoring system (risk factors are: Hb < 10 g/dl, White blood count
             (WBC) < 4 or > 30 x 109/L; risk group: 0 factor(s) = low, 1 factor(s) = intermediate,
             2 factor(s) = high) or with symptomatic splenomegaly

          2. Understanding and voluntary signing an Institutional Review Board (IRB)-approved
             informed consent form.

          3. Age >/= 18 years at the time of signing the informed consent.

          4. Disease-free of prior malignancies for >/= 2-years with exception of basal cell or
             squamous cell carcinoma of the skin, or carcinoma "in situ" of the cervix or breast.

          5. Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2.

          6. Patients must have adequate organ function as demonstrated by the following: Total
             bilirubin </= 2.0 mg/dL (unless higher due to MF); Serum creatinine </= 2.0 mg/dL
             (unless higher due to MF); Absolute neutrophil count >/= 1 x 10^9/L; Alanine
             transaminase (ALT) </= 3 x upper limit of normal (unless higher due to MF).

          7. 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 starting 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.

          8. Continuation of 7. Men must agree to use a condom during sexual contact with a female
             of child bearing potential even if they have had a successful vasectomy. All patients
             must be counseled at a minimum of every 28 days about pregnancy precautions and risks
             of fetal exposure. See Appendix J: Risks of Fetal Exposure, Pregnancy Testing
             Guidelines and Acceptable Birth Control Methods

          9. footnote to no 7. † A female of childbearing potential is a sexually mature woman who:
             1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been
             naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at
             any time in the preceding 24 consecutive months).

         10. All study participants must be registered into the mandatory RevAssist® program, and
             be willing and able to comply with the requirements of RevAssist®.

        Exclusion Criteria:

          1. Use of any other standard (e.g. hydroxyurea, anagrelide, growth factors) or
             experimental drug or therapy within 28 days of starting lenalidomide and/or lack of
             recovery from all toxicity from previous therapy to grade 1 or better.

          2. Known prior clinically relevant hypersensitivity reaction to thalidomide, including
             the development of erythema nodosum if characterized by a desquamating rash.

          3. Prior therapy with lenalidomide.

          4. Any serious medical condition, laboratory abnormality, or psychiatric illness that
             would prevent the subject from signing the informed consent form.

          5. Suspected Pregnancy. Pregnant or lactating females.

          6. 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.

          7. Known positive for HIV or infectious hepatitis, type A, B or C.

          8. Known prior clinically relevant hypersensitivity to prednisone.

          9. Participants with a heart rate (HR) of less than or equal to 50, as a HR less than 50
             indicates underlying cardiac abnormalities.

         10. Participants with prior history of thromboembolic disease (i.e.-deep venous thrombosis
             (DVT) or pulmonary embolism (PE)) within the last six months, as Lenalidomide has
             demonstrated a significantly increased risk of DVT or PE.