A Phase II Study of CC-5013 in Myelofibrosis
Condition: Myelofibrosis
MeSH terms: Primary Myelofibrosis
Intervention: CC-5013
Intervention description: 10 mg orally (2 capsules) daily
Intervention MeSH terms: Lenalidomide
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 41.0
Sex: All
Healthy volunteers: No
Keywords: Myelofibrosis; Philadelphia negative myeloproliferative disorder; CC-5013; Lenalidomide; Revlimid; Antiangiogenesis

Summary:

      The goal of this clinical research study is to learn if CC-5013 (lenalidomide) can help to
      control myelofibrosis. The safety of lenalidomide in the treatment of myelofibrosis will also
      be studied.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of myelofibrosis or Philadelphia negative myeloproliferative disorder with
             myelofibrosis requiring therapy.

          -  Disease-free of prior malignancies for greater than or equal to 2 years with exception
             of basal cell, squamous cell carcinoma of the skin, or carcinoma "in situ" of the
             cervix or breast.

          -  Eastern Cooperative Oncology Group (ECOG) performance status 0 to 3.

          -  Total bilirubin less than or equal to 3.0 mg/dL (unless due to tumor) and serum
             creatinine less than or equal to 3.0 mg/dL (unless due to tumor).

          -  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.

          -  continued from above.....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.

          -  continued from above.....† 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).

          -  Signed informed consent.

        Exclusion Criteria:

          -  Use of any other experimental drug or therapy within 28 days of therapy, except in
             cases with rapidly progressive disease and/or recovery from all toxicity from previous
             therapy (does not apply to growth factors).

          -  Platelet count less than 30,000.

          -  Known prior clinically relevant hypersensitivity reaction or desquamating rash with
             thalidomide.

          -  Prior therapy with CC-5013.

          -  Pregnancy, suspected pregnancy or breast feeding females.