Please select the eligibility criteria that correspond to the clinical trial below.
Title: Evaluation of Lenalidomide (CC-5013) and Prednisone as a Therapy for Patients With Myelofibrosis (MF)
Brief 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.


Options:
A: Inclusion Criteria:

* Diagnosed with PMF or Post-PV/ET MF
* Patients with myelofibrosis requiring therapy
* Adequate bone marrow reserve

Exclusion Criteria:

* Received anti-cancer medications or investigational therapy in the past 14 days
B: Inclusion Criteria:

* Patient must be diagnosed with myelofibrosis with myeloid metaplasia (MMM); agnogenic myeloid metaplasia, post-polycythemic myeloid metaplasia, or post-thrombocythemic myeloid metaplasia are included

  * NOTE: Diagnosis must be confirmed by central pathology review; diagnostic samples must be submitted; patient may register and begin treatment based on the local pathology review. If the central review does not confirm patient's eligibility to participate in the trial, protocol treatment must be discontinued
* Patient must have discontinued chemotherapy (hydroxyurea, alpha interferon, anagrelide, other myelosuppressive agents, thalidomide, or any other experimental therapy) as well as growth factors and systemic use of corticosteroids \>= 28 days prior to starting study drug

  * All non-hematologic toxicity must be resolved to =\< grade 1
* Patient must be lenalidomide-naïve (never treated with lenalidomide)
* ECOG performance status (PS) of 0, 1, or 2 at study entry
* Hemoglobin level =\< 10 g/dL or transfusion-dependent
* Absolute neutrophil count \>= 1,000 uL
* Platelet count \>= 100,000 uL
* Serum creatinine =\< 2.0 mg/dL
* Total bilirubin =\< 2.0 mg/dL (if elevated; direct bilirubin =\< 2.0 mg/dL)
* AST (SGOT) =\< 3 x ULN unless attributed to hepatic extramedullary hematopoiesis
* Women must not be pregnant or breastfeeding because this study involves an investigational agent whose genotoxic, mutagenic, and teratogenetic effects on the developing fetus and newborn are unknown; women of childbearing potential who are sexually active, must use 2 accepted methods of birth control at the same time for 4 weeks prior to lenalidomide treatment, during lenalidomide treatment, and up to 4 weeks after lenalidomide treatment is finished; sexually active males must use a latex condom for contraception during the study and up to 4 weeks after treatment with lenalidomide has ended

  * All females of childbearing potential must have a blood test 10-14 days prior to the start of lenalidomide treatment to rule out pregnancy; another blood test to rule out pregnancy must be done 24 hours prior to the start of treatment with lenalidomide
* Patient must not have any condition, including the presence of laboratory abnormalities, which, based on the physician's opinion, places the patient at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study
* Patient must not have any known hypersensitivity to thalidomide or lenalidomide
* Patient must not have any known positive status for HIV or infectious hepatitis type A, B or C
* Patient must not have any other active malignancy

  * NOTE: SWOG patients are strongly encouraged to be registered on SWOG-9007 ("Cytogenetic Studies in Leukemia Patients"); SWOG institutions registering patients to SWOG-9007 should follow the instructions for specimen submission
C: 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.
D: Inclusion Criteria:

* Subjects must be diagnosed with primary myelofibrosis (PMF), post-polycythemia vera-myelofibrosis (PPV-MF) or post-essential thrombocythemia-myelofibrosis (PET-MF) according to the 2008 World Health Organization criteria
* Subjects with myelofibrosis requiring therapy must be classified as high risk OR intermediate risk level 2 according to the prognostic factors defined by the International Working Group
* Subjects with an Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, 2 or 3
* Subjects who have not previously received treatment with a Janus kinase (JAK) inhibitor

Exclusion Criteria:

* Subjects with a life expectancy of less than 6 months
* Subjects with inadequate bone marrow reserve as demonstrated by specific clinical laboratory counts
* Subjects with inadequate liver or renal function
* Subjects with clinically significant bacterial, fungal, parasitic or viral infection which require therapy
* Subjects with an active malignancy over the previous 5 years except specific skin cancers.
* Subjects with severe cardiac conditions
* Subjects who have had splenic irradiation within 12 months

Answer: C