Please select the eligibility criteria that correspond to the clinical trial below.
Title: Evaluation of Lenalidomide (REVLIMID®) in Cutaneous LE: A Prospective, Non Controlled, Open Label Pilot Study to Evaluate the Off-Label Use of the FDA-approved Drug Lenalidomide (REVLIMID®) in Patients With Cutaneous Lupus Erythematosus
Brief Summary: This study is being conducted to evaluate the safety and effectiveness of lenalidomide (Revlimid®) in subjects with Cutaneous Lupus Erythematosus (CLE). The study drug will be used in an off-label indication to treat 6 subjects for 12 months each. Men and women over the age of 18, who have a biopsy proven diagnosis of CLE and who have failed standard treatment, will be included in the study.


Options:
A: Inclusion Criteria:

* Subjects must understand and voluntarily sign Informed Consent and HIPAA forms.
* Males and females over the age of 18 at the time of signing informed consent form.
* Able to adhere to the study visit schedule and other protocol requirements
* Subjects must have biopsy proven Cutaneous Lupus Erythematosus (CLE) either in the form of Discoid Lupus Erythematosus (DLE) or Subacute Lupus Erythematosus (SCLE), with or without systemic involvement.
* Subjects must have grade II erythema in at least three skin locations as defined by the Cutaneous Lupus Activity and Severity Index (CLASI).
* Subjects must have failed standard treatment with hydroxychloroquine (Plaquenil) for up to three months.
* Female subjects who are not pregnant.
* 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 method AT THE SAME TIME, at least 28 days before starting to take lenalidomide (Revlimid®). FCBP must also agree to ongoing pregnancy testing. Males must agree to use a latex condom during sexual contact with a FCBP even if they have had a successful vasectomy. All subjects must be counseled at a minimum of every 28 days about pregnancy precautions and risks of fetal exposure.
* If pregnancy or a positive pregnancy test is noted in a study subject or in the partner of a male study subject during study participation, the study drug must be discontinued immediately.

Exclusion Criteria:

* Any serious medical condition, laboratory abnormality or psychiatric illness that would prevent the subject from signing the informed consent form.
* Female subjects who are pregnant, plan to be pregnant during the study, or who are breastfeeding.
* Any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk for study participation, or confounds the ability to interpret data from the study.
* 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.
* Prior history of deep vein thrombosis (DVT).
* Prior history of pulmonary embolus (PE).
* Known positive for HIV viral DNA by qPCR.
* Positive hepatitis B surface antigen, or hepatitis C.
* Platelet count \< 50,000/mcL.
* Absolute neutrophil count \< 750/mcL
* Lymphopenia \< 500/mcL.
* Have current signs or symptoms of severe progressive or uncontrolled renal disease (creatinine ≥1.5 x ULN).
* If female, unwillingness to use one highly effective method and one additional method of birth control.
* If male, unwillingness to use a latex condom during intercourse with females of childbearing potential.
* Continued therapy with thalidomide.
B: Inclusion Criteria:

* Diagnosis of SLE by American College of Rheumatology guidelines.
* On stable SLE treatment
* Active SLE disease
* Serologically active
* 18 years of age or older
* Receiving stable doses of prednisone between 7.5 mg and 40 mg per day

Exclusion Criteria:

* Severe active vasculitis, active central nervous system lupus, active lupus nephritis, uncontrolled hypertension, or uncontrolled diabetes.
* Known to be positive for HIV and/or positive at the screening visit for hepatitis B, or hepatitis C.
* Liver disease.
* Anemia, neutropenia, or thrombocytopenia.
* Malignancy within past 5 years
* Active infection requiring hospitalization or treatment with parenteral antibiotics within the past 60 days or history of repeated herpetic viral infections.
* History of active tuberculosis or a history of tuberculosis infection.
* Participation in the active treatment arm of any Phase 2 or Phase 3 clinical trial for a molecule that primarily targets the B cell pathway in the past 18 months.
* Prior administration of any B cell depleting therapy in the past 18 months.
* Pregnant or nursing
* History of congenital immunodeficiency
C: Inclusion Criteria:

* Diagnosis of cutaneous lupus erythematosus (CLE, including subacute cutaneous lupus erythematosus, discoid lupus erythematosus, or lupus erythematosus tumidus) or systemic lupus erythematosus (SLE)

  * Had a body weight less than or equal to 100 kg
  * Patients in Part A who were taking systemic medications for CLE had to be on a stable dose for 4 weeks before the first study agent infusion
  * Patients in Part B taking systemic medications for SLE had to be on a stable dose for at least 3 months before the first study agent infusion
  * Given informed consent and willing and able to adhere to the study visit schedule and other protocol requirements; agreed to avoid alcohol intake; and took adequate measures to prevent pregnancy

Exclusion Criteria:

* Significant history of or concurrent medical condition (other than lupus)
* Use of specific previous or concurrent medications or investigational therapies
* Known or suspected allergy to the study agent or it constituents, having recently donated blood, or having any significant laboratory test values requiring intervention
* Patients with SLE in Part B could not have active central nervous system lupus
D: Inclusion Criteria:

* participants must be diagnosed with SLE and be experiencing an active lupus flare in at least one of three organ systems: skin (discoid lesions), inflammation of the lining of the heart (pericarditis), or inflammation of the lining of the lung (pleuritis/pleurisy); or inflammation of more than 4 joints within 14 days of a screening visit (arthritis)
* Stable dose of prednisone (\<30mg) for at least one month

Exclusion Criteria:

* participants experiencing an active lupus flare in the kidney or central nervous systems
* Treatment with a stable dose of azathioprine, mycophenolate mofetil, hydroxychloroquine, chloroquine, or methotrexate for less than three months prior to the study
* participants with active viral or bacterial infections
* participants with any other autoimmune disease as a main diagnosis
* Prior treatment with rituximab

Answer: A