Please select the eligibility criteria that correspond to the clinical trial below.
Title: Low Molecular Weight Heparin in Advanced Non Small Cell Lung Cancer (NSCLC): a Randomized Open Label Phase III Study Evaluating the Effect of Enoxaparin (Clexane) on Survival and Symptom Control in Patients With Stage IIIB and IV NSCLC Undergoing a Cisplatin Based First Line Chemotherapy: the SYRINGES Trial
Brief Summary: Rationale: a number of recent phase III randomized trials have shown a survival benefit of a treatment with subcutaneous low-molecular weight heparin in patients with advanced solid malignancies. The survival advantages observed in the studies persist for months after the active treatment with LMWHs. Therefore these survival advantages are thought to be due to effects of LMWHs on tumor cell biology.

First line treatment of advanced NSCLC patients with the Cisplatin + Docetaxel combination has been widely studied, and is amongst the most active treatments currently available. The occurrence of grade 3/4 thrombopenia in several phase III trials was in the 0-3% range, making it an ideal chemotherapy regimen to combine with LMWHs in the treatment of advanced NSCLC.


Options:
A: Inclusion Criteria:

* Men and women
* Age \> 18 years
* Current or prior diagnosis of symptomatic MM based on International Myeloma Working Group (IMWG) guidelines (http://imwg.myeloma.org/category/guidelines-2/) and will be starting or already receiving IMiD therapy with thalidomide \[Thalomid\], lenalinomide \[Revlimid\], or pomalidomide \[Pomalyst\]
* IMiD therapy given in the setting of newly diagnosed MM, relapsed MM, progressive MM, maintenance therapy or consolidation therapy as per IMWG criteria
* Willing to provide written informed consent
* Eastern Cooperative Oncology Group (ECOG) functional status ≤ 2
* Providers must plan to treat the patient with IMiD therapy for a minimum of 6 cycles

Exclusion Criteria:

* Pregnancy
* Breastfeeding
* Women of child-bearing potential who are unwilling or unable to use an acceptable method of birth control (such as oral contraceptives, other hormonal contraceptives \[vaginal products, skin patches, or implanted or injectable products\], or mechanical products such as an intrauterine device or barrier methods \[diaphragm, condoms, spermicides\]) to avoid pregnancy for the entire study
* Any prior venous thromboembolism
* Contraindication to anticoagulant therapy
* Conditions for which serious bleeding may occur including:

  1. Current or within last 6 months: intracranial bleeding, intraocular bleeding, gastrointestinal bleeding, endoscopically documented ulcer disease
  2. Current or within last month: head trauma or other major trauma, major surgery
  3. Current or within last 2 weeks: stroke, neurosurgical procedure
  4. Current: gross hematuria, major unhealed wound, major surgery planned during the trial period, intracranial mass, vascular malformation, or aneurysm, overt bleeding, blood dyscrasia
  5. CNS involvement of MM or other history of CNS malignancy
* Active and clinically significant liver disease
* Uncontrolled hypertension: systolic blood pressure \>180 mm Hg or diastolic blood pressure \>100 mm Hg
* Current endocarditis
* Requirement for ongoing anticoagulant therapy, including mechanical heart valve replacement and atrial fibrillation
* Severe valvular heart disease, including rheumatic heart disease and mitral stenosis
* Bioprosthetic heart valve replacement
* Requirement for dual antiplatelet therapy or single agent antiplatelet therapy with clopidogrel, prasugrel, or ticagrelor
* Requirement for aspirin at a dose higher than 165 mg daily.
* Hemoglobin \< 9 mg/dL at time of screening
* Platelet count \< 100,000/mm3 at time of screening
* Serum calculated creatinine clearance (CrCl) \< 25 ml/m at time of screening
* Alanine aminotransferase or aspartate aminotransferase level \> 2 times the upper limit of the normal at time of screening
* Total bilirubin level \> 1.5 times the upper limit of the normal at time of screening
* Life expectancy \< 12 months or hospice care
* Prisoners or subjects who are involuntarily incarcerated
* Subjects who are compulsorily detained for treatment of either a psychiatric or physical (e.g., infectious disease) illness
* Receiving concurrent non-FDA-approved or investigational agents or has received an investigational agent within the past 30 days prior to the first dose of study treatment (with the exception of approved medications being used for an approved indication, e.g., investigating a new dosing regimen for an approved indication).
* Any condition, which in the opinion of the investigator, would put the subject at an unacceptable risk from participating in the study
* Any other medical, social, logistical, or psychological reason, which in the opinion of the investigator, would preclude compliance with, or successful completion of, the study protocol
B: Inclusion Criteria:

* Locally advanced or metastatic NSCLC (stage IIIB or IV)
* Patients who are not candidates for radical combined modality treatments or high-dose radiation therapy
* At least one measurable lesion according to RECIST criteria
* Good performance status
* Adequate haematological, renal and liver function
* Written informed consent

Exclusion Criteria:

* Previous chemotherapy for NSCLC
* Brain metastasis
* History of cerebral haemorrhage, neurosurgery within 3 previous months or surgery within the past 6 months
* Indication for anticoagulant therapy, thrombolytic therapy or antiplatelet therapy for cardiovascular disease
* Concomitant therapy with an anti-angiogenesis agent
* Contra-indication for LMWH
* Life expectancy of \< 3 months
* Serious concomitant systemic disease, uncontrolled arterial hypertension, active peptic ulcer or other condition which does not permit study treatment or follow-up required to comply with the study protocol
C: Key Inclusion Criteria:

* Recipients of either first- or second-line chemotherapy for advanced or metastatic lung, breast, gastrointestinal, bladder, ovarian, or prostate cancer or myeloma, selected lymphomas, or cancer of unknown origin
* Able to begin study medication ≤6 weeks of starting either first- or second-line chemotherapy.
* Expected course of chemotherapy must have been ≥ 90 days after the start of chemotherapy
* Per Protocol Amendment 5, patients receiving bevacizumab were eligible to participate, provided that bevacizumab was used for indications approved by local country law

Key Exclusion Criteria:

* Women who are pregnant, breastfeeding
* History of deep vein thrombosis or pulmonary embolism
* Active bleeding or at high risk of bleeding
* Metastatic brain cancer
* Familial bleeding diathesis
* Serious hemorrhage requiring hospitalization, transfusion, or surgical intervention within 4 weeks of study entry
* Expected survival \<6 months or an Eastern Cooperative Oncology Group performance status ≥3.
* Candidates for bone marrow transplantation within the 12-week treatment period or 30-day follow-up period
* Uncontrolled hypertension (systolic blood pressure \>200 mm Hg and/or diastolic blood pressure \>110 mm Hg
* Coagulopathy (international normalized ratio \>1.5 or platelet count \<100\*10\^9/L) if not yet receiving chemotherapy or \<50\*10\^9/L if receiving chemotherapy). Platelet count must have been \>100\*10\^9/L before starting study medication
* One or more of the following: alanine aminotransferase \>3 times the upper limit of normal (ULN), total bilirubin \>2\*ULN, or calculated creatinine clearance \<30 mL/min.
D: Inclusion Criteria:

1. Patients with the diagnosis of advanced stage (unresectable or metastatic) adenocarinoma of the pancreas. Patients with borderline resectable will also be eligible if they are starting chemotherapy and/or chemo/radiation therapy (RT) prior to attempting resection.
2. Patients must be planning to initiate systemic chemotherapy within 2 weeks. Chemotherapy that is being given concurrently with radiation is allowed.
3. Age \>/= 18 years old
4. Adequate renal function defined as a calculated creatinine clearance of \> 50 mL/min (as reported by the MDACC laboratory using MDRD method or using Cockroft and Gault formula).
5. Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2.
6. Negative urine or serum pregnancy test in women with childbearing potential, within one week prior to initiation of treatment.
7. Patients must sign an Informed Consent.
8. Patient must agree to transfusion of blood products, when indicated.
9. Ability to administer subcutaneous injections of the study drug by the patient and/or care giver.

Exclusion Criteria:

1. Patients with evidence of venous thrombosis on the initial lower extremity screening ultrasound or incidental VTE of other sites (e.g. PE, Abdominal/pelvic vein thrombosis, etc.).
2. Patients already taking prophylactic or full dose anticoagulation (eg. heparin, low-molecular weight heparin, fondaparinux, or coumadin).
3. Patients with currently active bleeding.
4. The presence of a condition with a high risk for bleeding, including but not limited to active peptic ulcer, recent neurosurgery, or cirrhosis with esophageal varices.
5. Patients with known brain metastases.
6. Patients with a known bleeding diathesis.
7. Patients with a platelet count \< 50,000.
8. Patients with known hypersensitivity to dalteparin.
9. Patients who regularly use medications known to increase the risk of bleeding such as \>/= 325 mg of aspirin daily, or daily clopidogrel, or daily non-steroidal antiinflammatory medications (eg., ibuprofen, naproxen).

Answer: B