Eligibility Refractory Multiple Myeloma NCT00182663

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StudyEvent: Eligibility
1. Eligibility Refractory Multiple Myeloma NCT00182663

Name

Tipo

Description | Question | Decode (Coded Value)

Tipo de dados

Alias

Inclusion Criteria

Item Group

C1512693 (UMLS CUI)

Item

any autologous or syngeneic patient who underwent high dose melphalan (>= 140 mg/m^2) therapy/peripheral blood stem cell (pbsc) or bone marrow (bm) rescue for any stage of multiple myeloma and did not participate in another clinical transplant trial which is also evaluating disease free survival or survival

boolean

C0030705 (UMLS CUI [1,1])
C0439859 (UMLS CUI [1,2])
C0030705 (UMLS CUI [2,1])
C2348628 (UMLS CUI [2,2])
C0025241 (UMLS CUI [3,1])
C0444956 (UMLS CUI [3,2])
C0242602 (UMLS CUI [4])
C0005961 (UMLS CUI [5])
C0026764 (UMLS CUI [6,1])
C2346508 (UMLS CUI [6,2])
C2348568 (UMLS CUI [7])
C1261322 (UMLS CUI [8,1])
C0242793 (UMLS CUI [8,2])
C1261322 (UMLS CUI [9,1])
C0038952 (UMLS CUI [9,2])

Platelet Count measurement Transfusion Independent of | High dose Recovered

Item

platelet count (transfusion independent) > 50,000 cells/mm^3 for 5 calendar days after recovery from high dose

boolean

C0032181 (UMLS CUI [1,1])
C1879316 (UMLS CUI [1,2])
C0332291 (UMLS CUI [1,3])
C0444956 (UMLS CUI [2,1])
C0521108 (UMLS CUI [2,2])

Absolute neutrophil count | High dose Recovered

Item

absolute granulocyte count > 1500 cells/mm^3 for 5 calendar days after recovery from high dose

boolean

C0948762 (UMLS CUI [1])
C0444956 (UMLS CUI [2,1])
C0521108 (UMLS CUI [2,2])

Therapeutic procedure Start Post Transplantation

Item

patients will start therapy between 30 days to 120 days after transplant

boolean

C0087111 (UMLS CUI [1,1])
C0439659 (UMLS CUI [1,2])
C0687676 (UMLS CUI [1,3])
C0040732 (UMLS CUI [1,4])

Compliance behavior

Item

willingness and ability to comply with food and drug administration (fda)-mandated s.t.e.p.s. (celgene system for thalidomide education and prescribing safety) program

boolean

C1321605 (UMLS CUI [1])

Informed Consent

Item

signing a written informed consent form

boolean

C0021430 (UMLS CUI [1])

Exclusion Criteria

Item Group

C0680251 (UMLS CUI)

Karnofsky Performance Status

Item

karnofsky score less than 70

boolean

C0206065 (UMLS CUI [1])

Left ventricular ejection fraction | Congestive heart failure | Myocardial Infarction | Coronary Artery Disease

Item

a left ventricular ejection fraction less than 45%; patients with congestive heart disease, history of myocardial infarction (mi), or coronary artery disease

boolean

C0428772 (UMLS CUI [1])
C0018802 (UMLS CUI [2])
C0027051 (UMLS CUI [3])
C1956346 (UMLS CUI [4])

Serum total bilirubin measurement | Gilbert Disease

Item

total bilirubin greater than 2 mg/ml (unless history of gilbert's disease)

boolean

C1278039 (UMLS CUI [1])
C0017551 (UMLS CUI [2])

Aspartate aminotransferase measurement increased | Alanine aminotransferase measurement increased

Item

serum glutamic oxaloacetic transaminase (sgot) or serum glutamic pyruvic transaminase (sgpt) > 2.5 x upper limit of normal

boolean

C0151904 (UMLS CUI [1])
C0151905 (UMLS CUI [2])

Deep Vein Thrombosis | Occlusion of artery | Pulmonary Embolism

Item

history of deep venous thrombus, arterial occlusions, or pulmonary emboli

boolean

C0149871 (UMLS CUI [1])
C0264995 (UMLS CUI [2])
C0034065 (UMLS CUI [3])

Pregnancy | Breast Feeding

Item

pregnant and/or lactating females

boolean

C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])

Informed Consent Unable

Item

patients who cannot give informed consent

boolean

C0021430 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])

Sepsis untreated

Item

patients with untreated systemic infection

boolean

C0243026 (UMLS CUI [1,1])
C0332155 (UMLS CUI [1,2])

Item

patients with history prior to transplant of treatment with combination therapy thalidomide/biaxin and steroid without response

boolean

C0040732 (UMLS CUI [1])
C0009429 (UMLS CUI [2])
C0039736 (UMLS CUI [3])
C0701281 (UMLS CUI [4])
C0038317 (UMLS CUI [5])
C0438286 (UMLS CUI [6])

Hypersensitivity Thalidomide | Hypersensitivity Biaxin | Dexamethasone allergy

Item

patients allergic to thalidomide, biaxin or dexamethasone

boolean

C0020517 (UMLS CUI [1,1])
C0039736 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0701281 (UMLS CUI [2,2])
C0571611 (UMLS CUI [3])

referring physician Compliance behavior Limited

Item

referring physician not registered with s.t.e.p.s. program or unwilling to oversee the care of the patients on study and comply with the fda-mandated s.t.e.p.s. program

boolean

C1709880 (UMLS CUI [1,1])
C1321605 (UMLS CUI [1,2])
C0439801 (UMLS CUI [1,3])

Item

patients unwilling to practice adequate forms of contraception if clinically indicated; male patients on study need to be consulted to use latex condoms even if they have had a vasectomy every time they have sex with a woman who is able to have children while they are being treated and for four weeks after stopping drugs

boolean

C0700589 (UMLS CUI [1,1])
C0558080 (UMLS CUI [1,2])
C3146298 (UMLS CUI [2,1])
C0700589 (UMLS CUI [2,2])
C0079399 (UMLS CUI [3,1])
C3873750 (UMLS CUI [3,2])
C0042387 (UMLS CUI [4])
C0036864 (UMLS CUI [5])
C3831118 (UMLS CUI [6])

Seizures

Item

patients with history of seizures

boolean

C0036572 (UMLS CUI [1])

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Eligibility Refractory Multiple Myeloma NCT00182663