Patient Autologous | Patient Syngeneic | Melphalan High dose | Peripheral Stem Cell Transplantation | Bone Marrow Transplantation | Multiple Myeloma International Staging System for Myeloma | Study Subject Participation Status | Evaluation Disease-Free Survival | Evaluation Continuance of life
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])
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])
Transplantation | Combined Modality Therapy | Thalidomide | Biaxin | Steroids | Absent response to treatment
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])
Contraceptive methods Unwilling | Indication Contraceptive methods | Gender Latex condom | Vasectomy | Sex Behavior | Childbearing Potential
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])