ID

19133

Beskrivning

Thalidomide, Dexamethasone, and Clarithromycin in Treating Patients With Multiple Myeloma Previously Treated With Transplant; ODM derived from: https://clinicaltrials.gov/show/NCT00182663

Länk

https://clinicaltrials.gov/show/NCT00182663

Nyckelord

Versioner (1)
  1. 2016-12-07 2016-12-07 -
Uppladdad den

7 december 2016

DOI

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Creative Commons BY 4.0
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Eligibility Refractory Multiple Myeloma NCT00182663

Engelsk

Eligibility Refractory Multiple Myeloma NCT00182663

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
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
Beskrivning

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

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C0439859
UMLS CUI [2,1]
C0030705
UMLS CUI [2,2]
C2348628
UMLS CUI [3,1]
C0025241
UMLS CUI [3,2]
C0444956
UMLS CUI [4]
C0242602
UMLS CUI [5]
C0005961
UMLS CUI [6,1]
C0026764
UMLS CUI [6,2]
C2346508
UMLS CUI [7]
C2348568
UMLS CUI [8,1]
C1261322
UMLS CUI [8,2]
C0242793
UMLS CUI [9,1]
C1261322
UMLS CUI [9,2]
C0038952
platelet count (transfusion independent) > 50,000 cells/mm^3 for 5 calendar days after recovery from high dose
Beskrivning

Platelet Count measurement Transfusion Independent of | High dose Recovered

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0032181
UMLS CUI [1,2]
C1879316
UMLS CUI [1,3]
C0332291
UMLS CUI [2,1]
C0444956
UMLS CUI [2,2]
C0521108
absolute granulocyte count > 1500 cells/mm^3 for 5 calendar days after recovery from high dose
Beskrivning

Absolute neutrophil count | High dose Recovered

Datatyp

boolean

Alias
UMLS CUI [1]
C0948762
UMLS CUI [2,1]
C0444956
UMLS CUI [2,2]
C0521108
patients will start therapy between 30 days to 120 days after transplant
Beskrivning

Therapeutic procedure Start Post Transplantation

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0439659
UMLS CUI [1,3]
C0687676
UMLS CUI [1,4]
C0040732
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
Beskrivning

Compliance behavior

Datatyp

boolean

Alias
UMLS CUI [1]
C1321605
signing a written informed consent form
Beskrivning

Informed Consent

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
karnofsky score less than 70
Beskrivning

Karnofsky Performance Status

Datatyp

boolean

Alias
UMLS CUI [1]
C0206065
a left ventricular ejection fraction less than 45%; patients with congestive heart disease, history of myocardial infarction (mi), or coronary artery disease
Beskrivning

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

Datatyp

boolean

Alias
UMLS CUI [1]
C0428772
UMLS CUI [2]
C0018802
UMLS CUI [3]
C0027051
UMLS CUI [4]
C1956346
total bilirubin greater than 2 mg/ml (unless history of gilbert's disease)
Beskrivning

Serum total bilirubin measurement | Gilbert Disease

Datatyp

boolean

Alias
UMLS CUI [1]
C1278039
UMLS CUI [2]
C0017551
serum glutamic oxaloacetic transaminase (sgot) or serum glutamic pyruvic transaminase (sgpt) > 2.5 x upper limit of normal
Beskrivning

Aspartate aminotransferase measurement increased | Alanine aminotransferase measurement increased

Datatyp

boolean

Alias
UMLS CUI [1]
C0151904
UMLS CUI [2]
C0151905
history of deep venous thrombus, arterial occlusions, or pulmonary emboli
Beskrivning

Deep Vein Thrombosis | Occlusion of artery | Pulmonary Embolism

Datatyp

boolean

Alias
UMLS CUI [1]
C0149871
UMLS CUI [2]
C0264995
UMLS CUI [3]
C0034065
pregnant and/or lactating females
Beskrivning

Pregnancy | Breast Feeding

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
patients who cannot give informed consent
Beskrivning

Informed Consent Unable

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C1299582
patients with untreated systemic infection
Beskrivning

Sepsis untreated

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0243026
UMLS CUI [1,2]
C0332155
patients with history prior to transplant of treatment with combination therapy thalidomide/biaxin and steroid without response
Beskrivning

Transplantation | Combined Modality Therapy | Thalidomide | Biaxin | Steroids | Absent response to treatment

Datatyp

boolean

Alias
UMLS CUI [1]
C0040732
UMLS CUI [2]
C0009429
UMLS CUI [3]
C0039736
UMLS CUI [4]
C0701281
UMLS CUI [5]
C0038317
UMLS CUI [6]
C0438286
patients allergic to thalidomide, biaxin or dexamethasone
Beskrivning

Hypersensitivity Thalidomide | Hypersensitivity Biaxin | Dexamethasone allergy

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0039736
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0701281
UMLS CUI [3]
C0571611
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
Beskrivning

referring physician Compliance behavior Limited

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1709880
UMLS CUI [1,2]
C1321605
UMLS CUI [1,3]
C0439801
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
Beskrivning

Contraceptive methods Unwilling | Indication Contraceptive methods | Gender Latex condom | Vasectomy | Sex Behavior | Childbearing Potential

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0700589
UMLS CUI [1,2]
C0558080
UMLS CUI [2,1]
C3146298
UMLS CUI [2,2]
C0700589
UMLS CUI [3,1]
C0079399
UMLS CUI [3,2]
C3873750
UMLS CUI [4]
C0042387
UMLS CUI [5]
C0036864
UMLS CUI [6]
C3831118
patients with history of seizures
Beskrivning

Seizures

Datatyp

boolean

Alias
UMLS CUI [1]
C0036572
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Similar models

Eligibility Refractory Multiple Myeloma NCT00182663

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
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])
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])
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])
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