ID

21899

Beskrivning

Sequential VAD and VTD Followed by HDT With ASCT and Velcade Maintenance for NDMM; ODM derived from: https://clinicaltrials.gov/show/NCT00378755

Länk

https://clinicaltrials.gov/show/NCT00378755

Nyckelord

Versioner (1)
  1. 2017-05-07 2017-05-07 -
Uppladdad den

7 maj 2017

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Multiple Myeloma NCT00378755

Engelsk

Eligibility Multiple Myeloma NCT00378755

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
1.previously untreated newly diagnosed patients with mm (stage ii-iii) 2.age < 65 3.eastern cooperative oncology group performance status 0-1 4.ef > 50%, fvc and fev > 50%, dlco >50% 5.platelet count ≥ 100 x 109/l (pretreatment platelet transfusion is not allowed, while transfusion during the treatment is permitted), hemoglobin ≥ 8 g/dl (≥ 4.96 mol/l), prior rbc transfusion or recombinant human erythropoietin use is allowed), absolute neutrophil count (anc) ≥ 1.0 x 109/l 6.adequate liver function (bilirubin < unl(upper normal limit) x 2 and alt/ast < unl x 3) 7.adequate renal function (serum creatinine < unl x 1.5 or creatine clearance > 60 ml/min) 8.signed the informed consent, have the will and ability to follow the protocol
Beskrivning

Multiple Myeloma International Staging System for Myeloma | Age | ECOG performance status | Cardiac ejection fraction | Forced Vital Capacity | Forced expiratory volume function | Carbon Monoxide Diffusing Capability Test | Platelet Count measurement | Platelet Transfusion | Hemoglobin measurement | Red Blood Cell Transfusion | Recombinant Erythropoietin | Absolute neutrophil count | Liver function | Serum total bilirubin measurement | Alanine aminotransferase measurement | Aspartate aminotransferase measurement | Renal function | Creatinine measurement, serum | Creatinine clearance measurement | Informed Consent | Protocol Compliance

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0026764
UMLS CUI [1,2]
C2346508
UMLS CUI [2]
C0001779
UMLS CUI [3]
C1520224
UMLS CUI [4]
C0232174
UMLS CUI [5]
C3714541
UMLS CUI [6]
C0016529
UMLS CUI [7]
C1516251
UMLS CUI [8]
C0032181
UMLS CUI [9]
C0086818
UMLS CUI [10]
C0518015
UMLS CUI [11]
C0086252
UMLS CUI [12]
C0376541
UMLS CUI [13]
C0948762
UMLS CUI [14]
C0232741
UMLS CUI [15]
C1278039
UMLS CUI [16]
C0201836
UMLS CUI [17]
C0201899
UMLS CUI [18]
C0232804
UMLS CUI [19]
C0201976
UMLS CUI [20]
C0373595
UMLS CUI [21]
C0021430
UMLS CUI [22]
C0525058
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. history of allergic reaction attributable to compounds containing boron or mannitol 2. known hypersensitivity to thalidomide or dexamethasone 3. peripheral neuropathy or neuropathic pain grade 2 or higher as defined by nci ctcae version 3 4. uncontrolled or severe cardiovascular disease, including mi within 6 months of enrollment, new york heart association (nyha) class iii or iv heart failure, uncontrolled angina, clinically significant pericardial disease, or cardiac amyloidosis 5. acute severe infection requiring antibiotic therapy 6. previous cancer history (except in situ carcinoma of cervix or basal cell cancer of skin) 7. pregnancy or breastfeeding 8. active ulcer detected by gastroscopy (gastroscopy is not routine in all patients, only to patients with symptoms of ulcer disease and/or history of previous ulcer therapy and/or physician's discretion) 9. previous renal transplantation 10. recurrent deep vein thrombosis or pulmonary embolism 11. uncontrolled diabetes mellitus 12. receipt of extensive radiation therapy within 4 weeks ((extensive means rt to more than 2 anatomic sites).
Beskrivning

Allergic Reaction Boron Compounds | Allergic Reaction Mannitol Compound | Hypersensitivity Thalidomide | Dexamethasone allergy | Peripheral Neuropathy CTCAE Grades | Peripheral neuropathic pain CTCAE Grades | Cardiovascular Diseases Uncontrolled | Cardiovascular Diseases Severe | Myocardial Infarction | Heart failure New York Heart Association Classification | Angina control - poor | Disorder of pericardium | Cardiac amyloidosis | Communicable Disease Severe Requirement Antibiotic therapy | Malignant Neoplasms | Carcinoma in situ of uterine cervix | Basal cell carcinoma | Pregnancy | Breast Feeding | Ulcer Endoscopy of stomach | Therapeutic procedure Ulcer | Kidney Transplantation | Recurrent deep vein thrombosis | Recurrent pulmonary embolism | Diabetic - poor control | Extensive Radiation | Therapeutic radiology procedure Anatomic Site Quantity

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1527304
UMLS CUI [1,2]
C0006031
UMLS CUI [2,1]
C1527304
UMLS CUI [2,2]
C0024730
UMLS CUI [2,3]
C1706082
UMLS CUI [3,1]
C0020517
UMLS CUI [3,2]
C0039736
UMLS CUI [4]
C0571611
UMLS CUI [5,1]
C0031117
UMLS CUI [5,2]
C1516728
UMLS CUI [6,1]
C0458960
UMLS CUI [6,2]
C1516728
UMLS CUI [7,1]
C0007222
UMLS CUI [7,2]
C0205318
UMLS CUI [8,1]
C0007222
UMLS CUI [8,2]
C0205082
UMLS CUI [9]
C0027051
UMLS CUI [10,1]
C0018801
UMLS CUI [10,2]
C1275491
UMLS CUI [11]
C0421196
UMLS CUI [12]
C0265122
UMLS CUI [13]
C0268407
UMLS CUI [14,1]
C0009450
UMLS CUI [14,2]
C0205082
UMLS CUI [14,3]
C1514873
UMLS CUI [14,4]
C0338237
UMLS CUI [15]
C0006826
UMLS CUI [16]
C0851140
UMLS CUI [17]
C0007117
UMLS CUI [18]
C0032961
UMLS CUI [19]
C0006147
UMLS CUI [20,1]
C0041582
UMLS CUI [20,2]
C0017195
UMLS CUI [21,1]
C0087111
UMLS CUI [21,2]
C0041582
UMLS CUI [22]
C0022671
UMLS CUI [23]
C1735901
UMLS CUI [24]
C1735914
UMLS CUI [25]
C0421258
UMLS CUI [26]
C1517030
UMLS CUI [27,1]
C1522449
UMLS CUI [27,2]
C1515974
UMLS CUI [27,3]
C1265611
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Similar models

Eligibility Multiple Myeloma NCT00378755

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Multiple Myeloma International Staging System for Myeloma | Age | ECOG performance status | Cardiac ejection fraction | Forced Vital Capacity | Forced expiratory volume function | Carbon Monoxide Diffusing Capability Test | Platelet Count measurement | Platelet Transfusion | Hemoglobin measurement | Red Blood Cell Transfusion | Recombinant Erythropoietin | Absolute neutrophil count | Liver function | Serum total bilirubin measurement | Alanine aminotransferase measurement | Aspartate aminotransferase measurement | Renal function | Creatinine measurement, serum | Creatinine clearance measurement | Informed Consent | Protocol Compliance
Item
1.previously untreated newly diagnosed patients with mm (stage ii-iii) 2.age < 65 3.eastern cooperative oncology group performance status 0-1 4.ef > 50%, fvc and fev > 50%, dlco >50% 5.platelet count ≥ 100 x 109/l (pretreatment platelet transfusion is not allowed, while transfusion during the treatment is permitted), hemoglobin ≥ 8 g/dl (≥ 4.96 mol/l), prior rbc transfusion or recombinant human erythropoietin use is allowed), absolute neutrophil count (anc) ≥ 1.0 x 109/l 6.adequate liver function (bilirubin < unl(upper normal limit) x 2 and alt/ast < unl x 3) 7.adequate renal function (serum creatinine < unl x 1.5 or creatine clearance > 60 ml/min) 8.signed the informed consent, have the will and ability to follow the protocol
boolean
C0026764 (UMLS CUI [1,1])
C2346508 (UMLS CUI [1,2])
C0001779 (UMLS CUI [2])
C1520224 (UMLS CUI [3])
C0232174 (UMLS CUI [4])
C3714541 (UMLS CUI [5])
C0016529 (UMLS CUI [6])
C1516251 (UMLS CUI [7])
C0032181 (UMLS CUI [8])
C0086818 (UMLS CUI [9])
C0518015 (UMLS CUI [10])
C0086252 (UMLS CUI [11])
C0376541 (UMLS CUI [12])
C0948762 (UMLS CUI [13])
C0232741 (UMLS CUI [14])
C1278039 (UMLS CUI [15])
C0201836 (UMLS CUI [16])
C0201899 (UMLS CUI [17])
C0232804 (UMLS CUI [18])
C0201976 (UMLS CUI [19])
C0373595 (UMLS CUI [20])
C0021430 (UMLS CUI [21])
C0525058 (UMLS CUI [22])
Item Group
C0680251 (UMLS CUI)
Allergic Reaction Boron Compounds | Allergic Reaction Mannitol Compound | Hypersensitivity Thalidomide | Dexamethasone allergy | Peripheral Neuropathy CTCAE Grades | Peripheral neuropathic pain CTCAE Grades | Cardiovascular Diseases Uncontrolled | Cardiovascular Diseases Severe | Myocardial Infarction | Heart failure New York Heart Association Classification | Angina control - poor | Disorder of pericardium | Cardiac amyloidosis | Communicable Disease Severe Requirement Antibiotic therapy | Malignant Neoplasms | Carcinoma in situ of uterine cervix | Basal cell carcinoma | Pregnancy | Breast Feeding | Ulcer Endoscopy of stomach | Therapeutic procedure Ulcer | Kidney Transplantation | Recurrent deep vein thrombosis | Recurrent pulmonary embolism | Diabetic - poor control | Extensive Radiation | Therapeutic radiology procedure Anatomic Site Quantity
Item
1. history of allergic reaction attributable to compounds containing boron or mannitol 2. known hypersensitivity to thalidomide or dexamethasone 3. peripheral neuropathy or neuropathic pain grade 2 or higher as defined by nci ctcae version 3 4. uncontrolled or severe cardiovascular disease, including mi within 6 months of enrollment, new york heart association (nyha) class iii or iv heart failure, uncontrolled angina, clinically significant pericardial disease, or cardiac amyloidosis 5. acute severe infection requiring antibiotic therapy 6. previous cancer history (except in situ carcinoma of cervix or basal cell cancer of skin) 7. pregnancy or breastfeeding 8. active ulcer detected by gastroscopy (gastroscopy is not routine in all patients, only to patients with symptoms of ulcer disease and/or history of previous ulcer therapy and/or physician's discretion) 9. previous renal transplantation 10. recurrent deep vein thrombosis or pulmonary embolism 11. uncontrolled diabetes mellitus 12. receipt of extensive radiation therapy within 4 weeks ((extensive means rt to more than 2 anatomic sites).
boolean
C1527304 (UMLS CUI [1,1])
C0006031 (UMLS CUI [1,2])
C1527304 (UMLS CUI [2,1])
C0024730 (UMLS CUI [2,2])
C1706082 (UMLS CUI [2,3])
C0020517 (UMLS CUI [3,1])
C0039736 (UMLS CUI [3,2])
C0571611 (UMLS CUI [4])
C0031117 (UMLS CUI [5,1])
C1516728 (UMLS CUI [5,2])
C0458960 (UMLS CUI [6,1])
C1516728 (UMLS CUI [6,2])
C0007222 (UMLS CUI [7,1])
C0205318 (UMLS CUI [7,2])
C0007222 (UMLS CUI [8,1])
C0205082 (UMLS CUI [8,2])
C0027051 (UMLS CUI [9])
C0018801 (UMLS CUI [10,1])
C1275491 (UMLS CUI [10,2])
C0421196 (UMLS CUI [11])
C0265122 (UMLS CUI [12])
C0268407 (UMLS CUI [13])
C0009450 (UMLS CUI [14,1])
C0205082 (UMLS CUI [14,2])
C1514873 (UMLS CUI [14,3])
C0338237 (UMLS CUI [14,4])
C0006826 (UMLS CUI [15])
C0851140 (UMLS CUI [16])
C0007117 (UMLS CUI [17])
C0032961 (UMLS CUI [18])
C0006147 (UMLS CUI [19])
C0041582 (UMLS CUI [20,1])
C0017195 (UMLS CUI [20,2])
C0087111 (UMLS CUI [21,1])
C0041582 (UMLS CUI [21,2])
C0022671 (UMLS CUI [22])
C1735901 (UMLS CUI [23])
C1735914 (UMLS CUI [24])
C0421258 (UMLS CUI [25])
C1517030 (UMLS CUI [26])
C1522449 (UMLS CUI [27,1])
C1515974 (UMLS CUI [27,2])
C1265611 (UMLS CUI [27,3])
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