ID

18144

Beschrijving

Study of Oral SCIO-469 in Relapsed, Refractory Patients With Multiple Myeloma; ODM derived from: https://clinicaltrials.gov/show/NCT00087867

Link

https://clinicaltrials.gov/show/NCT00087867

Trefwoorden

Versies (1)
  1. 23-10-16 23-10-16 -
Geüploaded op

23 oktober 2016

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Multiple Myeloma NCT00087867

Engels

Eligibility Multiple Myeloma NCT00087867

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
life expectancy more than three months
Beschrijving

Life Expectancy

Datatype

boolean

Alias
UMLS CUI [1]
C0023671
diagnosed with multiple myeloma (mm)
Beschrijving

Multiple Myeloma

Datatype

boolean

Alias
UMLS CUI [1]
C0026764
relapsed following a response to any conventional mm therapy, and refractory to their most recent mm therapy
Beschrijving

Conventional Treatment Multiple Myeloma Response | Recurrent disease | Therapeutic procedure Recent Multiple Myeloma Unresponsive to Treatment

Datatype

boolean

Alias
UMLS CUI [1,1]
C2945704
UMLS CUI [1,2]
C0026764
UMLS CUI [1,3]
C1704632
UMLS CUI [2]
C0277556
UMLS CUI [3,1]
C0087111
UMLS CUI [3,2]
C0332185
UMLS CUI [3,3]
C0026764
UMLS CUI [3,4]
C0205269
karnofsky performance status = 60
Beschrijving

Karnofsky Performance Status

Datatype

boolean

Alias
UMLS CUI [1]
C0206065
no electrocardiographic evidence of acute ischemia or new conduction system abnormalities
Beschrijving

Ischemia | Conduction system abnormalities New | Electrocardiography Evidence

Datatype

boolean

Alias
UMLS CUI [1]
C0022116
UMLS CUI [2,1]
C0151236
UMLS CUI [2,2]
C0205314
UMLS CUI [3,1]
C1623258
UMLS CUI [3,2]
C3887511
no history of myocardial infarction within last 6 months
Beschrijving

Myocardial Infarction

Datatype

boolean

Alias
UMLS CUI [1]
C0027051
serum concentrations of aspartate aminotransferase (ast) and alanine aminotransferase (alt) = 3x upper limit of normal (uln)
Beschrijving

Aspartate aminotransferase measurement | Alanine aminotransferase measurement

Datatype

boolean

Alias
UMLS CUI [1]
C0201899
UMLS CUI [2]
C0201836
total serum bilirubin = 2x uln
Beschrijving

Serum total bilirubin measurement

Datatype

boolean

Alias
UMLS CUI [1]
C1278039
calculated or measured creatinine clearance >30 ml/min
Beschrijving

Estimation of creatinine clearance by Cockcroft-Gault formula | Creatinine clearance measurement

Datatype

boolean

Alias
UMLS CUI [1]
C2711451
UMLS CUI [2]
C0373595
platelet count = 30 x 10(9)/l
Beschrijving

Platelet Count measurement

Datatype

boolean

Alias
UMLS CUI [1]
C0032181
hemoglobin concentration = 8 g/dl
Beschrijving

Hemoglobin

Datatype

boolean

Alias
UMLS CUI [1]
C0019046
white blood cell count = 2.0 x 10(9)/l
Beschrijving

White Blood Cell Count procedure

Datatype

boolean

Alias
UMLS CUI [1]
C0023508
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients with non-secretory myeloma, plasma cell leukemia, or poems syndrome (plasma cell dyscrasia with polyneuropathy, organomegaly, endocrinopathy, m-protein and skin changes)
Beschrijving

Non-secretory myeloma | Leukemia, Plasma Cell | POEMS Syndrome | Plasma cell dyscrasia with polyneuropathy | Organomegaly | Endocrine System Diseases | M Protein Change | skin; change

Datatype

boolean

Alias
UMLS CUI [1]
C0456845
UMLS CUI [2]
C0023484
UMLS CUI [3]
C0085404
UMLS CUI [4]
C0272255
UMLS CUI [5]
C4054315
UMLS CUI [6]
C0014130
UMLS CUI [7,1]
C0700271
UMLS CUI [7,2]
C0392747
UMLS CUI [8]
C1399787
major surgery within four weeks of enrollment
Beschrijving

major surgery

Datatype

boolean

Alias
UMLS CUI [1]
C0679637
severe elevated serum calcium
Beschrijving

Serum calcium increased Severe

Datatype

boolean

Alias
UMLS CUI [1,1]
C0595928
UMLS CUI [1,2]
C0205082
heart failure
Beschrijving

Heart failure

Datatype

boolean

Alias
UMLS CUI [1]
C0018801
receipt of chemotherapy within 21 days before enrollment, receiving immunotherapy, radiation therapy, or other investigational agents
Beschrijving

Chemotherapy | Immunotherapy | Therapeutic radiology procedure | Investigational New Drugs

Datatype

boolean

Alias
UMLS CUI [1]
C0392920
UMLS CUI [2]
C0021083
UMLS CUI [3]
C1522449
UMLS CUI [4]
C0013230
receipt of corticosteroids equivalent to more than 10 mg/day of prednisone within two weeks before enrollment
Beschrijving

Adrenal Cortex Hormones | Prednisone

Datatype

boolean

Alias
UMLS CUI [1]
C0001617
UMLS CUI [2]
C0032952
known allergies to agents used in bortezomib (e.g., boron or mannitol)
Beschrijving

Hypersensitivity bortezomib | Hypersensitivity Boron | Mannitol allergy

Datatype

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C1176309
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0006030
UMLS CUI [3]
C0571922
poorly controlled hypertension, diabetes mellitus, or other serious medical or psychiatric illness that could potentially interfere with the completion of treatment according to this protocol
Beschrijving

Poor hypertension control | poorly controlled diabetes mellitus | Illness Serious Interferes with Protocol Compliance | Serious mental illness Interferes with Protocol Compliance

Datatype

boolean

Alias
UMLS CUI [1]
C0421190
UMLS CUI [2]
C0554876
UMLS CUI [3,1]
C0221423
UMLS CUI [3,2]
C0205404
UMLS CUI [3,3]
C0521102
UMLS CUI [3,4]
C0525058
UMLS CUI [4,1]
C3841614
UMLS CUI [4,2]
C0521102
UMLS CUI [4,3]
C0525058
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Eligibility Multiple Myeloma NCT00087867

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Life Expectancy
Item
life expectancy more than three months
boolean
C0023671 (UMLS CUI [1])
Multiple Myeloma
Item
diagnosed with multiple myeloma (mm)
boolean
C0026764 (UMLS CUI [1])
Conventional Treatment Multiple Myeloma Response | Recurrent disease | Therapeutic procedure Recent Multiple Myeloma Unresponsive to Treatment
Item
relapsed following a response to any conventional mm therapy, and refractory to their most recent mm therapy
boolean
C2945704 (UMLS CUI [1,1])
C0026764 (UMLS CUI [1,2])
C1704632 (UMLS CUI [1,3])
C0277556 (UMLS CUI [2])
C0087111 (UMLS CUI [3,1])
C0332185 (UMLS CUI [3,2])
C0026764 (UMLS CUI [3,3])
C0205269 (UMLS CUI [3,4])
Karnofsky Performance Status
Item
karnofsky performance status = 60
boolean
C0206065 (UMLS CUI [1])
Ischemia | Conduction system abnormalities New | Electrocardiography Evidence
Item
no electrocardiographic evidence of acute ischemia or new conduction system abnormalities
boolean
C0022116 (UMLS CUI [1])
C0151236 (UMLS CUI [2,1])
C0205314 (UMLS CUI [2,2])
C1623258 (UMLS CUI [3,1])
C3887511 (UMLS CUI [3,2])
Myocardial Infarction
Item
no history of myocardial infarction within last 6 months
boolean
C0027051 (UMLS CUI [1])
Aspartate aminotransferase measurement | Alanine aminotransferase measurement
Item
serum concentrations of aspartate aminotransferase (ast) and alanine aminotransferase (alt) = 3x upper limit of normal (uln)
boolean
C0201899 (UMLS CUI [1])
C0201836 (UMLS CUI [2])
Serum total bilirubin measurement
Item
total serum bilirubin = 2x uln
boolean
C1278039 (UMLS CUI [1])
Estimation of creatinine clearance by Cockcroft-Gault formula | Creatinine clearance measurement
Item
calculated or measured creatinine clearance >30 ml/min
boolean
C2711451 (UMLS CUI [1])
C0373595 (UMLS CUI [2])
Platelet Count measurement
Item
platelet count = 30 x 10(9)/l
boolean
C0032181 (UMLS CUI [1])
Hemoglobin
Item
hemoglobin concentration = 8 g/dl
boolean
C0019046 (UMLS CUI [1])
White Blood Cell Count procedure
Item
white blood cell count = 2.0 x 10(9)/l
boolean
C0023508 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Non-secretory myeloma | Leukemia, Plasma Cell | POEMS Syndrome | Plasma cell dyscrasia with polyneuropathy | Organomegaly | Endocrine System Diseases | M Protein Change | skin; change
Item
patients with non-secretory myeloma, plasma cell leukemia, or poems syndrome (plasma cell dyscrasia with polyneuropathy, organomegaly, endocrinopathy, m-protein and skin changes)
boolean
C0456845 (UMLS CUI [1])
C0023484 (UMLS CUI [2])
C0085404 (UMLS CUI [3])
C0272255 (UMLS CUI [4])
C4054315 (UMLS CUI [5])
C0014130 (UMLS CUI [6])
C0700271 (UMLS CUI [7,1])
C0392747 (UMLS CUI [7,2])
C1399787 (UMLS CUI [8])
major surgery
Item
major surgery within four weeks of enrollment
boolean
C0679637 (UMLS CUI [1])
Serum calcium increased Severe
Item
severe elevated serum calcium
boolean
C0595928 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
Heart failure
Item
heart failure
boolean
C0018801 (UMLS CUI [1])
Chemotherapy | Immunotherapy | Therapeutic radiology procedure | Investigational New Drugs
Item
receipt of chemotherapy within 21 days before enrollment, receiving immunotherapy, radiation therapy, or other investigational agents
boolean
C0392920 (UMLS CUI [1])
C0021083 (UMLS CUI [2])
C1522449 (UMLS CUI [3])
C0013230 (UMLS CUI [4])
Adrenal Cortex Hormones | Prednisone
Item
receipt of corticosteroids equivalent to more than 10 mg/day of prednisone within two weeks before enrollment
boolean
C0001617 (UMLS CUI [1])
C0032952 (UMLS CUI [2])
Hypersensitivity bortezomib | Hypersensitivity Boron | Mannitol allergy
Item
known allergies to agents used in bortezomib (e.g., boron or mannitol)
boolean
C0020517 (UMLS CUI [1,1])
C1176309 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0006030 (UMLS CUI [2,2])
C0571922 (UMLS CUI [3])
Poor hypertension control | poorly controlled diabetes mellitus | Illness Serious Interferes with Protocol Compliance | Serious mental illness Interferes with Protocol Compliance
Item
poorly controlled hypertension, diabetes mellitus, or other serious medical or psychiatric illness that could potentially interfere with the completion of treatment according to this protocol
boolean
C0421190 (UMLS CUI [1])
C0554876 (UMLS CUI [2])
C0221423 (UMLS CUI [3,1])
C0205404 (UMLS CUI [3,2])
C0521102 (UMLS CUI [3,3])
C0525058 (UMLS CUI [3,4])
C3841614 (UMLS CUI [4,1])
C0521102 (UMLS CUI [4,2])
C0525058 (UMLS CUI [4,3])
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