ID

21957

Descripción

Consolidation Therapy With Bortezomib in Elderly Patients With Multiple Myeloma; ODM derived from: https://clinicaltrials.gov/show/NCT00416208

Link

https://clinicaltrials.gov/show/NCT00416208

Palabras clave

Versiones (1)
  1. 9/5/17 9/5/17 -
Subido en

9 de mayo de 2017

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Multiple Myeloma DRKS00002426 NCT00416208

Inglés

Eligibility Multiple Myeloma NCT00416208

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients who have had pretreatment with single or tandem high dose melphalan therapy and autologous stem cell transplantation as first line therapy
Descripción

Melphalan High dose Single | Melphalan High dose Consecutive | Transplantation of autologous hematopoietic stem cell First line treatment

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0025241
UMLS CUI [1,2]
C0444956
UMLS CUI [1,3]
C0205171
UMLS CUI [2,1]
C0025241
UMLS CUI [2,2]
C0444956
UMLS CUI [2,3]
C1707491
UMLS CUI [3,1]
C1831743
UMLS CUI [3,2]
C1708063
at least stable disease after stem cell transplantation
Descripción

Stable Disease Post Stem cell transplant

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0677946
UMLS CUI [1,2]
C0687676
UMLS CUI [1,3]
C1504389
adequate hematological, hepatic and renal lab parameters
Descripción

Laboratory Results Hematologic | Laboratory Results Hepatic | Laboratory Results renal

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1254595
UMLS CUI [1,2]
C0205488
UMLS CUI [2,1]
C1254595
UMLS CUI [2,2]
C0205054
UMLS CUI [3,1]
C1254595
UMLS CUI [3,2]
C0022646
karnofsky status of 70 or more
Descripción

Karnofsky Performance Status

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0206065
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
non-secretory multiple myeloma
Descripción

Non-secretory myeloma

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0456845
previous treatment with bortezomib
Descripción

bortezomib

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1176309
allogenic stem cell transplantation
Descripción

Allogeneic Stem Cell Transplantation

Tipo de datos

boolean

Alias
UMLS CUI [1]
C2242529
other co-existing malignancy beside basaliome
Descripción

Malignant Neoplasm | Basal cell carcinoma

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2]
C0007117
peripheral neuropathy
Descripción

Peripheral Neuropathy

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0031117
epilepsia
Descripción

Epilepsy

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0014544
other severe comorbidities (renal, hepatic, cardiovascular, metabolic, infectious etc.)
Descripción

Comorbidity Severe | Kidney Diseases | Liver diseases | Cardiovascular Diseases | Metabolic Diseases | Communicable Diseases

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0205082
UMLS CUI [2]
C0022658
UMLS CUI [3]
C0023895
UMLS CUI [4]
C0007222
UMLS CUI [5]
C0025517
UMLS CUI [6]
C0009450
history of allergic reactions to bortezomib or mannitol
Descripción

Allergic Reaction bortezomib | Mannitol allergy

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1527304
UMLS CUI [1,2]
C1176309
UMLS CUI [2]
C0571922
expected life expectancy of less than 3 months
Descripción

Life Expectancy

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0023671
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Similar models

Eligibility Multiple Myeloma NCT00416208

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
Melphalan High dose Single | Melphalan High dose Consecutive | Transplantation of autologous hematopoietic stem cell First line treatment
Item
patients who have had pretreatment with single or tandem high dose melphalan therapy and autologous stem cell transplantation as first line therapy
boolean
C0025241 (UMLS CUI [1,1])
C0444956 (UMLS CUI [1,2])
C0205171 (UMLS CUI [1,3])
C0025241 (UMLS CUI [2,1])
C0444956 (UMLS CUI [2,2])
C1707491 (UMLS CUI [2,3])
C1831743 (UMLS CUI [3,1])
C1708063 (UMLS CUI [3,2])
Stable Disease Post Stem cell transplant
Item
at least stable disease after stem cell transplantation
boolean
C0677946 (UMLS CUI [1,1])
C0687676 (UMLS CUI [1,2])
C1504389 (UMLS CUI [1,3])
Laboratory Results Hematologic | Laboratory Results Hepatic | Laboratory Results renal
Item
adequate hematological, hepatic and renal lab parameters
boolean
C1254595 (UMLS CUI [1,1])
C0205488 (UMLS CUI [1,2])
C1254595 (UMLS CUI [2,1])
C0205054 (UMLS CUI [2,2])
C1254595 (UMLS CUI [3,1])
C0022646 (UMLS CUI [3,2])
Karnofsky Performance Status
Item
karnofsky status of 70 or more
boolean
C0206065 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Non-secretory myeloma
Item
non-secretory multiple myeloma
boolean
C0456845 (UMLS CUI [1])
bortezomib
Item
previous treatment with bortezomib
boolean
C1176309 (UMLS CUI [1])
Allogeneic Stem Cell Transplantation
Item
allogenic stem cell transplantation
boolean
C2242529 (UMLS CUI [1])
Malignant Neoplasm | Basal cell carcinoma
Item
other co-existing malignancy beside basaliome
boolean
C0006826 (UMLS CUI [1])
C0007117 (UMLS CUI [2])
Peripheral Neuropathy
Item
peripheral neuropathy
boolean
C0031117 (UMLS CUI [1])
Epilepsy
Item
epilepsia
boolean
C0014544 (UMLS CUI [1])
Comorbidity Severe | Kidney Diseases | Liver diseases | Cardiovascular Diseases | Metabolic Diseases | Communicable Diseases
Item
other severe comorbidities (renal, hepatic, cardiovascular, metabolic, infectious etc.)
boolean
C0009488 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0022658 (UMLS CUI [2])
C0023895 (UMLS CUI [3])
C0007222 (UMLS CUI [4])
C0025517 (UMLS CUI [5])
C0009450 (UMLS CUI [6])
Allergic Reaction bortezomib | Mannitol allergy
Item
history of allergic reactions to bortezomib or mannitol
boolean
C1527304 (UMLS CUI [1,1])
C1176309 (UMLS CUI [1,2])
C0571922 (UMLS CUI [2])
Life Expectancy
Item
expected life expectancy of less than 3 months
boolean
C0023671 (UMLS CUI [1])
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