ID

16915

Descripción

Zoledronic Acid in the Management of Patients With Asymptomatic/Early Stage Multiple Myeloma; ODM derived from: https://clinicaltrials.gov/show/NCT00216151

Link

https://clinicaltrials.gov/show/NCT00216151

Palabras clave

Versiones (1)
  1. 14/8/16 14/8/16 -
Subido en

14 de agosto de 2016

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Multiple Myeloma NCT00216151

Inglés

Eligibility Multiple Myeloma NCT00216151

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
diagnosis of asymptomatic multiple myeloma as defined by the criteria below:
Descripción

Asymptomatic multiple myeloma

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0026764
UMLS CUI [1,2]
C0231221
presence of bone marrow clonal plasma cells (more than 10%)
Descripción

Presence of bone marrow clonal plasma cells

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1514065
presence of an m-protein in serum and/or urine (no concentration specified)
Descripción

M-protein

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0700271
serum calcium < 12 mg/dl within 14 days prior to registration. less than 3 lytic lesions, no pathologic fractures and no osteopenia noted on skeletal survey
Descripción

Serum calcium, lytic lesions, pathologic fractures, osteopenia

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0728876
UMLS CUI [2]
C0221204
UMLS CUI [3]
C0016663
UMLS CUI [4]
C0029453
no symptoms of hyperviscosity, amyloidosis or recurrent infection
Descripción

Hyperviscosity, amyloidosis, recurrent infection

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0221104
UMLS CUI [2]
C0002726
UMLS CUI [3]
C0239998
bone mineral density with a t score higher than -2.0 standard deviation (not have osteoporosis) within 28 days prior to registration
Descripción

Bone Mineral Density

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0177804
UMLS CUI [1,2]
C3854607
negative pregnancy test
Descripción

Pregnancy test

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0032976
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
no previous treatment with bisphosphonates
Descripción

Bisphosphonates

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0012544
no disorders of the parathyroid or thyroid glands
Descripción

Disorders of the parathyroid or thyroid glands

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0030517
UMLS CUI [2]
C0040128
no current breastfeeding
Descripción

Breast feeding

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0006147
no prior malignancy is allowed except for adequately treated in situ cervical cancer, gleason < grade 7 prostate cancers
Descripción

Prior malignancy

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0006826
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Similar models

Eligibility Multiple Myeloma NCT00216151

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
Asymptomatic multiple myeloma
Item
diagnosis of asymptomatic multiple myeloma as defined by the criteria below:
boolean
C0026764 (UMLS CUI [1,1])
C0231221 (UMLS CUI [1,2])
Presence of bone marrow clonal plasma cells
Item
presence of bone marrow clonal plasma cells (more than 10%)
boolean
C1514065 (UMLS CUI [1])
M-protein
Item
presence of an m-protein in serum and/or urine (no concentration specified)
boolean
C0700271 (UMLS CUI [1])
Serum calcium, lytic lesions, pathologic fractures, osteopenia
Item
serum calcium < 12 mg/dl within 14 days prior to registration. less than 3 lytic lesions, no pathologic fractures and no osteopenia noted on skeletal survey
boolean
C0728876 (UMLS CUI [1])
C0221204 (UMLS CUI [2])
C0016663 (UMLS CUI [3])
C0029453 (UMLS CUI [4])
Hyperviscosity, amyloidosis, recurrent infection
Item
no symptoms of hyperviscosity, amyloidosis or recurrent infection
boolean
C0221104 (UMLS CUI [1])
C0002726 (UMLS CUI [2])
C0239998 (UMLS CUI [3])
Bone Mineral Density
Item
bone mineral density with a t score higher than -2.0 standard deviation (not have osteoporosis) within 28 days prior to registration
boolean
C0177804 (UMLS CUI [1,1])
C3854607 (UMLS CUI [1,2])
Pregnancy test
Item
negative pregnancy test
boolean
C0032976 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Bisphosphonates
Item
no previous treatment with bisphosphonates
boolean
C0012544 (UMLS CUI [1])
Disorders of the parathyroid or thyroid glands
Item
no disorders of the parathyroid or thyroid glands
boolean
C0030517 (UMLS CUI [1])
C0040128 (UMLS CUI [2])
Breast feeding
Item
no current breastfeeding
boolean
C0006147 (UMLS CUI [1])
Prior malignancy
Item
no prior malignancy is allowed except for adequately treated in situ cervical cancer, gleason < grade 7 prostate cancers
boolean
C0006826 (UMLS CUI [1])
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