ID

30869

Beschrijving

Study of Bortezomib and Dexamethasone With or Without Cyclophosphamide in Patients With Relapsed or Not Controllable Multiple Myeloma; ODM derived from: https://clinicaltrials.gov/show/NCT00813150

Link

https://clinicaltrials.gov/show/NCT00813150

Trefwoorden

Versies (1)
  1. 29-06-18 29-06-18 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

29 juni 2018

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Multiple Myeloma NCT00813150

Engels

Eligibility Multiple Myeloma NCT00813150

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
previously diagnosed with multiple myeloma
Beschrijving

Multiple Myeloma

Datatype

boolean

Alias
UMLS CUI [1]
C0026764
primary refractory multiple myeloma or relapsed following 1 to 3 previous lines of therapy
Beschrijving

Refractory multiple myeloma Primary | Recurrent multiple myeloma Post Line of Therapy Quantity

Datatype

boolean

Alias
UMLS CUI [1,1]
C0278620
UMLS CUI [1,2]
C0205225
UMLS CUI [2,1]
C1370446
UMLS CUI [2,2]
C0687676
UMLS CUI [2,3]
C4524693
UMLS CUI [2,4]
C1265611
karnofsky performance status must be equal to 60 percentage (ie, better or equal performance than requiring some help and taking care of most personal requirements)
Beschrijving

Karnofsky Performance Status

Datatype

boolean

Alias
UMLS CUI [1]
C0206065
has life expectancy estimated at screening must be of at least 6 months
Beschrijving

Life Expectancy

Datatype

boolean

Alias
UMLS CUI [1]
C0023671
agrees to protocol-defined use of effective contraception
Beschrijving

Contraceptive methods Willing

Datatype

boolean

Alias
UMLS CUI [1,1]
C0700589
UMLS CUI [1,2]
C0600109
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
not received more than three previous lines of therapy for multiple myeloma
Beschrijving

Line of Therapy Quantity Multiple Myeloma

Datatype

boolean

Alias
UMLS CUI [1,1]
C4524693
UMLS CUI [1,2]
C1265611
UMLS CUI [1,3]
C0026764
not received nitrosoureas or any other chemotherapy or immunotherapy or antibody therapy for multiple myeloma within 6 to 8 weeks before enrolment. plasmapheresis must not be applied within 2 weeks before enrolment
Beschrijving

Nitrosoureas Multiple Myeloma | Chemotherapy Multiple Myeloma | Immunotherapy Multiple Myeloma | Antibody therapy Multiple Myeloma | Plasmapheresis

Datatype

boolean

Alias
UMLS CUI [1,1]
C0028210
UMLS CUI [1,2]
C0026764
UMLS CUI [2,1]
C0392920
UMLS CUI [2,2]
C0026764
UMLS CUI [3,1]
C0021083
UMLS CUI [3,2]
C0026764
UMLS CUI [4,1]
C0281176
UMLS CUI [4,2]
C0026764
UMLS CUI [5]
C0032134
patients with peripheral neuropathy or neuropathic pain of grade 2 or greater intensity
Beschrijving

Peripheral Neuropathy CTCAE Grades | Peripheral neuropathic pain CTCAE Grades

Datatype

boolean

Alias
UMLS CUI [1,1]
C0031117
UMLS CUI [1,2]
C1516728
UMLS CUI [2,1]
C0458960
UMLS CUI [2,2]
C1516728
patients with poorly controlled cardio vascular, vascular, pulmonary, gastro-intestinal, endocrine, neurological, psychiatric, hepatic, renal or metabolic diseases or hematological disorders
Beschrijving

Cardiovascular Diseases Poorly controlled | Vascular Diseases Poorly controlled | Lung diseases Poorly controlled | Gastrointestinal Diseases Poorly controlled | Endocrine System Diseases Poorly controlled | Nervous system disorder Poorly controlled | Mental disorders Poorly controlled | Liver diseases Poorly controlled | Kidney Diseases Poorly controlled | Metabolic Diseases Poorly controlled | Hematological Disease Poorly controlled

Datatype

boolean

Alias
UMLS CUI [1,1]
C0007222
UMLS CUI [1,2]
C3853134
UMLS CUI [2,1]
C0042373
UMLS CUI [2,2]
C3853134
UMLS CUI [3,1]
C0024115
UMLS CUI [3,2]
C3853134
UMLS CUI [4,1]
C0017178
UMLS CUI [4,2]
C3853134
UMLS CUI [5,1]
C0014130
UMLS CUI [5,2]
C3853134
UMLS CUI [6,1]
C0027765
UMLS CUI [6,2]
C3853134
UMLS CUI [7,1]
C0004936
UMLS CUI [7,2]
C3853134
UMLS CUI [8,1]
C0023895
UMLS CUI [8,2]
C3853134
UMLS CUI [9,1]
C0022658
UMLS CUI [9,2]
C3853134
UMLS CUI [10,1]
C0025517
UMLS CUI [10,2]
C3853134
UMLS CUI [11,1]
C0018939
UMLS CUI [11,2]
C3853134
not have oligosecretory or non-secretory multiple myeloma
Beschrijving

Multiple Myeloma M Protein Very low | Non-secretory myeloma

Datatype

boolean

Alias
UMLS CUI [1,1]
C0026764
UMLS CUI [1,2]
C0700271
UMLS CUI [1,3]
C0442811
UMLS CUI [2]
C0456845
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Similar models

Eligibility Multiple Myeloma NCT00813150

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Multiple Myeloma
Item
previously diagnosed with multiple myeloma
boolean
C0026764 (UMLS CUI [1])
Refractory multiple myeloma Primary | Recurrent multiple myeloma Post Line of Therapy Quantity
Item
primary refractory multiple myeloma or relapsed following 1 to 3 previous lines of therapy
boolean
C0278620 (UMLS CUI [1,1])
C0205225 (UMLS CUI [1,2])
C1370446 (UMLS CUI [2,1])
C0687676 (UMLS CUI [2,2])
C4524693 (UMLS CUI [2,3])
C1265611 (UMLS CUI [2,4])
Karnofsky Performance Status
Item
karnofsky performance status must be equal to 60 percentage (ie, better or equal performance than requiring some help and taking care of most personal requirements)
boolean
C0206065 (UMLS CUI [1])
Life Expectancy
Item
has life expectancy estimated at screening must be of at least 6 months
boolean
C0023671 (UMLS CUI [1])
Contraceptive methods Willing
Item
agrees to protocol-defined use of effective contraception
boolean
C0700589 (UMLS CUI [1,1])
C0600109 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Line of Therapy Quantity Multiple Myeloma
Item
not received more than three previous lines of therapy for multiple myeloma
boolean
C4524693 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0026764 (UMLS CUI [1,3])
Nitrosoureas Multiple Myeloma | Chemotherapy Multiple Myeloma | Immunotherapy Multiple Myeloma | Antibody therapy Multiple Myeloma | Plasmapheresis
Item
not received nitrosoureas or any other chemotherapy or immunotherapy or antibody therapy for multiple myeloma within 6 to 8 weeks before enrolment. plasmapheresis must not be applied within 2 weeks before enrolment
boolean
C0028210 (UMLS CUI [1,1])
C0026764 (UMLS CUI [1,2])
C0392920 (UMLS CUI [2,1])
C0026764 (UMLS CUI [2,2])
C0021083 (UMLS CUI [3,1])
C0026764 (UMLS CUI [3,2])
C0281176 (UMLS CUI [4,1])
C0026764 (UMLS CUI [4,2])
C0032134 (UMLS CUI [5])
Peripheral Neuropathy CTCAE Grades | Peripheral neuropathic pain CTCAE Grades
Item
patients with peripheral neuropathy or neuropathic pain of grade 2 or greater intensity
boolean
C0031117 (UMLS CUI [1,1])
C1516728 (UMLS CUI [1,2])
C0458960 (UMLS CUI [2,1])
C1516728 (UMLS CUI [2,2])
Cardiovascular Diseases Poorly controlled | Vascular Diseases Poorly controlled | Lung diseases Poorly controlled | Gastrointestinal Diseases Poorly controlled | Endocrine System Diseases Poorly controlled | Nervous system disorder Poorly controlled | Mental disorders Poorly controlled | Liver diseases Poorly controlled | Kidney Diseases Poorly controlled | Metabolic Diseases Poorly controlled | Hematological Disease Poorly controlled
Item
patients with poorly controlled cardio vascular, vascular, pulmonary, gastro-intestinal, endocrine, neurological, psychiatric, hepatic, renal or metabolic diseases or hematological disorders
boolean
C0007222 (UMLS CUI [1,1])
C3853134 (UMLS CUI [1,2])
C0042373 (UMLS CUI [2,1])
C3853134 (UMLS CUI [2,2])
C0024115 (UMLS CUI [3,1])
C3853134 (UMLS CUI [3,2])
C0017178 (UMLS CUI [4,1])
C3853134 (UMLS CUI [4,2])
C0014130 (UMLS CUI [5,1])
C3853134 (UMLS CUI [5,2])
C0027765 (UMLS CUI [6,1])
C3853134 (UMLS CUI [6,2])
C0004936 (UMLS CUI [7,1])
C3853134 (UMLS CUI [7,2])
C0023895 (UMLS CUI [8,1])
C3853134 (UMLS CUI [8,2])
C0022658 (UMLS CUI [9,1])
C3853134 (UMLS CUI [9,2])
C0025517 (UMLS CUI [10,1])
C3853134 (UMLS CUI [10,2])
C0018939 (UMLS CUI [11,1])
C3853134 (UMLS CUI [11,2])
Multiple Myeloma M Protein Very low | Non-secretory myeloma
Item
not have oligosecretory or non-secretory multiple myeloma
boolean
C0026764 (UMLS CUI [1,1])
C0700271 (UMLS CUI [1,2])
C0442811 (UMLS CUI [1,3])
C0456845 (UMLS CUI [2])
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