ID

35868

Descrição

CDD Plus Bortezomib or CDDin Relapsed or Refractory Multiple Myeloma With Extramedullary Plasmacytoma; ODM derived from: https://clinicaltrials.gov/show/NCT02336386

Link

https://clinicaltrials.gov/show/NCT02336386

Palavras-chave

Versões (1)
  1. 30/03/2019 30/03/2019 -
Titular dos direitos

See clinicaltrials.gov

Transferido a

30 de março de 2019

DOI

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Licença

Creative Commons BY 4.0
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Eligibility Extramedullary Plasmacytoma NCT02336386

Inglês

Eligibility Extramedullary Plasmacytoma NCT02336386

1 Formulários  
Inclusion Criteria
Descrição

Inclusion Criteria

Alias
UMLS CUI
C1512693
male or female patients from 18 to 80
Descrição

Age

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0001779
biopsy-proven emp with relapsed or refractory myeloma disease. patients may be proteasome inhibitor-exposed or naive, but cannot be refractory to proteasome inhibitor therapy
Descrição

Extramedullary Plasmacytoma | Plasma cell myeloma recurrent | Myeloma Refractory | Exposure to Proteasome inhibitor | Proteasome inhibitor Absent | Absence Unresponsive to Treatment Proteasome inhibitor

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0278619
UMLS CUI [2]
C1370446
UMLS CUI [3,1]
C0026764
UMLS CUI [3,2]
C0205269
UMLS CUI [4,1]
C0332157
UMLS CUI [4,2]
C1443643
UMLS CUI [5,1]
C1443643
UMLS CUI [5,2]
C0332197
UMLS CUI [6,1]
C0332197
UMLS CUI [6,2]
C0205269
UMLS CUI [6,3]
C1443643
disease requiring further treatment
Descrição

Disease Treatment required for Additional

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0332121
UMLS CUI [1,3]
C1524062
measurable disease such as m protein and objective and measurable of emp
Descrição

Measurable Disease | M Protein Measurable | Extramedullary Plasmacytoma Measurable

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1513041
UMLS CUI [2,1]
C0700271
UMLS CUI [2,2]
C1513040
UMLS CUI [3,1]
C0278619
UMLS CUI [3,2]
C1513040
eastern cooperative oncology group (ecog) performance status of less than or equal to 2
Descrição

ECOG performance status

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1520224
meet the clinical laboratories criteria as specified in the protocol
Descrição

Laboratory Criteria Fulfill

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0022877
UMLS CUI [1,2]
C0243161
UMLS CUI [1,3]
C1550543
voluntary written consent
Descrição

Informed Consent

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Descrição

Exclusion Criteria

Alias
UMLS CUI
C0680251
female patients who are lactating, breastfeeding or pregnant
Descrição

Pregnancy | Breast Feeding

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
evidence of current uncontrolled cardiovascular conditions as specified in study protocol
Descrição

Cardiovascular Diseases Uncontrolled

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0007222
UMLS CUI [1,2]
C0205318
requirement for other concomitant chemotherapy, immunotherapy, radiotherapy, which would be considered as a treatment of emp.
Descrição

Chemotherapy Other Extramedullary Plasmacytoma | Immunotherapy Other Extramedullary Plasmacytoma | Therapeutic radiology procedure Other Extramedullary Plasmacytoma

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0392920
UMLS CUI [1,2]
C0205394
UMLS CUI [1,3]
C0278619
UMLS CUI [2,1]
C0021083
UMLS CUI [2,2]
C0205394
UMLS CUI [2,3]
C0278619
UMLS CUI [3,1]
C1522449
UMLS CUI [3,2]
C0205394
UMLS CUI [3,3]
C0278619
comorbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens
Descrição

Comorbidity Systemic Study Subject Participation Status Inappropriate | Comorbidity Severe Study Subject Participation Status Inappropriate | Comorbidity Systemic Interferes with Evaluation | Comorbidity Severe Interferes with Evaluation

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0205373
UMLS CUI [1,3]
C2348568
UMLS CUI [1,4]
C1548788
UMLS CUI [2,1]
C0009488
UMLS CUI [2,2]
C0205082
UMLS CUI [2,3]
C2348568
UMLS CUI [2,4]
C1548788
UMLS CUI [3,1]
C0009488
UMLS CUI [3,2]
C0205373
UMLS CUI [3,3]
C0521102
UMLS CUI [3,4]
C1261322
UMLS CUI [4,1]
C0009488
UMLS CUI [4,2]
C0205082
UMLS CUI [4,3]
C0521102
UMLS CUI [4,4]
C1261322
ongoing or active infection, known hiv positive, active hepatitis b or c infection
Descrição

Communicable Disease | HIV Seropositivity | Hepatitis B | Hepatitis C

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0009450
UMLS CUI [2]
C0019699
UMLS CUI [3]
C0019163
UMLS CUI [4]
C0019196
psychiatric illness/social situations that would limit compliance with study requirements
Descrição

Mental disorders Limiting Protocol Compliance | Social situation Limiting Protocol Compliance

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0004936
UMLS CUI [1,2]
C0439801
UMLS CUI [1,3]
C0525058
UMLS CUI [2,1]
C0748872
UMLS CUI [2,2]
C0439801
UMLS CUI [2,3]
C0525058
known allergy to any of the study medications
Descrição

Hypersensitivity Investigational New Drugs

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0013230
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Similar models

Eligibility Extramedullary Plasmacytoma NCT02336386

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
male or female patients from 18 to 80
boolean
C0001779 (UMLS CUI [1])
Extramedullary Plasmacytoma | Plasma cell myeloma recurrent | Myeloma Refractory | Exposure to Proteasome inhibitor | Proteasome inhibitor Absent | Absence Unresponsive to Treatment Proteasome inhibitor
Item
biopsy-proven emp with relapsed or refractory myeloma disease. patients may be proteasome inhibitor-exposed or naive, but cannot be refractory to proteasome inhibitor therapy
boolean
C0278619 (UMLS CUI [1])
C1370446 (UMLS CUI [2])
C0026764 (UMLS CUI [3,1])
C0205269 (UMLS CUI [3,2])
C0332157 (UMLS CUI [4,1])
C1443643 (UMLS CUI [4,2])
C1443643 (UMLS CUI [5,1])
C0332197 (UMLS CUI [5,2])
C0332197 (UMLS CUI [6,1])
C0205269 (UMLS CUI [6,2])
C1443643 (UMLS CUI [6,3])
Disease Treatment required for Additional
Item
disease requiring further treatment
boolean
C0012634 (UMLS CUI [1,1])
C0332121 (UMLS CUI [1,2])
C1524062 (UMLS CUI [1,3])
Measurable Disease | M Protein Measurable | Extramedullary Plasmacytoma Measurable
Item
measurable disease such as m protein and objective and measurable of emp
boolean
C1513041 (UMLS CUI [1])
C0700271 (UMLS CUI [2,1])
C1513040 (UMLS CUI [2,2])
C0278619 (UMLS CUI [3,1])
C1513040 (UMLS CUI [3,2])
ECOG performance status
Item
eastern cooperative oncology group (ecog) performance status of less than or equal to 2
boolean
C1520224 (UMLS CUI [1])
Laboratory Criteria Fulfill
Item
meet the clinical laboratories criteria as specified in the protocol
boolean
C0022877 (UMLS CUI [1,1])
C0243161 (UMLS CUI [1,2])
C1550543 (UMLS CUI [1,3])
Informed Consent
Item
voluntary written consent
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Pregnancy | Breast Feeding
Item
female patients who are lactating, breastfeeding or pregnant
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Cardiovascular Diseases Uncontrolled
Item
evidence of current uncontrolled cardiovascular conditions as specified in study protocol
boolean
C0007222 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
Chemotherapy Other Extramedullary Plasmacytoma | Immunotherapy Other Extramedullary Plasmacytoma | Therapeutic radiology procedure Other Extramedullary Plasmacytoma
Item
requirement for other concomitant chemotherapy, immunotherapy, radiotherapy, which would be considered as a treatment of emp.
boolean
C0392920 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C0278619 (UMLS CUI [1,3])
C0021083 (UMLS CUI [2,1])
C0205394 (UMLS CUI [2,2])
C0278619 (UMLS CUI [2,3])
C1522449 (UMLS CUI [3,1])
C0205394 (UMLS CUI [3,2])
C0278619 (UMLS CUI [3,3])
Comorbidity Systemic Study Subject Participation Status Inappropriate | Comorbidity Severe Study Subject Participation Status Inappropriate | Comorbidity Systemic Interferes with Evaluation | Comorbidity Severe Interferes with Evaluation
Item
comorbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens
boolean
C0009488 (UMLS CUI [1,1])
C0205373 (UMLS CUI [1,2])
C2348568 (UMLS CUI [1,3])
C1548788 (UMLS CUI [1,4])
C0009488 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
C2348568 (UMLS CUI [2,3])
C1548788 (UMLS CUI [2,4])
C0009488 (UMLS CUI [3,1])
C0205373 (UMLS CUI [3,2])
C0521102 (UMLS CUI [3,3])
C1261322 (UMLS CUI [3,4])
C0009488 (UMLS CUI [4,1])
C0205082 (UMLS CUI [4,2])
C0521102 (UMLS CUI [4,3])
C1261322 (UMLS CUI [4,4])
Communicable Disease | HIV Seropositivity | Hepatitis B | Hepatitis C
Item
ongoing or active infection, known hiv positive, active hepatitis b or c infection
boolean
C0009450 (UMLS CUI [1])
C0019699 (UMLS CUI [2])
C0019163 (UMLS CUI [3])
C0019196 (UMLS CUI [4])
Mental disorders Limiting Protocol Compliance | Social situation Limiting Protocol Compliance
Item
psychiatric illness/social situations that would limit compliance with study requirements
boolean
C0004936 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
C0525058 (UMLS CUI [1,3])
C0748872 (UMLS CUI [2,1])
C0439801 (UMLS CUI [2,2])
C0525058 (UMLS CUI [2,3])
Hypersensitivity Investigational New Drugs
Item
known allergy to any of the study medications
boolean
C0020517 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
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