ID

21880

Descrição

An Extension Study to Provide Bortezomib to Patients With Relapsed or Refractory Multiple Myeloma Who Previously Participated in a Bortezomib Phase I/II Study and Who May Benefit From Re-Treatment With or Continuation of Bortezomib Therapy; ODM derived from: https://clinicaltrials.gov/show/NCT00216697

Link

https://clinicaltrials.gov/show/NCT00216697

Palavras-chave

Versões (1)
  1. 05/05/2017 05/05/2017 -
Transferido a

5 de maio de 2017

DOI

Para um pedido faça login.

Licença

Creative Commons BY 4.0
Comentários do modelo :

Aqui pode comentar o modelo. Pode comentá-lo especificamente através dos balões de texto nos grupos de itens e itens.

Voltar para os comentários do modelo
Comentários do grupo de itens para :

Comentários do item para :

Para descarregar formulários, precisa de ter uma sessão iniciada. Por favor faça login ou registe-se gratuitamente.

Eligibility Multiple Myeloma NCT00216697

Inglês

Eligibility Multiple Myeloma NCT00216697

1 Formulários  
Inclusion Criteria
Descrição

Inclusion Criteria

Alias
UMLS CUI
C1512693
complete 6 cycles treatment in preceding phase i/ii study
Descrição

Therapeutic procedure Quantity Completed | Clinical Trial Specified

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C1265611
UMLS CUI [1,3]
C0205197
UMLS CUI [2,1]
C0008976
UMLS CUI [2,2]
C0205369
response (cr, pr, mr or nc) was obtained in 6 cycles treatment during the preceding phase i/ii study and investigator considers that the patient is expected to have benefit such as antitumor effect, pain relief or improvement of performance state
Descrição

Therapeutic procedure Quantity | Response In complete remission | Partial response | Minimal therapeutic response | Response No change | Effect Against Neoplasm | Pain relief | Performance status Improved

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C1265611
UMLS CUI [2,1]
C1704632
UMLS CUI [2,2]
C0677874
UMLS CUI [3]
C1521726
UMLS CUI [4]
C0184783
UMLS CUI [5,1]
C1704632
UMLS CUI [5,2]
C0442739
UMLS CUI [6,1]
C1280500
UMLS CUI [6,2]
C0521124
UMLS CUI [6,3]
C0027651
UMLS CUI [7]
C0451615
UMLS CUI [8,1]
C1518965
UMLS CUI [8,2]
C0184511
patients who did not have grade >=3 non-hematologic toxicity or grade 4 hematologic toxicity during the preceding phase i/ii study or extension treatment of this study
Descrição

Toxicity CTCAE Grades | Toxicity hematologic CTCAE Grades

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0600688
UMLS CUI [1,2]
C1516728
UMLS CUI [2,1]
C0600688
UMLS CUI [2,2]
C0205488
UMLS CUI [2,3]
C1516728
investigator considers that the patient is expected to have benefit of this drug such as antitumor effect, pain relief or improvement of performance state.
Descrição

Investigational New Drug Benefit Expected | Effect Against Neoplasm | Pain relief | Performance status Improved

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0013230
UMLS CUI [1,2]
C0814225
UMLS CUI [1,3]
C1517001
UMLS CUI [2,1]
C1280500
UMLS CUI [2,2]
C0521124
UMLS CUI [2,3]
C0027651
UMLS CUI [3]
C0451615
UMLS CUI [4,1]
C1518965
UMLS CUI [4,2]
C0184511
Exclusion Criteria
Descrição

Exclusion Criteria

Alias
UMLS CUI
C0680251
patient is known to be hbs antigen positive, hcv antibody positive or hiv antibody positive (check is required for patients who received blood product during phase i/ii study)
Descrição

Hepatitis B surface antigen positive | Hepatitis C antibody positive | HIV antibody positive | Blood product Requirement Check

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0149709
UMLS CUI [2]
C0281863
UMLS CUI [3]
C0920548
UMLS CUI [4,1]
C0456388
UMLS CUI [4,2]
C1514873
UMLS CUI [4,3]
C1283174
patients who receive g-csf product or blood transfusion within 7 days before the start of treatment
Descrição

Granulocyte Colony-Stimulating Factor | Blood Transfusion

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0079459
UMLS CUI [2]
C0005841
disease progress was observed during the phase i/ii or this study when patients receive recommended dose
Descrição

Investigational New Drug Dose Recommended | Disease Progression

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0013230
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0034866
UMLS CUI [2]
C0242656
patients who suffer grade >=2 peripheral neuropathy or grade >=2 neuropathic pain
Descrição

Peripheral Neuropathy CTCAE Grades | Neuropathic pain CTCAE Grades

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0031117
UMLS CUI [1,2]
C1516728
UMLS CUI [2,1]
C3714625
UMLS CUI [2,2]
C1516728
patient has new york heart association (nyha) class iii or iv heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, acute ischemia or active conduction system abnormalities.
Descrição

Heart failure New York Heart Association Classification | Angina control - poor | Ventricular arrhythmia Uncontrolled Severe | Ischemia | Conduction system abnormalities

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0018801
UMLS CUI [1,2]
C1275491
UMLS CUI [2]
C0421196
UMLS CUI [3,1]
C0085612
UMLS CUI [3,2]
C0205318
UMLS CUI [3,3]
C0205082
UMLS CUI [4]
C0022116
UMLS CUI [5]
C0151236
Voltar ao início da página

Similar models

Eligibility Multiple Myeloma NCT00216697

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
C1512693 (UMLS CUI)
Therapeutic procedure Quantity Completed | Clinical Trial Specified
Item
complete 6 cycles treatment in preceding phase i/ii study
boolean
C0087111 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0205197 (UMLS CUI [1,3])
C0008976 (UMLS CUI [2,1])
C0205369 (UMLS CUI [2,2])
Therapeutic procedure Quantity | Response In complete remission | Partial response | Minimal therapeutic response | Response No change | Effect Against Neoplasm | Pain relief | Performance status Improved
Item
response (cr, pr, mr or nc) was obtained in 6 cycles treatment during the preceding phase i/ii study and investigator considers that the patient is expected to have benefit such as antitumor effect, pain relief or improvement of performance state
boolean
C0087111 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C1704632 (UMLS CUI [2,1])
C0677874 (UMLS CUI [2,2])
C1521726 (UMLS CUI [3])
C0184783 (UMLS CUI [4])
C1704632 (UMLS CUI [5,1])
C0442739 (UMLS CUI [5,2])
C1280500 (UMLS CUI [6,1])
C0521124 (UMLS CUI [6,2])
C0027651 (UMLS CUI [6,3])
C0451615 (UMLS CUI [7])
C1518965 (UMLS CUI [8,1])
C0184511 (UMLS CUI [8,2])
Toxicity CTCAE Grades | Toxicity hematologic CTCAE Grades
Item
patients who did not have grade >=3 non-hematologic toxicity or grade 4 hematologic toxicity during the preceding phase i/ii study or extension treatment of this study
boolean
C0600688 (UMLS CUI [1,1])
C1516728 (UMLS CUI [1,2])
C0600688 (UMLS CUI [2,1])
C0205488 (UMLS CUI [2,2])
C1516728 (UMLS CUI [2,3])
Investigational New Drug Benefit Expected | Effect Against Neoplasm | Pain relief | Performance status Improved
Item
investigator considers that the patient is expected to have benefit of this drug such as antitumor effect, pain relief or improvement of performance state.
boolean
C0013230 (UMLS CUI [1,1])
C0814225 (UMLS CUI [1,2])
C1517001 (UMLS CUI [1,3])
C1280500 (UMLS CUI [2,1])
C0521124 (UMLS CUI [2,2])
C0027651 (UMLS CUI [2,3])
C0451615 (UMLS CUI [3])
C1518965 (UMLS CUI [4,1])
C0184511 (UMLS CUI [4,2])
Item Group
C0680251 (UMLS CUI)
Hepatitis B surface antigen positive | Hepatitis C antibody positive | HIV antibody positive | Blood product Requirement Check
Item
patient is known to be hbs antigen positive, hcv antibody positive or hiv antibody positive (check is required for patients who received blood product during phase i/ii study)
boolean
C0149709 (UMLS CUI [1])
C0281863 (UMLS CUI [2])
C0920548 (UMLS CUI [3])
C0456388 (UMLS CUI [4,1])
C1514873 (UMLS CUI [4,2])
C1283174 (UMLS CUI [4,3])
Granulocyte Colony-Stimulating Factor | Blood Transfusion
Item
patients who receive g-csf product or blood transfusion within 7 days before the start of treatment
boolean
C0079459 (UMLS CUI [1])
C0005841 (UMLS CUI [2])
Investigational New Drug Dose Recommended | Disease Progression
Item
disease progress was observed during the phase i/ii or this study when patients receive recommended dose
boolean
C0013230 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0034866 (UMLS CUI [1,3])
C0242656 (UMLS CUI [2])
Peripheral Neuropathy CTCAE Grades | Neuropathic pain CTCAE Grades
Item
patients who suffer grade >=2 peripheral neuropathy or grade >=2 neuropathic pain
boolean
C0031117 (UMLS CUI [1,1])
C1516728 (UMLS CUI [1,2])
C3714625 (UMLS CUI [2,1])
C1516728 (UMLS CUI [2,2])
Heart failure New York Heart Association Classification | Angina control - poor | Ventricular arrhythmia Uncontrolled Severe | Ischemia | Conduction system abnormalities
Item
patient has new york heart association (nyha) class iii or iv heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, acute ischemia or active conduction system abnormalities.
boolean
C0018801 (UMLS CUI [1,1])
C1275491 (UMLS CUI [1,2])
C0421196 (UMLS CUI [2])
C0085612 (UMLS CUI [3,1])
C0205318 (UMLS CUI [3,2])
C0205082 (UMLS CUI [3,3])
C0022116 (UMLS CUI [4])
C0151236 (UMLS CUI [5])
Voltar ao início da página 

Contacto

Use este formulário para feedback, perguntas e sugestões de aperfeiçoamento.

Campos marcados com * são obrigatórios.

Ajuda

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial