ID

18099

Description

VELCADE in Subjects With Relapsed or Refractory Mantle Cell Lymphoma; ODM derived from: https://clinicaltrials.gov/show/NCT00063713

Link

https://clinicaltrials.gov/show/NCT00063713

Keywords

Versions (1)
  1. 10/19/16 10/19/16 -
Uploaded on

October 19, 2016

DOI

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License

Creative Commons BY 4.0
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Eligibility Mantle Cell Lymphoma NCT00063713

English

Eligibility Mantle Cell Lymphoma NCT00063713

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
18 years of age or older
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
confirmed diagnosis of mantle cell lymphoma
Description

Mantle cell lymphoma

Data type

boolean

Alias
UMLS CUI [1]
C0334634
documented relapse or progressive disease following 1 or 2 prior lines of anti-cancer therapy. at least one of those regimens must have included an anthracycline or mitoxantrone. relapsed or progressive disease, since last therapy must be documented by new lesions or objective evidence of the progression of existing lesions.
Description

Recurrent disease | Progressive Disease | cancer treatment Quantity | Anthracycline | Mitoxantrone | New Lesion | Lesion Progressive Evidence of

Data type

boolean

Alias
UMLS CUI [1]
C0277556
UMLS CUI [2]
C1335499
UMLS CUI [3,1]
C0920425
UMLS CUI [3,2]
C1265611
UMLS CUI [4]
C0003234
UMLS CUI [5]
C0026259
UMLS CUI [6]
C2986548
UMLS CUI [7,1]
C0221198
UMLS CUI [7,2]
C0205329
UMLS CUI [7,3]
C0332120
at least 1 measurable or evaluable site of disease
Description

Measurable Disease Site Quantity | Evaluable Disease Site Quantity

Data type

boolean

Alias
UMLS CUI [1,1]
C1513041
UMLS CUI [1,2]
C1515974
UMLS CUI [1,3]
C1265611
UMLS CUI [2,1]
C1516986
UMLS CUI [2,2]
C1515974
UMLS CUI [2,3]
C1265611
voluntary consent
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
previous treatment with velcade
Description

Velcade

Data type

boolean

Alias
UMLS CUI [1]
C1174739
any experimental or anti-cancer therapy within 3 weeks before the first dose of study drug
Description

Therapies, Investigational | cancer treatment

Data type

boolean

Alias
UMLS CUI [1]
C0949266
UMLS CUI [2]
C0920425
radiation therapy within 3 weeks before the first dose of study drug
Description

Therapeutic radiology procedure

Data type

boolean

Alias
UMLS CUI [1]
C1522449
major surgery with 2 weeks before the first dose of study drug
Description

major surgery

Data type

boolean

Alias
UMLS CUI [1]
C0679637
rituximab, campath, or other unconjugated therapeutic antibody within 4 weeks before the first dose of study drug
Description

rituximab | Campath | Monoclonal antibody unconjugated therapy

Data type

boolean

Alias
UMLS CUI [1]
C0393022
UMLS CUI [2]
C0939276
UMLS CUI [3]
C0854644
radioimmunotherapy or other toxin immunoconjugates such as zevalin or bexxar within 10 weeks before the first dose of study drug
Description

Radioimmunotherapy | Toxin Immunoconjugates | Zevalin | Bexxar

Data type

boolean

Alias
UMLS CUI [1]
C0085101
UMLS CUI [2,1]
C0040549
UMLS CUI [2,2]
C0243020
UMLS CUI [3]
C0919274
UMLS CUI [4]
C0919272
history of allergic reactions to boron or mannitol compounds
Description

Allergic Reaction Boron Compounds | Mannitol allergy

Data type

boolean

Alias
UMLS CUI [1,1]
C1527304
UMLS CUI [1,2]
C0006031
UMLS CUI [2]
C0571922
diagnosed or treated for another malignancy other than mantle cell lymphoma with 5 years before the first dose of study drug
Description

Malignant Neoplasms | Mantle cell lymphoma

Data type

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2]
C0334634
active systemic infection requiring treatment
Description

Sepsis Requirement Therapeutic procedure

Data type

boolean

Alias
UMLS CUI [1,1]
C0243026
UMLS CUI [1,2]
C1514873
UMLS CUI [1,3]
C0087111
women patients must not be pregnant or breast-feeding, confirmed through pregnancy test obtained during screening (this test is not required for women who are post-menopausal or surgically sterile)
Description

Pregnancy Pregnancy Test | Breast Feeding | Postmenopausal state | Female Sterilization

Data type

boolean

Alias
UMLS CUI [1,1]
C0032961
UMLS CUI [1,2]
C0032976
UMLS CUI [2]
C0006147
UMLS CUI [3]
C0232970
UMLS CUI [4]
C0015787
serious medical or psychiatric illness likely to interfere with participation in this clinical study
Description

Illness Serious Interferes with Study Subject Participation Status | Mental disorder Interferes with Study Subject Participation Status

Data type

boolean

Alias
UMLS CUI [1,1]
C0221423
UMLS CUI [1,2]
C0205404
UMLS CUI [1,3]
C0521102
UMLS CUI [1,4]
C2348568
UMLS CUI [2,1]
C0004936
UMLS CUI [2,2]
C0521102
UMLS CUI [2,3]
C2348568
concurrent treatment with another investigational drug or participation in non-treatment studies is not allowed if it interferes with participation in this clinical study
Description

Study Subject Participation Status | Investigational New Drugs

Data type

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0013230
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Similar models

Eligibility Mantle Cell Lymphoma NCT00063713

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
18 years of age or older
boolean
C0001779 (UMLS CUI [1])
Mantle cell lymphoma
Item
confirmed diagnosis of mantle cell lymphoma
boolean
C0334634 (UMLS CUI [1])
Recurrent disease | Progressive Disease | cancer treatment Quantity | Anthracycline | Mitoxantrone | New Lesion | Lesion Progressive Evidence of
Item
documented relapse or progressive disease following 1 or 2 prior lines of anti-cancer therapy. at least one of those regimens must have included an anthracycline or mitoxantrone. relapsed or progressive disease, since last therapy must be documented by new lesions or objective evidence of the progression of existing lesions.
boolean
C0277556 (UMLS CUI [1])
C1335499 (UMLS CUI [2])
C0920425 (UMLS CUI [3,1])
C1265611 (UMLS CUI [3,2])
C0003234 (UMLS CUI [4])
C0026259 (UMLS CUI [5])
C2986548 (UMLS CUI [6])
C0221198 (UMLS CUI [7,1])
C0205329 (UMLS CUI [7,2])
C0332120 (UMLS CUI [7,3])
Measurable Disease Site Quantity | Evaluable Disease Site Quantity
Item
at least 1 measurable or evaluable site of disease
boolean
C1513041 (UMLS CUI [1,1])
C1515974 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
C1516986 (UMLS CUI [2,1])
C1515974 (UMLS CUI [2,2])
C1265611 (UMLS CUI [2,3])
Informed Consent
Item
voluntary consent
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Velcade
Item
previous treatment with velcade
boolean
C1174739 (UMLS CUI [1])
Therapies, Investigational | cancer treatment
Item
any experimental or anti-cancer therapy within 3 weeks before the first dose of study drug
boolean
C0949266 (UMLS CUI [1])
C0920425 (UMLS CUI [2])
Therapeutic radiology procedure
Item
radiation therapy within 3 weeks before the first dose of study drug
boolean
C1522449 (UMLS CUI [1])
major surgery
Item
major surgery with 2 weeks before the first dose of study drug
boolean
C0679637 (UMLS CUI [1])
rituximab | Campath | Monoclonal antibody unconjugated therapy
Item
rituximab, campath, or other unconjugated therapeutic antibody within 4 weeks before the first dose of study drug
boolean
C0393022 (UMLS CUI [1])
C0939276 (UMLS CUI [2])
C0854644 (UMLS CUI [3])
Radioimmunotherapy | Toxin Immunoconjugates | Zevalin | Bexxar
Item
radioimmunotherapy or other toxin immunoconjugates such as zevalin or bexxar within 10 weeks before the first dose of study drug
boolean
C0085101 (UMLS CUI [1])
C0040549 (UMLS CUI [2,1])
C0243020 (UMLS CUI [2,2])
C0919274 (UMLS CUI [3])
C0919272 (UMLS CUI [4])
Allergic Reaction Boron Compounds | Mannitol allergy
Item
history of allergic reactions to boron or mannitol compounds
boolean
C1527304 (UMLS CUI [1,1])
C0006031 (UMLS CUI [1,2])
C0571922 (UMLS CUI [2])
Malignant Neoplasms | Mantle cell lymphoma
Item
diagnosed or treated for another malignancy other than mantle cell lymphoma with 5 years before the first dose of study drug
boolean
C0006826 (UMLS CUI [1])
C0334634 (UMLS CUI [2])
Sepsis Requirement Therapeutic procedure
Item
active systemic infection requiring treatment
boolean
C0243026 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C0087111 (UMLS CUI [1,3])
Pregnancy Pregnancy Test | Breast Feeding | Postmenopausal state | Female Sterilization
Item
women patients must not be pregnant or breast-feeding, confirmed through pregnancy test obtained during screening (this test is not required for women who are post-menopausal or surgically sterile)
boolean
C0032961 (UMLS CUI [1,1])
C0032976 (UMLS CUI [1,2])
C0006147 (UMLS CUI [2])
C0232970 (UMLS CUI [3])
C0015787 (UMLS CUI [4])
Illness Serious Interferes with Study Subject Participation Status | Mental disorder Interferes with Study Subject Participation Status
Item
serious medical or psychiatric illness likely to interfere with participation in this clinical study
boolean
C0221423 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C0521102 (UMLS CUI [1,3])
C2348568 (UMLS CUI [1,4])
C0004936 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C2348568 (UMLS CUI [2,3])
Study Subject Participation Status | Investigational New Drugs
Item
concurrent treatment with another investigational drug or participation in non-treatment studies is not allowed if it interferes with participation in this clinical study
boolean
C2348568 (UMLS CUI [1])
C0013230 (UMLS CUI [2])
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