ID

21938

Description

An Efficacy and Safety Study of Siltuximab in Participants With Relapsed or Refractory Multiple Myeloma; ODM derived from: https://clinicaltrials.gov/show/NCT00402181

Link

https://clinicaltrials.gov/show/NCT00402181

Keywords

Versions (1)
  1. 5/9/17 5/9/17 -
Uploaded on

May 9, 2017

DOI

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License

Creative Commons BY 4.0
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Eligibility Multiple Myeloma NCT00402181

English

Eligibility Multiple Myeloma NCT00402181

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
confirmed diagnosis of multiple myeloma with relapsed or refractory disease after failing at least 2 prior lines of therapy
Description

Multiple Myeloma | Therapeutic procedure Quantity failed | Recurrent disease | Refractory Disease

Data type

boolean

Alias
UMLS CUI [1]
C0026764
UMLS CUI [2,1]
C0087111
UMLS CUI [2,2]
C1265611
UMLS CUI [2,3]
C0231175
UMLS CUI [3]
C0277556
UMLS CUI [4]
C1514815
prior treatment regimen must have included bortezomib (alone or in combination with other agents)
Description

bortezomib | Combined Modality Therapy

Data type

boolean

Alias
UMLS CUI [1]
C1176309
UMLS CUI [2]
C0009429
measurable secretory disease defined as either serum monoclonal paraprotein (m-
Description

Measurable Disease secretion | Serum paraprotein measurement monoclonal

Data type

boolean

Alias
UMLS CUI [1,1]
C1513041
UMLS CUI [1,2]
C1327616
UMLS CUI [2,1]
C0585639
UMLS CUI [2,2]
C0746619
protein) greater than or equal to (>=) 1 gram per deciliter (g/dl) or urine monoclonal (light chain) protein (greater than (>) 200 milligram/24 hours)
Description

M Protein | Monoclonal Protein Measurement In Urine

Data type

boolean

Alias
UMLS CUI [1]
C0700271
UMLS CUI [2,1]
C2984963
UMLS CUI [2,2]
C0042037
eastern cooperative oncology group (ecog) performance status score of less than or equal to (<=) 2 - participants of childbearing potential must use adequate birth control measures, female participants of childbearing potential must have a negative serum pregnancy test at screening
Description

ECOG performance status | Childbearing Potential Contraceptive methods | Childbearing Potential Serum pregnancy test negative

Data type

boolean

Alias
UMLS CUI [1]
C1520224
UMLS CUI [2,1]
C3831118
UMLS CUI [2,2]
C0700589
UMLS CUI [3,1]
C3831118
UMLS CUI [3,2]
C0430061
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
treatment with systemic cancer therapy (including clarithromycin) or radiotherapy within 30 days before the first dose of study agent - treatment with nitrosoureas (a group of alkylating agents used as antineoplastic drugs in the chemotherapy) within 42 days before the first dose of study agent
Description

Cancer treatment Systemic | Clarithromycin | Therapeutic radiology procedure | Nitrosoureas | Alkylating Agents | Antineoplastic Agents | Chemotherapy

Data type

boolean

Alias
UMLS CUI [1,1]
C0920425
UMLS CUI [1,2]
C0205373
UMLS CUI [2]
C0055856
UMLS CUI [3]
C1522449
UMLS CUI [4]
C0028210
UMLS CUI [5]
C0002073
UMLS CUI [6]
C0003392
UMLS CUI [7]
C0392920
major surgery within 30 days before the first dose of study agent or planning to have surgery (except for minor surgical procedures) during the study
Description

Major surgery | Operative Surgical Procedures Planned | Minor Surgical Procedures

Data type

boolean

Alias
UMLS CUI [1]
C0679637
UMLS CUI [2,1]
C0543467
UMLS CUI [2,2]
C1301732
UMLS CUI [3]
C0038904
serious concurrent illness (medical or psychiatric), uncontrolled infection, or significant cardiac disease characterized by significant ischemic coronary disease (an imbalance between myocardial functional requirements and the capacity of the coronary vessels to supply sufficient blood flow) or congestive heart failure (condition in which the heart is unable to pump out sufficient blood to meet the metabolic need of the body) not under medical control, or any uncontrolled medical condition (for example: uncontrolled diabetes), including the presence of clinical laboratory abnormalities, that places the subject at unacceptable risk by participating in the study or confounds the ability to interpret data from the study
Description

Comorbidity Serious | Mental disorders Serious | Communicable Diseases Uncontrolled | Heart Diseases | Ischaemic coronary artery disorders | Congestive heart failure Uncontrolled | Medical condition Uncontrolled | Diabetic - poor control | LABORATORY ABNORMALITIES At risk Study Subject Participation Status | LABORATORY ABNORMALITIES Interfere with Research results

Data type

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0205404
UMLS CUI [2,1]
C0004936
UMLS CUI [2,2]
C0205404
UMLS CUI [3,1]
C0009450
UMLS CUI [3,2]
C0205318
UMLS CUI [4]
C0018799
UMLS CUI [5]
C0852149
UMLS CUI [6,1]
C0018802
UMLS CUI [6,2]
C0205318
UMLS CUI [7,1]
C3843040
UMLS CUI [7,2]
C0205318
UMLS CUI [8]
C0421258
UMLS CUI [9,1]
C1853129
UMLS CUI [9,2]
C1444641
UMLS CUI [9,3]
C2348568
UMLS CUI [10,1]
C1853129
UMLS CUI [10,2]
C0521102
UMLS CUI [10,3]
C0683954
known to be seropositive (giving a positive result in a test of blood serum) for human immunodeficiency virus (hiv), or active hepatitis a, b or c infection
Description

HIV Seropositivity Serum blood test Positive | Hepatitis A | Hepatitis B | Hepatitis C

Data type

boolean

Alias
UMLS CUI [1,1]
C0019699
UMLS CUI [1,2]
C0558979
UMLS CUI [1,3]
C1514241
UMLS CUI [2]
C0019159
UMLS CUI [3]
C0019163
UMLS CUI [4]
C0019196
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Similar models

Eligibility Multiple Myeloma NCT00402181

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Multiple Myeloma | Therapeutic procedure Quantity failed | Recurrent disease | Refractory Disease
Item
confirmed diagnosis of multiple myeloma with relapsed or refractory disease after failing at least 2 prior lines of therapy
boolean
C0026764 (UMLS CUI [1])
C0087111 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
C0231175 (UMLS CUI [2,3])
C0277556 (UMLS CUI [3])
C1514815 (UMLS CUI [4])
bortezomib | Combined Modality Therapy
Item
prior treatment regimen must have included bortezomib (alone or in combination with other agents)
boolean
C1176309 (UMLS CUI [1])
C0009429 (UMLS CUI [2])
Measurable Disease secretion | Serum paraprotein measurement monoclonal
Item
measurable secretory disease defined as either serum monoclonal paraprotein (m-
boolean
C1513041 (UMLS CUI [1,1])
C1327616 (UMLS CUI [1,2])
C0585639 (UMLS CUI [2,1])
C0746619 (UMLS CUI [2,2])
M Protein | Monoclonal Protein Measurement In Urine
Item
protein) greater than or equal to (>=) 1 gram per deciliter (g/dl) or urine monoclonal (light chain) protein (greater than (>) 200 milligram/24 hours)
boolean
C0700271 (UMLS CUI [1])
C2984963 (UMLS CUI [2,1])
C0042037 (UMLS CUI [2,2])
ECOG performance status | Childbearing Potential Contraceptive methods | Childbearing Potential Serum pregnancy test negative
Item
eastern cooperative oncology group (ecog) performance status score of less than or equal to (<=) 2 - participants of childbearing potential must use adequate birth control measures, female participants of childbearing potential must have a negative serum pregnancy test at screening
boolean
C1520224 (UMLS CUI [1])
C3831118 (UMLS CUI [2,1])
C0700589 (UMLS CUI [2,2])
C3831118 (UMLS CUI [3,1])
C0430061 (UMLS CUI [3,2])
Item Group
C0680251 (UMLS CUI)
Cancer treatment Systemic | Clarithromycin | Therapeutic radiology procedure | Nitrosoureas | Alkylating Agents | Antineoplastic Agents | Chemotherapy
Item
treatment with systemic cancer therapy (including clarithromycin) or radiotherapy within 30 days before the first dose of study agent - treatment with nitrosoureas (a group of alkylating agents used as antineoplastic drugs in the chemotherapy) within 42 days before the first dose of study agent
boolean
C0920425 (UMLS CUI [1,1])
C0205373 (UMLS CUI [1,2])
C0055856 (UMLS CUI [2])
C1522449 (UMLS CUI [3])
C0028210 (UMLS CUI [4])
C0002073 (UMLS CUI [5])
C0003392 (UMLS CUI [6])
C0392920 (UMLS CUI [7])
Major surgery | Operative Surgical Procedures Planned | Minor Surgical Procedures
Item
major surgery within 30 days before the first dose of study agent or planning to have surgery (except for minor surgical procedures) during the study
boolean
C0679637 (UMLS CUI [1])
C0543467 (UMLS CUI [2,1])
C1301732 (UMLS CUI [2,2])
C0038904 (UMLS CUI [3])
Comorbidity Serious | Mental disorders Serious | Communicable Diseases Uncontrolled | Heart Diseases | Ischaemic coronary artery disorders | Congestive heart failure Uncontrolled | Medical condition Uncontrolled | Diabetic - poor control | LABORATORY ABNORMALITIES At risk Study Subject Participation Status | LABORATORY ABNORMALITIES Interfere with Research results
Item
serious concurrent illness (medical or psychiatric), uncontrolled infection, or significant cardiac disease characterized by significant ischemic coronary disease (an imbalance between myocardial functional requirements and the capacity of the coronary vessels to supply sufficient blood flow) or congestive heart failure (condition in which the heart is unable to pump out sufficient blood to meet the metabolic need of the body) not under medical control, or any uncontrolled medical condition (for example: uncontrolled diabetes), including the presence of clinical laboratory abnormalities, that places the subject at unacceptable risk by participating in the study or confounds the ability to interpret data from the study
boolean
C0009488 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C0004936 (UMLS CUI [2,1])
C0205404 (UMLS CUI [2,2])
C0009450 (UMLS CUI [3,1])
C0205318 (UMLS CUI [3,2])
C0018799 (UMLS CUI [4])
C0852149 (UMLS CUI [5])
C0018802 (UMLS CUI [6,1])
C0205318 (UMLS CUI [6,2])
C3843040 (UMLS CUI [7,1])
C0205318 (UMLS CUI [7,2])
C0421258 (UMLS CUI [8])
C1853129 (UMLS CUI [9,1])
C1444641 (UMLS CUI [9,2])
C2348568 (UMLS CUI [9,3])
C1853129 (UMLS CUI [10,1])
C0521102 (UMLS CUI [10,2])
C0683954 (UMLS CUI [10,3])
HIV Seropositivity Serum blood test Positive | Hepatitis A | Hepatitis B | Hepatitis C
Item
known to be seropositive (giving a positive result in a test of blood serum) for human immunodeficiency virus (hiv), or active hepatitis a, b or c infection
boolean
C0019699 (UMLS CUI [1,1])
C0558979 (UMLS CUI [1,2])
C1514241 (UMLS CUI [1,3])
C0019159 (UMLS CUI [2])
C0019163 (UMLS CUI [3])
C0019196 (UMLS CUI [4])
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