ID

18140

Description

UARK 2003-33, Total Therapy III; ODM derived from: https://clinicaltrials.gov/show/NCT00081939

Link

https://clinicaltrials.gov/show/NCT00081939

Keywords

Versions (1)
  1. 10/23/16 10/23/16 -
Uploaded on

October 23, 2016

DOI

To request one please log in.

License

Creative Commons BY 4.0
Model comments :

You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.

Back to model comments
Itemgroup comments for :

Item comments for :

In order to download data models you must be logged in. Please log in or register for free.

Eligibility Multiple Myeloma NCT00081939

English

Eligibility Multiple Myeloma NCT00081939

1 forms  
Criteria
Description

Criteria

patients must have newly diagnosed active mm requiring treatment. patients with a previous history of smoldering myeloma will be eligible if there is evidence of progressive disease requiring chemotherapy.
Description

Multiple Myeloma Requirement Therapeutic procedure | Smoldering myeloma | Progressive Disease Evidence Requirement Chemotherapy

Data type

boolean

Alias
UMLS CUI [1,1]
C0026764
UMLS CUI [1,2]
C1514873
UMLS CUI [1,3]
C0087111
UMLS CUI [2]
C1531608
UMLS CUI [3,1]
C1335499
UMLS CUI [3,2]
C0332120
UMLS CUI [3,3]
C1514873
UMLS CUI [3,4]
C0392920
protein criteria must be present (quantifiable m-component of igg, iga, igd, or ige and/or urinary kappa or lambda light chain or bence jones protein) in order to evaluate response. non-secretory patients are eligible provided the patient has > 20% plasmacytosis or multiple (>3) focal plasmacytomas on mri or diffuse hyperintense signal on stir images in the absence of hematopoietic growth factors.
Description

Proteins criteria | M component Immunoglobulin G | M component Immunoglobulin A | M component Immunoglobulin D | M component Immunoglobulin E | Immunoglobulin kappa-Chains urinary | Immunoglobulin lambda-Chains urinary | Bence Jones Protein | Response Evaluation | Plasmacytosis Percentage | Multiple solitary plasmacytomas Focal | Magnetic Resonance Imaging | Hematopoietic Cell Growth Factors Absence

Data type

boolean

Alias
UMLS CUI [1,1]
C0033684
UMLS CUI [1,2]
C0243161
UMLS CUI [2,1]
C2363751
UMLS CUI [2,2]
C0020852
UMLS CUI [3,1]
C2363751
UMLS CUI [3,2]
C0020835
UMLS CUI [4,1]
C2363751
UMLS CUI [4,2]
C0020843
UMLS CUI [5,1]
C2363751
UMLS CUI [5,2]
C0020846
UMLS CUI [6,1]
C0021036
UMLS CUI [6,2]
C1524119
UMLS CUI [7,1]
C0021037
UMLS CUI [7,2]
C1524119
UMLS CUI [8]
C0004965
UMLS CUI [9,1]
C1704632
UMLS CUI [9,2]
C1261322
UMLS CUI [10,1]
C0085663
UMLS CUI [10,2]
C0439165
UMLS CUI [11,1]
C1533062
UMLS CUI [11,2]
C0205234
UMLS CUI [12]
C0024485
UMLS CUI [13,1]
C0079490
UMLS CUI [13,2]
C0332197
patients must have received no more than one cycle of prior chemotherapy for this disease. patients may have received prior radiotherapy provided approval has been obtained by the principal investigator.
Description

Prior Chemotherapy Quantity Multiple Myeloma | prior radiation therapy

Data type

boolean

Alias
UMLS CUI [1,1]
C1514457
UMLS CUI [1,2]
C1265611
UMLS CUI [1,3]
C0026764
UMLS CUI [2]
C0279134
patients must be < or = 75 years of age at the time of initial registration.
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
ejection fraction by echo or muga >40% performed within 60 days prior to registration.
Description

Cardiac ejection fraction | Echocardiography | Multiple gated acquisition scanning

Data type

boolean

Alias
UMLS CUI [1]
C0232174
UMLS CUI [2]
C0013516
UMLS CUI [3]
C0521317
patients must have adequate pulmonary function studies > or = 50% of predicted on mechanical aspects (fev1, fvc, etc) and diffusion capacity (dlco) > or =50% of predicted, within 60 days of registration. if the patient is unable to complete pulmonary function tests due to mm related pain or condition, there must be a pulmonary consult documenting that the patient is a candidate for high dose therapy.
Description

Pulmonary function | FEV1 | Forced vital capacity | Carbon Monoxide Diffusing Capability Test

Data type

boolean

Alias
UMLS CUI [1]
C0231921
UMLS CUI [2]
C0748133
UMLS CUI [3]
C1287681
UMLS CUI [4]
C1516251
patients must have a performance status of 0-2 based on swog criteria. patients with a poor performance status (3-4), based solely on bone pain, will be eligible.
Description

performance status | Bone pain

Data type

boolean

Alias
UMLS CUI [1]
C1518965
UMLS CUI [2]
C0151825
all patients must be informed of the investigational nature of this study and must have signed an irb-approved informed consent in accordance with institutional and federal guidelines.
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
induction exclusion criteria:
Description

Exclusion Criteria Neoadjuvant Therapy

Data type

boolean

Alias
UMLS CUI [1,1]
C0680251
UMLS CUI [1,2]
C0600558
platelet count < 30 x 10^9/l, unless myeloma-related
Description

Platelet Count measurement | Platelet Count measurement Related Multiple Myeloma

Data type

boolean

Alias
UMLS CUI [1]
C0032181
UMLS CUI [2,1]
C0032181
UMLS CUI [2,2]
C0439849
UMLS CUI [2,3]
C0026764
anc < 1.0 x 10^9/l, unless myeloma-related
Description

Absolute neutrophil count | Absolute neutrophil count Related Multiple Myeloma

Data type

boolean

Alias
UMLS CUI [1]
C0948762
UMLS CUI [2,1]
C0948762
UMLS CUI [2,2]
C0439849
UMLS CUI [2,3]
C0026764
grade > or =2 peripheral neuropathy
Description

Peripheral Neuropathy | CTCAE Grades

Data type

boolean

Alias
UMLS CUI [1]
C0031117
UMLS CUI [2]
C1516728
hypersensitivity to bortezomib, boron, or mannitol
Description

Hypersensitivity bortezomib | Hypersensitivity Boron | Hypersensitivity Mannitol

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C1176309
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0006030
UMLS CUI [3,1]
C0020517
UMLS CUI [3,2]
C0024730
uncontrolled diabetes.
Description

Diabetic - poor control

Data type

boolean

Alias
UMLS CUI [1]
C0421258
recent (< or =6 months) myocardial infarction, unstable angina, difficult to control congestive heart failure, uncontrolled hypertension, or difficult to control cardiac arrhythmias.
Description

Myocardial Infarction | Angina, Unstable | Congestive heart failure CONTROL DIFFICULT | Uncontrolled hypertension | Cardiac Arrhythmia CONTROL DIFFICULT

Data type

boolean

Alias
UMLS CUI [1]
C0027051
UMLS CUI [2]
C0002965
UMLS CUI [3,1]
C0018802
UMLS CUI [3,2]
C0742800
UMLS CUI [4]
C1868885
UMLS CUI [5,1]
C0003811
UMLS CUI [5,2]
C0742800
evidence of chronic obstructive or chronic restrictive pulmonary disease.
Description

Chronic Obstructive Airway Disease | Restrictive pulmonary disease chronic

Data type

boolean

Alias
UMLS CUI [1]
C0024117
UMLS CUI [2,1]
C0877013
UMLS CUI [2,2]
C0205191
prior malignancy, except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer for which the patient has been disease free for at least three years.
Description

Malignant Neoplasms | Basal cell carcinoma Treated | Squamous cell carcinoma of skin Treated | Carcinoma in situ of uterine cervix

Data type

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2,1]
C0007117
UMLS CUI [2,2]
C1522326
UMLS CUI [3,1]
C0553723
UMLS CUI [3,2]
C1522326
UMLS CUI [4]
C0851140
patients must not have significant co-morbid medical conditions or uncontrolled life threatening infection.
Description

Comorbidity Significant | Life-threatening infection Uncontrolled

Data type

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0750502
UMLS CUI [2,1]
C1859430
UMLS CUI [2,2]
C0205318
pregnant or nursing women. women of child-bearing potential must have a negative pregnancy test documented within one week of registration. women and men of reproductive potential may not participate unless they have agreed to use an effective contraceptive method.
Description

Pregnancy | Breast Feeding | Childbearing Potential Pregnancy test negative | Fertility Contraceptive methods

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3,1]
C3831118
UMLS CUI [3,2]
C0427780
UMLS CUI [4,1]
C0015895
UMLS CUI [4,2]
C0700589
Back to the top of the page

Similar models

Eligibility Multiple Myeloma NCT00081939

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Multiple Myeloma Requirement Therapeutic procedure | Smoldering myeloma | Progressive Disease Evidence Requirement Chemotherapy
Item
patients must have newly diagnosed active mm requiring treatment. patients with a previous history of smoldering myeloma will be eligible if there is evidence of progressive disease requiring chemotherapy.
boolean
C0026764 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C0087111 (UMLS CUI [1,3])
C1531608 (UMLS CUI [2])
C1335499 (UMLS CUI [3,1])
C0332120 (UMLS CUI [3,2])
C1514873 (UMLS CUI [3,3])
C0392920 (UMLS CUI [3,4])
Proteins criteria | M component Immunoglobulin G | M component Immunoglobulin A | M component Immunoglobulin D | M component Immunoglobulin E | Immunoglobulin kappa-Chains urinary | Immunoglobulin lambda-Chains urinary | Bence Jones Protein | Response Evaluation | Plasmacytosis Percentage | Multiple solitary plasmacytomas Focal | Magnetic Resonance Imaging | Hematopoietic Cell Growth Factors Absence
Item
protein criteria must be present (quantifiable m-component of igg, iga, igd, or ige and/or urinary kappa or lambda light chain or bence jones protein) in order to evaluate response. non-secretory patients are eligible provided the patient has > 20% plasmacytosis or multiple (>3) focal plasmacytomas on mri or diffuse hyperintense signal on stir images in the absence of hematopoietic growth factors.
boolean
C0033684 (UMLS CUI [1,1])
C0243161 (UMLS CUI [1,2])
C2363751 (UMLS CUI [2,1])
C0020852 (UMLS CUI [2,2])
C2363751 (UMLS CUI [3,1])
C0020835 (UMLS CUI [3,2])
C2363751 (UMLS CUI [4,1])
C0020843 (UMLS CUI [4,2])
C2363751 (UMLS CUI [5,1])
C0020846 (UMLS CUI [5,2])
C0021036 (UMLS CUI [6,1])
C1524119 (UMLS CUI [6,2])
C0021037 (UMLS CUI [7,1])
C1524119 (UMLS CUI [7,2])
C0004965 (UMLS CUI [8])
C1704632 (UMLS CUI [9,1])
C1261322 (UMLS CUI [9,2])
C0085663 (UMLS CUI [10,1])
C0439165 (UMLS CUI [10,2])
C1533062 (UMLS CUI [11,1])
C0205234 (UMLS CUI [11,2])
C0024485 (UMLS CUI [12])
C0079490 (UMLS CUI [13,1])
C0332197 (UMLS CUI [13,2])
Prior Chemotherapy Quantity Multiple Myeloma | prior radiation therapy
Item
patients must have received no more than one cycle of prior chemotherapy for this disease. patients may have received prior radiotherapy provided approval has been obtained by the principal investigator.
boolean
C1514457 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0026764 (UMLS CUI [1,3])
C0279134 (UMLS CUI [2])
Age
Item
patients must be < or = 75 years of age at the time of initial registration.
boolean
C0001779 (UMLS CUI [1])
Cardiac ejection fraction | Echocardiography | Multiple gated acquisition scanning
Item
ejection fraction by echo or muga >40% performed within 60 days prior to registration.
boolean
C0232174 (UMLS CUI [1])
C0013516 (UMLS CUI [2])
C0521317 (UMLS CUI [3])
Pulmonary function | FEV1 | Forced vital capacity | Carbon Monoxide Diffusing Capability Test
Item
patients must have adequate pulmonary function studies > or = 50% of predicted on mechanical aspects (fev1, fvc, etc) and diffusion capacity (dlco) > or =50% of predicted, within 60 days of registration. if the patient is unable to complete pulmonary function tests due to mm related pain or condition, there must be a pulmonary consult documenting that the patient is a candidate for high dose therapy.
boolean
C0231921 (UMLS CUI [1])
C0748133 (UMLS CUI [2])
C1287681 (UMLS CUI [3])
C1516251 (UMLS CUI [4])
performance status | Bone pain
Item
patients must have a performance status of 0-2 based on swog criteria. patients with a poor performance status (3-4), based solely on bone pain, will be eligible.
boolean
C1518965 (UMLS CUI [1])
C0151825 (UMLS CUI [2])
Informed Consent
Item
all patients must be informed of the investigational nature of this study and must have signed an irb-approved informed consent in accordance with institutional and federal guidelines.
boolean
C0021430 (UMLS CUI [1])
Exclusion Criteria Neoadjuvant Therapy
Item
induction exclusion criteria:
boolean
C0680251 (UMLS CUI [1,1])
C0600558 (UMLS CUI [1,2])
Platelet Count measurement | Platelet Count measurement Related Multiple Myeloma
Item
platelet count < 30 x 10^9/l, unless myeloma-related
boolean
C0032181 (UMLS CUI [1])
C0032181 (UMLS CUI [2,1])
C0439849 (UMLS CUI [2,2])
C0026764 (UMLS CUI [2,3])
Absolute neutrophil count | Absolute neutrophil count Related Multiple Myeloma
Item
anc < 1.0 x 10^9/l, unless myeloma-related
boolean
C0948762 (UMLS CUI [1])
C0948762 (UMLS CUI [2,1])
C0439849 (UMLS CUI [2,2])
C0026764 (UMLS CUI [2,3])
Peripheral Neuropathy | CTCAE Grades
Item
grade > or =2 peripheral neuropathy
boolean
C0031117 (UMLS CUI [1])
C1516728 (UMLS CUI [2])
Hypersensitivity bortezomib | Hypersensitivity Boron | Hypersensitivity Mannitol
Item
hypersensitivity to bortezomib, boron, or mannitol
boolean
C0020517 (UMLS CUI [1,1])
C1176309 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0006030 (UMLS CUI [2,2])
C0020517 (UMLS CUI [3,1])
C0024730 (UMLS CUI [3,2])
Diabetic - poor control
Item
uncontrolled diabetes.
boolean
C0421258 (UMLS CUI [1])
Myocardial Infarction | Angina, Unstable | Congestive heart failure CONTROL DIFFICULT | Uncontrolled hypertension | Cardiac Arrhythmia CONTROL DIFFICULT
Item
recent (< or =6 months) myocardial infarction, unstable angina, difficult to control congestive heart failure, uncontrolled hypertension, or difficult to control cardiac arrhythmias.
boolean
C0027051 (UMLS CUI [1])
C0002965 (UMLS CUI [2])
C0018802 (UMLS CUI [3,1])
C0742800 (UMLS CUI [3,2])
C1868885 (UMLS CUI [4])
C0003811 (UMLS CUI [5,1])
C0742800 (UMLS CUI [5,2])
Chronic Obstructive Airway Disease | Restrictive pulmonary disease chronic
Item
evidence of chronic obstructive or chronic restrictive pulmonary disease.
boolean
C0024117 (UMLS CUI [1])
C0877013 (UMLS CUI [2,1])
C0205191 (UMLS CUI [2,2])
Malignant Neoplasms | Basal cell carcinoma Treated | Squamous cell carcinoma of skin Treated | Carcinoma in situ of uterine cervix
Item
prior malignancy, except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer for which the patient has been disease free for at least three years.
boolean
C0006826 (UMLS CUI [1])
C0007117 (UMLS CUI [2,1])
C1522326 (UMLS CUI [2,2])
C0553723 (UMLS CUI [3,1])
C1522326 (UMLS CUI [3,2])
C0851140 (UMLS CUI [4])
Comorbidity Significant | Life-threatening infection Uncontrolled
Item
patients must not have significant co-morbid medical conditions or uncontrolled life threatening infection.
boolean
C0009488 (UMLS CUI [1,1])
C0750502 (UMLS CUI [1,2])
C1859430 (UMLS CUI [2,1])
C0205318 (UMLS CUI [2,2])
Pregnancy | Breast Feeding | Childbearing Potential Pregnancy test negative | Fertility Contraceptive methods
Item
pregnant or nursing women. women of child-bearing potential must have a negative pregnancy test documented within one week of registration. women and men of reproductive potential may not participate unless they have agreed to use an effective contraceptive method.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C3831118 (UMLS CUI [3,1])
C0427780 (UMLS CUI [3,2])
C0015895 (UMLS CUI [4,1])
C0700589 (UMLS CUI [4,2])
Back to the top of the page 

Contact

Please use this form for feedback, questions and suggestions for improvements.

Fields marked with * are required.

Help

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