ID

21948

Description

Study of Azacitidine to Treat Relapsed or Refractory Multiple Myeloma; ODM derived from: https://clinicaltrials.gov/show/NCT00412919

Link

https://clinicaltrials.gov/show/NCT00412919

Keywords

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

May 9, 2017

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 NCT00412919

English

Eligibility Multiple Myeloma NCT00412919

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
diagnosis of mm as per imwg criteria
Description

Multiple Myeloma

Data type

boolean

Alias
UMLS CUI [1]
C0026764
age greater than 17 years
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
have received at least 2 but no more than 4 prior lines of therapy
Description

Therapeutic procedure Quantity

Data type

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C1265611
have failed to respond to the most recently administered anti-mm therapy or have demonstrably progressive disease as defined by accepted standard criteria
Description

Multiple Myeloma Absent response to treatment | Progressive Disease

Data type

boolean

Alias
UMLS CUI [1,1]
C0026764
UMLS CUI [1,2]
C0438286
UMLS CUI [2]
C1335499
have a life expectancy of at least 3 months
Description

Life Expectancy

Data type

boolean

Alias
UMLS CUI [1]
C0023671
ecog performance status < 3
Description

ECOG performance status

Data type

boolean

Alias
UMLS CUI [1]
C1520224
at registration haematological values within the following limits:
Description

Results Hematologic

Data type

boolean

Alias
UMLS CUI [1,1]
C1254595
UMLS CUI [1,2]
C0205488
1. absolute neutrophil count (anc) > 1.0 x 109/l
Description

Absolute neutrophil count

Data type

boolean

Alias
UMLS CUI [1]
C0948762
2. platelet count > 50 x 109/l unsupported
Description

Platelet Count measurement

Data type

boolean

Alias
UMLS CUI [1]
C0032181
at registration biochemical values within the following limits
Description

Results Biochemical

Data type

boolean

Alias
UMLS CUI [1,1]
C1254595
UMLS CUI [1,2]
C0205474
1. bilirubin < 1.5 x upper limit of normal (uln) and transaminases < 2 x uln unless considered secondary to hepatic myelomatous infiltration
Description

Serum total bilirubin measurement | Transaminases | Serum total bilirubin measurement Secondary to Infiltration Myeloma Liver | Transaminases Secondary to Infiltration Myeloma Liver

Data type

boolean

Alias
UMLS CUI [1]
C1278039
UMLS CUI [2]
C0002594
UMLS CUI [3,1]
C1278039
UMLS CUI [3,2]
C0175668
UMLS CUI [3,3]
C0332448
UMLS CUI [3,4]
C0026764
UMLS CUI [3,5]
C0023884
UMLS CUI [4,1]
C0002594
UMLS CUI [4,2]
C0175668
UMLS CUI [4,3]
C0332448
UMLS CUI [4,4]
C0026764
UMLS CUI [4,5]
C0023884
2. serum creatinine < 0.19mmol/l
Description

Creatinine measurement, serum

Data type

boolean

Alias
UMLS CUI [1]
C0201976
written informed consent
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
must agree to use adequate contraceptive measures if indicated. specifically, women of childbearing potential (wocbp) may participate provided they meet the following conditions:
Description

Indication Contraceptive methods | Childbearing Potential Criteria Fulfill

Data type

boolean

Alias
UMLS CUI [1,1]
C3146298
UMLS CUI [1,2]
C0700589
UMLS CUI [2,1]
C3831118
UMLS CUI [2,2]
C0243161
UMLS CUI [2,3]
C1550543
1. agree to use at least 2 effective contraceptive methods throughout the study and for 30 days following the study
Description

Childbearing Potential Contraceptive methods Quantity

Data type

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0700589
UMLS CUI [1,3]
C1265611
2. have a negative serum pregnancy test within 24 hours of commencing on study medication
Description

Childbearing Potential Serum pregnancy test negative

Data type

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0430061
3. male participants with female partners that are wocbp must agree to use 2 effective contraceptive methods throughout the study and for 30 days following the study
Description

Gender Contraceptive methods Quantity | Partner Childbearing Potential

Data type

boolean

Alias
UMLS CUI [1,1]
C0079399
UMLS CUI [1,2]
C0700589
UMLS CUI [1,3]
C1265611
UMLS CUI [2,1]
C0682323
UMLS CUI [2,2]
C3831118
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients with monoclonal gammopathy of undetermined significance (mgus) or indolent/smouldering mm
Description

Monoclonal Gammopathy of Undetermined Significance | Indolent multiple myeloma | Smoldering myeloma

Data type

boolean

Alias
UMLS CUI [1]
C0026470
UMLS CUI [2]
C2049069
UMLS CUI [3]
C1531608
known or suspected hypersensitivity to aza or mannitol
Description

Hypersensitivity Azathioprine | Mannitol allergy | Hypersensitivity Azathioprine Suspected | Mannitol allergy Suspected

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0004482
UMLS CUI [2]
C0571922
UMLS CUI [3,1]
C0020517
UMLS CUI [3,2]
C0004482
UMLS CUI [3,3]
C0750491
UMLS CUI [4,1]
C0571922
UMLS CUI [4,2]
C0750491
patients whose general condition makes them unsuitable for intensive treatment e.g. significant cardiac or pulmonary disease
Description

General condition of patient Therapeutic procedure With intensity Inappropriate | Heart Disease | Lung disease

Data type

boolean

Alias
UMLS CUI [1,1]
C0424449
UMLS CUI [1,2]
C0087111
UMLS CUI [1,3]
C0522510
UMLS CUI [1,4]
C1548788
UMLS CUI [2]
C0018799
UMLS CUI [3]
C0024115
active infections or other illnesses that precludes chemotherapy administration or patient compliance
Description

Communicable Diseases Exclude Chemotherapy | Illness Excludes Chemotherapy | Communicable Diseases Exclude Compliance behavior | Illness Excludes Compliance behavior

Data type

boolean

Alias
UMLS CUI [1,1]
C0009450
UMLS CUI [1,2]
C0332196
UMLS CUI [1,3]
C0392920
UMLS CUI [2,1]
C0221423
UMLS CUI [2,2]
C0332196
UMLS CUI [2,3]
C0392920
UMLS CUI [3,1]
C0009450
UMLS CUI [3,2]
C0332196
UMLS CUI [3,3]
C1321605
UMLS CUI [4,1]
C0221423
UMLS CUI [4,2]
C0332196
UMLS CUI [4,3]
C1321605
active viral infection with known human immunodeficiency virus (hiv) or viral hepatitis type b or c
Description

HIV Infection | Hepatitis B | Hepatitis C

Data type

boolean

Alias
UMLS CUI [1]
C0019693
UMLS CUI [2]
C0019163
UMLS CUI [3]
C0019196
pregnant or lactating women
Description

Pregnancy | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
Back to the top of the page

Similar models

Eligibility Multiple Myeloma NCT00412919

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Multiple Myeloma
Item
diagnosis of mm as per imwg criteria
boolean
C0026764 (UMLS CUI [1])
Age
Item
age greater than 17 years
boolean
C0001779 (UMLS CUI [1])
Therapeutic procedure Quantity
Item
have received at least 2 but no more than 4 prior lines of therapy
boolean
C0087111 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
Multiple Myeloma Absent response to treatment | Progressive Disease
Item
have failed to respond to the most recently administered anti-mm therapy or have demonstrably progressive disease as defined by accepted standard criteria
boolean
C0026764 (UMLS CUI [1,1])
C0438286 (UMLS CUI [1,2])
C1335499 (UMLS CUI [2])
Life Expectancy
Item
have a life expectancy of at least 3 months
boolean
C0023671 (UMLS CUI [1])
ECOG performance status
Item
ecog performance status < 3
boolean
C1520224 (UMLS CUI [1])
Results Hematologic
Item
at registration haematological values within the following limits:
boolean
C1254595 (UMLS CUI [1,1])
C0205488 (UMLS CUI [1,2])
Absolute neutrophil count
Item
1. absolute neutrophil count (anc) > 1.0 x 109/l
boolean
C0948762 (UMLS CUI [1])
Platelet Count measurement
Item
2. platelet count > 50 x 109/l unsupported
boolean
C0032181 (UMLS CUI [1])
Results Biochemical
Item
at registration biochemical values within the following limits
boolean
C1254595 (UMLS CUI [1,1])
C0205474 (UMLS CUI [1,2])
Serum total bilirubin measurement | Transaminases | Serum total bilirubin measurement Secondary to Infiltration Myeloma Liver | Transaminases Secondary to Infiltration Myeloma Liver
Item
1. bilirubin < 1.5 x upper limit of normal (uln) and transaminases < 2 x uln unless considered secondary to hepatic myelomatous infiltration
boolean
C1278039 (UMLS CUI [1])
C0002594 (UMLS CUI [2])
C1278039 (UMLS CUI [3,1])
C0175668 (UMLS CUI [3,2])
C0332448 (UMLS CUI [3,3])
C0026764 (UMLS CUI [3,4])
C0023884 (UMLS CUI [3,5])
C0002594 (UMLS CUI [4,1])
C0175668 (UMLS CUI [4,2])
C0332448 (UMLS CUI [4,3])
C0026764 (UMLS CUI [4,4])
C0023884 (UMLS CUI [4,5])
Creatinine measurement, serum
Item
2. serum creatinine < 0.19mmol/l
boolean
C0201976 (UMLS CUI [1])
Informed Consent
Item
written informed consent
boolean
C0021430 (UMLS CUI [1])
Indication Contraceptive methods | Childbearing Potential Criteria Fulfill
Item
must agree to use adequate contraceptive measures if indicated. specifically, women of childbearing potential (wocbp) may participate provided they meet the following conditions:
boolean
C3146298 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C3831118 (UMLS CUI [2,1])
C0243161 (UMLS CUI [2,2])
C1550543 (UMLS CUI [2,3])
Childbearing Potential Contraceptive methods Quantity
Item
1. agree to use at least 2 effective contraceptive methods throughout the study and for 30 days following the study
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
Childbearing Potential Serum pregnancy test negative
Item
2. have a negative serum pregnancy test within 24 hours of commencing on study medication
boolean
C3831118 (UMLS CUI [1,1])
C0430061 (UMLS CUI [1,2])
Gender Contraceptive methods Quantity | Partner Childbearing Potential
Item
3. male participants with female partners that are wocbp must agree to use 2 effective contraceptive methods throughout the study and for 30 days following the study
boolean
C0079399 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
C0682323 (UMLS CUI [2,1])
C3831118 (UMLS CUI [2,2])
Item Group
C0680251 (UMLS CUI)
Monoclonal Gammopathy of Undetermined Significance | Indolent multiple myeloma | Smoldering myeloma
Item
patients with monoclonal gammopathy of undetermined significance (mgus) or indolent/smouldering mm
boolean
C0026470 (UMLS CUI [1])
C2049069 (UMLS CUI [2])
C1531608 (UMLS CUI [3])
Hypersensitivity Azathioprine | Mannitol allergy | Hypersensitivity Azathioprine Suspected | Mannitol allergy Suspected
Item
known or suspected hypersensitivity to aza or mannitol
boolean
C0020517 (UMLS CUI [1,1])
C0004482 (UMLS CUI [1,2])
C0571922 (UMLS CUI [2])
C0020517 (UMLS CUI [3,1])
C0004482 (UMLS CUI [3,2])
C0750491 (UMLS CUI [3,3])
C0571922 (UMLS CUI [4,1])
C0750491 (UMLS CUI [4,2])
General condition of patient Therapeutic procedure With intensity Inappropriate | Heart Disease | Lung disease
Item
patients whose general condition makes them unsuitable for intensive treatment e.g. significant cardiac or pulmonary disease
boolean
C0424449 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
C0522510 (UMLS CUI [1,3])
C1548788 (UMLS CUI [1,4])
C0018799 (UMLS CUI [2])
C0024115 (UMLS CUI [3])
Communicable Diseases Exclude Chemotherapy | Illness Excludes Chemotherapy | Communicable Diseases Exclude Compliance behavior | Illness Excludes Compliance behavior
Item
active infections or other illnesses that precludes chemotherapy administration or patient compliance
boolean
C0009450 (UMLS CUI [1,1])
C0332196 (UMLS CUI [1,2])
C0392920 (UMLS CUI [1,3])
C0221423 (UMLS CUI [2,1])
C0332196 (UMLS CUI [2,2])
C0392920 (UMLS CUI [2,3])
C0009450 (UMLS CUI [3,1])
C0332196 (UMLS CUI [3,2])
C1321605 (UMLS CUI [3,3])
C0221423 (UMLS CUI [4,1])
C0332196 (UMLS CUI [4,2])
C1321605 (UMLS CUI [4,3])
HIV Infection | Hepatitis B | Hepatitis C
Item
active viral infection with known human immunodeficiency virus (hiv) or viral hepatitis type b or c
boolean
C0019693 (UMLS CUI [1])
C0019163 (UMLS CUI [2])
C0019196 (UMLS CUI [3])
Pregnancy | Breast Feeding
Item
pregnant or lactating women
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [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