ID

30868

Description

Study of ENMD-2076 in Patients With Multiple Myeloma; ODM derived from: https://clinicaltrials.gov/show/NCT00806065

Link

https://clinicaltrials.gov/show/NCT00806065

Keywords

Versions (1)
  1. 6/29/18 6/29/18 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

June 29, 2018

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 NCT00806065

English

Eligibility Multiple Myeloma NCT00806065

1 forms  
Criteria
Description

Criteria

1. histological evidence of mm and evidence of relapse or refractory disease. patients with non secretory myeloma or plasmacytoma only will be excluded.
Description

Multiple Myeloma | Recurrent disease | Refractory Disease | Non-secretory myeloma Excluded | Plasmacytoma Excluded

Data type

boolean

Alias
UMLS CUI [1]
C0026764
UMLS CUI [2]
C0277556
UMLS CUI [3]
C1514815
UMLS CUI [4,1]
C0456845
UMLS CUI [4,2]
C0332196
UMLS CUI [5,1]
C0032131
UMLS CUI [5,2]
C0332196
2. patients must have failed thalidomide, lenalidomide, or velcade or be intolerant or ineligible to receive these agents.
Description

Therapeutic procedure failed | Thalidomide | Lenalidomide | Velcade | Intolerance to Thalidomide | Intolerance to Lenalidomide | Intolerance to Velcade

Data type

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0231175
UMLS CUI [2]
C0039736
UMLS CUI [3]
C1144149
UMLS CUI [4]
C1174739
UMLS CUI [5,1]
C1744706
UMLS CUI [5,2]
C0039736
UMLS CUI [6,1]
C1744706
UMLS CUI [6,2]
C1144149
UMLS CUI [7,1]
C1744706
UMLS CUI [7,2]
C1174739
3. age ≥18 years.
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
4. ecog performance status 0-2.
Description

ECOG performance status

Data type

boolean

Alias
UMLS CUI [1]
C1520224
5. patients must have adequate organ and marrow function
Description

Organ function | Bone Marrow function

Data type

boolean

Alias
UMLS CUI [1]
C0678852
UMLS CUI [2,1]
C0005953
UMLS CUI [2,2]
C0031843
major exclusion criteria:
Description

Exclusion Criteria Major

Data type

boolean

Alias
UMLS CUI [1,1]
C0680251
UMLS CUI [1,2]
C0205164
1. prior cytotoxic chemotherapy or investigational agent within 28 days or autologous stem cell transplant within 6 months of receiving study drug enmd-2076.
Description

Cytotoxic Chemotherapy | Investigational New Drugs | Autologous hematopoietic stem cell transplant | Time Period Receive ENMD 2076

Data type

boolean

Alias
UMLS CUI [1]
C0677881
UMLS CUI [2]
C0013230
UMLS CUI [3]
C2193200
UMLS CUI [4,1]
C1948053
UMLS CUI [4,2]
C1514756
UMLS CUI [4,3]
C2703108
2. prior radiation therapy to > 25% of bone marrow forming bones (i.e., pelvis).
Description

Irradiation of pelvis Bone Marrow Percent

Data type

boolean

Alias
UMLS CUI [1,1]
C0747411
UMLS CUI [1,2]
C0005953
UMLS CUI [1,3]
C0439165
3. concomitant corticosteroid therapy in doses greater than 10 mg daily of prednisone (or equivalent) if given for management of co-morbid conditions.
Description

Steroid therapy | Prednisone U/day | Dose Equivalent | Management Comorbidity

Data type

boolean

Alias
UMLS CUI [1]
C0149783
UMLS CUI [2,1]
C0032952
UMLS CUI [2,2]
C0456683
UMLS CUI [3,1]
C0178602
UMLS CUI [3,2]
C0205163
UMLS CUI [4,1]
C0376636
UMLS CUI [4,2]
C0009488
4. have unstable angina pectoris or recent myocardial infarction (within 6 months.
Description

Angina, Unstable | Myocardial Infarction

Data type

boolean

Alias
UMLS CUI [1]
C0002965
UMLS CUI [2]
C0027051
5. have uncontrolled hypertension or congestive heart failure.
Description

Uncontrolled hypertension | Congestive heart failure

Data type

boolean

Alias
UMLS CUI [1]
C1868885
UMLS CUI [2]
C0018802
Back to the top of the page

Similar models

Eligibility Multiple Myeloma NCT00806065

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Multiple Myeloma | Recurrent disease | Refractory Disease | Non-secretory myeloma Excluded | Plasmacytoma Excluded
Item
1. histological evidence of mm and evidence of relapse or refractory disease. patients with non secretory myeloma or plasmacytoma only will be excluded.
boolean
C0026764 (UMLS CUI [1])
C0277556 (UMLS CUI [2])
C1514815 (UMLS CUI [3])
C0456845 (UMLS CUI [4,1])
C0332196 (UMLS CUI [4,2])
C0032131 (UMLS CUI [5,1])
C0332196 (UMLS CUI [5,2])
Therapeutic procedure failed | Thalidomide | Lenalidomide | Velcade | Intolerance to Thalidomide | Intolerance to Lenalidomide | Intolerance to Velcade
Item
2. patients must have failed thalidomide, lenalidomide, or velcade or be intolerant or ineligible to receive these agents.
boolean
C0087111 (UMLS CUI [1,1])
C0231175 (UMLS CUI [1,2])
C0039736 (UMLS CUI [2])
C1144149 (UMLS CUI [3])
C1174739 (UMLS CUI [4])
C1744706 (UMLS CUI [5,1])
C0039736 (UMLS CUI [5,2])
C1744706 (UMLS CUI [6,1])
C1144149 (UMLS CUI [6,2])
C1744706 (UMLS CUI [7,1])
C1174739 (UMLS CUI [7,2])
Age
Item
3. age ≥18 years.
boolean
C0001779 (UMLS CUI [1])
ECOG performance status
Item
4. ecog performance status 0-2.
boolean
C1520224 (UMLS CUI [1])
Organ function | Bone Marrow function
Item
5. patients must have adequate organ and marrow function
boolean
C0678852 (UMLS CUI [1])
C0005953 (UMLS CUI [2,1])
C0031843 (UMLS CUI [2,2])
Exclusion Criteria Major
Item
major exclusion criteria:
boolean
C0680251 (UMLS CUI [1,1])
C0205164 (UMLS CUI [1,2])
Cytotoxic Chemotherapy | Investigational New Drugs | Autologous hematopoietic stem cell transplant | Time Period Receive ENMD 2076
Item
1. prior cytotoxic chemotherapy or investigational agent within 28 days or autologous stem cell transplant within 6 months of receiving study drug enmd-2076.
boolean
C0677881 (UMLS CUI [1])
C0013230 (UMLS CUI [2])
C2193200 (UMLS CUI [3])
C1948053 (UMLS CUI [4,1])
C1514756 (UMLS CUI [4,2])
C2703108 (UMLS CUI [4,3])
Irradiation of pelvis Bone Marrow Percent
Item
2. prior radiation therapy to > 25% of bone marrow forming bones (i.e., pelvis).
boolean
C0747411 (UMLS CUI [1,1])
C0005953 (UMLS CUI [1,2])
C0439165 (UMLS CUI [1,3])
Steroid therapy | Prednisone U/day | Dose Equivalent | Management Comorbidity
Item
3. concomitant corticosteroid therapy in doses greater than 10 mg daily of prednisone (or equivalent) if given for management of co-morbid conditions.
boolean
C0149783 (UMLS CUI [1])
C0032952 (UMLS CUI [2,1])
C0456683 (UMLS CUI [2,2])
C0178602 (UMLS CUI [3,1])
C0205163 (UMLS CUI [3,2])
C0376636 (UMLS CUI [4,1])
C0009488 (UMLS CUI [4,2])
Angina, Unstable | Myocardial Infarction
Item
4. have unstable angina pectoris or recent myocardial infarction (within 6 months.
boolean
C0002965 (UMLS CUI [1])
C0027051 (UMLS CUI [2])
Uncontrolled hypertension | Congestive heart failure
Item
5. have uncontrolled hypertension or congestive heart failure.
boolean
C1868885 (UMLS CUI [1])
C0018802 (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