ID

30831

Description

Fludarabine, Busulfan, Antithymocyte Globulin, and Donor Stem Cell Transplant in Treating Patients With Multiple Myeloma That Has Not Responded to Treatment; ODM derived from: https://clinicaltrials.gov/show/NCT00802568

Link

https://clinicaltrials.gov/show/NCT00802568

Keywords

Versions (1)
  1. 6/25/18 6/25/18 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

June 25, 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 and Plasma Cell Neoplasm NCT00802568

English

Eligibility Multiple Myeloma and Plasma Cell Neoplasm NCT00802568

1 forms  
Criteria
Description

Criteria

diagnosis of multiple myeloma, meeting 1 of the following criteria:
Description

Multiple Myeloma | Criteria Fulfill

Data type

boolean

Alias
UMLS CUI [1]
C0026764
UMLS CUI [2,1]
C0243161
UMLS CUI [2,2]
C1550543
stage i disease with a bone lesion
Description

Disease Tumor stage | Bone lesion

Data type

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C1300072
UMLS CUI [2]
C0238792
stage ii or iii disease meeting any of the following criteria:
Description

Disease Tumor stage | Criteria Fulfill

Data type

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C1300072
UMLS CUI [2,1]
C0243161
UMLS CUI [2,2]
C1550543
elevated beta-2 microglobulin
Description

Beta 2 microglobulin increased

Data type

boolean

Alias
UMLS CUI [1]
C0855565
deletion of chromosome 13
Description

Loss of Chromosome 13

Data type

boolean

Alias
UMLS CUI [1]
C1517957
refractory or relapsed disease
Description

Refractory Disease | Recurrent disease

Data type

boolean

Alias
UMLS CUI [1]
C1514815
UMLS CUI [2]
C0277556
presence of an evaluable monoclonal component
Description

Presence Component monoclonal

Data type

boolean

Alias
UMLS CUI [1,1]
C0150312
UMLS CUI [1,2]
C1179435
UMLS CUI [1,3]
C0746619
must have achieved reduction of primary tumor after receiving prior intensified chemotherapy with high-dose melphalan and cyclosporine with autologous transplantation
Description

Primary tumor Reduction | Chemotherapy intense | Melphalan High dose | Cyclosporine High dose | Transplantation, Autologous

Data type

boolean

Alias
UMLS CUI [1,1]
C0677930
UMLS CUI [1,2]
C0392756
UMLS CUI [2,1]
C0392920
UMLS CUI [2,2]
C0522510
UMLS CUI [3,1]
C0025241
UMLS CUI [3,2]
C0444956
UMLS CUI [4,1]
C0010592
UMLS CUI [4,2]
C0444956
UMLS CUI [5]
C0040736
hla identical family donor available
Description

Availability of Family Donor | Donor HLA Identical

Data type

boolean

Alias
UMLS CUI [1,1]
C0470187
UMLS CUI [1,2]
C0015576
UMLS CUI [1,3]
C0013018
UMLS CUI [2,1]
C0013018
UMLS CUI [2,2]
C0019721
UMLS CUI [2,3]
C0205280
bone marrow transplantation is allowed in case hematopoietic stem cell collection fails
Description

Bone Marrow Transplantation allowed | Hematopoietic stem cells Collection fails

Data type

boolean

Alias
UMLS CUI [1,1]
C0005961
UMLS CUI [1,2]
C0683607
UMLS CUI [2,1]
C0018956
UMLS CUI [2,2]
C0200345
UMLS CUI [2,3]
C0231175
patient characteristics:
Description

Client Characteristics

Data type

boolean

Alias
UMLS CUI [1]
C0815172
karnofsky 70-100%
Description

Karnofsky Performance Status

Data type

boolean

Alias
UMLS CUI [1]
C0206065
no contraindications to allogeneic transplantation
Description

Medical contraindication Absent Allogeneic Stem Cell Transplantation

Data type

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0332197
UMLS CUI [1,3]
C2242529
no contraindications to drugs used in conditioning regimen
Description

Medical contraindication Absent Pharmaceutical Preparations Transplantation Conditioning

Data type

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0332197
UMLS CUI [1,3]
C0013227
UMLS CUI [1,4]
C0376450
no psychiatric illness
Description

Exclusion | Mental disorders

Data type

boolean

Alias
UMLS CUI [1]
C2828389
UMLS CUI [2]
C0004936
no other cancer within the past 5 years except basal cell skin cancer or epithelioma in situ of the cervix
Description

Exclusion | Cancer Other | Exception Basal cell carcinoma | Exception Carcinoma in situ of uterine cervix

Data type

boolean

Alias
UMLS CUI [1]
C2828389
UMLS CUI [2]
C1707251
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0007117
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0851140
no serious and uncontrolled infection
Description

Exclusion | Communicable Disease Serious Uncontrolled

Data type

boolean

Alias
UMLS CUI [1]
C2828389
UMLS CUI [2,1]
C0009450
UMLS CUI [2,2]
C0205404
UMLS CUI [2,3]
C0205318
not pregnant or nursing
Description

Exclusion Criteria | Pregnancy | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0680251
UMLS CUI [2]
C0032961
UMLS CUI [3]
C0006147
fertile patients must use effective contraception
Description

Fertility Contraceptive methods

Data type

boolean

Alias
UMLS CUI [1,1]
C0015895
UMLS CUI [1,2]
C0700589
prior concurrent therapy:
Description

Therapeutic procedure

Data type

boolean

Alias
UMLS CUI [1]
C0087111
see disease characteristics
Description

ID.21

Data type

boolean

at least 1 month since participation in another prior clinical trial
Description

Study Subject Participation Status

Data type

boolean

Alias
UMLS CUI [1]
C2348568
Back to the top of the page

Similar models

Eligibility Multiple Myeloma and Plasma Cell Neoplasm NCT00802568

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Multiple Myeloma | Criteria Fulfill
Item
diagnosis of multiple myeloma, meeting 1 of the following criteria:
boolean
C0026764 (UMLS CUI [1])
C0243161 (UMLS CUI [2,1])
C1550543 (UMLS CUI [2,2])
Disease Tumor stage | Bone lesion
Item
stage i disease with a bone lesion
boolean
C0012634 (UMLS CUI [1,1])
C1300072 (UMLS CUI [1,2])
C0238792 (UMLS CUI [2])
Disease Tumor stage | Criteria Fulfill
Item
stage ii or iii disease meeting any of the following criteria:
boolean
C0012634 (UMLS CUI [1,1])
C1300072 (UMLS CUI [1,2])
C0243161 (UMLS CUI [2,1])
C1550543 (UMLS CUI [2,2])
Beta 2 microglobulin increased
Item
elevated beta-2 microglobulin
boolean
C0855565 (UMLS CUI [1])
Loss of Chromosome 13
Item
deletion of chromosome 13
boolean
C1517957 (UMLS CUI [1])
Refractory Disease | Recurrent disease
Item
refractory or relapsed disease
boolean
C1514815 (UMLS CUI [1])
C0277556 (UMLS CUI [2])
Presence Component monoclonal
Item
presence of an evaluable monoclonal component
boolean
C0150312 (UMLS CUI [1,1])
C1179435 (UMLS CUI [1,2])
C0746619 (UMLS CUI [1,3])
Primary tumor Reduction | Chemotherapy intense | Melphalan High dose | Cyclosporine High dose | Transplantation, Autologous
Item
must have achieved reduction of primary tumor after receiving prior intensified chemotherapy with high-dose melphalan and cyclosporine with autologous transplantation
boolean
C0677930 (UMLS CUI [1,1])
C0392756 (UMLS CUI [1,2])
C0392920 (UMLS CUI [2,1])
C0522510 (UMLS CUI [2,2])
C0025241 (UMLS CUI [3,1])
C0444956 (UMLS CUI [3,2])
C0010592 (UMLS CUI [4,1])
C0444956 (UMLS CUI [4,2])
C0040736 (UMLS CUI [5])
Availability of Family Donor | Donor HLA Identical
Item
hla identical family donor available
boolean
C0470187 (UMLS CUI [1,1])
C0015576 (UMLS CUI [1,2])
C0013018 (UMLS CUI [1,3])
C0013018 (UMLS CUI [2,1])
C0019721 (UMLS CUI [2,2])
C0205280 (UMLS CUI [2,3])
Bone Marrow Transplantation allowed | Hematopoietic stem cells Collection fails
Item
bone marrow transplantation is allowed in case hematopoietic stem cell collection fails
boolean
C0005961 (UMLS CUI [1,1])
C0683607 (UMLS CUI [1,2])
C0018956 (UMLS CUI [2,1])
C0200345 (UMLS CUI [2,2])
C0231175 (UMLS CUI [2,3])
Client Characteristics
Item
patient characteristics:
boolean
C0815172 (UMLS CUI [1])
Karnofsky Performance Status
Item
karnofsky 70-100%
boolean
C0206065 (UMLS CUI [1])
Medical contraindication Absent Allogeneic Stem Cell Transplantation
Item
no contraindications to allogeneic transplantation
boolean
C1301624 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C2242529 (UMLS CUI [1,3])
Medical contraindication Absent Pharmaceutical Preparations Transplantation Conditioning
Item
no contraindications to drugs used in conditioning regimen
boolean
C1301624 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0013227 (UMLS CUI [1,3])
C0376450 (UMLS CUI [1,4])
Exclusion | Mental disorders
Item
no psychiatric illness
boolean
C2828389 (UMLS CUI [1])
C0004936 (UMLS CUI [2])
Exclusion | Cancer Other | Exception Basal cell carcinoma | Exception Carcinoma in situ of uterine cervix
Item
no other cancer within the past 5 years except basal cell skin cancer or epithelioma in situ of the cervix
boolean
C2828389 (UMLS CUI [1])
C1707251 (UMLS CUI [2])
C1705847 (UMLS CUI [3,1])
C0007117 (UMLS CUI [3,2])
C1705847 (UMLS CUI [4,1])
C0851140 (UMLS CUI [4,2])
Exclusion | Communicable Disease Serious Uncontrolled
Item
no serious and uncontrolled infection
boolean
C2828389 (UMLS CUI [1])
C0009450 (UMLS CUI [2,1])
C0205404 (UMLS CUI [2,2])
C0205318 (UMLS CUI [2,3])
Exclusion Criteria | Pregnancy | Breast Feeding
Item
not pregnant or nursing
boolean
C0680251 (UMLS CUI [1])
C0032961 (UMLS CUI [2])
C0006147 (UMLS CUI [3])
Fertility Contraceptive methods
Item
fertile patients must use effective contraception
boolean
C0015895 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
Therapeutic procedure
Item
prior concurrent therapy:
boolean
C0087111 (UMLS CUI [1])
ID.21
Item
see disease characteristics
boolean
Study Subject Participation Status
Item
at least 1 month since participation in another prior clinical trial
boolean
C2348568 (UMLS CUI [1])
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