ID

18188

Description

Study of DOXIL/CAELYX (Pegylated Liposomal Doxorubicin) and VELCADE (Bortezomib) or VELCADE Monotherapy for the Treatment of Relapsed Multiple Myeloma; ODM derived from: https://clinicaltrials.gov/show/NCT00103506

Link

https://clinicaltrials.gov/show/NCT00103506

Keywords

Versions (1)
  1. 10/24/16 10/24/16 -
Uploaded on

October 24, 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 NCT00103506

English

Eligibility Multiple Myeloma NCT00103506

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients with multiple myeloma who have received at least 1 prior therapy and who have either responded and later had progressive disease or have progressed during their first therapy (primary refractory) are eligible for the study
Description

Multiple Myeloma | Prior Therapy Quantity | Disease Response | Progressive Disease | First treatment Primary Refractory

Data type

boolean

Alias
UMLS CUI [1]
C0026764
UMLS CUI [2,1]
C1514463
UMLS CUI [2,2]
C1265611
UMLS CUI [3]
C1704632
UMLS CUI [4]
C1335499
UMLS CUI [5,1]
C1708063
UMLS CUI [5,2]
C2347678
patients who may have received prior doxorubicin but not more than a cumulative dose of 240 milligram per meter square (mg/m^2) doxorubicin, doxil, or the equivalent amount of another anthracycline (i.e., 1 mg doxorubicin = 1 mg doxil/caelyx = 1.8 mg epirubicin = 0.3 mg mitoxantrone = 0.25 mg idarubicin)
Description

Doxorubicin Cumulative Dose | Doxil | Anthracycline Antibiotics | Caelyx | Epirubicin | Mitoxantrone | Idarubicin

Data type

boolean

Alias
UMLS CUI [1,1]
C0013089
UMLS CUI [1,2]
C2986497
UMLS CUI [2]
C0279284
UMLS CUI [3]
C0003234
UMLS CUI [4]
C0701183
UMLS CUI [5]
C0014582
UMLS CUI [6]
C0026259
UMLS CUI [7]
C0020789
must have normal cardiac function, as evidenced by a left lvef within institutional normal limits.
Description

Cardiac function | Left ventricular ejection fraction

Data type

boolean

Alias
UMLS CUI [1]
C0232164
UMLS CUI [2]
C0428772
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
history of treatment with velcade or progressive disease while receiving an anthracycline-containing regimen
Description

Velcade | Anthracycline Antibiotics | Progressive Disease

Data type

boolean

Alias
UMLS CUI [1]
C1174739
UMLS CUI [2]
C0003234
UMLS CUI [3]
C1335499
no change in disease status during initial therapy
Description

First line treatment Disease No status change

Data type

boolean

Alias
UMLS CUI [1,1]
C1708063
UMLS CUI [1,2]
C0012634
UMLS CUI [1,3]
C0442739
no treatment for malignancy within past 5 yrs (other than multiple myeloma) or progressive disease while receiving anthracycline-containing regimen
Description

Malignant Neoplasm untreated | Multiple Myeloma | Anthracycline Antibiotics | Progressive Disease

Data type

boolean

Alias
UMLS CUI [1,1]
C0006826
UMLS CUI [1,2]
C0332155
UMLS CUI [2]
C0026764
UMLS CUI [3]
C0003234
UMLS CUI [4]
C1335499
non-secretory disease
Description

Non-secretory myeloma

Data type

boolean

Alias
UMLS CUI [1]
C0456845
myocardial infarct within past 6 months
Description

Myocardial Infarction

Data type

boolean

Alias
UMLS CUI [1]
C0027051
no major surgery in past 30 days.
Description

major surgery

Data type

boolean

Alias
UMLS CUI [1]
C0679637
Back to the top of the page

Similar models

Eligibility Multiple Myeloma NCT00103506

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Multiple Myeloma | Prior Therapy Quantity | Disease Response | Progressive Disease | First treatment Primary Refractory
Item
patients with multiple myeloma who have received at least 1 prior therapy and who have either responded and later had progressive disease or have progressed during their first therapy (primary refractory) are eligible for the study
boolean
C0026764 (UMLS CUI [1])
C1514463 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
C1704632 (UMLS CUI [3])
C1335499 (UMLS CUI [4])
C1708063 (UMLS CUI [5,1])
C2347678 (UMLS CUI [5,2])
Doxorubicin Cumulative Dose | Doxil | Anthracycline Antibiotics | Caelyx | Epirubicin | Mitoxantrone | Idarubicin
Item
patients who may have received prior doxorubicin but not more than a cumulative dose of 240 milligram per meter square (mg/m^2) doxorubicin, doxil, or the equivalent amount of another anthracycline (i.e., 1 mg doxorubicin = 1 mg doxil/caelyx = 1.8 mg epirubicin = 0.3 mg mitoxantrone = 0.25 mg idarubicin)
boolean
C0013089 (UMLS CUI [1,1])
C2986497 (UMLS CUI [1,2])
C0279284 (UMLS CUI [2])
C0003234 (UMLS CUI [3])
C0701183 (UMLS CUI [4])
C0014582 (UMLS CUI [5])
C0026259 (UMLS CUI [6])
C0020789 (UMLS CUI [7])
Cardiac function | Left ventricular ejection fraction
Item
must have normal cardiac function, as evidenced by a left lvef within institutional normal limits.
boolean
C0232164 (UMLS CUI [1])
C0428772 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
Velcade | Anthracycline Antibiotics | Progressive Disease
Item
history of treatment with velcade or progressive disease while receiving an anthracycline-containing regimen
boolean
C1174739 (UMLS CUI [1])
C0003234 (UMLS CUI [2])
C1335499 (UMLS CUI [3])
First line treatment Disease No status change
Item
no change in disease status during initial therapy
boolean
C1708063 (UMLS CUI [1,1])
C0012634 (UMLS CUI [1,2])
C0442739 (UMLS CUI [1,3])
Malignant Neoplasm untreated | Multiple Myeloma | Anthracycline Antibiotics | Progressive Disease
Item
no treatment for malignancy within past 5 yrs (other than multiple myeloma) or progressive disease while receiving anthracycline-containing regimen
boolean
C0006826 (UMLS CUI [1,1])
C0332155 (UMLS CUI [1,2])
C0026764 (UMLS CUI [2])
C0003234 (UMLS CUI [3])
C1335499 (UMLS CUI [4])
Non-secretory myeloma
Item
non-secretory disease
boolean
C0456845 (UMLS CUI [1])
Myocardial Infarction
Item
myocardial infarct within past 6 months
boolean
C0027051 (UMLS CUI [1])
major surgery
Item
no major surgery in past 30 days.
boolean
C0679637 (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