ID

18188

Descripción

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

Palabras clave

Versiones (1)
  1. 24/10/16 24/10/16 -
Subido en

24 de octubre de 2016

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Multiple Myeloma NCT00103506

Inglés

Eligibility Multiple Myeloma NCT00103506

1 formularios  
Inclusion Criteria
Descripción

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
Descripción

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

Tipo de datos

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)
Descripción

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

Tipo de datos

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.
Descripción

Cardiac function | Left ventricular ejection fraction

Tipo de datos

boolean

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

Exclusion Criteria

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

Velcade | Anthracycline Antibiotics | Progressive Disease

Tipo de datos

boolean

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

First line treatment Disease No status change

Tipo de datos

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
Descripción

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

Tipo de datos

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
Descripción

Non-secretory myeloma

Tipo de datos

boolean

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

Myocardial Infarction

Tipo de datos

boolean

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

major surgery

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0679637
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Similar models

Eligibility Multiple Myeloma NCT00103506

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
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])
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