ID

18248

Description

Arsenic Trioxide With Ascorbic Acid and Melphalan for Myeloma Patients; ODM derived from: https://clinicaltrials.gov/show/NCT00661544

Lien

https://clinicaltrials.gov/show/NCT00661544

Mots-clés

Versions (1)
  1. 26/10/2016 26/10/2016 -
Téléchargé le

26 octobre 2016

DOI

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Licence

Creative Commons BY 4.0
Modèle Commentaires :

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Eligibility Multiple Myeloma NCT00661544

Anglais

Eligibility Multiple Myeloma NCT00661544

1 Formulaires  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. patients with multiple myeloma in any of the following disease categories: a) primary refractory disease b) consolidation of a partial remission (defined as a decrease but continued presence of monoclonal protein on serum and urine immunofixation electrophoresis, and/or the presence of plasmacytosis on bone marrow aspirate and biopsy) c) all patients relapsing after prior therapy .
Description

Multiple Myeloma | Multiple Myeloma Primary Refractory | Multiple Myeloma partial response Consolidation | Multiple Myeloma Decrease | Serum M Protein | Urine M Protein | Immunofixation electrophoresis | Plasmacytosis | Marrow aspirate | Bone marrow biopsy | Recurrent disease Post Prior Therapy

Type de données

boolean

Alias
UMLS CUI [1]
C0026764
UMLS CUI [2,1]
C0026764
UMLS CUI [2,2]
C2347678
UMLS CUI [3,1]
C0026764
UMLS CUI [3,2]
C1521726
UMLS CUI [3,3]
C0702116
UMLS CUI [4,1]
C0026764
UMLS CUI [4,2]
C0547047
UMLS CUI [5,1]
C0229671
UMLS CUI [5,2]
C0700271
UMLS CUI [6,1]
C0042036
UMLS CUI [6,2]
C0700271
UMLS CUI [7]
C1611269
UMLS CUI [8]
C0085663
UMLS CUI [9]
C0857285
UMLS CUI [10]
C0005954
UMLS CUI [11,1]
C0277556
UMLS CUI [11,2]
C0687676
UMLS CUI [11,3]
C1514463
2. age up to 70 years.
Description

Age

Type de données

boolean

Alias
UMLS CUI [1]
C0001779
3. zubrod performance status (ps) of <2.
Description

Zubrod Performance Status

Type de données

boolean

Alias
UMLS CUI [1]
C3714786
4. left ventricular ejection fraction >40%. no uncontrolled arrhythmias or symptomatic cardiac disease.
Description

Left ventricular ejection fraction | Cardiac Arrhythmia Uncontrolled | Heart Disease Symptomatic

Type de données

boolean

Alias
UMLS CUI [1]
C0428772
UMLS CUI [2,1]
C0003811
UMLS CUI [2,2]
C0205318
UMLS CUI [3,1]
C0018799
UMLS CUI [3,2]
C0231220
5. forced vital capacity (fvc); forced expiratory volume in 1 second (fev1), forced vital capacity (fvc) and carbon monoxide diffusing capacity (dl co) >40%. no symptomatic pulmonary disease.
Description

Forced vital capacity | FEV1 | Carbon Monoxide Diffusing Capability Test | Lung disease Symptomatic

Type de données

boolean

Alias
UMLS CUI [1]
C1287681
UMLS CUI [2]
C0748133
UMLS CUI [3]
C1516251
UMLS CUI [4,1]
C0024115
UMLS CUI [4,2]
C0231220
6. serum bilirubin <2 times upper limit of normal, sgpt <4 times upper limit of normal. no evidence of chronic active hepatitis or cirrhosis. no effusion or ascites >1l prior to drainage.
Description

Serum bilirubin measurement | Alanine aminotransferase measurement | Chronic Hepatitis Evidence | Chronic Liver Cirrhosis Evidence | effusion | Ascites | Drainage

Type de données

boolean

Alias
UMLS CUI [1]
C0428441
UMLS CUI [2]
C0201836
UMLS CUI [3,1]
C0019189
UMLS CUI [3,2]
C3887511
UMLS CUI [4,1]
C0023890
UMLS CUI [4,2]
C0205191
UMLS CUI [4,3]
C3887511
UMLS CUI [5]
C0013687
UMLS CUI [6]
C0003962
UMLS CUI [7]
C0013103
7. hiv-negative.
Description

HIV negative

Type de données

boolean

Alias
UMLS CUI [1]
C0481430
8. patient is not pregnant.
Description

Pregnancy

Type de données

boolean

Alias
UMLS CUI [1]
C0032961
9. patient or guardian able to sign informed consent.
Description

Informed Consent

Type de données

boolean

Alias
UMLS CUI [1]
C0021430
10. corrected qt interval less than 500 msec.
Description

QTc

Type de données

boolean

Alias
UMLS CUI [1]
C0860814
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. corrected qt interval greater than 500 msec
Description

QTc

Type de données

boolean

Alias
UMLS CUI [1]
C0860814
2. patients in complete remission (defined as the absence of monoclonal protein on serum and urine immunofixation electrophoresis, and the absence of plasmacytosis in bone marrow aspirate and biopsy).
Description

In complete remission | Serum M Protein Absent | Urine M Protein Absent | Immunofixation electrophoresis | Plasmacytosis Absent | Marrow aspirate | Bone marrow biopsy

Type de données

boolean

Alias
UMLS CUI [1]
C0677874
UMLS CUI [2,1]
C0229671
UMLS CUI [2,2]
C0700271
UMLS CUI [2,3]
C0332197
UMLS CUI [3,1]
C0042036
UMLS CUI [3,2]
C0700271
UMLS CUI [3,3]
C0332197
UMLS CUI [4]
C1611269
UMLS CUI [5,1]
C0085663
UMLS CUI [5,2]
C0332197
UMLS CUI [6]
C0857285
UMLS CUI [7]
C0005954
3. patients with non-secretory myeloma.
Description

Non-secretory myeloma

Type de données

boolean

Alias
UMLS CUI [1]
C0456845
Retour au début de la page

Similar models

Eligibility Multiple Myeloma NCT00661544

1 Formulaires
Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
C1512693 (UMLS CUI)
Multiple Myeloma | Multiple Myeloma Primary Refractory | Multiple Myeloma partial response Consolidation | Multiple Myeloma Decrease | Serum M Protein | Urine M Protein | Immunofixation electrophoresis | Plasmacytosis | Marrow aspirate | Bone marrow biopsy | Recurrent disease Post Prior Therapy
Item
1. patients with multiple myeloma in any of the following disease categories: a) primary refractory disease b) consolidation of a partial remission (defined as a decrease but continued presence of monoclonal protein on serum and urine immunofixation electrophoresis, and/or the presence of plasmacytosis on bone marrow aspirate and biopsy) c) all patients relapsing after prior therapy .
boolean
C0026764 (UMLS CUI [1])
C0026764 (UMLS CUI [2,1])
C2347678 (UMLS CUI [2,2])
C0026764 (UMLS CUI [3,1])
C1521726 (UMLS CUI [3,2])
C0702116 (UMLS CUI [3,3])
C0026764 (UMLS CUI [4,1])
C0547047 (UMLS CUI [4,2])
C0229671 (UMLS CUI [5,1])
C0700271 (UMLS CUI [5,2])
C0042036 (UMLS CUI [6,1])
C0700271 (UMLS CUI [6,2])
C1611269 (UMLS CUI [7])
C0085663 (UMLS CUI [8])
C0857285 (UMLS CUI [9])
C0005954 (UMLS CUI [10])
C0277556 (UMLS CUI [11,1])
C0687676 (UMLS CUI [11,2])
C1514463 (UMLS CUI [11,3])
Age
Item
2. age up to 70 years.
boolean
C0001779 (UMLS CUI [1])
Zubrod Performance Status
Item
3. zubrod performance status (ps) of <2.
boolean
C3714786 (UMLS CUI [1])
Left ventricular ejection fraction | Cardiac Arrhythmia Uncontrolled | Heart Disease Symptomatic
Item
4. left ventricular ejection fraction >40%. no uncontrolled arrhythmias or symptomatic cardiac disease.
boolean
C0428772 (UMLS CUI [1])
C0003811 (UMLS CUI [2,1])
C0205318 (UMLS CUI [2,2])
C0018799 (UMLS CUI [3,1])
C0231220 (UMLS CUI [3,2])
Forced vital capacity | FEV1 | Carbon Monoxide Diffusing Capability Test | Lung disease Symptomatic
Item
5. forced vital capacity (fvc); forced expiratory volume in 1 second (fev1), forced vital capacity (fvc) and carbon monoxide diffusing capacity (dl co) >40%. no symptomatic pulmonary disease.
boolean
C1287681 (UMLS CUI [1])
C0748133 (UMLS CUI [2])
C1516251 (UMLS CUI [3])
C0024115 (UMLS CUI [4,1])
C0231220 (UMLS CUI [4,2])
Serum bilirubin measurement | Alanine aminotransferase measurement | Chronic Hepatitis Evidence | Chronic Liver Cirrhosis Evidence | effusion | Ascites | Drainage
Item
6. serum bilirubin <2 times upper limit of normal, sgpt <4 times upper limit of normal. no evidence of chronic active hepatitis or cirrhosis. no effusion or ascites >1l prior to drainage.
boolean
C0428441 (UMLS CUI [1])
C0201836 (UMLS CUI [2])
C0019189 (UMLS CUI [3,1])
C3887511 (UMLS CUI [3,2])
C0023890 (UMLS CUI [4,1])
C0205191 (UMLS CUI [4,2])
C3887511 (UMLS CUI [4,3])
C0013687 (UMLS CUI [5])
C0003962 (UMLS CUI [6])
C0013103 (UMLS CUI [7])
HIV negative
Item
7. hiv-negative.
boolean
C0481430 (UMLS CUI [1])
Pregnancy
Item
8. patient is not pregnant.
boolean
C0032961 (UMLS CUI [1])
Informed Consent
Item
9. patient or guardian able to sign informed consent.
boolean
C0021430 (UMLS CUI [1])
QTc
Item
10. corrected qt interval less than 500 msec.
boolean
C0860814 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
QTc
Item
1. corrected qt interval greater than 500 msec
boolean
C0860814 (UMLS CUI [1])
In complete remission | Serum M Protein Absent | Urine M Protein Absent | Immunofixation electrophoresis | Plasmacytosis Absent | Marrow aspirate | Bone marrow biopsy
Item
2. patients in complete remission (defined as the absence of monoclonal protein on serum and urine immunofixation electrophoresis, and the absence of plasmacytosis in bone marrow aspirate and biopsy).
boolean
C0677874 (UMLS CUI [1])
C0229671 (UMLS CUI [2,1])
C0700271 (UMLS CUI [2,2])
C0332197 (UMLS CUI [2,3])
C0042036 (UMLS CUI [3,1])
C0700271 (UMLS CUI [3,2])
C0332197 (UMLS CUI [3,3])
C1611269 (UMLS CUI [4])
C0085663 (UMLS CUI [5,1])
C0332197 (UMLS CUI [5,2])
C0857285 (UMLS CUI [6])
C0005954 (UMLS CUI [7])
Non-secretory myeloma
Item
3. patients with non-secretory myeloma.
boolean
C0456845 (UMLS CUI [1])
Retour au début de la page 

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