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Eligibility Myeloma NCT00469209

1 forms  
  1. StudyEvent: Eligibility
    1. Eligibility Myeloma NCT00469209
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. a) primary refractory disease (defined as failure to achieve even a partial response to induction therapy) 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) relapsing after prior therapy (disease relapsing after achieving a partial or complete response to prior conventional or high-dose therapy).
Description

Refractory Disease Primary | Induction therapy Partial response failed | Partial response Consolidation | M Protein Decrease Serum immunofixation Electrophoresis | M Protein Decrease Urine immunofixation Electrophoresis | Plasmacytosis Present Marrow aspirate | Plasmacytosis Present Bone marrow biopsy | Relapse Post Therapeutic procedure | Standard therapy | Therapeutic procedure High dose | Relapse post partial response | Relapse post complete response

Data type

boolean

Alias
UMLS CUI [1,1]
C1514815
UMLS CUI [1,2]
C0205225
UMLS CUI [2,1]
C0600558
UMLS CUI [2,2]
C1521726
UMLS CUI [2,3]
C0231175
UMLS CUI [3,1]
C1521726
UMLS CUI [3,2]
C0702116
UMLS CUI [4,1]
C0700271
UMLS CUI [4,2]
C0547047
UMLS CUI [4,3]
C1271678
UMLS CUI [4,4]
C0013855
UMLS CUI [5,1]
C0700271
UMLS CUI [5,2]
C0547047
UMLS CUI [5,3]
C1271641
UMLS CUI [5,4]
C0013855
UMLS CUI [6,1]
C0085663
UMLS CUI [6,2]
C0150312
UMLS CUI [6,3]
C0857285
UMLS CUI [7,1]
C0085663
UMLS CUI [7,2]
C0150312
UMLS CUI [7,3]
C0005954
UMLS CUI [8,1]
C0035020
UMLS CUI [8,2]
C0687676
UMLS CUI [8,3]
C0087111
UMLS CUI [9]
C2936643
UMLS CUI [10,1]
C0087111
UMLS CUI [10,2]
C0444956
UMLS CUI [11,1]
C0035020
UMLS CUI [11,2]
C0687676
UMLS CUI [11,3]
C1521726
UMLS CUI [12,1]
C0035020
UMLS CUI [12,2]
C0687676
UMLS CUI [12,3]
C0677874
2. age up to 75 years.
Description

Age

Data type

boolean

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

Zubrod Performance Status

Data type

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

Data type

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 expiratory volume (fev1), forced volume vital capacity (fvc) and diffusing capacity of the lung for carbon monoxide (dlco) >40%. no symptomatic pulmonary disease.
Description

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

Data type

boolean

Alias
UMLS CUI [1]
C0748133
UMLS CUI [2]
C1287681
UMLS CUI [3]
C1516251
UMLS CUI [4,1]
C0024115
UMLS CUI [4,2]
C0231220
6. serum bilirubin <2 times upper limit of normal, alanine aminotransferase/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 total bilirubin measurement | Alanine aminotransferase measurement | Chronic Hepatitis Evidence | Liver Cirrhosis chronic Evidence | Effusion | Ascites | Drainage

Data type

boolean

Alias
UMLS CUI [1]
C1278039
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

Data type

boolean

Alias
UMLS CUI [1]
C0481430
8. negative beta human chorionic gonadotrophin (hcg) test in a woman with child bearing potential, defined as not post-menopausal for 12 months or no previous surgical sterilization
Description

Childbearing Potential Serum pregnancy test (B-HCG) Negative | Postmenopausal state | Female Sterilization

Data type

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0430060
UMLS CUI [1,3]
C1513916
UMLS CUI [2]
C0232970
UMLS CUI [3]
C0015787
9. patient or guardian able to sign informed consent
Description

Informed Consent | Informed Consent Guardian

Data type

boolean

Alias
UMLS CUI [1]
C0021430
UMLS CUI [2,1]
C0021430
UMLS CUI [2,2]
C1274041
10. corrected qt interval less than 470 msec.
Description

QTc

Data type

boolean

Alias
UMLS CUI [1]
C0860814
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. corrected qt interval greater than 470 msec.
Description

QTc

Data type

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 | M Protein Absent Serum immunofixation Electrophoresis | M Protein Absent Urine immunofixation Electrophoresis | Plasmacytosis Absent Marrow aspirate | Plasmacytosis Absent Bone marrow biopsy

Data type

boolean

Alias
UMLS CUI [1]
C0677874
UMLS CUI [2,1]
C0700271
UMLS CUI [2,2]
C0332197
UMLS CUI [2,3]
C1271678
UMLS CUI [2,4]
C0013855
UMLS CUI [3,1]
C0700271
UMLS CUI [3,2]
C0332197
UMLS CUI [3,3]
C1271641
UMLS CUI [3,4]
C0013855
UMLS CUI [4,1]
C0085663
UMLS CUI [4,2]
C0332197
UMLS CUI [4,3]
C0857285
UMLS CUI [5,1]
C0085663
UMLS CUI [5,2]
C0332197
UMLS CUI [5,3]
C0005954
3. patients with non-secretory myeloma.
Description

Non-secretory myeloma

Data type

boolean

Alias
UMLS CUI [1]
C0456845
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Similar models

Eligibility Myeloma NCT00469209

1 forms
  1. StudyEvent: Eligibility
    1. Eligibility Myeloma NCT00469209
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Refractory Disease Primary | Induction therapy Partial response failed | Partial response Consolidation | M Protein Decrease Serum immunofixation Electrophoresis | M Protein Decrease Urine immunofixation Electrophoresis | Plasmacytosis Present Marrow aspirate | Plasmacytosis Present Bone marrow biopsy | Relapse Post Therapeutic procedure | Standard therapy | Therapeutic procedure High dose | Relapse post partial response | Relapse post complete response
Item
1. a) primary refractory disease (defined as failure to achieve even a partial response to induction therapy) 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) relapsing after prior therapy (disease relapsing after achieving a partial or complete response to prior conventional or high-dose therapy).
boolean
C1514815 (UMLS CUI [1,1])
C0205225 (UMLS CUI [1,2])
C0600558 (UMLS CUI [2,1])
C1521726 (UMLS CUI [2,2])
C0231175 (UMLS CUI [2,3])
C1521726 (UMLS CUI [3,1])
C0702116 (UMLS CUI [3,2])
C0700271 (UMLS CUI [4,1])
C0547047 (UMLS CUI [4,2])
C1271678 (UMLS CUI [4,3])
C0013855 (UMLS CUI [4,4])
C0700271 (UMLS CUI [5,1])
C0547047 (UMLS CUI [5,2])
C1271641 (UMLS CUI [5,3])
C0013855 (UMLS CUI [5,4])
C0085663 (UMLS CUI [6,1])
C0150312 (UMLS CUI [6,2])
C0857285 (UMLS CUI [6,3])
C0085663 (UMLS CUI [7,1])
C0150312 (UMLS CUI [7,2])
C0005954 (UMLS CUI [7,3])
C0035020 (UMLS CUI [8,1])
C0687676 (UMLS CUI [8,2])
C0087111 (UMLS CUI [8,3])
C2936643 (UMLS CUI [9])
C0087111 (UMLS CUI [10,1])
C0444956 (UMLS CUI [10,2])
C0035020 (UMLS CUI [11,1])
C0687676 (UMLS CUI [11,2])
C1521726 (UMLS CUI [11,3])
C0035020 (UMLS CUI [12,1])
C0687676 (UMLS CUI [12,2])
C0677874 (UMLS CUI [12,3])
Age
Item
2. age up to 75 years.
boolean
C0001779 (UMLS CUI [1])
Zubrod Performance Status
Item
3. zubrod performance status 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])
FEV1 | Forced vital capacity | Carbon Monoxide Diffusing Capability Test | Lung disease Symptomatic
Item
5. forced expiratory volume (fev1), forced volume vital capacity (fvc) and diffusing capacity of the lung for carbon monoxide (dlco) >40%. no symptomatic pulmonary disease.
boolean
C0748133 (UMLS CUI [1])
C1287681 (UMLS CUI [2])
C1516251 (UMLS CUI [3])
C0024115 (UMLS CUI [4,1])
C0231220 (UMLS CUI [4,2])
Serum total bilirubin measurement | Alanine aminotransferase measurement | Chronic Hepatitis Evidence | Liver Cirrhosis chronic Evidence | Effusion | Ascites | Drainage
Item
6. serum bilirubin <2 times upper limit of normal, alanine aminotransferase/sgpt <4 times upper limit of normal. no evidence of chronic active hepatitis or cirrhosis. no effusion or ascites >1l prior to drainage.
boolean
C1278039 (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])
Childbearing Potential Serum pregnancy test (B-HCG) Negative | Postmenopausal state | Female Sterilization
Item
8. negative beta human chorionic gonadotrophin (hcg) test in a woman with child bearing potential, defined as not post-menopausal for 12 months or no previous surgical sterilization
boolean
C3831118 (UMLS CUI [1,1])
C0430060 (UMLS CUI [1,2])
C1513916 (UMLS CUI [1,3])
C0232970 (UMLS CUI [2])
C0015787 (UMLS CUI [3])
Informed Consent | Informed Consent Guardian
Item
9. patient or guardian able to sign informed consent
boolean
C0021430 (UMLS CUI [1])
C0021430 (UMLS CUI [2,1])
C1274041 (UMLS CUI [2,2])
QTc
Item
10. corrected qt interval less than 470 msec.
boolean
C0860814 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
QTc
Item
1. corrected qt interval greater than 470 msec.
boolean
C0860814 (UMLS CUI [1])
In complete remission | M Protein Absent Serum immunofixation Electrophoresis | M Protein Absent Urine immunofixation Electrophoresis | Plasmacytosis Absent Marrow aspirate | Plasmacytosis Absent 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])
C0700271 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C1271678 (UMLS CUI [2,3])
C0013855 (UMLS CUI [2,4])
C0700271 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
C1271641 (UMLS CUI [3,3])
C0013855 (UMLS CUI [3,4])
C0085663 (UMLS CUI [4,1])
C0332197 (UMLS CUI [4,2])
C0857285 (UMLS CUI [4,3])
C0085663 (UMLS CUI [5,1])
C0332197 (UMLS CUI [5,2])
C0005954 (UMLS CUI [5,3])
Non-secretory myeloma
Item
3. patients with non-secretory myeloma.
boolean
C0456845 (UMLS CUI [1])
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