ID

19126

Description

Bortezomib in Combination With CC-5013 in Patients With Relapsed/Refractory Multiple Myeloma; ODM derived from: https://clinicaltrials.gov/show/NCT00153933

Link

https://clinicaltrials.gov/show/NCT00153933

Keywords

Versions (1)
  1. 12/6/16 12/6/16 -
Uploaded on

December 6, 2016

DOI

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License

Creative Commons BY 4.0
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Eligibility Refractory Multiple Myeloma NCT00153933

English

Eligibility Refractory Multiple Myeloma NCT00153933

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
diagnosis of multiple myeloma based on standard diagnosis criteria: plasmacytomas on tissue biopsy; bone marrow plasmacytosis; monoclonal immunoglobulin spike on serum electrophoresis; lytic bone lesions.
Description

Multiple Myeloma | Plasmacytoma | Biopsy | BONE MARROW PLASMACYTOSIS | Monoclonal immunoglobulin present | serum electrophoresis test | Lytic lesion

Data type

boolean

Alias
UMLS CUI [1]
C0026764
UMLS CUI [2]
C0032131
UMLS CUI [3]
C0005558
UMLS CUI [4]
C0238803
UMLS CUI [5]
C0860896
UMLS CUI [6]
C0851095
UMLS CUI [7]
C0221204
must have relapsed or relapsed/refractory disease
Description

Recurrent disease | Recurrent disease refractory

Data type

boolean

Alias
UMLS CUI [1]
C0277556
UMLS CUI [2,1]
C0277556
UMLS CUI [2,2]
C0205269
18 years of age or older
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
all baseline studies must be performed within 21 days of enrollment.
Description

Baseline Tests Duration

Data type

boolean

Alias
UMLS CUI [1,1]
C1442488
UMLS CUI [1,2]
C0392366
UMLS CUI [1,3]
C0449238
ecog performance status of 0 to 2
Description

ECOG performance status

Data type

boolean

Alias
UMLS CUI [1]
C1520224
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
renal insufficiency (serum creatinine levels > 2mg/dl)
Description

Renal Insufficiency | Creatinine measurement, serum

Data type

boolean

Alias
UMLS CUI [1]
C1565489
UMLS CUI [2]
C0201976
concomitant therapy medications that include corticosteroids
Description

Pharmacotherapy Including Adrenal Cortex Hormones

Data type

boolean

Alias
UMLS CUI [1,1]
C0013216
UMLS CUI [1,2]
C0332257
UMLS CUI [1,3]
C0001617
peripheral neuropathy of grade 3 or greater or painful grade 2
Description

Peripheral Neuropathy CTCAE Grades | Pain CTCAE Grades

Data type

boolean

Alias
UMLS CUI [1,1]
C0031117
UMLS CUI [1,2]
C1516728
UMLS CUI [2,1]
C0030193
UMLS CUI [2,2]
C1516728
evidence of mucosal or internal bleeding and/or platelet refractory
Description

Mucosal bleeding Evidence of | Internal hemorrhage Evidence of | Platelet Transfusion refractory

Data type

boolean

Alias
UMLS CUI [1,1]
C2748540
UMLS CUI [1,2]
C0332120
UMLS CUI [2,1]
C1390214
UMLS CUI [2,2]
C0332120
UMLS CUI [3,1]
C0086818
UMLS CUI [3,2]
C0205269
anc < 1000 cells/mm3
Description

Absolute neutrophil count

Data type

boolean

Alias
UMLS CUI [1]
C0948762
hemoglobin < 8.0 g/dl
Description

Hemoglobin measurement

Data type

boolean

Alias
UMLS CUI [1]
C0518015
ast (sgot and alt) > 2 x uln
Description

Aspartate aminotransferase measurement | Alanine aminotransferase measurement

Data type

boolean

Alias
UMLS CUI [1]
C0201899
UMLS CUI [2]
C0201836
intolerance to bortezomib or cc-5013 in the past or significant allergy to either compound, boron or mannitol
Description

intolerance to bortezomib | intolerance to CC-5013 | Hypersensitivity Significant Boron Compound | Hypersensitivity Significant Mannitol Compound

Data type

boolean

Alias
UMLS CUI [1,1]
C1744706
UMLS CUI [1,2]
C1176309
UMLS CUI [2,1]
C1744706
UMLS CUI [2,2]
C1134588
UMLS CUI [3,1]
C0020517
UMLS CUI [3,2]
C0750502
UMLS CUI [3,3]
C0006031
UMLS CUI [4,1]
C0020517
UMLS CUI [4,2]
C0750502
UMLS CUI [4,3]
C0024730
UMLS CUI [4,4]
C1706082
known hypersensitivity to thalidomide or the development of erythema nodosum
Description

Hypersensitivity Thalidomide | Erythema Nodosum

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0039736
UMLS CUI [2]
C0014743
active infection or serious co-morbid medical condition
Description

Communicable Disease | Comorbidity Serious

Data type

boolean

Alias
UMLS CUI [1]
C0009450
UMLS CUI [2,1]
C0009488
UMLS CUI [2,2]
C0205404
pregnant or breast-feeding women
Description

Pregnancy | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
prior malignancy with the last three years except adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, in situ breast cancer, on in-situ prostate cancer
Description

Malignant Neoplasms | Basal cell carcinoma Treated | Squamous cell carcinoma of skin Treated | Carcinoma in situ of uterine cervix Treated | Carcinoma in situ of female breast Treated | Carcinoma in situ of prostate Treated

Data type

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2,1]
C0007117
UMLS CUI [2,2]
C1522326
UMLS CUI [3,1]
C0553723
UMLS CUI [3,2]
C1522326
UMLS CUI [4,1]
C0851140
UMLS CUI [4,2]
C1522326
UMLS CUI [5,1]
C0686288
UMLS CUI [5,2]
C1522326
UMLS CUI [6,1]
C0154088
UMLS CUI [6,2]
C1522326
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Similar models

Eligibility Refractory Multiple Myeloma NCT00153933

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Multiple Myeloma | Plasmacytoma | Biopsy | BONE MARROW PLASMACYTOSIS | Monoclonal immunoglobulin present | serum electrophoresis test | Lytic lesion
Item
diagnosis of multiple myeloma based on standard diagnosis criteria: plasmacytomas on tissue biopsy; bone marrow plasmacytosis; monoclonal immunoglobulin spike on serum electrophoresis; lytic bone lesions.
boolean
C0026764 (UMLS CUI [1])
C0032131 (UMLS CUI [2])
C0005558 (UMLS CUI [3])
C0238803 (UMLS CUI [4])
C0860896 (UMLS CUI [5])
C0851095 (UMLS CUI [6])
C0221204 (UMLS CUI [7])
Recurrent disease | Recurrent disease refractory
Item
must have relapsed or relapsed/refractory disease
boolean
C0277556 (UMLS CUI [1])
C0277556 (UMLS CUI [2,1])
C0205269 (UMLS CUI [2,2])
Age
Item
18 years of age or older
boolean
C0001779 (UMLS CUI [1])
Baseline Tests Duration
Item
all baseline studies must be performed within 21 days of enrollment.
boolean
C1442488 (UMLS CUI [1,1])
C0392366 (UMLS CUI [1,2])
C0449238 (UMLS CUI [1,3])
ECOG performance status
Item
ecog performance status of 0 to 2
boolean
C1520224 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Renal Insufficiency | Creatinine measurement, serum
Item
renal insufficiency (serum creatinine levels > 2mg/dl)
boolean
C1565489 (UMLS CUI [1])
C0201976 (UMLS CUI [2])
Pharmacotherapy Including Adrenal Cortex Hormones
Item
concomitant therapy medications that include corticosteroids
boolean
C0013216 (UMLS CUI [1,1])
C0332257 (UMLS CUI [1,2])
C0001617 (UMLS CUI [1,3])
Peripheral Neuropathy CTCAE Grades | Pain CTCAE Grades
Item
peripheral neuropathy of grade 3 or greater or painful grade 2
boolean
C0031117 (UMLS CUI [1,1])
C1516728 (UMLS CUI [1,2])
C0030193 (UMLS CUI [2,1])
C1516728 (UMLS CUI [2,2])
Mucosal bleeding Evidence of | Internal hemorrhage Evidence of | Platelet Transfusion refractory
Item
evidence of mucosal or internal bleeding and/or platelet refractory
boolean
C2748540 (UMLS CUI [1,1])
C0332120 (UMLS CUI [1,2])
C1390214 (UMLS CUI [2,1])
C0332120 (UMLS CUI [2,2])
C0086818 (UMLS CUI [3,1])
C0205269 (UMLS CUI [3,2])
Absolute neutrophil count
Item
anc < 1000 cells/mm3
boolean
C0948762 (UMLS CUI [1])
Hemoglobin measurement
Item
hemoglobin < 8.0 g/dl
boolean
C0518015 (UMLS CUI [1])
Aspartate aminotransferase measurement | Alanine aminotransferase measurement
Item
ast (sgot and alt) > 2 x uln
boolean
C0201899 (UMLS CUI [1])
C0201836 (UMLS CUI [2])
intolerance to bortezomib | intolerance to CC-5013 | Hypersensitivity Significant Boron Compound | Hypersensitivity Significant Mannitol Compound
Item
intolerance to bortezomib or cc-5013 in the past or significant allergy to either compound, boron or mannitol
boolean
C1744706 (UMLS CUI [1,1])
C1176309 (UMLS CUI [1,2])
C1744706 (UMLS CUI [2,1])
C1134588 (UMLS CUI [2,2])
C0020517 (UMLS CUI [3,1])
C0750502 (UMLS CUI [3,2])
C0006031 (UMLS CUI [3,3])
C0020517 (UMLS CUI [4,1])
C0750502 (UMLS CUI [4,2])
C0024730 (UMLS CUI [4,3])
C1706082 (UMLS CUI [4,4])
Hypersensitivity Thalidomide | Erythema Nodosum
Item
known hypersensitivity to thalidomide or the development of erythema nodosum
boolean
C0020517 (UMLS CUI [1,1])
C0039736 (UMLS CUI [1,2])
C0014743 (UMLS CUI [2])
Communicable Disease | Comorbidity Serious
Item
active infection or serious co-morbid medical condition
boolean
C0009450 (UMLS CUI [1])
C0009488 (UMLS CUI [2,1])
C0205404 (UMLS CUI [2,2])
Pregnancy | Breast Feeding
Item
pregnant or breast-feeding women
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Malignant Neoplasms | Basal cell carcinoma Treated | Squamous cell carcinoma of skin Treated | Carcinoma in situ of uterine cervix Treated | Carcinoma in situ of female breast Treated | Carcinoma in situ of prostate Treated
Item
prior malignancy with the last three years except adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, in situ breast cancer, on in-situ prostate cancer
boolean
C0006826 (UMLS CUI [1])
C0007117 (UMLS CUI [2,1])
C1522326 (UMLS CUI [2,2])
C0553723 (UMLS CUI [3,1])
C1522326 (UMLS CUI [3,2])
C0851140 (UMLS CUI [4,1])
C1522326 (UMLS CUI [4,2])
C0686288 (UMLS CUI [5,1])
C1522326 (UMLS CUI [5,2])
C0154088 (UMLS CUI [6,1])
C1522326 (UMLS CUI [6,2])
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