ID
43071
Description
ODM derived from http://clinicaltrials.gov/show/NCT01311687
Link
http://clinicaltrials.gov/show/NCT01311687
Keywords
Versions (3)
- 3/21/13 3/21/13 - Martin Dugas
- 4/19/14 4/19/14 - Julian Varghese
- 9/20/21 9/20/21 -
Uploaded on
September 20, 2021
DOI
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License
Creative Commons BY 4.0
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Eligibility NCT01311687 Multiple Myeloma
Eligibility
- StudyEvent: Eligibility
Description
Exclusion Criteria
Description
Any of the following laboratory abnormalities:
Data type
boolean
Alias
- UMLS CUI 2011AA
- C0332282
- SNOMED CT 2011_0131
- 255260001
- UMLS CUI 2011AA
- C0438215
- SNOMED CT 2011_0131
- 165346000
- MedDRA 14.1
- 10023547
Description
Absolute neutrophil count (ANC) < 1,000/microL
Data type
boolean
Alias
- UMLS CUI 2011AA
- C0948762
- MedDRA 14.1
- 10052033
Description
Platelet count < 75,000/microL for subjects in whom < 50% of bone marrow nucleated cells are plasma cells
Data type
boolean
Alias
- UMLS CUI 2011AA
- C1287267
Description
Creatinine Clearance < 45 mL/min
Data type
boolean
Alias
- UMLS CUI 2011AA
- C0373595
- SNOMED CT 2011_0131
- 167181009
- MedDRA 14.1
- 10011371
Description
Corrected serum calcium > 14 mg/dL
Data type
boolean
Alias
- UMLS CUI 2011AA
- C0455288
- SNOMED CT 2011_0131
- 166708003
Description
Hemoglobin <= 8 g/dL
Data type
boolean
Alias
- UMLS CUI 2011AA
- C0518015
- SNOMED CT 2011_0131
- 38082009
- MedDRA 14.1
- 10019481
- LOINC Version 232
- LP14449-0
Description
Serum glutamic oxaloacetic transaminase (SGOT)/ aspartate aminotransferase (AST) or Transaminase, serum glutamic pyruvic (SGPT)/ alanine aminotransferase (ALT) > 3.0 x upper limit of normal (ULN)
Data type
boolean
Alias
- UMLS CUI 2011AA
- C0004002
- SNOMED CT 2011_0131
- 26091008
- LOINC Version 232
- MTHU004883
- UMLS CUI 2011AA
- C0001899
- SNOMED CT 2011_0131
- 56935002
- LOINC Version 232
- MTHU006766
- UMLS CUI 2011AA
- C1519815
Description
Serum total bilirubin > 2.0 mg/dL
Data type
boolean
Alias
- UMLS CUI 2011AA
- C1278039
- SNOMED CT 2011_0131
- 313840000
- MedDRA 14.1
- 10040162
Description
Previous therapy with Pomalidomide
Data type
boolean
Alias
- UMLS CUI 2011AA
- C1514463
- UMLS CUI 2011AA
- C2347624
Description
Hypersensitivity to thalidomide, lenalidomide, or dexamethasone
Data type
boolean
Alias
- UMLS CUI 2011AA
- C0020517
- SNOMED CT 2011_0131
- 418634005
- ICD-10-CM Version 2010
- T78.40
- UMLS CUI 2011AA
- C0039736
- SNOMED CT 2011_0131
- 78702007
- UMLS CUI 2011AA
- C1144149
- SNOMED CT 2011_0131
- 421471009
- UMLS CUI 2011AA
- C0011777
- SNOMED CT 2011_0131
- 372584003
- LOINC Version 232
- MTHU004621
Description
Resistance to high-dose dexamethasone used in the last line of therapy
Data type
boolean
Alias
- UMLS CUI 2011AA
- C1514892
- UMLS CUI 2011AA
- C0444956
- SNOMED CT 2011_0131
- 261829003
- UMLS CUI 2011AA
- C0011777
- SNOMED CT 2011_0131
- 372584003
- LOINC Version 232
- MTHU004621
Description
Peripheral neuropathy >= Grade 2
Data type
boolean
Alias
- UMLS CUI 2011AA
- C0031117
- MedDRA 14.1
- 10029331
- ICD-10-CM Version 2010
- G64
- ICD-9-CM Version 2011
- 350-359.99
- SNOMED CT 2011_0131
- 258349007
- LOINC Version 232
- MTHU003112
Description
Subjects who received an allogeneic bone marrow or allogeneic peripheral blood stem cell transplant
Data type
boolean
Alias
- UMLS CUI 2011AA
- C0149615
Description
Subjects who are planning for or who are eligible for stem cell transplant
Data type
boolean
Alias
- UMLS CUI 2011AA
- C1301732
- SNOMED CT 2011_0131
- 397943006
- UMLS CUI 2011AA
- C1548635
- HL7 V3 2006_05
- ELG
- UMLS CUI 2011AA
- C1504389
- MedDRA 14.1
- 10063581
Description
Subjects with any one of the following: 1) Congestive heart failure, 2) Myocardial infarction within 12 months prior to starting study treatment, 3) Unstable or poorly controlled angina pectoris, including Prinzmetal variant angina pectoris
Data type
boolean
Alias
- UMLS CUI 2011AA
- C0018802
- SNOMED CT 2011_0131
- 42343007
- MedDRA 14.1
- 10007559
- LOINC Version 232
- MTHU020787
- ICD-10-CM Version 2010
- I50.9
- ICD-9-CM Version 2011
- 428.0
- UMLS CUI 2011AA
- C0027051
- SNOMED CT 2011_0131
- 22298006
- MedDRA 14.1
- 10028596
- LOINC Version 232
- MTHU035551
- ICD-10-CM Version 2010
- I21-I22
- ICD-9-CM Version 2011
- 410
- CTCAE 1105E
- E10152
- UMLS CUI 2011AA
- C0002965
- SNOMED CT 2011_0131
- 4557003
- MedDRA 14.1
- 10002388
- ICD-10-CM Version 2010
- I20.0
- ICD-9-CM Version 2011
- 411.1
- UMLS CUI 2011AA
- C0205169
- SNOMED CT 2011_0131
- 556001
- UMLS CUI 2011AA
- C2587213
- SNOMED CT 2011_0131
- 31509003
- UMLS CUI 2011AA
- C0002962
- SNOMED CT 2011_0131
- 194828000
- MedDRA 14.1
- 10002383
- ICD-10-CM Version 2010
- I20
- ICD-9-CM Version 2011
- 413
- UMLS CUI 2011AA
- C0002963
- SNOMED CT 2011_0131
- 87343002
- MedDRA 14.1
- 10036759
- ICD-10-CM Version 2010
- I20.1
- ICD-9-CM Version 2011
- 413.1
Description
Subjects who received any of the following within the last 14 days of initiation of study treatment: 1) Plasmapheresis, 2) Major surgery, 3) Radiation therapy, 4) Use of any anti-myeloma drug therapy
Data type
boolean
Alias
- UMLS CUI 2011AA
- C1514756
- UMLS CUI 2011AA
- C0032134
- SNOMED CT 2011_0131
- 20720000
- MedDRA 14.1
- 10035486
- ICD-9-CM Version 2011
- 99.71
- UMLS CUI 2011AA
- C0679637
- UMLS CUI 2011AA
- C0034619
- UMLS CUI 2011AA
- C0521124
- SNOMED CT 2011_0131
- 65897001
Description
Use of any investigational agents within 28 days or 5 half-lives (whichever is longer) of treatment
Data type
boolean
Alias
- UMLS CUI 2011AA
- C1524063
- SNOMED CT 2011_0131
- 260676000
- UMLS CUI 2011AA
- C0013230
Description
Subjects with conditions requiring chronic steroid or immunosuppressive treatment
Data type
boolean
Alias
- UMLS CUI 2011AA
- C0348080
- SNOMED CT 2011_0131
- 260905004
- HL7 V3 2006_05
- COND
- UMLS CUI 2011AA
- C1514873
- UMLS CUI 2011AA
- C0205191
- SNOMED CT 2011_0131
- 90734009
- UMLS CUI 2011AA
- C0149783
- SNOMED CT 2011_0131
- 297279009
- MedDRA 14.1
- 10062117
- UMLS CUI 2011AA
- C0021079
- SNOMED CT 2011_0131
- 86553008
Description
Any condition including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study
Data type
boolean
Alias
- UMLS CUI 2011AA
- C0348080
- SNOMED CT 2011_0131
- 260905004
- HL7 V3 2006_05
- COND
- UMLS CUI 2011AA
- C0438215
- SNOMED CT 2011_0131
- 165346000
- MedDRA 14.1
- 10023547
- UMLS CUI 2011AA
- C0678227
- SNOMED CT 2011_0131
- 23981006
- UMLS CUI 2011AA
- C1883420
- UMLS CUI 2011AA
- C0035647
- SNOMED CT 2011_0131
- 30207005
- HL7 V3 2006_05
- RSK
- UMLS CUI 2011AA
- C2348568
Description
Incidence of gastrointestinal disease that may significantly alter the absorption of pomalidomide
Data type
boolean
Alias
- UMLS CUI 2011AA
- C0021149
- UMLS CUI 2011AA
- C0017178
- SNOMED CT 2011_0131
- 119292006
- MedDRA 14.1
- 10017944
- UMLS CUI 2011AA
- C0750502
- SNOMED CT 2011_0131
- 386134007
- UMLS CUI 2011AA
- C1515926
- UMLS CUI 2011AA
- C0000854
- UMLS CUI 2011AA
- C2347624
Description
Subjects unable or unwilling to undergo antithrombotic prophylactic treatment
Data type
boolean
Alias
- UMLS CUI 2011AA
- C1299582
- SNOMED CT 2011_0131
- 371151008
- UMLS CUI 2011AA
- C0558080
- SNOMED CT 2011_0131
- 225465005
- UMLS CUI 2011AA
- C1514756
- UMLS CUI 2011AA
- C0445202
- SNOMED CT 2011_0131
- 262073000
- MedDRA 14.1
- 10036893
- UMLS CUI 2011AA
- C1704311
- UMLS CUI 2011AA
- C0039798
Description
Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subjects from signing the informed consent form
Data type
boolean
Alias
- UMLS CUI 2011AA
- C1699700
- HL7 V3 2006_05
- MEDCCAT
- UMLS CUI 2011AA
- C0438215
- SNOMED CT 2011_0131
- 165346000
- MedDRA 14.1
- 10023547
- UMLS CUI 2011AA
- C0004936
- SNOMED CT 2011_0131
- 74732009
- MedDRA 14.1
- 10037174
- ICD-10-CM Version 2010
- F99
- ICD-9-CM Version 2011
- 290-319.99
- UMLS CUI 2011AA
- C2348583
Description
Pregnant or breastfeeding females
Data type
boolean
Alias
- UMLS CUI 2011AA
- C0549206
- MedDRA 14.1
- 10036586
- UMLS CUI 2011AA
- C0006147
- MedDRA 14.1
- 10006247
- UMLS CUI 2011AA
- C0086287
- SNOMED CT 2011_0131
- 248152002
- HL7 V3 2006_05
- F
Description
Known Human Immunodeficiency Virus (HIV) positivity or active infectious hepatitis A, B or C
Data type
boolean
Alias
- UMLS CUI 2011AA
- C0019699
- SNOMED CT 2011_0131
- 165816005
- MedDRA 14.1
- 10020188
- ICD-10-CM Version 2010
- Z21
- UMLS CUI 2011AA
- C0205177
- SNOMED CT 2011_0131
- 55561003
- UMLS CUI 2011AA
- C0019159
- SNOMED CT 2011_0131
- 40468003
- MedDRA 14.1
- 10019780
- UMLS CUI 2011AA
- C0019163
- SNOMED CT 2011_0131
- 66071002
- MedDRA 14.1
- 10019731
- UMLS CUI 2011AA
- C0019196
- SNOMED CT 2011_0131
- 50711007
- MedDRA 14.1
- 10019744
- ICD-10-CM Version 2010
- B19.20
- ICD-9-CM Version 2011
- 070.7
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Eligibility
- StudyEvent: Eligibility
397669002 (SNOMED CT 2011_0131)
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26091008 (SNOMED CT 2011_0131)
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56935002 (SNOMED CT 2011_0131)
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22298006 (SNOMED CT 2011_0131)
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386134007 (SNOMED CT 2011_0131)
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225465005 (SNOMED CT 2011_0131)
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262073000 (SNOMED CT 2011_0131)
10036893 (MedDRA 14.1)
C1704311 (UMLS CUI 2011AA)
C0039798 (UMLS CUI 2011AA)
MEDCCAT (HL7 V3 2006_05)
C0438215 (UMLS CUI 2011AA)
165346000 (SNOMED CT 2011_0131)
10023547 (MedDRA 14.1)
C0004936 (UMLS CUI 2011AA)
74732009 (SNOMED CT 2011_0131)
10037174 (MedDRA 14.1)
F99 (ICD-10-CM Version 2010)
290-319.99 (ICD-9-CM Version 2011)
C2348583 (UMLS CUI 2011AA)
10036586 (MedDRA 14.1)
C0006147 (UMLS CUI 2011AA)
10006247 (MedDRA 14.1)
C0086287 (UMLS CUI 2011AA)
248152002 (SNOMED CT 2011_0131)
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165816005 (SNOMED CT 2011_0131)
10020188 (MedDRA 14.1)
Z21 (ICD-10-CM Version 2010)
C0205177 (UMLS CUI 2011AA)
55561003 (SNOMED CT 2011_0131)
C0019159 (UMLS CUI 2011AA)
40468003 (SNOMED CT 2011_0131)
10019780 (MedDRA 14.1)
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10019731 (MedDRA 14.1)
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50711007 (SNOMED CT 2011_0131)
10019744 (MedDRA 14.1)
B19.20 (ICD-10-CM Version 2010)
070.7 (ICD-9-CM Version 2011)