ID

5127

Description

ODM derived from http://clinicaltrials.gov/show/NCT01311687

Link

http://clinicaltrials.gov/show/NCT01311687

Keywords

Versions (3)
  1. 3/21/13 3/21/13 - Martin Dugas
  2. 4/19/14 4/19/14 - Julian Varghese
  3. 9/20/21 9/20/21 -
Uploaded on

April 19, 2014

DOI

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License

Creative Commons BY 4.0
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Eligibility NCT01311687 Multiple Myeloma

German English

Eligibility

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

Inclusion Criteria

age at least 18 Years
Description

age at least 18 Years

Data type

boolean

Alias
UMLS CUI 2011AA
C0001779
SNOMED CT 2011_0131
397669002
Subjects must have documented diagnosis of multiple myeloma and have measurable disease
Description

Subjects must have documented diagnosis of multiple myeloma and have measurable disease

Data type

boolean

Alias
UMLS CUI 2011AA
C1301725
SNOMED CT 2011_0131
397934002
UMLS CUI 2011AA
C0011900
SNOMED CT 2011_0131
439401001
LOINC Version 232
MTHU008876
UMLS CUI 2011AA
C0026764
SNOMED CT 2011_0131
109989006
MedDRA 14.1
10028228
ICD-10-CM Version 2010
C90.0
ICD-9-CM Version 2011
203.0
UMLS CUI 2011AA
C1513041
Subjects must have undergone prior treatment with >= 2 treatment lines of anti-myeloma therapy
Description

Subjects must have undergone prior treatment with >= 2 treatment lines of anti-myeloma therapy

Data type

boolean

Alias
UMLS CUI 2011AA
C1514756
UMLS CUI 2011AA
C1514463
UMLS CUI 2011AA
C0521124
SNOMED CT 2011_0131
65897001
Subjects must have either refractory or relapsed and refractory disease defined as documented disease progression during or within 60 days of completing their last myeloma therapy
Description

Subjects must have either refractory or relapsed and refractory disease defined as documented disease progression during or within 60 days of completing their last myeloma therapy

Data type

boolean

Alias
UMLS CUI 2011AA
C1514815
UMLS CUI 2011AA
C0277556
SNOMED CT 2011_0131
58184002
UMLS CUI 2011AA
C1301725
SNOMED CT 2011_0131
397934002
UMLS CUI 2011AA
C1947901
All subjects must have received at least 2 consecutive cycles of prior treatment that included lenalidomide and bortezomib
Description

All subjects must have received at least 2 consecutive cycles of prior treatment that included lenalidomide and bortezomib

Data type

boolean

Alias
UMLS CUI 2011AA
C1514756
UMLS CUI 2011AA
C1707491
UMLS CUI 2011AA
C0439596
SNOMED CT 2011_0131
44180009
UMLS CUI 2011AA
C1514463
UMLS CUI 2011AA
C1144149
SNOMED CT 2011_0131
421471009
UMLS CUI 2011AA
C1176309
SNOMED CT 2011_0131
407097007
All subjects must have failed treatment with both lenalidomide and bortezomib in one of the following ways:
Description

All subjects must have failed treatment with both lenalidomide and bortezomib in one of the following ways:

Data type

boolean

Alias
UMLS CUI 2011AA
C0162643
MedDRA 14.1
10066901
UMLS CUI 2011AA
C1144149
SNOMED CT 2011_0131
421471009
UMLS CUI 2011AA
C1176309
SNOMED CT 2011_0131
407097007
1) Documented progressive disease on or within 60 days of completing treatment with lenalidomide and/or bortezomib, or
Description

1) Documented progressive disease on or within 60 days of completing treatment with lenalidomide and/or bortezomib, or

Data type

boolean

Alias
UMLS CUI 2011AA
C1301725
SNOMED CT 2011_0131
397934002
UMLS CUI 2011AA
C1335499
2) In case of prior response [>= partial response (PR)] to lenalidomide or bortezomib, subjects must have relapsed within 6 months after stopping treatment with lenalidomide and/or bortezomib-containing regimens, or
Description

2) In case of prior response [>= partial response (PR)] to lenalidomide or bortezomib, subjects must have relapsed within 6 months after stopping treatment with lenalidomide and/or bortezomib-containing regimens, or

Data type

boolean

Alias
UMLS CUI 2011AA
C0277556
SNOMED CT 2011_0131
58184002
UMLS CUI 2011AA
C0750557
UMLS CUI 2011AA
C0439091
SNOMED CT 2011_0131
276138003
HL7 V3 2006_05
GE
UMLS CUI 2011AA
C1521726
SNOMED CT 2011_0131
103337004
3) Subjects who have not had a >= minimal response (MR) and have developed intolerance/toxicity after a minimum of two cycles of lenalidomide
Description

3) Subjects who have not had a >= minimal response (MR) and have developed intolerance/toxicity after a minimum of two cycles of lenalidomide

Data type

boolean

Alias
UMLS CUI 2011AA
C1511795
UMLS CUI 2011AA
C1744706
UMLS CUI 2011AA
C0600688
SNOMED CT 2011_0131
75478009
UMLS CUI 2011AA
C1518422
UMLS CUI 2011AA
C0439091
SNOMED CT 2011_0131
276138003
HL7 V3 2006_05
GE
UMLS CUI 2011AA
C0547040
SNOMED CT 2011_0131
255605001
UMLS CUI 2011AA
C0521982
SNOMED CT 2011_0131
182985004
Patients must have received adequate prior alkylator therapy
Description

Patients must have received adequate prior alkylator therapy

Data type

boolean

Alias
UMLS CUI 2011AA
C0027552
SNOMED CT 2011_0131
410525008
UMLS CUI 2011AA
C0205411
SNOMED CT 2011_0131
88323005
UMLS CUI 2011AA
C1514463
UMLS CUI 2011AA
C0002073
SNOMED CT 2011_0131
372669002
Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1, or 2
Description

Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1, or 2

Data type

boolean

Alias
UMLS CUI 2011AA
C1520224
Females of childbearing potential (FCBP) must not become pregnant for 28 days prior to initiation of study drug, during the study, and for 28 days after discontinuation
Description

Females of childbearing potential (FCBP) must not become pregnant for 28 days prior to initiation of study drug, during the study, and for 28 days after discontinuation

Data type

boolean

Alias
UMLS CUI 2011AA
C0015780
SNOMED CT 2011_0131
248152002
HL7 V3 2006_05
F
UMLS CUI 2011AA
C1148523
UMLS CUI 2011AA
C0237399
UMLS CUI 2011AA
C0027552
SNOMED CT 2011_0131
410525008
UMLS CUI 2011AA
C0232973
SNOMED CT 2011_0131
60001007
Females must agree to abstain from breastfeeding during study participation and 28 days after study drug discontinuation
Description

Females must agree to abstain from breastfeeding during study participation and 28 days after study drug discontinuation

Data type

boolean

Alias
UMLS CUI 2011AA
C0015780
SNOMED CT 2011_0131
248152002
HL7 V3 2006_05
F
UMLS CUI 2011AA
C0680240
UMLS CUI 2011AA
C0006147
MedDRA 14.1
10006247
Males must agree to use a latex condom during any sexual during the study and for 28 days following discontinuation from this study
Description

Males must agree to use a latex condom during any sexual during the study and for 28 days following discontinuation from this study

Data type

boolean

Alias
UMLS CUI 2011AA
C0024554
SNOMED CT 2011_0131
248153007
HL7 V3 2006_05
M
UMLS CUI 2011AA
C0680240
UMLS CUI 2011AA
C1524063
SNOMED CT 2011_0131
260676000
UMLS CUI 2011AA
C0023115
SNOMED CT 2011_0131
400664008
UMLS CUI 2011AA
C0677582
Males must also agree to refrain from donating semen or sperm while on pomalidomide and for 28 days after discontinuation from this study
Description

Males must also agree to refrain from donating semen or sperm while on pomalidomide and for 28 days after discontinuation from this study

Data type

boolean

Alias
UMLS CUI 2011AA
C0024554
SNOMED CT 2011_0131
248153007
HL7 V3 2006_05
M
UMLS CUI 2011AA
C0680240
UMLS CUI 2011AA
C0870186
UMLS CUI 2011AA
C2756969
SNOMED CT 2011_0131
6993007
LOINC Version 232
MTHU001953
UMLS CUI 2011AA
C0680854
UMLS CUI 2011AA
C0871414
MedDRA 14.1
10053369
UMLS CUI 2011AA
C0347984
SNOMED CT 2011_0131
371881003
UMLS CUI 2011AA
C1512806
UMLS CUI 2011AA
C2347624
Exclusion Criteria
Description

Exclusion Criteria

Any of the following laboratory abnormalities:
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
Absolute Neutrophil Count
Description

Absolute neutrophil count (ANC) < 1,000/microL

Data type

boolean

Alias
UMLS CUI 2011AA
C0948762
MedDRA 14.1
10052033
Platelet count < 75,000/microL for subjects in whom < 50% of bone marrow nucleated cells are plasma cells
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
Creatinine clearance (CrCl) measurement
Description

Creatinine Clearance < 45 mL/min

Data type

boolean

Alias
UMLS CUI 2011AA
C0373595
SNOMED CT 2011_0131
167181009
MedDRA 14.1
10011371
Corrected Serum Calcium Measurement
Description

Corrected serum calcium > 14 mg/dL

Data type

boolean

Alias
UMLS CUI 2011AA
C0455288
SNOMED CT 2011_0131
166708003
Hemoglobin
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
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)
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
Serum Total Bilirubin Measurement
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
Previous therapy with Pomalidomide
Description

Previous therapy with Pomalidomide

Data type

boolean

Alias
UMLS CUI 2011AA
C1514463
UMLS CUI 2011AA
C2347624
Hypersensitivity to thalidomide, lenalidomide, or dexamethasone
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
Resistance to high-dose dexamethasone used in the last line of therapy
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
Peripheral neuropathy >= Grade 2
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
Subjects who received an allogeneic bone marrow or allogeneic peripheral blood stem cell transplant
Description

Subjects who received an allogeneic bone marrow or allogeneic peripheral blood stem cell transplant

Data type

boolean

Alias
UMLS CUI 2011AA
C0149615
Subjects who are planning for or who are eligible for stem cell transplant
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
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
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
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
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
Use of any investigational agents within 28 days or 5 half-lives (whichever is longer) of treatment
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
Subjects with conditions requiring chronic steroid or immunosuppressive treatment
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
Any condition including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study
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
Incidence of gastrointestinal disease that may significantly alter the absorption of pomalidomide
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
Subjects unable or unwilling to undergo antithrombotic prophylactic treatment
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
Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subjects from signing the informed consent form
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
Pregnant or breastfeeding females
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
C0015780
SNOMED CT 2011_0131
248152002
HL7 V3 2006_05
F
Known Human Immunodeficiency Virus (HIV) positivity or active infectious hepatitis A, B or C
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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Similar models

Eligibility

1 forms
  1. StudyEvent: Eligibility
    1. Eligibility
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Inclusion Criteria
age at least 18 Years
Item
age at least 18 Years
boolean
C0001779 (UMLS CUI 2011AA)
397669002 (SNOMED CT 2011_0131)
Subjects must have documented diagnosis of multiple myeloma and have measurable disease
Item
Subjects must have documented diagnosis of multiple myeloma and have measurable disease
boolean
C1301725 (UMLS CUI 2011AA)
397934002 (SNOMED CT 2011_0131)
C0011900 (UMLS CUI 2011AA)
439401001 (SNOMED CT 2011_0131)
MTHU008876 (LOINC Version 232)
C0026764 (UMLS CUI 2011AA)
109989006 (SNOMED CT 2011_0131)
10028228 (MedDRA 14.1)
C90.0 (ICD-10-CM Version 2010)
203.0 (ICD-9-CM Version 2011)
C1513041 (UMLS CUI 2011AA)
Subjects must have undergone prior treatment with >= 2 treatment lines of anti-myeloma therapy
Item
Subjects must have undergone prior treatment with >= 2 treatment lines of anti-myeloma therapy
boolean
C1514756 (UMLS CUI 2011AA)
C1514463 (UMLS CUI 2011AA)
C0521124 (UMLS CUI 2011AA)
65897001 (SNOMED CT 2011_0131)
Subjects must have either refractory or relapsed and refractory disease defined as documented disease progression during or within 60 days of completing their last myeloma therapy
Item
Subjects must have either refractory or relapsed and refractory disease defined as documented disease progression during or within 60 days of completing their last myeloma therapy
boolean
C1514815 (UMLS CUI 2011AA)
C0277556 (UMLS CUI 2011AA)
58184002 (SNOMED CT 2011_0131)
C1301725 (UMLS CUI 2011AA)
397934002 (SNOMED CT 2011_0131)
C1947901 (UMLS CUI 2011AA)
All subjects must have received at least 2 consecutive cycles of prior treatment that included lenalidomide and bortezomib
Item
All subjects must have received at least 2 consecutive cycles of prior treatment that included lenalidomide and bortezomib
boolean
C1514756 (UMLS CUI 2011AA)
C1707491 (UMLS CUI 2011AA)
C0439596 (UMLS CUI 2011AA)
44180009 (SNOMED CT 2011_0131)
C1514463 (UMLS CUI 2011AA)
C1144149 (UMLS CUI 2011AA)
421471009 (SNOMED CT 2011_0131)
C1176309 (UMLS CUI 2011AA)
407097007 (SNOMED CT 2011_0131)
All subjects must have failed treatment with both lenalidomide and bortezomib in one of the following ways:
Item
All subjects must have failed treatment with both lenalidomide and bortezomib in one of the following ways:
boolean
C0162643 (UMLS CUI 2011AA)
10066901 (MedDRA 14.1)
C1144149 (UMLS CUI 2011AA)
421471009 (SNOMED CT 2011_0131)
C1176309 (UMLS CUI 2011AA)
407097007 (SNOMED CT 2011_0131)
1) Documented progressive disease on or within 60 days of completing treatment with lenalidomide and/or bortezomib, or
Item
1) Documented progressive disease on or within 60 days of completing treatment with lenalidomide and/or bortezomib, or
boolean
C1301725 (UMLS CUI 2011AA)
397934002 (SNOMED CT 2011_0131)
C1335499 (UMLS CUI 2011AA)
2) In case of prior response [>= partial response (PR)] to lenalidomide or bortezomib, subjects must have relapsed within 6 months after stopping treatment with lenalidomide and/or bortezomib-containing regimens, or
Item
2) In case of prior response [>= partial response (PR)] to lenalidomide or bortezomib, subjects must have relapsed within 6 months after stopping treatment with lenalidomide and/or bortezomib-containing regimens, or
boolean
C0277556 (UMLS CUI 2011AA)
58184002 (SNOMED CT 2011_0131)
C0750557 (UMLS CUI 2011AA)
C0439091 (UMLS CUI 2011AA)
276138003 (SNOMED CT 2011_0131)
GE (HL7 V3 2006_05)
C1521726 (UMLS CUI 2011AA)
103337004 (SNOMED CT 2011_0131)
3) Subjects who have not had a >= minimal response (MR) and have developed intolerance/toxicity after a minimum of two cycles of lenalidomide
Item
3) Subjects who have not had a >= minimal response (MR) and have developed intolerance/toxicity after a minimum of two cycles of lenalidomide
boolean
C1511795 (UMLS CUI 2011AA)
C1744706 (UMLS CUI 2011AA)
C0600688 (UMLS CUI 2011AA)
75478009 (SNOMED CT 2011_0131)
C1518422 (UMLS CUI 2011AA)
C0439091 (UMLS CUI 2011AA)
276138003 (SNOMED CT 2011_0131)
GE (HL7 V3 2006_05)
C0547040 (UMLS CUI 2011AA)
255605001 (SNOMED CT 2011_0131)
C0521982 (UMLS CUI 2011AA)
182985004 (SNOMED CT 2011_0131)
Patients must have received adequate prior alkylator therapy
Item
Patients must have received adequate prior alkylator therapy
boolean
C0027552 (UMLS CUI 2011AA)
410525008 (SNOMED CT 2011_0131)
C0205411 (UMLS CUI 2011AA)
88323005 (SNOMED CT 2011_0131)
C1514463 (UMLS CUI 2011AA)
C0002073 (UMLS CUI 2011AA)
372669002 (SNOMED CT 2011_0131)
Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1, or 2
Item
Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1, or 2
boolean
C1520224 (UMLS CUI 2011AA)
Females of childbearing potential (FCBP) must not become pregnant for 28 days prior to initiation of study drug, during the study, and for 28 days after discontinuation
Item
Females of childbearing potential (FCBP) must not become pregnant for 28 days prior to initiation of study drug, during the study, and for 28 days after discontinuation
boolean
C0015780 (UMLS CUI 2011AA)
248152002 (SNOMED CT 2011_0131)
F (HL7 V3 2006_05)
C1148523 (UMLS CUI 2011AA)
C0237399 (UMLS CUI 2011AA)
C0027552 (UMLS CUI 2011AA)
410525008 (SNOMED CT 2011_0131)
C0232973 (UMLS CUI 2011AA)
60001007 (SNOMED CT 2011_0131)
Females must agree to abstain from breastfeeding during study participation and 28 days after study drug discontinuation
Item
Females must agree to abstain from breastfeeding during study participation and 28 days after study drug discontinuation
boolean
C0015780 (UMLS CUI 2011AA)
248152002 (SNOMED CT 2011_0131)
F (HL7 V3 2006_05)
C0680240 (UMLS CUI 2011AA)
C0006147 (UMLS CUI 2011AA)
10006247 (MedDRA 14.1)
Males must agree to use a latex condom during any sexual during the study and for 28 days following discontinuation from this study
Item
Males must agree to use a latex condom during any sexual during the study and for 28 days following discontinuation from this study
boolean
C0024554 (UMLS CUI 2011AA)
248153007 (SNOMED CT 2011_0131)
M (HL7 V3 2006_05)
C0680240 (UMLS CUI 2011AA)
C1524063 (UMLS CUI 2011AA)
260676000 (SNOMED CT 2011_0131)
C0023115 (UMLS CUI 2011AA)
400664008 (SNOMED CT 2011_0131)
C0677582 (UMLS CUI 2011AA)
Males must also agree to refrain from donating semen or sperm while on pomalidomide and for 28 days after discontinuation from this study
Item
Males must also agree to refrain from donating semen or sperm while on pomalidomide and for 28 days after discontinuation from this study
boolean
C0024554 (UMLS CUI 2011AA)
248153007 (SNOMED CT 2011_0131)
M (HL7 V3 2006_05)
C0680240 (UMLS CUI 2011AA)
C0870186 (UMLS CUI 2011AA)
C2756969 (UMLS CUI 2011AA)
6993007 (SNOMED CT 2011_0131)
MTHU001953 (LOINC Version 232)
C0680854 (UMLS CUI 2011AA)
C0871414 (UMLS CUI 2011AA)
10053369 (MedDRA 14.1)
C0347984 (UMLS CUI 2011AA)
371881003 (SNOMED CT 2011_0131)
C1512806 (UMLS CUI 2011AA)
C2347624 (UMLS CUI 2011AA)
Item Group
Exclusion Criteria
Any of the following laboratory abnormalities:
Item
Any of the following laboratory abnormalities:
boolean
C0332282 (UMLS CUI 2011AA)
255260001 (SNOMED CT 2011_0131)
C0438215 (UMLS CUI 2011AA)
165346000 (SNOMED CT 2011_0131)
10023547 (MedDRA 14.1)
Absolute neutrophil count (ANC) < 1,000/microL
Item
Absolute Neutrophil Count
boolean
C0948762 (UMLS CUI 2011AA)
10052033 (MedDRA 14.1)
Platelet count < 75,000/microL for subjects in whom < 50% of bone marrow nucleated cells are plasma cells
Item
Platelet count < 75,000/microL for subjects in whom < 50% of bone marrow nucleated cells are plasma cells
boolean
C1287267 (UMLS CUI 2011AA)
Creatinine Clearance < 45 mL/min
Item
Creatinine clearance (CrCl) measurement
boolean
C0373595 (UMLS CUI 2011AA)
167181009 (SNOMED CT 2011_0131)
10011371 (MedDRA 14.1)
Corrected serum calcium > 14 mg/dL
Item
Corrected Serum Calcium Measurement
boolean
C0455288 (UMLS CUI 2011AA)
166708003 (SNOMED CT 2011_0131)
Hemoglobin <= 8 g/dL
Item
Hemoglobin
boolean
C0518015 (UMLS CUI 2011AA)
38082009 (SNOMED CT 2011_0131)
10019481 (MedDRA 14.1)
LP14449-0 (LOINC Version 232)
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)
Item
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)
boolean
C0004002 (UMLS CUI 2011AA)
26091008 (SNOMED CT 2011_0131)
MTHU004883 (LOINC Version 232)
C0001899 (UMLS CUI 2011AA)
56935002 (SNOMED CT 2011_0131)
MTHU006766 (LOINC Version 232)
C1519815 (UMLS CUI 2011AA)
Serum total bilirubin > 2.0 mg/dL
Item
Serum Total Bilirubin Measurement
boolean
C1278039 (UMLS CUI 2011AA)
313840000 (SNOMED CT 2011_0131)
10040162 (MedDRA 14.1)
Previous therapy with Pomalidomide
Item
Previous therapy with Pomalidomide
boolean
C1514463 (UMLS CUI 2011AA)
C2347624 (UMLS CUI 2011AA)
Hypersensitivity to thalidomide, lenalidomide, or dexamethasone
Item
Hypersensitivity to thalidomide, lenalidomide, or dexamethasone
boolean
C0020517 (UMLS CUI 2011AA)
418634005 (SNOMED CT 2011_0131)
T78.40 (ICD-10-CM Version 2010)
C0039736 (UMLS CUI 2011AA)
78702007 (SNOMED CT 2011_0131)
C1144149 (UMLS CUI 2011AA)
421471009 (SNOMED CT 2011_0131)
C0011777 (UMLS CUI 2011AA)
372584003 (SNOMED CT 2011_0131)
MTHU004621 (LOINC Version 232)
Resistance to high-dose dexamethasone used in the last line of therapy
Item
Resistance to high-dose dexamethasone used in the last line of therapy
boolean
C1514892 (UMLS CUI 2011AA)
C0444956 (UMLS CUI 2011AA)
261829003 (SNOMED CT 2011_0131)
C0011777 (UMLS CUI 2011AA)
372584003 (SNOMED CT 2011_0131)
MTHU004621 (LOINC Version 232)
Peripheral neuropathy >= Grade 2
Item
Peripheral neuropathy >= Grade 2
boolean
C0031117 (UMLS CUI 2011AA)
10029331 (MedDRA 14.1)
G64 (ICD-10-CM Version 2010)
350-359.99 (ICD-9-CM Version 2011)
258349007 (SNOMED CT 2011_0131)
MTHU003112 (LOINC Version 232)
Subjects who received an allogeneic bone marrow or allogeneic peripheral blood stem cell transplant
Item
Subjects who received an allogeneic bone marrow or allogeneic peripheral blood stem cell transplant
boolean
C0149615 (UMLS CUI 2011AA)
Subjects who are planning for or who are eligible for stem cell transplant
Item
Subjects who are planning for or who are eligible for stem cell transplant
boolean
C1301732 (UMLS CUI 2011AA)
397943006 (SNOMED CT 2011_0131)
C1548635 (UMLS CUI 2011AA)
ELG (HL7 V3 2006_05)
C1504389 (UMLS CUI 2011AA)
10063581 (MedDRA 14.1)
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
Item
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
boolean
C0018802 (UMLS CUI 2011AA)
42343007 (SNOMED CT 2011_0131)
10007559 (MedDRA 14.1)
MTHU020787 (LOINC Version 232)
I50.9 (ICD-10-CM Version 2010)
428.0 (ICD-9-CM Version 2011)
C0027051 (UMLS CUI 2011AA)
22298006 (SNOMED CT 2011_0131)
10028596 (MedDRA 14.1)
MTHU035551 (LOINC Version 232)
I21-I22 (ICD-10-CM Version 2010)
410 (ICD-9-CM Version 2011)
E10152 (CTCAE 1105E)
C0002965 (UMLS CUI 2011AA)
4557003 (SNOMED CT 2011_0131)
10002388 (MedDRA 14.1)
I20.0 (ICD-10-CM Version 2010)
411.1 (ICD-9-CM Version 2011)
C0205169 (UMLS CUI 2011AA)
556001 (SNOMED CT 2011_0131)
C2587213 (UMLS CUI 2011AA)
31509003 (SNOMED CT 2011_0131)
C0002962 (UMLS CUI 2011AA)
194828000 (SNOMED CT 2011_0131)
10002383 (MedDRA 14.1)
I20 (ICD-10-CM Version 2010)
413 (ICD-9-CM Version 2011)
C0002963 (UMLS CUI 2011AA)
87343002 (SNOMED CT 2011_0131)
10036759 (MedDRA 14.1)
I20.1 (ICD-10-CM Version 2010)
413.1 (ICD-9-CM Version 2011)
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
Item
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
boolean
C1514756 (UMLS CUI 2011AA)
C0032134 (UMLS CUI 2011AA)
20720000 (SNOMED CT 2011_0131)
10035486 (MedDRA 14.1)
99.71 (ICD-9-CM Version 2011)
C0679637 (UMLS CUI 2011AA)
C0034619 (UMLS CUI 2011AA)
C0521124 (UMLS CUI 2011AA)
65897001 (SNOMED CT 2011_0131)
Use of any investigational agents within 28 days or 5 half-lives (whichever is longer) of treatment
Item
Use of any investigational agents within 28 days or 5 half-lives (whichever is longer) of treatment
boolean
C1524063 (UMLS CUI 2011AA)
260676000 (SNOMED CT 2011_0131)
C0013230 (UMLS CUI 2011AA)
Subjects with conditions requiring chronic steroid or immunosuppressive treatment
Item
Subjects with conditions requiring chronic steroid or immunosuppressive treatment
boolean
C0348080 (UMLS CUI 2011AA)
260905004 (SNOMED CT 2011_0131)
COND (HL7 V3 2006_05)
C1514873 (UMLS CUI 2011AA)
C0205191 (UMLS CUI 2011AA)
90734009 (SNOMED CT 2011_0131)
C0149783 (UMLS CUI 2011AA)
297279009 (SNOMED CT 2011_0131)
10062117 (MedDRA 14.1)
C0021079 (UMLS CUI 2011AA)
86553008 (SNOMED CT 2011_0131)
Any condition including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study
Item
Any condition including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study
boolean
C0348080 (UMLS CUI 2011AA)
260905004 (SNOMED CT 2011_0131)
COND (HL7 V3 2006_05)
C0438215 (UMLS CUI 2011AA)
165346000 (SNOMED CT 2011_0131)
10023547 (MedDRA 14.1)
C0678227 (UMLS CUI 2011AA)
23981006 (SNOMED CT 2011_0131)
C1883420 (UMLS CUI 2011AA)
C0035647 (UMLS CUI 2011AA)
30207005 (SNOMED CT 2011_0131)
RSK (HL7 V3 2006_05)
C2348568 (UMLS CUI 2011AA)
Incidence of gastrointestinal disease that may significantly alter the absorption of pomalidomide
Item
Incidence of gastrointestinal disease that may significantly alter the absorption of pomalidomide
boolean
C0021149 (UMLS CUI 2011AA)
C0017178 (UMLS CUI 2011AA)
119292006 (SNOMED CT 2011_0131)
10017944 (MedDRA 14.1)
C0750502 (UMLS CUI 2011AA)
386134007 (SNOMED CT 2011_0131)
C1515926 (UMLS CUI 2011AA)
C0000854 (UMLS CUI 2011AA)
C2347624 (UMLS CUI 2011AA)
Subjects unable or unwilling to undergo antithrombotic prophylactic treatment
Item
Subjects unable or unwilling to undergo antithrombotic prophylactic treatment
boolean
C1299582 (UMLS CUI 2011AA)
371151008 (SNOMED CT 2011_0131)
C0558080 (UMLS CUI 2011AA)
225465005 (SNOMED CT 2011_0131)
C1514756 (UMLS CUI 2011AA)
C0445202 (UMLS CUI 2011AA)
262073000 (SNOMED CT 2011_0131)
10036893 (MedDRA 14.1)
C1704311 (UMLS CUI 2011AA)
C0039798 (UMLS CUI 2011AA)
Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subjects from signing the informed consent form
Item
Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subjects from signing the informed consent form
boolean
C1699700 (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)
Pregnant or breastfeeding females
Item
Pregnant or breastfeeding females
boolean
C0549206 (UMLS CUI 2011AA)
10036586 (MedDRA 14.1)
C0006147 (UMLS CUI 2011AA)
10006247 (MedDRA 14.1)
C0015780 (UMLS CUI 2011AA)
248152002 (SNOMED CT 2011_0131)
F (HL7 V3 2006_05)
Known Human Immunodeficiency Virus (HIV) positivity or active infectious hepatitis A, B or C
Item
Known Human Immunodeficiency Virus (HIV) positivity or active infectious hepatitis A, B or C
boolean
C0019699 (UMLS CUI 2011AA)
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)
C0019163 (UMLS CUI 2011AA)
66071002 (SNOMED CT 2011_0131)
10019731 (MedDRA 14.1)
C0019196 (UMLS CUI 2011AA)
50711007 (SNOMED CT 2011_0131)
10019744 (MedDRA 14.1)
B19.20 (ICD-10-CM Version 2010)
070.7 (ICD-9-CM Version 2011)
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