age at least 18 Years
Item
age at least 18 Years
boolean
C0001779 (UMLS CUI 2011AA)
397669002 (SNOMED CT 2011_0131)
Subjects with refractory or relapsed and refractory multiple myeloma who were enrolled in Study CC-4047-MM-003 and discontinued study therapy with dexamethasone alone after disease progression.
Item
Subjects with refractory or relapsed and refractory multiple myeloma who were enrolled in Study CC-4047-MM-003 and discontinued study therapy with dexamethasone alone after disease progression.
boolean
C0277556 (UMLS CUI 2011AA)
58184002 (SNOMED CT 2011_0131)
CL388335 (UMLS CUI 2011AA)
C0011900 (UMLS CUI 2011AA)
439401001 (SNOMED CT 2011_0131)
MTHU008876 (LOINC Version 232)
C1516879 (UMLS CUI 2011AA)
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C0008976 (UMLS CUI 2011AA)
110465008 (SNOMED CT 2011_0131)
C1947901 (UMLS CUI 2011AA)
C1444662 (UMLS CUI 2011AA)
410546004 (SNOMED CT 2011_0131)
C0011777 (UMLS CUI 2011AA)
372584003 (SNOMED CT 2011_0131)
MTHU004621 (LOINC Version 232)
C0039798 (UMLS CUI 2011AA)
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)
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 discontinuation.
Item
Females must agree to abstain from breastfeeding during study participation and 28 days after study discontinuation.
boolean
C0015780 (UMLS CUI 2011AA)
248152002 (SNOMED CT 2011_0131)
F (HL7 V3 2006_05)
C0680240 (UMLS CUI 2011AA)
CL068143 (UMLS CUI 2011AA)
C0006147 (UMLS CUI 2011AA)
10006247 (MedDRA 14.1)
Males must agree to use a latex condom during any sexual contact during the study and for 28 days following discontinuation from this study
Item
Males must agree to use a latex condom during any sexual contact 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)
Subjects with multiple myeloma who were not treated as a part of Study CC-4047-MM-003 (high dose dexamethasone).
Item
Subjects with multiple myeloma who were not treated as a part of Study CC-4047-MM-003 (high dose dexamethasone).
boolean
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)
C1518422 (UMLS CUI 2011AA)
CL415147 (UMLS CUI 2011AA)
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C0008976 (UMLS CUI 2011AA)
110465008 (SNOMED CT 2011_0131)
C0444956 (UMLS CUI 2011AA)
261829003 (SNOMED CT 2011_0131)
C0011777 (UMLS CUI 2011AA)
372584003 (SNOMED CT 2011_0131)
MTHU004621 (LOINC Version 232)
Subjects who received any treatments (steroids, anti-myeloma, or anti-cancer therapy) within the last 14 days before initiation of study treatment.
Item
Subjects who received any treatments (steroids, anti-myeloma, or anti-cancer therapy) within the last 14 days before initiation of study treatment.
boolean
C0332185 (UMLS CUI 2011AA)
6493001 (SNOMED CT 2011_0131)
C0149783 (UMLS CUI 2011AA)
297279009 (SNOMED CT 2011_0131)
10062117 (MedDRA 14.1)
C0920425 (UMLS CUI 2011AA)
C0039798 (UMLS CUI 2011AA)
C0521124 (UMLS CUI 2011AA)
65897001 (SNOMED CT 2011_0131)
CL324441 (UMLS CUI 2011AA)
Subjects who discontinued CC-4047-MM-003 study ≥120 days.
Item
Subjects who discontinued CC-4047-MM-003 study ≥120 days.
boolean
C0457454 (UMLS CUI 2011AA)
278308006 (SNOMED CT 2011_0131)
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C0008976 (UMLS CUI 2011AA)
110465008 (SNOMED CT 2011_0131)
C0439093 (UMLS CUI 2011AA)
276140008 (SNOMED CT 2011_0131)
GT (HL7 V3 2006_05)
C0205450 (UMLS CUI 2011AA)
9362000 (SNOMED CT 2011_0131)
C0439231 (UMLS CUI 2011AA)
258706009 (SNOMED CT 2011_0131)
MO (HL7 V3 2006_05)
Subjects who initiate another anti-myeloma therapy from the time of disease progression on study CC-4047-MM-003 to the time of treatment initiation in the companion study.
Item
Subjects who initiate another anti-myeloma therapy from the time of disease progression on study CC-4047-MM-003 to the time of treatment initiation in the companion study.
boolean
C1704686 (UMLS CUI 2011AA)
C0205394 (UMLS CUI 2011AA)
74964007 (SNOMED CT 2011_0131)
C0039798 (UMLS CUI 2011AA)
C0521124 (UMLS CUI 2011AA)
65897001 (SNOMED CT 2011_0131)
CL324441 (UMLS CUI 2011AA)
Any of the following laboratory abnormalities:
Item
Abnormal Laboratory Test Result
boolean
C0438215 (UMLS CUI 2011AA)
165346000 (SNOMED CT 2011_0131)
10023547 (MedDRA 14.1)
Absolute neutrophil count (ANC) <1,000/μL
Item
Absolute Neutrophil Count
boolean
C0948762 (UMLS CUI 2011AA)
10052033 (MedDRA 14.1)
Platelet count < 75,000/uL for subjects in whom < 50% of bone marrow nucleated cells are plasma cells, or a platelet count < 30,000/uL for subjects in whom >= 50% of bone marrow nucleated cells are plasma cells
Item
Platelet count < 75,000/μL for subjects in whom < 50% of bone marrow nucleated cells are plasma cells, or a platelet count < 30,000/uL 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 Hemoglobin ≤ 8 g/dL
Item
Corrected serum calcium > 14 mg/dL Hemoglobin ≤ 8 g/dL
boolean
C0455288 (UMLS CUI 2011AA)
166708003 (SNOMED CT 2011_0131)
C0019046 (UMLS CUI 2011AA)
38082009 (SNOMED CT 2011_0131)
10019481 (MedDRA 14.1)
LP14449-0 (LOINC Version 232)
SGOT/AST or SGPT/ALT > 3.0 x upper limit of normal (ULN)
Item
SGOT/AST or SGPT/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)
Prior history of malignancies, other than MM, unless the subject has been free of the disease for ≥ 3 years.
Item
Prior history of malignancies, other than MM, unless the subject has been free of the disease for ≥ 3 years.
boolean
C2735088 (UMLS CUI 2011AA)
MTHU034770 (LOINC Version 232)
CL411789 (UMLS CUI 2011AA)
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)
C1554961 (UMLS CUI 2011AA)
E (HL7 V3 2006_05)
C2004454 (UMLS CUI 2011AA)
C0439091 (UMLS CUI 2011AA)
276138003 (SNOMED CT 2011_0131)
GE (HL7 V3 2006_05)
C0205449 (UMLS CUI 2011AA)
421291004 (SNOMED CT 2011_0131)
C0439234 (UMLS CUI 2011AA)
258707000 (SNOMED CT 2011_0131)
Y (HL7 V3 2006_05)
Hypersensitivity to thalidomide or lenalidomide
Item
Hypersensitivity to thalidomide or lenalidomide
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)
Peripheral neuropathy ≥ Grade 2.
Item
Peripheral neuropathy ≥ Grade 2.
boolean
C0031117 (UMLS CUI 2011AA)
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
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
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)
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 chronic conditions such as rheumatoid arthritis, multiple sclerosis and lupus.
Item
Subjects with chronic conditions such as rheumatoid arthritis, multiple sclerosis and lupus.
boolean
C0205191 (UMLS CUI 2011AA)
90734009 (SNOMED CT 2011_0131)
C0348080 (UMLS CUI 2011AA)
260905004 (SNOMED CT 2011_0131)
COND (HL7 V3 2006_05)
C0003873 (UMLS CUI 2011AA)
69896004 (SNOMED CT 2011_0131)
10039073 (MedDRA 14.1)
M06.9 (ICD-10-CM Version 2010)
714.0 (ICD-9-CM Version 2011)
C0026769 (UMLS CUI 2011AA)
24700007 (SNOMED CT 2011_0131)
10028245 (MedDRA 14.1)
MTHU020805 (LOINC Version 232)
G35 (ICD-10-CM Version 2010)
340 (ICD-9-CM Version 2011)
C0409974 (UMLS CUI 2011AA)
200936003 (SNOMED CT 2011_0131)
10025134 (MedDRA 14.1)
L93 (ICD-10-CM Version 2010)
695.4 (ICD-9-CM Version 2011)
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 subject from signing the informed consent form.
Item
Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject 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)
CL414898 (UMLS CUI 2011AA)
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)