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)
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)