age at least 18 Years
Item
Alter mindestens 18 Jahre
boolean
C0001779 (UMLS CUI 2011AA)
397669002 (SNOMED CT 2011_0131)
Understand and voluntarily sign an informed consent form.
Item
Understand and voluntarily sign an informed consent form.
boolean
C0021430 (UMLS CUI 2011AA)
Able to adhere to the study visit schedule and other protocol requirements.
Item
Able to adhere to the study visit schedule and other protocol requirements.
boolean
C0085732 (UMLS CUI 2011AA)
371150009 (SNOMED CT 2011_0131)
C1321605 (UMLS CUI 2011AA)
405078008 (SNOMED CT 2011_0131)
C1709747 (UMLS CUI 2011AA)
Previously diagnosed with multiple myeloma based on standard criteria and requires therapy for primary refractory disease or 1st - 3rd relapse because of progressive disease (PD), defined as a 25% increase in M-protein, development of new or worsening of existing lytic bone lesions or soft tissue plasmacytoma, or hypercalcemia (serum calcium > 11.3 mg/dL), or clinical relapse from CR.
Item
Previously diagnosed with multiple myeloma based on standard criteria and requires therapy for primary refractory disease or 1st - 3rd relapse because of progressive disease (PD), defined as a 25% increase in M-protein, development of new or worsening of existing lytic bone lesions or soft tissue plasmacytoma, or hypercalcemia (serum calcium > 11.3 mg/dL), or clinical relapse from CR.
boolean
C0332132 (UMLS CUI 2011AA)
48318009 (SNOMED CT 2011_0131)
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)
C1514873 (UMLS CUI 2011AA)
C0039798 (UMLS CUI 2011AA)
C1514815 (UMLS CUI 2011AA)
C0277556 (UMLS CUI 2011AA)
58184002 (SNOMED CT 2011_0131)
C1335499 (UMLS CUI 2011AA)
C0205217 (UMLS CUI 2011AA)
U (HL7 V3 2006_05)
C0065450 (UMLS CUI 2011AA)
C0741592 (UMLS CUI 2011AA)
C0225317 (UMLS CUI 2011AA)
87784001 (SNOMED CT 2011_0131)
MTHU016974 (LOINC Version 232)
C0032131 (UMLS CUI 2011AA)
10639003 (SNOMED CT 2011_0131)
10035484 (MedDRA 14.1)
C90.3 (ICD-10-CM Version 2010)
C0020437 (UMLS CUI 2011AA)
66931009 (SNOMED CT 2011_0131)
10020583 (MedDRA 14.1)
E83.52 (ICD-10-CM Version 2010)
275.42 (ICD-9-CM Version 2011)
E12270 (CTCAE 1105E)
C0595928 (UMLS CUI 2011AA)
10006965 (SNOMED CT 2011_0131)
C2347944 (UMLS CUI 2011AA)
At least one measurable disease manifestation defined as follows:
Item
At least one measurable disease manifestation defined as follows:
boolean
C1513041 (UMLS CUI 2011AA)
C0205319 (UMLS CUI 2011AA)
250255003 (SNOMED CT 2011_0131)
C1704788 (UMLS CUI 2011AA)
C0332282 (UMLS CUI 2011AA)
255260001 (SNOMED CT 2011_0131)
For secretory multiple myeloma, measurable disease is defined as any quantifiable serum monoclonal protein value (generally, but not exclusively, > 1g/dL IgG M-protein or > 0.5 g/dL IgA) and, where applicable, urine light-chain excretion of >= 200 mg/24 h.
Item
For secretory multiple myeloma, measurable disease is defined as any quantifiable serum monoclonal protein value (generally, but not exclusively, > 1g/dL IgG M-protein or > 0.5 g/dL IgA) and, where applicable, urine light-chain excretion of >= 200 mg/24 h.
boolean
C0036536 (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)
C0241988 (UMLS CUI 2011AA)
414763006 (SNOMED CT 2011_0131)
C0020852 (UMLS CUI 2011AA)
29246005 (SNOMED CT 2011_0131)
MTHU005225 (LOINC Version 232)
C0020835 (UMLS CUI 2011AA)
46046006 (SNOMED CT 2011_0131)
MTHU005223 (LOINC Version 232)
C0065450 (UMLS CUI 2011AA)
C1445962 (UMLS CUI 2011AA)
412813009 (SNOMED CT 2011_0131)
For oligo- or non-secretory multiple myeloma, measurable disease is defined by the presence of soft tissue (not bone) plasmacytomas as determined by clinical examination or applicable radiographs (i.e. MRI, CT-Scan) or a quantifiable plasma cell infiltration of the bone marrow as determined by bone marrow biopsy.
Item
For oligo- or non-secretory multiple myeloma, measurable disease is defined by the presence of soft tissue (not bone) plasmacytomas as determined by clinical examination or applicable radiographs (i.e. MRI, CT-Scan) or a quantifiable plasma cell infiltration of the bone marrow as determined by bone marrow biopsy.
boolean
C0456845 (UMLS CUI 2011AA)
277580004 (SNOMED CT 2011_0131)
10029662 (MedDRA 14.1)
C0225317 (UMLS CUI 2011AA)
87784001 (SNOMED CT 2011_0131)
MTHU016974 (LOINC Version 232)
C0032131 (UMLS CUI 2011AA)
10639003 (SNOMED CT 2011_0131)
10035484 (MedDRA 14.1)
C90.3 (ICD-10-CM Version 2010)
C0521095 (UMLS CUI 2011AA)
436000 (SNOMED CT 2011_0131)
C0582103 (UMLS CUI 2011AA)
225886003 (SNOMED CT 2011_0131)
C0043299 (UMLS CUI 2011AA)
363680008 (SNOMED CT 2011_0131)
87 (ICD-9-CM Version 2011)
C0024485 (UMLS CUI 2011AA)
113091000 (SNOMED CT 2011_0131)
10028049 (MedDRA 14.1)
C0040405 (UMLS CUI 2011AA)
10011603 (MedDRA 14.1)
C0391861 (UMLS CUI 2011AA)
26246006 (SNOMED CT 2011_0131)
C0005954 (UMLS CUI 2011AA)
234326005 (SNOMED CT 2011_0131)
10004737 (MedDRA 14.1)
41.31 (ICD-9-CM Version 2011)
ECOG performance status <= 2 at time of randomization/registration (see Appendix I).
Item
ECOG performance status <= 2 at time of randomization/registration (see Appendix I).
boolean
C1828127 (UMLS CUI 2011AA)
424122007 (SNOMED CT 2011_0131)
C0439547 (UMLS CUI 2011AA)
272105005 (SNOMED CT 2011_0131)
C0034656 (UMLS CUI 2011AA)
Laboratory test results within these ranges within 1 week prior to randomization/registration:
Item
Laboratory test results within these ranges within 1 week prior to randomization/registration:
boolean
C0587081 (UMLS CUI 2011AA)
118246004 (SNOMED CT 2011_0131)
C0332285 (UMLS CUI 2011AA)
18720000 (SNOMED CT 2011_0131)
C0332282 (UMLS CUI 2011AA)
255260001 (SNOMED CT 2011_0131)
C1514721 (UMLS CUI 2011AA)
Absolute neutrophil count >= 1.5 x 109/L without the use of colony stimulating factors within 14 days before the laboratory test.
Item
Absolute neutrophil count >= 1.5 x 109/L without the use of colony stimulating factors within 14 days before the laboratory test.
boolean
C0948762 (UMLS CUI 2011AA)
10052033 (MedDRA 14.1)
C0445107 (UMLS CUI 2011AA)
262009000 (SNOMED CT 2011_0131)
C0009392 (UMLS CUI 2011AA)
372559001 (SNOMED CT 2011_0131)
Platelet count >= 75 x 109/L without transfusion support within 14 days before the laboratory test.
Item
Platelet count >= 75 x 109/L without transfusion support within 14 days before the laboratory test.
boolean
C1287267 (UMLS CUI 2011AA)
365632008 (SNOMED CT 2011_0131)
777-3 (LOINC Version 232)
C0332197 (UMLS CUI 2011AA)
2667000 (SNOMED CT 2011_0131)
C1879316 (UMLS CUI 2011AA)
5447007 (SNOMED CT 2011_0131)
10066152 (MedDRA 14.1)
C1521721 (UMLS CUI 2011AA)
Hemoglobin >= 7.5 g/dL (regardless of transfusion support or prior medication with erythropoietin).
Item
Hemoglobin >= 7.5 g/dL (regardless of transfusion support or prior medication with erythropoietin).
boolean
C0019046 (UMLS CUI 2011AA)
38082009 (SNOMED CT 2011_0131)
10019481 (MedDRA 14.1)
LP14449-0 (LOINC Version 232)
C0085862 (UMLS CUI 2011AA)
MTHU013536 (LOINC Version 232)
C1879316 (UMLS CUI 2011AA)
5447007 (SNOMED CT 2011_0131)
10066152 (MedDRA 14.1)
C1521721 (UMLS CUI 2011AA)
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C0014822 (UMLS CUI 2011AA)
111167001 (SNOMED CT 2011_0131)
MTHU004935 (LOINC Version 232)
Calculated creatinine clearance >= 50 mL/minute.
Item
Calculated creatinine clearance >= 50 mL/minute.
boolean
C0444686 (UMLS CUI 2011AA)
258090004 (SNOMED CT 2011_0131)
C0373595 (UMLS CUI 2011AA)
167181009 (SNOMED CT 2011_0131)
10011371 (MedDRA 14.1)
Total bilirubin <= 1.5 mg/dL.
Item
Gesamtbilirubin
boolean
C1278039 (UMLS CUI 2011AA)
359986008 (SNOMED CT 2011_0131)
10004696 (MedDRA 14.1)
AST (SGOT) and ALT (SGPT) <= 2,5 x ULN.
Item
AST (SGOT) and ALT (SGPT) <= 2,5 x 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)
Corrected serum calcium < 14 mg/dL (< 3.5 mmol/L).
Item
korrigiertes Serumkalzium
boolean
C0455288 (UMLS CUI 2011AA)
166708003 (SNOMED CT 2011_0131)
Female subjects of childbearing potential must:
Item
Female subjects of childbearing potential must:
boolean
C0086287 (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)
Understand that the study medication could have a potential teratogenic risk
Item
Understand that the study medication could have a potential teratogenic risk
boolean
C0162340 (UMLS CUI 2011AA)
66216009 (SNOMED CT 2011_0131)
C0304229 (UMLS CUI 2011AA)
902003 (SNOMED CT 2011_0131)
C0035647 (UMLS CUI 2011AA)
30207005 (SNOMED CT 2011_0131)
RSK (HL7 V3 2006_05)
C0232910 (UMLS CUI 2011AA)
58694006 (SNOMED CT 2011_0131)
10043275 (MedDRA 14.1)
Agree to use, and be able to comply with, effective contraception without interruption, 4 weeks before starting study drug, throughout study drug therapy (including dose interruptions) and for 4 weeks after the end of study drug therapy, even if she has amenorrhoea. This applies unless the subject commits to absolute and continued abstinence confirmed on a monthly basis. The following are effective methods of contraception:
Item
Agree to use, and be able to comply with, effective contraception without interruption, 4 weeks before starting study drug, throughout study drug therapy (including dose interruptions) and for 4 weeks after the end of study drug therapy, even if she has amenorrhoea. This applies unless the subject commits to absolute and continued abstinence confirmed on a monthly basis. The following are effective methods of contraception:
boolean
C0680240 (UMLS CUI 2011AA)
C1321605 (UMLS CUI 2011AA)
405078008 (SNOMED CT 2011_0131)
C0700589 (UMLS CUI 2011AA)
146680009 (SNOMED CT 2011_0131)
10010808 (MedDRA 14.1)
C1554961 (UMLS CUI 2011AA)
E (HL7 V3 2006_05)
C0680240 (UMLS CUI 2011AA)
C0205344 (UMLS CUI 2011AA)
56136002 (SNOMED CT 2011_0131)
C0549178 (UMLS CUI 2011AA)
C0036899 (UMLS CUI 2011AA)
47037006 (SNOMED CT 2011_0131)
10029805 (MedDRA 14.1)
Implant
Item
Contraceptive Implant
boolean
CL424925 (UMLS CUI 2011AA)
Levonorgestrel-releasing intrauterine system (IUS)
Item
INSERTION OF LEVONORGESTREL-RELEASING INTRAUTERINE SYSTEM
boolean
C0994146 (UMLS CUI 2011AA)
Medroxyprogesterone acetate depot
Item
Medroxyprogesterone acetate depot
boolean
C0065864 (UMLS CUI 2011AA)
27707001 (SNOMED CT 2011_0131)
C0419530 (UMLS CUI 2011AA)
268464009 (SNOMED CT 2011_0131)
Tubal sterilisation
Item
Tubensterilisation, Eileiterunterbindung
boolean
C0038289 (UMLS CUI 2011AA)
189234004 (SNOMED CT 2011_0131)
Sexual intercourse with a vasectomised male partner only. Vasectomy must be confirmed by two negative semen analyses
Item
Sexual intercourse with a vasectomised male partner only. Vasectomy must be confirmed by two negative semen analyses
boolean
C0009253 (UMLS CUI 2011AA)
258139002 (SNOMED CT 2011_0131)
C0205171 (UMLS CUI 2011AA)
50607009 (SNOMED CT 2011_0131)
C0420842 (UMLS CUI 2011AA)
268457007 (SNOMED CT 2011_0131)
C0042387 (UMLS CUI 2011AA)
22523008 (SNOMED CT 2011_0131)
10047133 (MedDRA 14.1)
63.73 (ICD-9-CM Version 2011)
C0750484 (UMLS CUI 2011AA)
CL415098 (UMLS CUI 2011AA)
C0202533 (UMLS CUI 2011AA)
11900001 (SNOMED CT 2011_0131)
10068482 (MedDRA 14.1)
Ovulation inhibitory progesterone-only pills (i.e., desogestrel).
Item
Ovulation inhibitory progesterone-only pills (i.e., desogestrel).
boolean
C0029968 (UMLS CUI 2011AA)
C0033308 (UMLS CUI 2011AA)
C0205171 (UMLS CUI 2011AA)
50607009 (SNOMED CT 2011_0131)
C0009905 (UMLS CUI 2011AA)
59261009 (SNOMED CT 2011_0131)
C0057558 (UMLS CUI 2011AA)
116074007 (SNOMED CT 2011_0131)
Combined oral contraceptive pills are not recommended. If a subject was using combined oral contraception, she must switch to one of the methods above. The increased risk of VTE continues for 4 to 6 weeks after stopping combined oral contraception
Item
Combined oral contraceptive pills are not recommended. If a subject was using combined oral contraception, she must switch to one of the methods above. The increased risk of VTE continues for 4 to 6 weeks after stopping combined oral contraception
boolean
C0009906 (UMLS CUI 2011AA)
346388008 (SNOMED CT 2011_0131)
C1518422 (UMLS CUI 2011AA)
C0034866 (UMLS CUI 2011AA)
MTHU036724 (LOINC Version 232)
RMD (HL7 V3 2006_05)
C0035647 (UMLS CUI 2011AA)
30207005 (SNOMED CT 2011_0131)
RSK (HL7 V3 2006_05)
C1861172 (UMLS CUI 2011AA)
10066899 (MedDRA 14.1)
Prophylactic antibiotics should be considered at the time of insertion particularly in patients with neutropenia due to risk of infection
Item
Prophylactic antibiotics should be considered at the time of insertion particularly in patients with neutropenia due to risk of infection
boolean
C0282638 (UMLS CUI 2011AA)
422181004 (SNOMED CT 2011_0131)
10064736 (MedDRA 14.1)
C0030705 (UMLS CUI 2011AA)
116154003 (SNOMED CT 2011_0131)
C0027947 (UMLS CUI 2011AA)
303011007 (SNOMED CT 2011_0131)
10029354 (MedDRA 14.1)
D70.9 (ICD-10-CM Version 2010)
288.00 (ICD-9-CM Version 2011)
C0582147 (UMLS CUI 2011AA)
78648007 (SNOMED CT 2011_0131)
MTHU013249 (LOINC Version 232)
Agree to have a medically supervised pregnancy test with a minimum sensitivity of 25 mIU/ml not more than 3 days from the start of study medication once the subject has been on effective contraception for at least 4 weeks. This requirement also applies to women of childbearing potential who practice complete and continued abstinence.
Item
Agree to have a medically supervised pregnancy test with a minimum sensitivity of 25 mIU/ml not more than 3 days from the start of study medication once the subject has been on effective contraception for at least 4 weeks. This requirement also applies to women of childbearing potential who practice complete and continued abstinence.
boolean
C0680240 (UMLS CUI 2011AA)
C0205476 (UMLS CUI 2011AA)
74188005 (SNOMED CT 2011_0131)
C0038842 (UMLS CUI 2011AA)
225313009 (SNOMED CT 2011_0131)
C0032976 (UMLS CUI 2011AA)
74036000 (SNOMED CT 2011_0131)
10036572 (MedDRA 14.1)
C1524031 (UMLS CUI 2011AA)
C0036667 (UMLS CUI 2011AA)
C0700589 (UMLS CUI 2011AA)
146680009 (SNOMED CT 2011_0131)
10010808 (MedDRA 14.1)
Agree to have a medically supervised pregnancy test every 4 weeks including 4 weeks after the end of study treatment, except in the case of confirmed tubal sterilization. These tests should be performed not more than 3 days before the start of next treatment. This requirement also applies to women of childbearing potential who practice complete and continued abstinence
Item
Agree to have a medically supervised pregnancy test every 4 weeks including 4 weeks after the end of study treatment, except in the case of confirmed tubal sterilization. These tests should be performed not more than 3 days before the start of next treatment. This requirement also applies to women of childbearing potential who practice complete and continued abstinence
boolean
C0680240 (UMLS CUI 2011AA)
C0205476 (UMLS CUI 2011AA)
74188005 (SNOMED CT 2011_0131)
C0038842 (UMLS CUI 2011AA)
225313009 (SNOMED CT 2011_0131)
C0032976 (UMLS CUI 2011AA)
74036000 (SNOMED CT 2011_0131)
10036572 (MedDRA 14.1)
C1275555 (UMLS CUI 2011AA)
396134005 (SNOMED CT 2011_0131)
C1554961 (UMLS CUI 2011AA)
E (HL7 V3 2006_05)
C0038289 (UMLS CUI 2011AA)
189234004 (SNOMED CT 2011_0131)
Male subjects must
Item
Male subjects must
boolean
C0086582 (UMLS CUI 2011AA)
248153007 (SNOMED CT 2011_0131)
M (HL7 V3 2006_05)
C0681850 (UMLS CUI 2011AA)
C0027552 (UMLS CUI 2011AA)
410525008 (SNOMED CT 2011_0131)
Agree to use condoms throughout study drug therapy, during any dose interruption and for one week after cessation of study therapy if their partner is of childbearing potential and has no contraception.
Item
Agree to use condoms throughout study drug therapy, during any dose interruption and for one week after cessation of study therapy if their partner is of childbearing potential and has no contraception.
boolean
C0680240 (UMLS CUI 2011AA)
C1524063 (UMLS CUI 2011AA)
260676000 (SNOMED CT 2011_0131)
C0677582 (UMLS CUI 2011AA)
Agree not to donate semen during study drug therapy and for one week after end of study drug therapy.
Item
Agree not to donate semen during study drug therapy and for one week after end of study drug therapy.
boolean
C0680240 (UMLS CUI 2011AA)
C1518422 (UMLS CUI 2011AA)
C0871414 (UMLS CUI 2011AA)
10053369 (MedDRA 14.1)
All subjects must
Item
All subjects must
boolean
C0444868 (UMLS CUI 2011AA)
261675009 (SNOMED CT 2011_0131)
C0681850 (UMLS CUI 2011AA)
C0027552 (UMLS CUI 2011AA)
410525008 (SNOMED CT 2011_0131)
Agree to abstain from donating blood while taking study drug therapy and for one week following discontinuation of study drug therapy.
Item
Agree to abstain from donating blood while taking study drug therapy and for one week following discontinuation of study drug therapy.
boolean
C0680240 (UMLS CUI 2011AA)
CL068143 (UMLS CUI 2011AA)
C0005794 (UMLS CUI 2011AA)
25179006 (SNOMED CT 2011_0131)
Agree not to share study medication with another person and to return all unused study drug to the investigator.
Item
Agree not to share study medication with another person and to return all unused study drug to the investigator.
boolean
C0680240 (UMLS CUI 2011AA)
C1518422 (UMLS CUI 2011AA)
CL415229 (UMLS CUI 2011AA)
C0304229 (UMLS CUI 2011AA)
902003 (SNOMED CT 2011_0131)
C0205394 (UMLS CUI 2011AA)
74964007 (SNOMED CT 2011_0131)
C0027361 (UMLS CUI 2011AA)
125676002 (SNOMED CT 2011_0131)
PSN (HL7 V3 2006_05)
CL415200 (UMLS CUI 2011AA)
C0445107 (UMLS CUI 2011AA)
262009000 (SNOMED CT 2011_0131)
C0304229 (UMLS CUI 2011AA)
902003 (SNOMED CT 2011_0131)
CL102947 (UMLS CUI 2011AA)
Disease free of prior malignancies for ≥ 5 years with exception of currently treated basal cell, squamous cell carcinoma of the skin, or carcinoma "in situ" of the cervix or breast
Item
Disease free of prior malignancies for ≥ 5 years with exception of currently treated basal cell, squamous cell carcinoma of the skin, or carcinoma "in situ" of the cervix or breast
boolean
C0012634 (UMLS CUI 2011AA)
64572001 (SNOMED CT 2011_0131)
C0332296 (UMLS CUI 2011AA)
37837009 (SNOMED CT 2011_0131)
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C0006826 (UMLS CUI 2011AA)
363346000 (SNOMED CT 2011_0131)
10028997 (MedDRA 14.1)
MTHU010328 (LOINC Version 232)
C00-C96 (ICD-10-CM Version 2010)
C1554961 (UMLS CUI 2011AA)
E (HL7 V3 2006_05)
CL415147 (UMLS CUI 2011AA)
C0007117 (UMLS CUI 2011AA)
1338007 (SNOMED CT 2011_0131)
10004146 (MedDRA 14.1)
C0553723 (UMLS CUI 2011AA)
254651007 (SNOMED CT 2011_0131)
10041834 (MedDRA 14.1)
C0851140 (UMLS CUI 2011AA)
92564006 (SNOMED CT 2011_0131)
10061809 (MedDRA 14.1)
D06.9 (ICD-10-CM Version 2010)
233.1 (ICD-9-CM Version 2011)
C0154084 (UMLS CUI 2011AA)
189336000 (SNOMED CT 2011_0131)
10006189 (MedDRA 14.1)
D05 (ICD-10-CM Version 2010)
233.0 (ICD-9-CM Version 2011)
Able and willing to take heparin (usually low-molecular weight - LMWH) or low acetylsalicylic acid (100 mg) daily as prophylactic anticoagulation.
Item
Able and willing to take heparin (usually low-molecular weight - LMWH) or low acetylsalicylic acid (100 mg) daily as prophylactic anticoagulation.
boolean
C0085732 (UMLS CUI 2011AA)
371150009 (SNOMED CT 2011_0131)
C0600109 (UMLS CUI 2011AA)
225466006 (SNOMED CT 2011_0131)
C1512806 (UMLS CUI 2011AA)
C0019134 (UMLS CUI 2011AA)
372877000 (SNOMED CT 2011_0131)
MTHU003766 (LOINC Version 232)
C0019139 (UMLS CUI 2011AA)
87233003 (SNOMED CT 2011_0131)
MTHU014939 (LOINC Version 232)
C0721444 (UMLS CUI 2011AA)
C0445202 (UMLS CUI 2011AA)
262073000 (SNOMED CT 2011_0131)
10036893 (MedDRA 14.1)
C0003281 (UMLS CUI 2011AA)
Life-expectancy > 3 months.
Item
Life-expectancy > 3 months.
boolean
C0023671 (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)
C2700409 (UMLS CUI 2011AA)
C2348583 (UMLS CUI 2011AA)
Females, who are pregnant, calculate to get pregnant or are breast feeding (Lactating females must agree not to breast feed while taking lenalidomide).
Item
Females, who are pregnant, calculate to get pregnant or are breast feeding (Lactating females must agree not to breast feed while taking lenalidomide).
boolean
C0086287 (UMLS CUI 2011AA)
248152002 (SNOMED CT 2011_0131)
F (HL7 V3 2006_05)
C0549206 (UMLS CUI 2011AA)
10036586 (MedDRA 14.1)
C0032992 (UMLS CUI 2011AA)
169565003 (SNOMED CT 2011_0131)
C0006147 (UMLS CUI 2011AA)
10006247 (MedDRA 14.1)
Any condition, including the presence of laboratory abnormalities, which places the subject at an unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study.
Item
Any condition, including the presence of laboratory abnormalities, which places the subject at an unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from 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)
C1883420 (UMLS CUI 2011AA)
C0035647 (UMLS CUI 2011AA)
30207005 (SNOMED CT 2011_0131)
RSK (HL7 V3 2006_05)
C2348568 (UMLS CUI 2011AA)
C0521102 (UMLS CUI 2011AA)
78235001 (SNOMED CT 2011_0131)
C0085732 (UMLS CUI 2011AA)
371150009 (SNOMED CT 2011_0131)
C0459471 (UMLS CUI 2011AA)
280452008 (SNOMED CT 2011_0131)
MTHU003869 (LOINC Version 232)
C0681873 (UMLS CUI 2011AA)
Patient currently is enrolled in another clinical research study or has been enrolled in such a study within 4 weeks before randomization/registration and/or is receiving an investigational agent for any reason or has received such an agent within 4 weeks before randomization/registration.
Item
Patient currently is enrolled in another clinical research study or has been enrolled in such a study within 4 weeks before randomization/registration and/or is receiving an investigational agent for any reason or has received such an agent within 4 weeks before randomization/registration.
boolean
C1516879 (UMLS CUI 2011AA)
C0205394 (UMLS CUI 2011AA)
74964007 (SNOMED CT 2011_0131)
C0008976 (UMLS CUI 2011AA)
110465008 (SNOMED CT 2011_0131)
C1514756 (UMLS CUI 2011AA)
C0013230 (UMLS CUI 2011AA)
C0521116 (UMLS CUI 2011AA)
15240007 (SNOMED CT 2011_0131)
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C0034656 (UMLS CUI 2011AA)
Known hypersensitivity to thalidomide, dexamethasone, or cyclophosphamide or similar drugs.
Item
Known hypersensitivity to thalidomide, dexamethasone, or cyclophosphamide or similar drugs.
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)
C0011777 (UMLS CUI 2011AA)
372584003 (SNOMED CT 2011_0131)
MTHU004621 (LOINC Version 232)
C0010583 (UMLS CUI 2011AA)
387420009 (SNOMED CT 2011_0131)
MTHU029970 (LOINC Version 232)
Any prior use of lenalidomide.
Item
Any prior use of lenalidomide.
boolean
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C1524063 (UMLS CUI 2011AA)
260676000 (SNOMED CT 2011_0131)
C1144149 (UMLS CUI 2011AA)
421471009 (SNOMED CT 2011_0131)
Concurrent use of other anti-cancer agents or treatments.
Item
Concurrent use of other anti-cancer agents or treatments.
boolean
C0205420 (UMLS CUI 2011AA)
68405009 (SNOMED CT 2011_0131)
C1524063 (UMLS CUI 2011AA)
260676000 (SNOMED CT 2011_0131)
C0205394 (UMLS CUI 2011AA)
74964007 (SNOMED CT 2011_0131)
C0003392 (UMLS CUI 2011AA)
372688009 (SNOMED CT 2011_0131)
C0920425 (UMLS CUI 2011AA)
Known positive for HIV or infectious hepatitis, type A, B or C.
Item
Known positive for HIV or infectious hepatitis, type A, B or C.
boolean
C0019699 (UMLS CUI 2011AA)
165816005 (SNOMED CT 2011_0131)
10020188 (MedDRA 14.1)
Z21 (ICD-10-CM Version 2010)
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)
Any other chemotherapy or high-dose dexamethasone within 4 weeks before randomization/registration.
Item
Any other chemotherapy or high-dose dexamethasone within 4 weeks before randomization/registration.
boolean
C0205394 (UMLS CUI 2011AA)
74964007 (SNOMED CT 2011_0131)
C0392920 (UMLS CUI 2011AA)
150415003 (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)
Immunotherapy or antibody therapy within 8 weeks before randomization/registration.
Item
Immunotherapy or antibody therapy within 8 weeks before randomization/registration.
boolean
C0021083 (UMLS CUI 2011AA)
Major surgery within 4 weeks before randomization/registration.
Item
major surgery
boolean
C0679637 (UMLS CUI 2011AA)
Myocardial infarction within 6 months before randomization/registration, New York Heart Association Class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities.
Item
Myocardial infarction within 6 months before randomization/registration, New York Heart Association Class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities.
boolean
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)
C1319795 (UMLS CUI 2011AA)
420913000 (SNOMED CT 2011_0131)
10064081 (MedDRA 14.1)
C1319796 (UMLS CUI 2011AA)
422293003 (SNOMED CT 2011_0131)
10064082 (MedDRA 14.1)
C0018801 (UMLS CUI 2011AA)
155374007 (SNOMED CT 2011_0131)
10019279 (MedDRA 14.1)
428 (ICD-9-CM Version 2011)
E10124 (CTCAE 1105E)
C0205318 (UMLS CUI 2011AA)
19032002 (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)
C0085612 (UMLS CUI 2011AA)
44103008 (SNOMED CT 2011_0131)
10047281 (MedDRA 14.1)
I49.01 (ICD-10-CM Version 2010)
E10230 (CTCAE 1105E)
C1623258 (UMLS CUI 2011AA)
46825001 (SNOMED CT 2011_0131)
10014084 (MedDRA 14.1)
C0022116 (UMLS CUI 2011AA)
52674009 (SNOMED CT 2011_0131)
10061255 (MedDRA 14.1)
C0018796 (UMLS CUI 2011AA)
24964005 (SNOMED CT 2011_0131)
C1704258 (UMLS CUI 2011AA)
Cardiac amyloidosis.
Item
Senile cardiac amyloidosis, Cardiac amyloidosis, AS transthyretin amyloidosis
boolean
C0268407 (UMLS CUI 2011AA)
16573007 (SNOMED CT 2011_0131)
10007509 (MedDRA 14.1)
Poorly controlled hypertension, diabetes mellitus, or other serious medical or psychiatric illness that could potentially interfere with the completion of treatment according to the protocol.
Item
Poorly controlled hypertension, diabetes mellitus, or other serious medical or psychiatric illness that could potentially interfere with the completion of treatment according to the protocol.
boolean
C1868885 (UMLS CUI 2011AA)
10066860 (MedDRA 14.1)
C0860161 (UMLS CUI 2011AA)
10012619 (MedDRA 14.1)
C0205476 (UMLS CUI 2011AA)
74188005 (SNOMED CT 2011_0131)
C0221423 (UMLS CUI 2011AA)
39104002 (SNOMED CT 2011_0131)
10040658 (MedDRA 14.1)
R69 (ICD-10-CM Version 2010)
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)
C0521102 (UMLS CUI 2011AA)
78235001 (SNOMED CT 2011_0131)
C1554962 (UMLS CUI 2011AA)
C (HL7 V3 2006_05)
C0008976 (UMLS CUI 2011AA)
110465008 (SNOMED CT 2011_0131)
Any systemic infection requiring treatment.
Item
Any systemic infection requiring treatment.
boolean
C0243026 (UMLS CUI 2011AA)
91302008 (SNOMED CT 2011_0131)
10040047 (MedDRA 14.1)
995.91 (ICD-9-CM Version 2011)
C1514873 (UMLS CUI 2011AA)
C0039798 (UMLS CUI 2011AA)
Cystitis.
Item
Zystitis
boolean
C0010692 (UMLS CUI 2011AA)
38822007 (SNOMED CT 2011_0131)
10011781 (MedDRA 14.1)
N30 (ICD-10-CM Version 2010)
595.9 (ICD-9-CM Version 2011)
E11309 (CTCAE 1105E)
Disturbance of urinary flow.
Item
Disturbance of urinary flow.
boolean
C2699787 (UMLS CUI 2011AA)
C0012797 (UMLS CUI 2011AA)
60309003 (SNOMED CT 2011_0131)
10013523 (MedDRA 14.1)
Unable or unwilling to take heparin (usually low-molecular weight - LMWH) or low acetylsalicylic acid (100 mg) daily as prophylactic anticoagulation.
Item
Unable or unwilling to take heparin (usually low-molecular weight - LMWH) or low acetylsalicylic acid (100 mg) daily as prophylactic anticoagulation.
boolean
C1299582 (UMLS CUI 2011AA)
371151008 (SNOMED CT 2011_0131)
C0558080 (UMLS CUI 2011AA)
225465005 (SNOMED CT 2011_0131)
C1512806 (UMLS CUI 2011AA)
C0019134 (UMLS CUI 2011AA)
372877000 (SNOMED CT 2011_0131)
MTHU003766 (LOINC Version 232)
C0019139 (UMLS CUI 2011AA)
87233003 (SNOMED CT 2011_0131)
MTHU014939 (LOINC Version 232)
C0721444 (UMLS CUI 2011AA)
C0445202 (UMLS CUI 2011AA)
262073000 (SNOMED CT 2011_0131)
10036893 (MedDRA 14.1)
C0003281 (UMLS CUI 2011AA)