age 60 Years to 75 Years
Item
age 60 Years to 75 Years
boolean
C0001779 (UMLS CUI 2011AA)
397669002 (SNOMED CT 2011_0131)
Informed consent
Item
Understand and voluntarily sign an informed consent form.
boolean
66216009 (SNOMED CT 2011_0131)
255375007 (SNOMED CT 2011_0131-2)
C0021430 (UMLS CUI [1])
Adherence
Item
Able to adhere to the study visit schedule and other protocol requirements.
boolean
371150009 (SNOMED CT 2011_0131)
405078008 (SNOMED CT 2011_0131-2)
110465008 (SNOMED CT 2011_0131-3)
ENC (HL7 V3 2006_05)
C1321605 (UMLS CUI [1])
Multiple Myeloma
Item
Symptomatic MM requiring therapy.
boolean
264931009 (SNOMED CT 2011_0131)
109989006 (SNOMED CT 2011_0131-2)
10028228 (MedDRA 14.1)
C90.0 (ICD-10-CM Version 2010)
203.0 (ICD-9-CM Version 2011)
439401001 (SNOMED CT 2011_0131-3)
MTHU008876 (LOINC Version 232)
C0026764 (UMLS CUI [1])
monoclonal protein
Item
Measurable monoclonal protein in serum and/or urine
boolean
414763006 (SNOMED CT 2011_0131)
67922002 (SNOMED CT 2011_0131-2)
MTHU001009 (LOINC Version 232)
78014005 (SNOMED CT 2011_0131-3)
MTHU001343 (LOINC Version 232-2)
C0241988 (UMLS CUI [1])
Monoclonal plasma cells
Item
Monoclonal plasma cells in the bone marrow >/= 10% and/or biopsy-proven plasmacytoma
boolean
113335003 (SNOMED CT 2011_0131)
MTHU011655 (LOINC Version 232)
14016003 (SNOMED CT 2011_0131-2)
MTHU016536 (LOINC Version 232-2)
86273004 (SNOMED CT 2011_0131-3)
10004720 (MedDRA 14.1)
MTHU028106 (LOINC Version 232-3)
277025001 (SNOMED CT 2011_0131-4)
10639003 (SNOMED CT 2011_0131-5)
10035484 (MedDRA 14.1-2)
C90.3 (ICD-10-CM Version 2010)
C0032112 (UMLS CUI [1,1])
C0746619 (UMLS CUI [1,2])
organ dysfunction
Item
Myeloma-related organ dysfunction, at least one of
boolean
263498003 (SNOMED CT 2011_0131)
251526004 (SNOMED CT 2011_0131-2)
C0342953 (UMLS CUI [1])
Calcium elevated
Item
Calcium Serum Increased
boolean
10006965 (SNOMED CT 2011_0131)
C0595928 (UMLS CUI [1])
Renal Insufficiency
Item
[R] Renal insufficiency (creatinine > 173 μmol/l or > 2 mg/dL)
boolean
10038474 (MedDRA 14.1)
15373003 (SNOMED CT 2011_0131)
10011358 (MedDRA 14.1-2)
38483-4 (LOINC Version 232)
C1565489 (UMLS CUI [1])
Anemia
Item
[A] Anemia (Hb < 10 g/dL or 2 g/dL < normal)
boolean
271737000 (SNOMED CT 2011_0131)
10002034 (MedDRA 14.1)
MTHU020823 (LOINC Version 232)
D64.9 (ICD-10-CM Version 2010)
285.9 (ICD-9-CM Version 2011)
E10010 (CTCAE 1105E)
38082009 (SNOMED CT 2011_0131-2)
10019481 (MedDRA 14.1-2)
LP14449-0 (LOINC Version 232-2)
C0002871 (UMLS CUI [1])
Bone lesions or general osteoporosis
Item
[B] Bone lesions or general osteoporosis
boolean
10061728 (MedDRA 14.1)
64859006 (SNOMED CT 2011_0131)
10031282 (MedDRA 14.1-2)
MTHU020796 (LOINC Version 232)
M81.0 (ICD-10-CM Version 2010)
733.00 (ICD-9-CM Version 2011)
E12508 (CTCAE 1105E)
C0238792 (UMLS CUI [1,1])
C0029456 (UMLS CUI [1,2])
ECOG
Item
ECOG performance status finding <=2
boolean
424122007 (SNOMED CT 2011_0131)
C1828127 (UMLS CUI [1])
within one week
Item
Laboratory test results within these ranges within 1 week prior to randomization:
boolean
118246004 (SNOMED CT 2011_0131)
18720000 (SNOMED CT 2011_0131-2)
255260001 (SNOMED CT 2011_0131-3)
C4047903 (UMLS CUI [1])
ANC
Item
Absolute Neutrophil Count
boolean
10052033 (MedDRA 14.1)
C0948762 (UMLS CUI [1])
Platelets
Item
Platelet count >/= 75 x 109/L or in case of bone marrow infiltration with myeloma cells >/= 30 x 109/L.
boolean
365632008 (SNOMED CT 2011_0131)
777-3 (LOINC Version 232)
167934009 (SNOMED CT 2011_0131-2)
C1287267 (UMLS CUI [1])
Total bilirubin </= 2 mg/dL.
Item
Total Bilirubin Measurement
boolean
C0201913 (UMLS CUI 2011AA)
359986008 (SNOMED CT 2011_0131)
10004696 (MedDRA 14.1)
AST and ALT
Item
AST (SGOT) and ALT (SGPT) </= 3 x ULN.
boolean
26091008 (SNOMED CT 2011_0131)
MTHU004883 (LOINC Version 232)
56935002 (SNOMED CT 2011_0131-2)
MTHU006766 (LOINC Version 232-2)
C0004002 (UMLS CUI [1,1])
C0001899 (UMLS CUI [1,2])
Understand teratogenic risk
Item
Understand the study drug is expected to have a teratogenic risk
boolean
66216009 (SNOMED CT 2011_0131)
902003 (SNOMED CT 2011_0131-2)
30207005 (SNOMED CT 2011_0131-3)
RSK (HL7 V3 2006_05)
58694006 (SNOMED CT 2011_0131-4)
10043275 (MedDRA 14.1)
C4023357 (UMLS CUI [1])
contraception
Item
Agree to use, ..., effective contraception without interruption,...
boolean
146680009 (SNOMED CT 2011_0131)
10010808 (MedDRA 14.1)
C0700589 (UMLS CUI [1])
contraception with amenorrhea
Item
Understand that even if she has amenorrhea, she must follow all the advice on effective contraception.
boolean
66216009 (SNOMED CT 2011_0131)
405078008 (SNOMED CT 2011_0131-2)
146680009 (SNOMED CT 2011_0131-3)
10010808 (MedDRA 14.1)
14302001 (SNOMED CT 2011_0131-4)
10001928 (MedDRA 14.1-2)
N91.2 (ICD-10-CM Version 2010)
626.0 (ICD-9-CM Version 2011)
C0700589 (UMLS CUI [1,1])
C0002453 (UMLS CUI [1,2])
understands pregnancy risks
Item
She understands the potential consequences of pregnancy and the need to rapidly consult if there is a risk of pregnancy
boolean
66216009 (SNOMED CT 2011_0131)
103332005 (SNOMED CT 2011_0131-2)
289908002 (SNOMED CT 2011_0131-3)
10036556 (MedDRA 14.1)
MTHU035048 (LOINC Version 232)
11429006, 223475005 (SNOMED CT 2011_0131-4)
89.09 (ICD-9-CM Version 2011)
30207005 (SNOMED CT 2011_0131-5)
RSK (HL7 V3 2006_05)
C0162340 (UMLS CUI [1,1])
C0032961 (UMLS CUI [1,2])
C0035647 (UMLS CUI [1,3])
pregnancy test
Item
Agree to have a medically supervised pregnancy test ...
boolean
74188005 (SNOMED CT 2011_0131)
225313009 (SNOMED CT 2011_0131-2)
74036000 (SNOMED CT 2011_0131-3)
10036572 (MedDRA 14.1)
C0032976 (UMLS CUI [1])
condoms
Item
Agree to use condoms throughout study drug therapy, during any dose interruption and for one week after cessation of study drug therapy ...
boolean
260676000 (SNOMED CT 2011_0131)
C0677582 (UMLS CUI [1])
no semen donation
Item
Agree not to donate semen during study drug therapy and for one week after end of study drug therapy.
boolean
10053369 (MedDRA 14.1)
C0871414 (UMLS CUI [1,1])
C1518422 (UMLS CUI [1,2])
no blood donation
Item
Agree to abstain from donating blood while taking study drug therapy and for one week following discontinuation of study drug therapy.
boolean
25179006 (SNOMED CT 2011_0131)
C0005794 (UMLS CUI [1,1])
C3640974 (UMLS CUI [1,2])
no drug sharing
Item
Agree not to share study drug with another person and to return all unused study drug to the investigator.
boolean
902003 (SNOMED CT 2011_0131)
74964007 (SNOMED CT 2011_0131-2)
125676002 (SNOMED CT 2011_0131-3)
PSN (HL7 V3 2006_05)
262009000 (SNOMED CT 2011_0131-4)
902003 (SNOMED CT 2011_0131-5)
C0677308 (UMLS CUI [1])
Disease free
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
37837009 (SNOMED CT 2011_0131)
288556008 (SNOMED CT 2011_0131-2)
363346000 (SNOMED CT 2011_0131-3)
10028997 (MedDRA 14.1)
MTHU010328 (LOINC Version 232)
C00-C96 (ICD-10-CM Version 2010)
E (HL7 V3 2006_05)
15240007 (SNOMED CT 2011_0131-4)
1338007 (SNOMED CT 2011_0131-5)
10004146 (MedDRA 14.1-2)
254651007 (SNOMED CT 2011_0131-6)
10041834 (MedDRA 14.1-3)
92564006 (SNOMED CT 2011_0131-7)
10061809 (MedDRA 14.1-4)
D06.9 (ICD-10-CM Version 2010-2)
233.1 (ICD-9-CM Version 2011)
189336000 (SNOMED CT 2011_0131-8)
10006189 (MedDRA 14.1-5)
D05 (ICD-10-CM Version 2010-3)
233.0 (ICD-9-CM Version 2011-2)
C0012634 (UMLS CUI [1,1])
C0332296 (UMLS CUI [1,2])
antithrombotic prophylaxis
Item
Able to receive antithrombotic prophylaxis (...).
boolean
371150009 (SNOMED CT 2011_0131)
360271000 (SNOMED CT 2011_0131-2)
10036898 (MedDRA 14.1)
C1704311 (UMLS CUI [1])
Life-expectancy
Item
Life-expectancy > 3 months.
boolean
LP75025-4 (LOINC Version 232)
276140008 (SNOMED CT 2011_0131)
GT (HL7 V3 2006_05)
421291004 (SNOMED CT 2011_0131-2)
258706009 (SNOMED CT 2011_0131-3)
MO (HL7 V3 2006_05-2)
C0023671 (UMLS CUI [1])
serious condition
Item
Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the ICF.
boolean
MEDCCAT (HL7 V3 2006_05)
165346000 (SNOMED CT 2011_0131)
10023547 (MedDRA 14.1)
74732009 (SNOMED CT 2011_0131-2)
10037174 (MedDRA 14.1-2)
F99 (ICD-10-CM Version 2010)
290-319.99 (ICD-9-CM Version 2011)
C0525058 (UMLS CUI [1,1])
C0009488 (UMLS CUI [1,2])
Pregnant or lactating
Item
Pregnant or lactating females
boolean
10036586 (MedDRA 14.1)
248152002 (SNOMED CT 2011_0131)
F (HL7 V3 2006_05)
C0549206 (UMLS CUI [1,1])
C2828358 (UMLS CUI [1,2])
unacceptable risk
Item
Any condition, incl. the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study.
boolean
260905004 (SNOMED CT 2011_0131)
COND (HL7 V3 2006_05)
165346000 (SNOMED CT 2011_0131-2)
10023547 (MedDRA 14.1)
23981006 (SNOMED CT 2011_0131-3)
30207005 (SNOMED CT 2011_0131-4)
RSK (HL7 V3 2006_05-2)
78235001 (SNOMED CT 2011_0131-5)
371150009 (SNOMED CT 2011_0131-6)
280452008 (SNOMED CT 2011_0131-7)
MTHU003869 (LOINC Version 232)
C1883420 (UMLS CUI [1,1])
C0035647 (UMLS CUI [1,2])
other trial
Item
Patient currently is enrolled in another clinical research study or has been enrolled ...within 4 weeks before randomization and/or is receiving an investigational agent for any reason ...
boolean
74964007 (SNOMED CT 2011_0131)
110465008 (SNOMED CT 2011_0131-2)
C2348568 (UMLS CUI [1])
allergy to study medication
Item
Known hypersensitivity to thalidomide, dexamethasone, or melphalan.
boolean
418634005 (SNOMED CT 2011_0131)
T78.40 (ICD-10-CM Version 2010)
78702007 (SNOMED CT 2011_0131-2)
372584003 (SNOMED CT 2011_0131-3)
MTHU004621 (LOINC Version 232)
387297002 (SNOMED CT 2011_0131-4)
C0020517 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
erythema nodosum
Item
The development of erythema nodosum if characterized by a desquamating rash while taking thalidomide or similar drugs.
boolean
32861005 (SNOMED CT 2011_0131)
10015226 (MedDRA 14.1)
L52 (ICD-10-CM Version 2010)
695.2 (ICD-9-CM Version 2011)
MTHU117394 (CTCAE 1105E)
78702007 (SNOMED CT 2011_0131-2)
C0014743 (UMLS CUI [1])
lenalidomide
Item
Any prior use of lenalidomide.
boolean
288556008 (SNOMED CT 2011_0131)
260676000 (SNOMED CT 2011_0131-2)
421471009 (SNOMED CT 2011_0131-3)
C1144149 (UMLS CUI [1])
Concurrent anti-cancer agents
Item
Concurrent use of other anti-cancer agents or treatments.
boolean
68405009 (SNOMED CT 2011_0131)
260676000 (SNOMED CT 2011_0131-2)
74964007 (SNOMED CT 2011_0131-3)
372688009 (SNOMED CT 2011_0131-4)
C0205420 (UMLS CUI [1,1])
C0003392 (UMLS CUI [1,2])
HIV, hepatitis or Syphilis
Item
Known positive for HIV or active infectious hepatitis, type A, B or C or treponema pallidum
boolean
165816005 (SNOMED CT 2011_0131)
10020188 (MedDRA 14.1)
Z21 (ICD-10-CM Version 2010)
40468003 (SNOMED CT 2011_0131-2)
10019780 (MedDRA 14.1-2)
66071002 (SNOMED CT 2011_0131-3)
10019731 (MedDRA 14.1-3)
50711007 (SNOMED CT 2011_0131-4)
10019744 (MedDRA 14.1-4)
B19.20 (ICD-10-CM Version 2010-2)
070.7 (ICD-9-CM Version 2011)
72904005 (SNOMED CT 2011_0131-5)
MTHU013914 (LOINC Version 232)
C0019699 (UMLS CUI [1,1])
C0019158 (UMLS CUI [1,2])
C0040840 (UMLS CUI [1,3])
dexamethasone toxicity
Item
Prior treatment with dexamethasone discontinued because of ≥ grade 3 dexamethasone-related toxicity.
boolean
372584003 (SNOMED CT 2011_0131)
MTHU004621 (LOINC Version 232)
410546004 (SNOMED CT 2011_0131-2)
C0011777 (UMLS CUI [1,1])
C0600688 (UMLS CUI [1,2])
prior chemotherapy
Item
Any prior chemotherapy with the exception of a short course of dexamethasone > 4 weeks before randomization.
boolean
E (HL7 V3 2006_05)
367450005 (SNOMED CT 2011_0131)
288524001 (SNOMED CT 2011_0131-2)
372584003 (SNOMED CT 2011_0131-3)
MTHU004621 (LOINC Version 232)
C1514457 (UMLS CUI [1])
Immunotherapy
Item
Immunotherapy or antibody therapy within 8 weeks before randomization.
boolean
146638005 (SNOMED CT 2011_0131)
C0021083 (UMLS CUI [1])
Major surgery
Item
Major surgery within 4 weeks before randomization.
boolean
C0679637 (UMLS CUI [1])
Dialysis
Item
Renal failure requiring dialysis.
boolean
10038474 (MedDRA 14.1)
108241001 (SNOMED CT 2011_0131)
10061105 (MedDRA 14.1-2)
C0011946 (UMLS CUI [1])
Severe heart disease
Item
Myocardial infarction within 6 months before randomization, NYHA Class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities.
boolean
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)
155374007 (SNOMED CT 2011_0131-2)
10019279 (MedDRA 14.1-2)
428 (ICD-9-CM Version 2011-2)
E10124 (CTCAE 1105E-2)
420913000 (SNOMED CT 2011_0131-3)
10064081 (MedDRA 14.1-3)
422293003 (SNOMED CT 2011_0131-4)
10064082 (MedDRA 14.1-4)
19032002 (SNOMED CT 2011_0131-5)
194828000 (SNOMED CT 2011_0131-6)
10002383 (MedDRA 14.1-5)
I20 (ICD-10-CM Version 2010-2)
413 (ICD-9-CM Version 2011-3)
44103008 (SNOMED CT 2011_0131-7)
10047281 (MedDRA 14.1-6)
I49.01 (ICD-10-CM Version 2010-3)
E10230 (CTCAE 1105E-3)
46825001 (SNOMED CT 2011_0131-8)
10014084 (MedDRA 14.1-7)
272118002 (SNOMED CT 2011_0131-9)
52674009 (SNOMED CT 2011_0131-10)
10061255 (MedDRA 14.1-8)
24964005 (SNOMED CT 2011_0131-11)
C0018799 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
Severe pulmonary disease
Item
Severe pulmonary disease (diffusion capacity < 60% of normal).
boolean
24484000 (SNOMED CT 2011_0131)
19829001 (SNOMED CT 2011_0131-2)
10025082 (MedDRA 14.1)
J98.4 (ICD-10-CM Version 2010)
54715006 (SNOMED CT 2011_0131-3)
C0024115 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
other cancer
Item
Treatment for cancer other than MM within 5 years before randomization, with the exception of basal cell carcinoma or cervical cancer in situ.
boolean
109989006 (SNOMED CT 2011_0131)
10028228 (MedDRA 14.1)
C90.0 (ICD-10-CM Version 2010)
203.0 (ICD-9-CM Version 2011)
E (HL7 V3 2006_05)
1338007 (SNOMED CT 2011_0131-2)
10004146 (MedDRA 14.1-2)
92564006 (SNOMED CT 2011_0131-3)
10061809 (MedDRA 14.1-3)
D06.9 (ICD-10-CM Version 2010-2)
233.1 (ICD-9-CM Version 2011-2)
C1707251 (UMLS CUI [1])
Cardiac amyloidosis
Item
Senile cardiac amyloidosis, Cardiac amyloidosis, AS transthyretin amyloidosis
boolean
16573007 (SNOMED CT 2011_0131)
10007509 (MedDRA 14.1)
C0268407 (UMLS CUI [1])
uncontrolled hypertension, diabetes mellitus, or psychiatric illness
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
10066860 (MedDRA 14.1)
10012619 (MedDRA 14.1-2)
39104002 (SNOMED CT 2011_0131)
10040658 (MedDRA 14.1-3)
R69 (ICD-10-CM Version 2010)
74732009 (SNOMED CT 2011_0131-2)
10037174 (MedDRA 14.1-4)
F99 (ICD-10-CM Version 2010-2)
290-319.99 (ICD-9-CM Version 2011)
78235001 (SNOMED CT 2011_0131-3)
C (HL7 V3 2006_05)
C1868885 (UMLS CUI [1,1])
C0860161 (UMLS CUI [1,2])
C0004936 (UMLS CUI [1,3])
systemic infection
Item
Any systemic infection requiring treatment.
boolean
91302008 (SNOMED CT 2011_0131)
10040047 (MedDRA 14.1)
995.91 (ICD-9-CM Version 2011)
C0243026 (UMLS CUI [1])
unwillingness to receive antithrombotic prophylaxis
Item
Unability or unwillingness of the patient to receive antithrombotic prophylaxis.
boolean
371151008 (SNOMED CT 2011_0131)
225465005 (SNOMED CT 2011_0131-2)
360271000 (SNOMED CT 2011_0131-3)
10036898 (MedDRA 14.1)
C0558080 (UMLS CUI [1,1])
C1704311 (UMLS CUI [1,2])