ID

43917

Description

ODM derived from http://clinicaltrials.gov/show/NCT01090089 The Combination of Lenalidomide and Dexamethasone With or Without Intensification by High-dose Melphalan in the Treatment of Multiple Myeloma

Link

http://clinicaltrials.gov/show/NCT01090089

Keywords

Versions (3)
  1. 7/29/17 7/29/17 - Martin Dugas
  2. 7/29/17 7/29/17 - Martin Dugas
  3. 9/20/21 9/20/21 -
Uploaded on

September 20, 2021

DOI

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License

Creative Commons BY 4.0
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Multiple Myeloma Lenalidomide Melphalan NCT01090089

German English

Eligibility

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

Inclusion Criteria

Alias
UMLS CUI-1
C1512693
age 60 Years to 75 Years
Description

age 60 Years to 75 Years

Data type

boolean

Alias
UMLS CUI 2011AA
C0001779
SNOMED CT 2011_0131
397669002
Understand and voluntarily sign an informed consent form.
Description

Informed consent

Data type

boolean

Alias
SNOMED CT 2011_0131
66216009
SNOMED CT 2011_0131-2
255375007
UMLS CUI [1]
C0021430
Able to adhere to the study visit schedule and other protocol requirements.
Description

Adherence

Data type

boolean

Alias
SNOMED CT 2011_0131
371150009
SNOMED CT 2011_0131-2
405078008
SNOMED CT 2011_0131-3
110465008
HL7 V3 2006_05
ENC
UMLS CUI [1]
C1321605
Symptomatic MM requiring therapy.
Description

Multiple Myeloma

Data type

boolean

Alias
SNOMED CT 2011_0131
264931009
SNOMED CT 2011_0131-2
109989006
MedDRA 14.1
10028228
ICD-10-CM Version 2010
C90.0
ICD-9-CM Version 2011
203.0
SNOMED CT 2011_0131-3
439401001
LOINC Version 232
MTHU008876
UMLS CUI [1]
C0026764
Measurable monoclonal protein in serum and/or urine
Description

monoclonal protein

Data type

boolean

Alias
SNOMED CT 2011_0131
414763006
SNOMED CT 2011_0131-2
67922002
LOINC Version 232
MTHU001009
SNOMED CT 2011_0131-3
78014005
LOINC Version 232-2
MTHU001343
UMLS CUI [1]
C0241988
Monoclonal plasma cells in the bone marrow >/= 10% and/or biopsy-proven plasmacytoma
Description

Monoclonal plasma cells

Data type

boolean

Alias
SNOMED CT 2011_0131
113335003
LOINC Version 232
MTHU011655
SNOMED CT 2011_0131-2
14016003
LOINC Version 232-2
MTHU016536
SNOMED CT 2011_0131-3
86273004
MedDRA 14.1
10004720
LOINC Version 232-3
MTHU028106
SNOMED CT 2011_0131-4
277025001
SNOMED CT 2011_0131-5
10639003
MedDRA 14.1-2
10035484
ICD-10-CM Version 2010
C90.3
UMLS CUI [1,1]
C0032112
UMLS CUI [1,2]
C0746619
Myeloma-related organ dysfunction, at least one of
Description

organ dysfunction

Data type

boolean

Alias
SNOMED CT 2011_0131
263498003
SNOMED CT 2011_0131-2
251526004
UMLS CUI [1]
C0342953
Calcium Serum Increased
Description

[C] Calcium elevation in the serum (> 11.5 mg/dL or > 2.65 mmol/l)

Data type

boolean

Alias
SNOMED CT 2011_0131
10006965
UMLS CUI [1]
C0595928
[R] Renal insufficiency (creatinine > 173 μmol/l or > 2 mg/dL)
Description

[R] Renal insufficiency (creatinine > 173 μmol/l or > 2 mg/dL)

Data type

boolean

Alias
MedDRA 14.1
10038474
SNOMED CT 2011_0131
15373003
MedDRA 14.1-2
10011358
LOINC Version 232
38483-4
UMLS CUI [1]
C1565489
[A] Anemia (Hb < 10 g/dL or 2 g/dL < normal)
Description

Anemia

Data type

boolean

Alias
SNOMED CT 2011_0131
271737000
MedDRA 14.1
10002034
LOINC Version 232
MTHU020823
ICD-10-CM Version 2010
D64.9
ICD-9-CM Version 2011
285.9
CTCAE 1105E
E10010
SNOMED CT 2011_0131-2
38082009
MedDRA 14.1-2
10019481
LOINC Version 232-2
LP14449-0
UMLS CUI [1]
C0002871
[B] Bone lesions or general osteoporosis
Description

Bone lesions or general osteoporosis

Data type

boolean

Alias
MedDRA 14.1
10061728
SNOMED CT 2011_0131
64859006
MedDRA 14.1-2
10031282
LOINC Version 232
MTHU020796
ICD-10-CM Version 2010
M81.0
ICD-9-CM Version 2011
733.00
CTCAE 1105E
E12508
UMLS CUI [1,1]
C0238792
UMLS CUI [1,2]
C0029456
ECOG performance status finding <=2
Description

ECOG

Data type

boolean

Alias
SNOMED CT 2011_0131
424122007
UMLS CUI [1]
C1828127
Laboratory test results within these ranges within 1 week prior to randomization:
Description

within one week

Data type

boolean

Alias
SNOMED CT 2011_0131
118246004
SNOMED CT 2011_0131-2
18720000
SNOMED CT 2011_0131-3
255260001
UMLS CUI [1]
C4047903
Absolute Neutrophil Count
Description

ANC >/= 1.0 x 109/L.

Data type

boolean

Alias
MedDRA 14.1
10052033
UMLS CUI [1]
C0948762
Platelet count >/= 75 x 109/L or in case of bone marrow infiltration with myeloma cells >/= 30 x 109/L.
Description

Platelets

Data type

boolean

Alias
SNOMED CT 2011_0131
365632008
LOINC Version 232
777-3
SNOMED CT 2011_0131-2
167934009
UMLS CUI [1]
C1287267
Total Bilirubin Measurement
Description

Total bilirubin </= 2 mg/dL.

Data type

boolean

Alias
UMLS CUI 2011AA
C0201913
SNOMED CT 2011_0131
359986008
MedDRA 14.1
10004696
AST (SGOT) and ALT (SGPT) </= 3 x ULN.
Description

AST and ALT

Data type

boolean

Alias
SNOMED CT 2011_0131
26091008
LOINC Version 232
MTHU004883
SNOMED CT 2011_0131-2
56935002
LOINC Version 232-2
MTHU006766
UMLS CUI [1,1]
C0004002
UMLS CUI [1,2]
C0001899
Understand the study drug is expected to have a teratogenic risk
Description

Understand teratogenic risk

Data type

boolean

Alias
SNOMED CT 2011_0131
66216009
SNOMED CT 2011_0131-2
902003
SNOMED CT 2011_0131-3
30207005
HL7 V3 2006_05
RSK
SNOMED CT 2011_0131-4
58694006
MedDRA 14.1
10043275
UMLS CUI [1]
C4023357
Agree to use, ..., effective contraception without interruption,...
Description

contraception

Data type

boolean

Alias
SNOMED CT 2011_0131
146680009
MedDRA 14.1
10010808
UMLS CUI [1]
C0700589
Understand that even if she has amenorrhea, she must follow all the advice on effective contraception.
Description

contraception with amenorrhea

Data type

boolean

Alias
SNOMED CT 2011_0131
66216009
SNOMED CT 2011_0131-2
405078008
SNOMED CT 2011_0131-3
146680009
MedDRA 14.1
10010808
SNOMED CT 2011_0131-4
14302001
MedDRA 14.1-2
10001928
ICD-10-CM Version 2010
N91.2
ICD-9-CM Version 2011
626.0
UMLS CUI [1,1]
C0700589
UMLS CUI [1,2]
C0002453
She understands the potential consequences of pregnancy and the need to rapidly consult if there is a risk of pregnancy
Description

understands pregnancy risks

Data type

boolean

Alias
SNOMED CT 2011_0131
66216009
SNOMED CT 2011_0131-2
103332005
SNOMED CT 2011_0131-3
289908002
MedDRA 14.1
10036556
LOINC Version 232
MTHU035048
SNOMED CT 2011_0131-4
11429006, 223475005
ICD-9-CM Version 2011
89.09
SNOMED CT 2011_0131-5
30207005
HL7 V3 2006_05
RSK
UMLS CUI [1,1]
C0162340
UMLS CUI [1,2]
C0032961
UMLS CUI [1,3]
C0035647
Agree to have a medically supervised pregnancy test ...
Description

pregnancy test

Data type

boolean

Alias
SNOMED CT 2011_0131
74188005
SNOMED CT 2011_0131-2
225313009
SNOMED CT 2011_0131-3
74036000
MedDRA 14.1
10036572
UMLS CUI [1]
C0032976
Agree to use condoms throughout study drug therapy, during any dose interruption and for one week after cessation of study drug therapy ...
Description

condoms

Data type

boolean

Alias
SNOMED CT 2011_0131
260676000
UMLS CUI [1]
C0677582
Agree not to donate semen during study drug therapy and for one week after end of study drug therapy.
Description

no semen donation

Data type

boolean

Alias
MedDRA 14.1
10053369
UMLS CUI [1,1]
C0871414
UMLS CUI [1,2]
C1518422
Agree to abstain from donating blood while taking study drug therapy and for one week following discontinuation of study drug therapy.
Description

no blood donation

Data type

boolean

Alias
SNOMED CT 2011_0131
25179006
UMLS CUI [1,1]
C0005794
UMLS CUI [1,2]
C3640974
Agree not to share study drug with another person and to return all unused study drug to the investigator.
Description

no drug sharing

Data type

boolean

Alias
SNOMED CT 2011_0131
902003
SNOMED CT 2011_0131-2
74964007
SNOMED CT 2011_0131-3
125676002
HL7 V3 2006_05
PSN
SNOMED CT 2011_0131-4
262009000
SNOMED CT 2011_0131-5
902003
UMLS CUI [1]
C0677308
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.
Description

Disease free

Data type

boolean

Alias
SNOMED CT 2011_0131
37837009
SNOMED CT 2011_0131-2
288556008
SNOMED CT 2011_0131-3
363346000
MedDRA 14.1
10028997
LOINC Version 232
MTHU010328
ICD-10-CM Version 2010
C00-C96
HL7 V3 2006_05
E
SNOMED CT 2011_0131-4
15240007
SNOMED CT 2011_0131-5
1338007
MedDRA 14.1-2
10004146
SNOMED CT 2011_0131-6
254651007
MedDRA 14.1-3
10041834
SNOMED CT 2011_0131-7
92564006
MedDRA 14.1-4
10061809
ICD-10-CM Version 2010-2
D06.9
ICD-9-CM Version 2011
233.1
SNOMED CT 2011_0131-8
189336000
MedDRA 14.1-5
10006189
ICD-10-CM Version 2010-3
D05
ICD-9-CM Version 2011-2
233.0
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0332296
Able to receive antithrombotic prophylaxis (...).
Description

antithrombotic prophylaxis

Data type

boolean

Alias
SNOMED CT 2011_0131
371150009
SNOMED CT 2011_0131-2
360271000
MedDRA 14.1
10036898
UMLS CUI [1]
C1704311
Life-expectancy > 3 months.
Description

Life-expectancy

Data type

boolean

Alias
LOINC Version 232
LP75025-4
SNOMED CT 2011_0131
276140008
HL7 V3 2006_05
GT
SNOMED CT 2011_0131-2
421291004
SNOMED CT 2011_0131-3
258706009
HL7 V3 2006_05-2
MO
UMLS CUI [1]
C0023671
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI-1
C0680251
Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the ICF.
Description

serious condition

Data type

boolean

Alias
HL7 V3 2006_05
MEDCCAT
SNOMED CT 2011_0131
165346000
MedDRA 14.1
10023547
SNOMED CT 2011_0131-2
74732009
MedDRA 14.1-2
10037174
ICD-10-CM Version 2010
F99
ICD-9-CM Version 2011
290-319.99
UMLS CUI [1,1]
C0525058
UMLS CUI [1,2]
C0009488
Pregnant or lactating females
Description

Pregnant or lactating

Data type

boolean

Alias
MedDRA 14.1
10036586
SNOMED CT 2011_0131
248152002
HL7 V3 2006_05
F
UMLS CUI [1,1]
C0549206
UMLS CUI [1,2]
C2828358
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.
Description

unacceptable risk

Data type

boolean

Alias
SNOMED CT 2011_0131
260905004
HL7 V3 2006_05
COND
SNOMED CT 2011_0131-2
165346000
MedDRA 14.1
10023547
SNOMED CT 2011_0131-3
23981006
SNOMED CT 2011_0131-4
30207005
HL7 V3 2006_05-2
RSK
SNOMED CT 2011_0131-5
78235001
SNOMED CT 2011_0131-6
371150009
SNOMED CT 2011_0131-7
280452008
LOINC Version 232
MTHU003869
UMLS CUI [1,1]
C1883420
UMLS CUI [1,2]
C0035647
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 ...
Description

other trial

Data type

boolean

Alias
SNOMED CT 2011_0131
74964007
SNOMED CT 2011_0131-2
110465008
UMLS CUI [1]
C2348568
Known hypersensitivity to thalidomide, dexamethasone, or melphalan.
Description

allergy to study medication

Data type

boolean

Alias
SNOMED CT 2011_0131
418634005
ICD-10-CM Version 2010
T78.40
SNOMED CT 2011_0131-2
78702007
SNOMED CT 2011_0131-3
372584003
LOINC Version 232
MTHU004621
SNOMED CT 2011_0131-4
387297002
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0013230
The development of erythema nodosum if characterized by a desquamating rash while taking thalidomide or similar drugs.
Description

erythema nodosum

Data type

boolean

Alias
SNOMED CT 2011_0131
32861005
MedDRA 14.1
10015226
ICD-10-CM Version 2010
L52
ICD-9-CM Version 2011
695.2
CTCAE 1105E
MTHU117394
SNOMED CT 2011_0131-2
78702007
UMLS CUI [1]
C0014743
Any prior use of lenalidomide.
Description

lenalidomide

Data type

boolean

Alias
SNOMED CT 2011_0131
288556008
SNOMED CT 2011_0131-2
260676000
SNOMED CT 2011_0131-3
421471009
UMLS CUI [1]
C1144149
Concurrent use of other anti-cancer agents or treatments.
Description

Concurrent anti-cancer agents

Data type

boolean

Alias
SNOMED CT 2011_0131
68405009
SNOMED CT 2011_0131-2
260676000
SNOMED CT 2011_0131-3
74964007
SNOMED CT 2011_0131-4
372688009
UMLS CUI [1,1]
C0205420
UMLS CUI [1,2]
C0003392
Known positive for HIV or active infectious hepatitis, type A, B or C or treponema pallidum
Description

HIV, hepatitis or Syphilis

Data type

boolean

Alias
SNOMED CT 2011_0131
165816005
MedDRA 14.1
10020188
ICD-10-CM Version 2010
Z21
SNOMED CT 2011_0131-2
40468003
MedDRA 14.1-2
10019780
SNOMED CT 2011_0131-3
66071002
MedDRA 14.1-3
10019731
SNOMED CT 2011_0131-4
50711007
MedDRA 14.1-4
10019744
ICD-10-CM Version 2010-2
B19.20
ICD-9-CM Version 2011
070.7
SNOMED CT 2011_0131-5
72904005
LOINC Version 232
MTHU013914
UMLS CUI [1,1]
C0019699
UMLS CUI [1,2]
C0019158
UMLS CUI [1,3]
C0040840
Prior treatment with dexamethasone discontinued because of ≥ grade 3 dexamethasone-related toxicity.
Description

dexamethasone toxicity

Data type

boolean

Alias
SNOMED CT 2011_0131
372584003
LOINC Version 232
MTHU004621
SNOMED CT 2011_0131-2
410546004
UMLS CUI [1,1]
C0011777
UMLS CUI [1,2]
C0600688
Any prior chemotherapy with the exception of a short course of dexamethasone > 4 weeks before randomization.
Description

prior chemotherapy

Data type

boolean

Alias
HL7 V3 2006_05
E
SNOMED CT 2011_0131
367450005
SNOMED CT 2011_0131-2
288524001
SNOMED CT 2011_0131-3
372584003
LOINC Version 232
MTHU004621
UMLS CUI [1]
C1514457
Immunotherapy or antibody therapy within 8 weeks before randomization.
Description

Immunotherapy

Data type

boolean

Alias
SNOMED CT 2011_0131
146638005
UMLS CUI [1]
C0021083
Major surgery within 4 weeks before randomization.
Description

Major surgery

Data type

boolean

Alias
UMLS CUI [1]
C0679637
Renal failure requiring dialysis.
Description

Dialysis

Data type

boolean

Alias
MedDRA 14.1
10038474
SNOMED CT 2011_0131
108241001
MedDRA 14.1-2
10061105
UMLS CUI [1]
C0011946
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.
Description

Severe heart disease

Data type

boolean

Alias
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
SNOMED CT 2011_0131-2
155374007
MedDRA 14.1-2
10019279
ICD-9-CM Version 2011-2
428
CTCAE 1105E-2
E10124
SNOMED CT 2011_0131-3
420913000
MedDRA 14.1-3
10064081
SNOMED CT 2011_0131-4
422293003
MedDRA 14.1-4
10064082
SNOMED CT 2011_0131-5
19032002
SNOMED CT 2011_0131-6
194828000
MedDRA 14.1-5
10002383
ICD-10-CM Version 2010-2
I20
ICD-9-CM Version 2011-3
413
SNOMED CT 2011_0131-7
44103008
MedDRA 14.1-6
10047281
ICD-10-CM Version 2010-3
I49.01
CTCAE 1105E-3
E10230
SNOMED CT 2011_0131-8
46825001
MedDRA 14.1-7
10014084
SNOMED CT 2011_0131-9
272118002
SNOMED CT 2011_0131-10
52674009
MedDRA 14.1-8
10061255
SNOMED CT 2011_0131-11
24964005
UMLS CUI [1,1]
C0018799
UMLS CUI [1,2]
C0205082
Severe pulmonary disease (diffusion capacity < 60% of normal).
Description

Severe pulmonary disease

Data type

boolean

Alias
SNOMED CT 2011_0131
24484000
SNOMED CT 2011_0131-2
19829001
MedDRA 14.1
10025082
ICD-10-CM Version 2010
J98.4
SNOMED CT 2011_0131-3
54715006
UMLS CUI [1,1]
C0024115
UMLS CUI [1,2]
C0205082
Treatment for cancer other than MM within 5 years before randomization, with the exception of basal cell carcinoma or cervical cancer in situ.
Description

other cancer

Data type

boolean

Alias
SNOMED CT 2011_0131
109989006
MedDRA 14.1
10028228
ICD-10-CM Version 2010
C90.0
ICD-9-CM Version 2011
203.0
HL7 V3 2006_05
E
SNOMED CT 2011_0131-2
1338007
MedDRA 14.1-2
10004146
SNOMED CT 2011_0131-3
92564006
MedDRA 14.1-3
10061809
ICD-10-CM Version 2010-2
D06.9
ICD-9-CM Version 2011-2
233.1
UMLS CUI [1]
C1707251
Senile cardiac amyloidosis, Cardiac amyloidosis, AS transthyretin amyloidosis
Description

Cardiac amyloidosis

Data type

boolean

Alias
SNOMED CT 2011_0131
16573007
MedDRA 14.1
10007509
UMLS CUI [1]
C0268407
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.
Description

uncontrolled hypertension, diabetes mellitus, or psychiatric illness

Data type

boolean

Alias
MedDRA 14.1
10066860
MedDRA 14.1-2
10012619
SNOMED CT 2011_0131
39104002
MedDRA 14.1-3
10040658
ICD-10-CM Version 2010
R69
SNOMED CT 2011_0131-2
74732009
MedDRA 14.1-4
10037174
ICD-10-CM Version 2010-2
F99
ICD-9-CM Version 2011
290-319.99
SNOMED CT 2011_0131-3
78235001
HL7 V3 2006_05
C
UMLS CUI [1,1]
C1868885
UMLS CUI [1,2]
C0860161
UMLS CUI [1,3]
C0004936
Any systemic infection requiring treatment.
Description

systemic infection

Data type

boolean

Alias
SNOMED CT 2011_0131
91302008
MedDRA 14.1
10040047
ICD-9-CM Version 2011
995.91
UMLS CUI [1]
C0243026
Unability or unwillingness of the patient to receive antithrombotic prophylaxis.
Description

unwillingness to receive antithrombotic prophylaxis

Data type

boolean

Alias
SNOMED CT 2011_0131
371151008
SNOMED CT 2011_0131-2
225465005
SNOMED CT 2011_0131-3
360271000
MedDRA 14.1
10036898
UMLS CUI [1,1]
C0558080
UMLS CUI [1,2]
C1704311
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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
C1512693 (UMLS CUI-1)
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])
Item Group
Exclusion Criteria
C0680251 (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])
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