ID

11637

Beskrivning

Eligibility NCT01239797 Multiple Myeloma Phase 3, Randomized, Open Label Trial of Lenalidomide/Dexamethasone With or Without Elotuzumab in Relapsed or Refractory Multiple Myeloma ODM derived from http://clinicaltrials.gov/show/NCT01239797

Länk

http://clinicaltrials.gov/show/NCT01239797

Nyckelord

Versioner (3)
  1. 2013-02-12 2013-02-12 - Martin Dugas
  2. 2014-04-19 2014-04-19 - Julian Varghese
  3. 2015-07-09 2015-07-09 - Martin Dugas
Uppladdad den

9 juli 2015

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Multiple Myeloma NCT01239797

Tysk Engelsk

Eligibility Multiple Myeloma NCT01239797

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI-1
C1512693
age at least 18 Years
Beskrivning

age at least 18 Years

Datatyp

boolean

Alias
UMLS CUI 2011AA
C0001779
SNOMED CT 2011_0131
397669002
Multiple Myeloma
Beskrivning

Multiple Myeloma

Datatyp

boolean

Alias
UMLS CUI 2011AA
C0026764
Documented progression from most recent line of therapy
Beskrivning

Documented progression from most recent line of therapy

Datatyp

boolean

Alias
UMLS CUI 2011AA
C1301725
SNOMED CT 2011_0131
397934002
UMLS CUI 2011AA
C0449258
SNOMED CT 2011_0131
246450006
UMLS CUI 2011AA
C1513491
HL7 V3 2006_05
RECENT
UMLS CUI 2011AA
CL415196
UMLS CUI 2011AA
C0039798
1 - 3 prior lines of therapy
Beskrivning

1 - 3 prior lines of therapy

Datatyp

boolean

Alias
SNOMED CT 2011_0131
421291004
SNOMED CT 2011_0131
288556008
UMLS CUI-1
C1514463
Measurable Disease
Beskrivning

Measurable disease

Datatyp

boolean

Alias
UMLS CUI 2011AA
C1513041
Life expectancy >=3 months
Beskrivning

Life expectancy >=3 months

Datatyp

boolean

Alias
UMLS CUI-1
C0023671
Prior treatment with Lenalidomide permitted if:
Beskrivning

Prior treatment with Lenalidomide permitted if:

Datatyp

boolean

Alias
UMLS CUI 2011AA
C1514463
UMLS CUI 2011AA
C1144149
SNOMED CT 2011_0131
421471009
UMLS CUI 2011AA
C0521104
SNOMED CT 2011_0131
75554001
UMLS CUI 2011AA
C0750557
Best response achieved was ≥ Partial Response (PR)
Beskrivning

Best response achieved was ≥ Partial Response (PR)

Datatyp

boolean

Alias
SNOMED CT 2011_0131
276138003
HL7 V3 2006_05
GE
SNOMED CT 2011_0131
103337004
UMLS CUI-1
C2986560
Patient was not refractory
Beskrivning

Patient was not refractory

Datatyp

boolean

Alias
UMLS CUI 2011AA
C1518422
UMLS CUI 2011AA
C0205269
SNOMED CT 2011_0131
20646008
Patient did not discontinue due to a Grade ≥ 3 related adverse event
Beskrivning

Patient did not discontinue due to a Grade ≥ 3 related adverse event

Datatyp

boolean

Alias
SNOMED CT 2011_0131
278308006
UMLS CUI-1
C2985911
Subject did not receive > 9 cycles of Lenalidomide and had at least 9 months between the last dose of Lenalidomide and progression
Beskrivning

Subject did not receive > 9 cycles of Lenalidomide and had at least 9 months between the last dose of Lenalidomide and progression

Datatyp

boolean

Alias
SNOMED CT 2011_0131
276140008
HL7 V3 2006_05
GT
SNOMED CT 2011_0131
422113007, 36987007
SNOMED CT 2011_0131
44180009
SNOMED CT 2011_0131
421471009
UMLS CUI-1
C1144149
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI-1
C0680251
Subjects with non-secretory or oligo-secretory or free light-chain only myeloma
Beskrivning

Subjects with non-secretory or oligo-secretory or free light-chain only myeloma

Datatyp

boolean

Alias
UMLS CUI 2011AA
C0456845
SNOMED CT 2011_0131
277580004
MedDRA 14.1
10029662
UMLS CUI 2011AA
C0205251
SNOMED CT 2011_0131
62482003
UMLS CUI 2011AA
C0036536
UMLS CUI 2011AA
CL324441
UMLS CUI 2011AA
C0332296
SNOMED CT 2011_0131
37837009
UMLS CUI 2011AA
C0456844
SNOMED CT 2011_0131
277579002
Active plasma cell leukemia
Beskrivning

Active plasma cell leukemia

Datatyp

boolean

Alias
UMLS CUI 2011AA
C0205177
SNOMED CT 2011_0131
55561003
UMLS CUI 2011AA
C0023484
SNOMED CT 2011_0131
95210003
MedDRA 14.1
10035222
ICD-10-CM Version 2010
C90.1
ICD-9-CM Version 2011
203.1
Positive for Hepatitis B, C or Human Immunodeficiency Virus (HIV)
Beskrivning

Positive for Hepatitis B, C or Human Immunodeficiency Virus (HIV)

Datatyp

boolean

Alias
UMLS CUI 2011AA
C0856706
MedDRA 14.1
10019738
UMLS CUI 2011AA
C1112419
MedDRA 14.1
10057394
UMLS CUI 2011AA
C0019699
SNOMED CT 2011_0131
165816005
MedDRA 14.1
10020188
ICD-10-CM Version 2010
Z21
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Similar models

Eligibility Multiple Myeloma NCT01239797

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
Inclusion Criteria
C1512693 (UMLS CUI-1)
age at least 18 Years
Item
age at least 18 Years
boolean
C0001779 (UMLS CUI 2011AA)
397669002 (SNOMED CT 2011_0131)
Multiple Myeloma
Item
Multiple Myeloma
boolean
C0026764 (UMLS CUI 2011AA)
Documented progression from most recent line of therapy
Item
Documented progression from most recent line of therapy
boolean
C1301725 (UMLS CUI 2011AA)
397934002 (SNOMED CT 2011_0131)
C0449258 (UMLS CUI 2011AA)
246450006 (SNOMED CT 2011_0131)
C1513491 (UMLS CUI 2011AA)
RECENT (HL7 V3 2006_05)
CL415196 (UMLS CUI 2011AA)
C0039798 (UMLS CUI 2011AA)
prior lines of therapy
Item
1 - 3 prior lines of therapy
boolean
421291004 (SNOMED CT 2011_0131)
288556008 (SNOMED CT 2011_0131)
C1514463 (UMLS CUI-1)
Measurable disease
Item
Measurable Disease
boolean
C1513041 (UMLS CUI 2011AA)
Life expectancy
Item
Life expectancy >=3 months
boolean
C0023671 (UMLS CUI-1)
Prior treatment with Lenalidomide permitted if:
Item
Prior treatment with Lenalidomide permitted if:
boolean
C1514463 (UMLS CUI 2011AA)
C1144149 (UMLS CUI 2011AA)
421471009 (SNOMED CT 2011_0131)
C0521104 (UMLS CUI 2011AA)
75554001 (SNOMED CT 2011_0131)
C0750557 (UMLS CUI 2011AA)
Best response
Item
Best response achieved was ≥ Partial Response (PR)
boolean
276138003 (SNOMED CT 2011_0131)
GE (HL7 V3 2006_05)
103337004 (SNOMED CT 2011_0131)
C2986560 (UMLS CUI-1)
Patient was not refractory
Item
Patient was not refractory
boolean
C1518422 (UMLS CUI 2011AA)
C0205269 (UMLS CUI 2011AA)
20646008 (SNOMED CT 2011_0131)
adverse event grade 3 or above
Item
Patient did not discontinue due to a Grade ≥ 3 related adverse event
boolean
278308006 (SNOMED CT 2011_0131)
C2985911 (UMLS CUI-1)
Lenalidomide cycles
Item
Subject did not receive > 9 cycles of Lenalidomide and had at least 9 months between the last dose of Lenalidomide and progression
boolean
276140008 (SNOMED CT 2011_0131)
GT (HL7 V3 2006_05)
422113007, 36987007 (SNOMED CT 2011_0131)
44180009 (SNOMED CT 2011_0131)
421471009 (SNOMED CT 2011_0131)
C1144149 (UMLS CUI-1)
Item Group
Exclusion Criteria
C0680251 (UMLS CUI-1)
Subjects with non-secretory or oligo-secretory or free light-chain only myeloma
Item
Subjects with non-secretory or oligo-secretory or free light-chain only myeloma
boolean
C0456845 (UMLS CUI 2011AA)
277580004 (SNOMED CT 2011_0131)
10029662 (MedDRA 14.1)
C0205251 (UMLS CUI 2011AA)
62482003 (SNOMED CT 2011_0131)
C0036536 (UMLS CUI 2011AA)
CL324441 (UMLS CUI 2011AA)
C0332296 (UMLS CUI 2011AA)
37837009 (SNOMED CT 2011_0131)
C0456844 (UMLS CUI 2011AA)
277579002 (SNOMED CT 2011_0131)
Active plasma cell leukemia
Item
Active plasma cell leukemia
boolean
C0205177 (UMLS CUI 2011AA)
55561003 (SNOMED CT 2011_0131)
C0023484 (UMLS CUI 2011AA)
95210003 (SNOMED CT 2011_0131)
10035222 (MedDRA 14.1)
C90.1 (ICD-10-CM Version 2010)
203.1 (ICD-9-CM Version 2011)
Positive for Hepatitis B, C or Human Immunodeficiency Virus (HIV)
Item
Positive for Hepatitis B, C or Human Immunodeficiency Virus (HIV)
boolean
C0856706 (UMLS CUI 2011AA)
10019738 (MedDRA 14.1)
C1112419 (UMLS CUI 2011AA)
10057394 (MedDRA 14.1)
C0019699 (UMLS CUI 2011AA)
165816005 (SNOMED CT 2011_0131)
10020188 (MedDRA 14.1)
Z21 (ICD-10-CM Version 2010)
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