ID

15518

Description

Phase II Study of Lenalidomide/Dexamethasone With or Without Elotuzumab for Newly Diagnosed MM Patients in Japan; ODM derived from: https://clinicaltrials.gov/show/NCT02272803

Link

https://clinicaltrials.gov/show/NCT02272803

Keywords

Versions (1)
  1. 6/2/16 6/2/16 -
Uploaded on

June 2, 2016

DOI

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License

Creative Commons BY 4.0
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Eligibility Multiple Myeloma NCT02272803

English

Eligibility Multiple Myeloma NCT02272803

1 forms  
Criteria
Description

Criteria

Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
newly diagnosed with symptomatic multiple myeloma (mm)
Description

Multiple Myeloma Symptomatic | Newly Diagnosed

Data type

boolean

Alias
UMLS CUI [1,1]
C0026764
UMLS CUI [1,2]
C0231220
UMLS CUI [2]
C1518321
have not received any prior systemic anti-myeloma therapy
Description

Multiple Myeloma Prior Therapy Systemic

Data type

boolean

Alias
UMLS CUI [1,1]
C0026764
UMLS CUI [1,2]
C1514463
UMLS CUI [1,3]
C0205373
have measurable disease
Description

Measurable Disease

Data type

boolean

Alias
UMLS CUI [1]
C1513041
are not candidates for high-dose therapy plus stem-cell transplantation (sct) because of age (≥ 65 years) or coexisting conditions. refusal to undergo high dose therapy with sct is not sufficient for entry onto ca204-116 for a subject < 65 years old. there must be a comorbidity that prevents sct for a subject < 65 years old
Description

Patient unsuitable for procedure | Therapeutic procedure High dose | Stem cell transplant | Age | Comorbidity

Data type

boolean

Alias
UMLS CUI [1]
C3839996
UMLS CUI [2,1]
C0087111
UMLS CUI [2,2]
C0444956
UMLS CUI [3]
C1504389
UMLS CUI [4]
C0001779
UMLS CUI [5]
C0009488
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
non-secretory or oligo-secretory or free light-chain only myeloma
Description

Non-secretory myeloma | Multiple Myeloma-Light Chain Only

Data type

boolean

Alias
UMLS CUI [1]
C0456845
UMLS CUI [2]
C2347305
smoldering mm, defined as asymptomatic mm with absence of lytic bone lesions
Description

Smoldering myeloma | Asymptomatic multiple myeloma | Lytic lesion Absent

Data type

boolean

Alias
UMLS CUI [1]
C1531608
UMLS CUI [2]
C2585107
UMLS CUI [3,1]
C0221204
UMLS CUI [3,2]
C0332197
monoclonal gammopathy of undetermined significance (mgus)
Description

Monoclonal Gammopathy of Undetermined Significance

Data type

boolean

Alias
UMLS CUI [1]
C0026470
active plasma cell leukemia
Description

Leukemia, Plasma Cell

Data type

boolean

Alias
UMLS CUI [1]
C0023484
known human immunodeficiency virus (hiv) infection or active hepatitis a, b, or c
Description

HIV Infection | Hepatitis A | Hepatitis B | Hepatitis C

Data type

boolean

Alias
UMLS CUI [1]
C0019693
UMLS CUI [2]
C0019159
UMLS CUI [3]
C0019163
UMLS CUI [4]
C0019196
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Similar models

Eligibility Multiple Myeloma NCT02272803

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Item Group
C1512693 (UMLS CUI)
Multiple Myeloma Symptomatic | Newly Diagnosed
Item
newly diagnosed with symptomatic multiple myeloma (mm)
boolean
C0026764 (UMLS CUI [1,1])
C0231220 (UMLS CUI [1,2])
C1518321 (UMLS CUI [2])
Multiple Myeloma Prior Therapy Systemic
Item
have not received any prior systemic anti-myeloma therapy
boolean
C0026764 (UMLS CUI [1,1])
C1514463 (UMLS CUI [1,2])
C0205373 (UMLS CUI [1,3])
Measurable Disease
Item
have measurable disease
boolean
C1513041 (UMLS CUI [1])
Patient unsuitable for procedure | Therapeutic procedure High dose | Stem cell transplant | Age | Comorbidity
Item
are not candidates for high-dose therapy plus stem-cell transplantation (sct) because of age (≥ 65 years) or coexisting conditions. refusal to undergo high dose therapy with sct is not sufficient for entry onto ca204-116 for a subject < 65 years old. there must be a comorbidity that prevents sct for a subject < 65 years old
boolean
C3839996 (UMLS CUI [1])
C0087111 (UMLS CUI [2,1])
C0444956 (UMLS CUI [2,2])
C1504389 (UMLS CUI [3])
C0001779 (UMLS CUI [4])
C0009488 (UMLS CUI [5])
Item Group
C0680251 (UMLS CUI)
Non-secretory myeloma | Multiple Myeloma-Light Chain Only
Item
non-secretory or oligo-secretory or free light-chain only myeloma
boolean
C0456845 (UMLS CUI [1])
C2347305 (UMLS CUI [2])
Smoldering myeloma | Asymptomatic multiple myeloma | Lytic lesion Absent
Item
smoldering mm, defined as asymptomatic mm with absence of lytic bone lesions
boolean
C1531608 (UMLS CUI [1])
C2585107 (UMLS CUI [2])
C0221204 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
Monoclonal Gammopathy of Undetermined Significance
Item
monoclonal gammopathy of undetermined significance (mgus)
boolean
C0026470 (UMLS CUI [1])
Leukemia, Plasma Cell
Item
active plasma cell leukemia
boolean
C0023484 (UMLS CUI [1])
HIV Infection | Hepatitis A | Hepatitis B | Hepatitis C
Item
known human immunodeficiency virus (hiv) infection or active hepatitis a, b, or c
boolean
C0019693 (UMLS CUI [1])
C0019159 (UMLS CUI [2])
C0019163 (UMLS CUI [3])
C0019196 (UMLS CUI [4])
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