ID

15518

Beschreibung

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

Stichworte

  1. 02.06.16 02.06.16 -
Hochgeladen am

2. Juni 2016

DOI

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Lizenz

Creative Commons BY 4.0

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Eligibility Multiple Myeloma NCT02272803

Eligibility Multiple Myeloma NCT02272803

Criteria
Beschreibung

Criteria

Inclusion Criteria
Beschreibung

Inclusion Criteria

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

Multiple Myeloma Symptomatic | Newly Diagnosed

Datentyp

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
Beschreibung

Multiple Myeloma Prior Therapy Systemic

Datentyp

boolean

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

Measurable Disease

Datentyp

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
Beschreibung

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

Datentyp

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
Beschreibung

Exclusion Criteria

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

Non-secretory myeloma | Multiple Myeloma-Light Chain Only

Datentyp

boolean

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

Smoldering myeloma | Asymptomatic multiple myeloma | Lytic lesion Absent

Datentyp

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)
Beschreibung

Monoclonal Gammopathy of Undetermined Significance

Datentyp

boolean

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

Leukemia, Plasma Cell

Datentyp

boolean

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

HIV Infection | Hepatitis A | Hepatitis B | Hepatitis C

Datentyp

boolean

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

Ähnliche Modelle

Eligibility Multiple Myeloma NCT02272803

Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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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