ID

34656

Description

Biomarker Study of Elotuzumab in High Risk Smoldering Myeloma; ODM derived from: https://clinicaltrials.gov/show/NCT01441973

Link

https://clinicaltrials.gov/show/NCT01441973

Keywords

  1. 1/22/19 1/22/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

January 22, 2019

DOI

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License

Creative Commons BY 4.0

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Eligibility Smoldering Multiple Myeloma NCT01441973

Eligibility Smoldering Multiple Myeloma NCT01441973

Criteria
Description

Criteria

Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
subjects with a confirmed diagnosis of smoldering multiple myeloma according to imwg and that is considered high risk according to the following:
Description

Smoldering myeloma

Data type

boolean

Alias
UMLS CUI [1]
C1531608
serum m protein ≥3 gm/dl and bone marrow plasma cells (bmpc) ≥10% or
Description

M Protein Measurement | Bone marrow plasma cells Percentage

Data type

boolean

Alias
UMLS CUI [1,1]
C0700271
UMLS CUI [1,2]
C0242485
UMLS CUI [2,1]
C2238293
UMLS CUI [2,2]
C0439165
serum m protein 1 - 3 g/dl and bmpc ≥10% and abnormal free light chain ratio of <0.125 or >8.0
Description

M Protein Measurement | Bone marrow plasma cells Percentage | Serum Immunoglobulin Free Light Chain Ratio Abnormal

Data type

boolean

Alias
UMLS CUI [1,1]
C0700271
UMLS CUI [1,2]
C0242485
UMLS CUI [2,1]
C2238293
UMLS CUI [2,2]
C0439165
UMLS CUI [3]
C2826181
urine m protein >200 mg/24 hours, ≥10% bone marrow plasma cells and serum free light chain (flc) ratio ≤0.125 or ≥8.0
Description

M Protein In Urine | Bone marrow plasma cells Percentage | Free Kappa Light Chain to Free Lambda Light Chain Ratio Measurement

Data type

boolean

Alias
UMLS CUI [1,1]
C0700271
UMLS CUI [1,2]
C0042037
UMLS CUI [2,1]
C2238293
UMLS CUI [2,2]
C0439165
UMLS CUI [3]
C3274398
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
active multiple myeloma
Description

Multiple Myeloma

Data type

boolean

Alias
UMLS CUI [1]
C0026764
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
positive for hepatitis b, c or human immunodeficiency virus (hiv)
Description

Hepatitis B positive | Hepatitis C positive | HIV Seropositivity

Data type

boolean

Alias
UMLS CUI [1]
C0856706
UMLS CUI [2]
C1112419
UMLS CUI [3]
C0019699

Similar models

Eligibility Smoldering Multiple Myeloma NCT01441973

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Item Group
C1512693 (UMLS CUI)
Smoldering myeloma
Item
subjects with a confirmed diagnosis of smoldering multiple myeloma according to imwg and that is considered high risk according to the following:
boolean
C1531608 (UMLS CUI [1])
M Protein Measurement | Bone marrow plasma cells Percentage
Item
serum m protein ≥3 gm/dl and bone marrow plasma cells (bmpc) ≥10% or
boolean
C0700271 (UMLS CUI [1,1])
C0242485 (UMLS CUI [1,2])
C2238293 (UMLS CUI [2,1])
C0439165 (UMLS CUI [2,2])
M Protein Measurement | Bone marrow plasma cells Percentage | Serum Immunoglobulin Free Light Chain Ratio Abnormal
Item
serum m protein 1 - 3 g/dl and bmpc ≥10% and abnormal free light chain ratio of <0.125 or >8.0
boolean
C0700271 (UMLS CUI [1,1])
C0242485 (UMLS CUI [1,2])
C2238293 (UMLS CUI [2,1])
C0439165 (UMLS CUI [2,2])
C2826181 (UMLS CUI [3])
M Protein In Urine | Bone marrow plasma cells Percentage | Free Kappa Light Chain to Free Lambda Light Chain Ratio Measurement
Item
urine m protein >200 mg/24 hours, ≥10% bone marrow plasma cells and serum free light chain (flc) ratio ≤0.125 or ≥8.0
boolean
C0700271 (UMLS CUI [1,1])
C0042037 (UMLS CUI [1,2])
C2238293 (UMLS CUI [2,1])
C0439165 (UMLS CUI [2,2])
C3274398 (UMLS CUI [3])
Item Group
C0680251 (UMLS CUI)
Multiple Myeloma
Item
active multiple myeloma
boolean
C0026764 (UMLS CUI [1])
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])
Hepatitis B positive | Hepatitis C positive | HIV Seropositivity
Item
positive for hepatitis b, c or human immunodeficiency virus (hiv)
boolean
C0856706 (UMLS CUI [1])
C1112419 (UMLS CUI [2])
C0019699 (UMLS CUI [3])

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