ID

44798

Description

Japanese Study of BMS-901608 (Elotuzumab) in Combination With Lenalidomide and Low Dose Dexamethasone; ODM derived from: https://clinicaltrials.gov/show/NCT01241292

Link

https://clinicaltrials.gov/show/NCT01241292

Keywords

  1. 11/30/21 11/30/21 - Tabea Kampen
Copyright Holder

Bristol-Myers Squibb

Uploaded on

November 30, 2021

DOI

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License

Creative Commons BY 4.0

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Eligibility Multiple Myeloma NCT01241292

Eligibility Multiple Myeloma NCT01241292

Criteria
Description

Criteria

Inclusion criteria
Description

Inclusion criteria

Alias
UMLS CUI [1]
C1512693
received between 1 to 4 prior lines of therapy
Description

Pre-treatment

Data type

boolean

Alias
UMLS CUI [1]
C1514463
measureable disease
Description

Diagnosis

Data type

boolean

Alias
UMLS CUI [1]
C1513041
men and women of childbearing potential (women) must be using two acceptable methods of contraception
Description

Kontraception

Data type

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0700589
men must agree to use a latex condom and a second form of birth control during sexual contact with women and must agree to not donate semen during study drug therapy
Description

Reproduction

Data type

boolean

Alias
UMLS CUI [1]
C0004764
UMLS CUI [2,1]
C0700589
UMLS CUI [2,2]
C0205394
UMLS CUI [3,1]
C0871414
UMLS CUI [3,2]
C1518422
subjects must be willing to refrain from blood donations during study drug therapy
Description

Blood donation

Data type

boolean

Alias
UMLS CUI [1,1]
C0005794
UMLS CUI [1,2]
C3640974
Exclusion criteria
Description

Exclusion criteria

Alias
UMLS CUI [1]
C0680251
subjects with non-secretory or oligo-secretory or light-chain only myeloma or active/prior plasma cell leukemia or known /suspect poems syndrome
Description

Excluded diagnoses

Data type

boolean

Alias
UMLS CUI [1]
C0456845
UMLS CUI [2,1]
C0205251
UMLS CUI [2,2]
C0036536
UMLS CUI [2,3]
C0332296
UMLS CUI [2,4]
C0026764
UMLS CUI [3]
C0456844
UMLS CUI [4]
C0023484
UMLS CUI [5]
C0085404
solitary bone or solitary extramedullary plasmacytoma as the only evidence of plasma cell dysplasia
Description

Manifestations

Data type

boolean

Alias
UMLS CUI [1,1]
C0032112
UMLS CUI [1,2]
C0334044
UMLS CUI [1,3]
C1868812
UMLS CUI [2,1]
C0032112
UMLS CUI [2,2]
C0334044
UMLS CUI [2,3]
C1512957
unable to take aspirin daily as prophylactic anticoagulation therapy. prior history of inability to tolerate weekly 40 mg dexamethasone
Description

Tolerability of other medication

Data type

boolean

Alias
UMLS CUI [1,1]
C0004057
UMLS CUI [1,2]
C0456683
UMLS CUI [1,3]
C0003281
UMLS CUI [1,4]
C0199176
UMLS CUI [2,1]
C0011777
UMLS CUI [2,2]
C1744706
history of renal failure
Description

Renal function

Data type

boolean

Alias
UMLS CUI [1]
C0035078
history of clinical significant thrombosis, such as treatment for thrombosis was required
Description

Thrombosis

Data type

boolean

Alias
UMLS CUI [1,1]
C0262926
UMLS CUI [1,2]
C0040053
UMLS CUI [1,3]
C1514873
UMLS CUI [1,4]
C0039798

Similar models

Eligibility Multiple Myeloma NCT01241292

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Item Group
Inclusion criteria
C1512693 (UMLS CUI [1])
Pre-treatment
Item
received between 1 to 4 prior lines of therapy
boolean
C1514463 (UMLS CUI [1])
Diagnosis
Item
measureable disease
boolean
C1513041 (UMLS CUI [1])
Kontraception
Item
men and women of childbearing potential (women) must be using two acceptable methods of contraception
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
Reproduction
Item
men must agree to use a latex condom and a second form of birth control during sexual contact with women and must agree to not donate semen during study drug therapy
boolean
C0004764 (UMLS CUI [1])
C0700589 (UMLS CUI [2,1])
C0205394 (UMLS CUI [2,2])
C0871414 (UMLS CUI [3,1])
C1518422 (UMLS CUI [3,2])
Blood donation
Item
subjects must be willing to refrain from blood donations during study drug therapy
boolean
C0005794 (UMLS CUI [1,1])
C3640974 (UMLS CUI [1,2])
Item Group
Exclusion criteria
C0680251 (UMLS CUI [1])
Excluded diagnoses
Item
subjects with non-secretory or oligo-secretory or light-chain only myeloma or active/prior plasma cell leukemia or known /suspect poems syndrome
boolean
C0456845 (UMLS CUI [1])
C0205251 (UMLS CUI [2,1])
C0036536 (UMLS CUI [2,2])
C0332296 (UMLS CUI [2,3])
C0026764 (UMLS CUI [2,4])
C0456844 (UMLS CUI [3])
C0023484 (UMLS CUI [4])
C0085404 (UMLS CUI [5])
Manifestations
Item
solitary bone or solitary extramedullary plasmacytoma as the only evidence of plasma cell dysplasia
boolean
C0032112 (UMLS CUI [1,1])
C0334044 (UMLS CUI [1,2])
C1868812 (UMLS CUI [1,3])
C0032112 (UMLS CUI [2,1])
C0334044 (UMLS CUI [2,2])
C1512957 (UMLS CUI [2,3])
Tolerability of other medication
Item
unable to take aspirin daily as prophylactic anticoagulation therapy. prior history of inability to tolerate weekly 40 mg dexamethasone
boolean
C0004057 (UMLS CUI [1,1])
C0456683 (UMLS CUI [1,2])
C0003281 (UMLS CUI [1,3])
C0199176 (UMLS CUI [1,4])
C0011777 (UMLS CUI [2,1])
C1744706 (UMLS CUI [2,2])
Renal function
Item
history of renal failure
boolean
C0035078 (UMLS CUI [1])
Thrombosis
Item
history of clinical significant thrombosis, such as treatment for thrombosis was required
boolean
C0262926 (UMLS CUI [1,1])
C0040053 (UMLS CUI [1,2])
C1514873 (UMLS CUI [1,3])
C0039798 (UMLS CUI [1,4])

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