ID

24650

Description

An Efficacy and Safety Study of Bortezomib in Participants Previously Treated for Multiple Myeloma With Limited Kidney Function; ODM derived from: https://clinicaltrials.gov/show/NCT00718640

Link

https://clinicaltrials.gov/show/NCT00718640

Keywords

Versions (1)
  1. 8/11/17 8/11/17 -
Uploaded on

August 11, 2017

DOI

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License

Creative Commons BY 4.0
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Eligibility Multiple Myeloma NCT00718640

English

Eligibility Multiple Myeloma NCT00718640

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
participants diagnosed with symptomatic multiple myeloma based on the international myeloma working group (imwg) criteria; greater than or equal to 10 percent plasma cells in the bone marrow (or tissue biopsy) detected, monoclonal protein in the serum or urine and the, presence of end-organ injury
Description

Multiple Myeloma Symptomatic | Bone marrow plasma cells Percentage | biopsy tissue | Monoclonal Protein Serum | Monoclonal Protein In Urine | end organ damage

Data type

boolean

Alias
UMLS CUI [1,1]
C0026764
UMLS CUI [1,2]
C0231220
UMLS CUI [2,1]
C2238293
UMLS CUI [2,2]
C0439165
UMLS CUI [3]
C3864006
UMLS CUI [4,1]
C0700271
UMLS CUI [4,2]
C0229671
UMLS CUI [5,1]
C0700271
UMLS CUI [5,2]
C0042037
UMLS CUI [6]
C0743496
participants with measurable disease defined by at least 1 of the following 5 measurements: a) serum m-protein greater than or equal to 1 gram per deciliter (g/dl), b) urine m protein greater than or equal to 200 milligram per 24 hour, c) serum free light chain (flc) assay: involved flc level greater than 10 mg per dl (mg/dl) provided serum flc ratio is abnormal, d) bone marrow plasma cells greater than or equal to 30 percent
Description

Measurable Disease | Serum M Protein g/dL | Urine M Protein mg/day | Serum Free Light Chain Assay | Serum FLC Involved Level mg/dL | Serum FLC Ratio Abnormal | Bone marrow plasma cells Percentage

Data type

boolean

Alias
UMLS CUI [1]
C1513041
UMLS CUI [2,1]
C0229671
UMLS CUI [2,2]
C0700271
UMLS CUI [2,3]
C0439267
UMLS CUI [3,1]
C0042036
UMLS CUI [3,2]
C0700271
UMLS CUI [3,3]
C0439422
UMLS CUI [4,1]
C2827352
UMLS CUI [4,2]
C1510438
UMLS CUI [5,1]
C2827352
UMLS CUI [5,2]
C1314939
UMLS CUI [5,3]
C0441889
UMLS CUI [5,4]
C0439269
UMLS CUI [6]
C2826181
UMLS CUI [7,1]
C2238293
UMLS CUI [7,2]
C0439165
participants who received at least 1 prior line of chemotherapy for multiple myeloma and, is refractory to or has relapsed after the last therapy
Description

Chemotherapy Quantity Multiple Myeloma | Refractory Disease | Recurrent disease

Data type

boolean

Alias
UMLS CUI [1,1]
C0392920
UMLS CUI [1,2]
C1265611
UMLS CUI [1,3]
C0026764
UMLS CUI [2]
C1514815
UMLS CUI [3]
C0277556
participants with karnofsky performance status greater than 60 or eastern cooperative oncology group (ecog) performance status of 0-2
Description

Karnofsky Performance Status | ECOG performance status

Data type

boolean

Alias
UMLS CUI [1]
C0206065
UMLS CUI [2]
C1520224
participants with calculated or measured creatinine clearance of less than or equal to 30 mililiter per minute (ml/min). during the screening period, 2 measures of creatinine clearance at least 7 days apart must be obtained, and both must be less than 30 ml/min
Description

Estimation of creatinine clearance by Cockcroft-Gault formula | Creatinine clearance measurement Quantity

Data type

boolean

Alias
UMLS CUI [1]
C2711451
UMLS CUI [2,1]
C0373595
UMLS CUI [2,2]
C1265611
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
participants who had received bortezomib in previous clinical trial and best response was progressive disease or experienced one or more serious events
Description

bortezomib | Best Response Progressive Disease | Serious Event Quantity

Data type

boolean

Alias
UMLS CUI [1]
C1176309
UMLS CUI [2,1]
C2986560
UMLS CUI [2,2]
C1335499
UMLS CUI [3,1]
C2826307
UMLS CUI [3,2]
C1265611
participants who received nitorsoureas within 6 weeks, or 2 consecutive weeks of intense corticosteroids, or immunotherapy or antibody therapy within 4 weeks before enrolment
Description

Nitrosoureas | Adrenal Cortex Hormones intense | Immunotherapy | antibody therapy

Data type

boolean

Alias
UMLS CUI [1]
C0028210
UMLS CUI [2,1]
C0001617
UMLS CUI [2,2]
C0522510
UMLS CUI [3]
C0021083
UMLS CUI [4]
C0281176
participants with history of allergic reaction attributable to compounds containing boron or mannitol
Description

Allergic Reaction Boron Compounds | Allergic Reaction Compound Containing Mannitol

Data type

boolean

Alias
UMLS CUI [1,1]
C1527304
UMLS CUI [1,2]
C0006031
UMLS CUI [2,1]
C1527304
UMLS CUI [2,2]
C1706082
UMLS CUI [2,3]
C0332256
UMLS CUI [2,4]
C0024730
participants with peripheral neuropathy of grade 2 or greater intensity at the time of signing informed consent form
Description

Peripheral Neuropathy CTCAE Grades

Data type

boolean

Alias
UMLS CUI [1,1]
C0031117
UMLS CUI [1,2]
C1516728
pregnant or breast-feeding female participants
Description

Pregnancy | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
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Similar models

Eligibility Multiple Myeloma NCT00718640

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Multiple Myeloma Symptomatic | Bone marrow plasma cells Percentage | biopsy tissue | Monoclonal Protein Serum | Monoclonal Protein In Urine | end organ damage
Item
participants diagnosed with symptomatic multiple myeloma based on the international myeloma working group (imwg) criteria; greater than or equal to 10 percent plasma cells in the bone marrow (or tissue biopsy) detected, monoclonal protein in the serum or urine and the, presence of end-organ injury
boolean
C0026764 (UMLS CUI [1,1])
C0231220 (UMLS CUI [1,2])
C2238293 (UMLS CUI [2,1])
C0439165 (UMLS CUI [2,2])
C3864006 (UMLS CUI [3])
C0700271 (UMLS CUI [4,1])
C0229671 (UMLS CUI [4,2])
C0700271 (UMLS CUI [5,1])
C0042037 (UMLS CUI [5,2])
C0743496 (UMLS CUI [6])
Measurable Disease | Serum M Protein g/dL | Urine M Protein mg/day | Serum Free Light Chain Assay | Serum FLC Involved Level mg/dL | Serum FLC Ratio Abnormal | Bone marrow plasma cells Percentage
Item
participants with measurable disease defined by at least 1 of the following 5 measurements: a) serum m-protein greater than or equal to 1 gram per deciliter (g/dl), b) urine m protein greater than or equal to 200 milligram per 24 hour, c) serum free light chain (flc) assay: involved flc level greater than 10 mg per dl (mg/dl) provided serum flc ratio is abnormal, d) bone marrow plasma cells greater than or equal to 30 percent
boolean
C1513041 (UMLS CUI [1])
C0229671 (UMLS CUI [2,1])
C0700271 (UMLS CUI [2,2])
C0439267 (UMLS CUI [2,3])
C0042036 (UMLS CUI [3,1])
C0700271 (UMLS CUI [3,2])
C0439422 (UMLS CUI [3,3])
C2827352 (UMLS CUI [4,1])
C1510438 (UMLS CUI [4,2])
C2827352 (UMLS CUI [5,1])
C1314939 (UMLS CUI [5,2])
C0441889 (UMLS CUI [5,3])
C0439269 (UMLS CUI [5,4])
C2826181 (UMLS CUI [6])
C2238293 (UMLS CUI [7,1])
C0439165 (UMLS CUI [7,2])
Chemotherapy Quantity Multiple Myeloma | Refractory Disease | Recurrent disease
Item
participants who received at least 1 prior line of chemotherapy for multiple myeloma and, is refractory to or has relapsed after the last therapy
boolean
C0392920 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0026764 (UMLS CUI [1,3])
C1514815 (UMLS CUI [2])
C0277556 (UMLS CUI [3])
Karnofsky Performance Status | ECOG performance status
Item
participants with karnofsky performance status greater than 60 or eastern cooperative oncology group (ecog) performance status of 0-2
boolean
C0206065 (UMLS CUI [1])
C1520224 (UMLS CUI [2])
Estimation of creatinine clearance by Cockcroft-Gault formula | Creatinine clearance measurement Quantity
Item
participants with calculated or measured creatinine clearance of less than or equal to 30 mililiter per minute (ml/min). during the screening period, 2 measures of creatinine clearance at least 7 days apart must be obtained, and both must be less than 30 ml/min
boolean
C2711451 (UMLS CUI [1])
C0373595 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
Item Group
C0680251 (UMLS CUI)
bortezomib | Best Response Progressive Disease | Serious Event Quantity
Item
participants who had received bortezomib in previous clinical trial and best response was progressive disease or experienced one or more serious events
boolean
C1176309 (UMLS CUI [1])
C2986560 (UMLS CUI [2,1])
C1335499 (UMLS CUI [2,2])
C2826307 (UMLS CUI [3,1])
C1265611 (UMLS CUI [3,2])
Nitrosoureas | Adrenal Cortex Hormones intense | Immunotherapy | antibody therapy
Item
participants who received nitorsoureas within 6 weeks, or 2 consecutive weeks of intense corticosteroids, or immunotherapy or antibody therapy within 4 weeks before enrolment
boolean
C0028210 (UMLS CUI [1])
C0001617 (UMLS CUI [2,1])
C0522510 (UMLS CUI [2,2])
C0021083 (UMLS CUI [3])
C0281176 (UMLS CUI [4])
Allergic Reaction Boron Compounds | Allergic Reaction Compound Containing Mannitol
Item
participants with history of allergic reaction attributable to compounds containing boron or mannitol
boolean
C1527304 (UMLS CUI [1,1])
C0006031 (UMLS CUI [1,2])
C1527304 (UMLS CUI [2,1])
C1706082 (UMLS CUI [2,2])
C0332256 (UMLS CUI [2,3])
C0024730 (UMLS CUI [2,4])
Peripheral Neuropathy CTCAE Grades
Item
participants with peripheral neuropathy of grade 2 or greater intensity at the time of signing informed consent form
boolean
C0031117 (UMLS CUI [1,1])
C1516728 (UMLS CUI [1,2])
Pregnancy | Breast Feeding
Item
pregnant or breast-feeding female participants
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
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