ID

13222

Description

Therapy With Zoledronic Acid in Patients With Multiple Myeloma Stage I; ODM derived from: https://clinicaltrials.gov/show/NCT00171925

Link

https://clinicaltrials.gov/show/NCT00171925

Keywords

  1. 1/24/16 1/24/16 -
Uploaded on

January 24, 2016

DOI

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License

Creative Commons BY 4.0

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Eligibility Multiple Myeloma Stage I NCT00171925

Eligibility Multiple Myeloma Stage I NCT00171925

Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
evidence of myeloma according to the criteria of the british columbia cancer agency (for the diagnosis, 2 of the 3 criteria must be met):
Description

mm

Data type

boolean

Alias
UMLS CUI [1]
C0026764
evidence of paraprotein in the serum or urine
Description

paraprotein

Data type

boolean

Alias
UMLS CUI [1,1]
C0030490
UMLS CUI [1,2]
C0229671
UMLS CUI [2,1]
C0030490
UMLS CUI [2,2]
C0042036
bone marrow infiltration with plasma cells which represent more than 10% of the nucleated cells
Description

bone marrow

Data type

boolean

Alias
UMLS CUI [1]
C0005953
radiologically, at least one osteolytic lesion
Description

osteolytic lesion

Data type

boolean

Alias
UMLS CUI [1]
C0302313
asymptomatic patients with stage i (durie and salmon) multiple myeloma
Description

tumor stage

Data type

boolean

Alias
UMLS CUI [1]
C1300072
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients with more than one osteolytic lesion on conventional skeletal radiography
Description

osteolytic lesion

Data type

boolean

Alias
UMLS CUI [1]
C0302313
previous treatment with bisphosphonates
Description

bisphosphonates

Data type

boolean

Alias
UMLS CUI [1]
C0012544
bilirubin > 2.5 mg/dl
Description

bilirubin

Data type

boolean

Alias
UMLS CUI [1]
C1278039
abnormal renal function as evidenced by: a calculated creatinine clearance < 30 ml/minute. creatinine clearance (crcl) is calculated using the cockcroft-gault formula: crcl= [140-age(years)] x weight(kg)/[72xserumcreatinine(mg/dl)] x {0.85 for female patients}
Description

creatinine clearance

Data type

boolean

Alias
UMLS CUI [1]
C0373595
patients with other malignant diseases or severe concomitant diseases
Description

malignancy, comorbidity

Data type

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2]
C0009488
potentially fertile patients who are not using a reliable and appropriate method of contraception
Description

contraception

Data type

boolean

Alias
UMLS CUI [1]
C0700589
pregnancy or breast-feeding
Description

pregnancy or breastfeeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
participation in another clinical study with an investigational drug within 12 weeks of study entry
Description

study subject participation status

Data type

boolean

Alias
UMLS CUI [1]
C2348568
current active dental problems including infection of the teeth or jawbone (maxilla or mandibular); dental or fixture trauma, or a current or prior diagnosis of osteonecrosis of the jaw (onj), of exposed bone in the mouth, or of slow healing after dental procedures.
Description

dental disease

Data type

boolean

Alias
UMLS CUI [1]
C1704330
recent (within 6 weeks) or planned dental or jaw surgery (e.g.. extraction, implants)
Description

dental or jaw surgery

Data type

boolean

Alias
UMLS CUI [1]
C0204324
UMLS CUI [2]
C0407713
other protocol-defined inclusion and exclusion criteria may apply.
Description

others

Data type

text

Similar models

Eligibility Multiple Myeloma Stage I NCT00171925

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
mm
Item
evidence of myeloma according to the criteria of the british columbia cancer agency (for the diagnosis, 2 of the 3 criteria must be met):
boolean
C0026764 (UMLS CUI [1])
paraprotein
Item
evidence of paraprotein in the serum or urine
boolean
C0030490 (UMLS CUI [1,1])
C0229671 (UMLS CUI [1,2])
C0030490 (UMLS CUI [2,1])
C0042036 (UMLS CUI [2,2])
bone marrow
Item
bone marrow infiltration with plasma cells which represent more than 10% of the nucleated cells
boolean
C0005953 (UMLS CUI [1])
osteolytic lesion
Item
radiologically, at least one osteolytic lesion
boolean
C0302313 (UMLS CUI [1])
tumor stage
Item
asymptomatic patients with stage i (durie and salmon) multiple myeloma
boolean
C1300072 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
osteolytic lesion
Item
patients with more than one osteolytic lesion on conventional skeletal radiography
boolean
C0302313 (UMLS CUI [1])
bisphosphonates
Item
previous treatment with bisphosphonates
boolean
C0012544 (UMLS CUI [1])
bilirubin
Item
bilirubin > 2.5 mg/dl
boolean
C1278039 (UMLS CUI [1])
creatinine clearance
Item
abnormal renal function as evidenced by: a calculated creatinine clearance < 30 ml/minute. creatinine clearance (crcl) is calculated using the cockcroft-gault formula: crcl= [140-age(years)] x weight(kg)/[72xserumcreatinine(mg/dl)] x {0.85 for female patients}
boolean
C0373595 (UMLS CUI [1])
malignancy, comorbidity
Item
patients with other malignant diseases or severe concomitant diseases
boolean
C0006826 (UMLS CUI [1])
C0009488 (UMLS CUI [2])
contraception
Item
potentially fertile patients who are not using a reliable and appropriate method of contraception
boolean
C0700589 (UMLS CUI [1])
pregnancy or breastfeeding
Item
pregnancy or breast-feeding
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
study subject participation status
Item
participation in another clinical study with an investigational drug within 12 weeks of study entry
boolean
C2348568 (UMLS CUI [1])
dental disease
Item
current active dental problems including infection of the teeth or jawbone (maxilla or mandibular); dental or fixture trauma, or a current or prior diagnosis of osteonecrosis of the jaw (onj), of exposed bone in the mouth, or of slow healing after dental procedures.
boolean
C1704330 (UMLS CUI [1])
dental or jaw surgery
Item
recent (within 6 weeks) or planned dental or jaw surgery (e.g.. extraction, implants)
boolean
C0204324 (UMLS CUI [1])
C0407713 (UMLS CUI [2])
others
Item
other protocol-defined inclusion and exclusion criteria may apply.
text

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