ID

18206

Beschreibung

Bortezomib and Thalidomide in Treating Patients With Newly Diagnosed Stage II or Stage III Multiple Myeloma; ODM derived from: https://clinicaltrials.gov/show/NCT00287872

Link

https://clinicaltrials.gov/show/NCT00287872

Stichworte

Versionen (1)
  1. 25.10.16 25.10.16 -
Hochgeladen am

25. Oktober 2016

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Multiple Myeloma NCT00287872

Englisch

Eligibility Multiple Myeloma NCT00287872

1 Formulare  
Criteria
Beschreibung

Criteria

newly diagnosed salmon-durie stage ii or iii multiple myeloma
Beschreibung

Multiple Myeloma | Staging

Datentyp

boolean

Alias
UMLS CUI [1]
C0026764
UMLS CUI [2]
C0332305
untreated disease or patient underwent prior therapy for this cancer that lasted no more than 2 weeks
Beschreibung

Disease untreated | Prior Therapy Multiple Myeloma

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0332155
UMLS CUI [2,1]
C1514463
UMLS CUI [2,2]
C0026764
measurable paraprotein in serum or urine (serum free-lite assay measurement allowed)
Beschreibung

Serum paraprotein measurement | Urine paraprotein measurement

Datentyp

boolean

Alias
UMLS CUI [1]
C0585639
UMLS CUI [2]
C0585640
no evidence of cord compression requiring concurrent steroids
Beschreibung

Compression of spinal cord Evidence Requirement Steroids

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0037926
UMLS CUI [1,2]
C3887511
UMLS CUI [1,3]
C1514873
UMLS CUI [1,4]
C0038317
patient characteristics:
Beschreibung

Client Characteristics

Datentyp

boolean

Alias
UMLS CUI [1]
C0815172
creatinine clearance ≥ 30 ml/min
Beschreibung

Creatinine clearance measurement

Datentyp

boolean

Alias
UMLS CUI [1]
C0373595
not pregnant or nursing
Beschreibung

Pregnancy | Breast Feeding

Datentyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
negative pregnancy test
Beschreibung

Pregnancy test negative

Datentyp

boolean

Alias
UMLS CUI [1]
C0427780
fertile patients must use 2 methods of contraception, including ≥ 1 highly effective method, 4 weeks before, during, and for ≥ 4 weeks after completion of study treatment
Beschreibung

Fertility Contraceptive methods Quantity | Fertility Contraceptive methods Effective Highly Quantity

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0015895
UMLS CUI [1,2]
C0700589
UMLS CUI [1,3]
C1265611
UMLS CUI [2,1]
C0015895
UMLS CUI [2,2]
C0700589
UMLS CUI [2,3]
C1280519
UMLS CUI [2,4]
C0205250
UMLS CUI [2,5]
C1265611
no known hiv positivity
Beschreibung

HIV Seropositivity

Datentyp

boolean

Alias
UMLS CUI [1]
C0019699
no peripheral neuropathy ≥ grade 2
Beschreibung

Peripheral Neuropathy | CTCAE Grades

Datentyp

boolean

Alias
UMLS CUI [1]
C0031117
UMLS CUI [2]
C1516728
no hypersensitivity to bortezomib, boron, or mannitol
Beschreibung

Hypersensitivity bortezomib | Hypersensitivity Boron | Mannitol allergy

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C1176309
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0006030
UMLS CUI [3]
C0571922
prior concurrent therapy:
Beschreibung

Prior Therapy

Datentyp

boolean

Alias
UMLS CUI [1]
C1514463
no prior bortezomib
Beschreibung

bortezomib

Datentyp

boolean

Alias
UMLS CUI [1]
C1176309
more than 28 days since prior regimens with a duration of > 1 week but ≤ 2 weeks
Beschreibung

Regimen Duration

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0040808
UMLS CUI [1,2]
C0449238
no steroids within 14 days prior to study entry
Beschreibung

Steroids

Datentyp

boolean

Alias
UMLS CUI [1]
C0038317
no concurrent corticosteroids except for the treatment of a nonmalignant condition
Beschreibung

Adrenal Cortex Hormones | Therapeutic procedure Nonmalignant Conditions

Datentyp

boolean

Alias
UMLS CUI [1]
C0001617
UMLS CUI [2,1]
C0087111
UMLS CUI [2,2]
C0032927
may not exceed the equivalent dose of prednisone 10 mg/day
Beschreibung

Prednisone Dosage Equivalent

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0032952
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0205163
no concurrent chemotherapy, immunotherapy, radiotherapy, or surgery
Beschreibung

Chemotherapy | Immunotherapy | Therapeutic radiology procedure | Operative Surgical Procedures

Datentyp

boolean

Alias
UMLS CUI [1]
C0392920
UMLS CUI [2]
C0021083
UMLS CUI [3]
C1522449
UMLS CUI [4]
C0543467
no other concurrent investigational agents
Beschreibung

Investigational New Drugs

Datentyp

boolean

Alias
UMLS CUI [1]
C0013230
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Ähnliche Modelle

Eligibility Multiple Myeloma NCT00287872

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Multiple Myeloma | Staging
Item
newly diagnosed salmon-durie stage ii or iii multiple myeloma
boolean
C0026764 (UMLS CUI [1])
C0332305 (UMLS CUI [2])
Disease untreated | Prior Therapy Multiple Myeloma
Item
untreated disease or patient underwent prior therapy for this cancer that lasted no more than 2 weeks
boolean
C0012634 (UMLS CUI [1,1])
C0332155 (UMLS CUI [1,2])
C1514463 (UMLS CUI [2,1])
C0026764 (UMLS CUI [2,2])
Serum paraprotein measurement | Urine paraprotein measurement
Item
measurable paraprotein in serum or urine (serum free-lite assay measurement allowed)
boolean
C0585639 (UMLS CUI [1])
C0585640 (UMLS CUI [2])
Compression of spinal cord Evidence Requirement Steroids
Item
no evidence of cord compression requiring concurrent steroids
boolean
C0037926 (UMLS CUI [1,1])
C3887511 (UMLS CUI [1,2])
C1514873 (UMLS CUI [1,3])
C0038317 (UMLS CUI [1,4])
Client Characteristics
Item
patient characteristics:
boolean
C0815172 (UMLS CUI [1])
Creatinine clearance measurement
Item
creatinine clearance ≥ 30 ml/min
boolean
C0373595 (UMLS CUI [1])
Pregnancy | Breast Feeding
Item
not pregnant or nursing
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Pregnancy test negative
Item
negative pregnancy test
boolean
C0427780 (UMLS CUI [1])
Fertility Contraceptive methods Quantity | Fertility Contraceptive methods Effective Highly Quantity
Item
fertile patients must use 2 methods of contraception, including ≥ 1 highly effective method, 4 weeks before, during, and for ≥ 4 weeks after completion of study treatment
boolean
C0015895 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
C0015895 (UMLS CUI [2,1])
C0700589 (UMLS CUI [2,2])
C1280519 (UMLS CUI [2,3])
C0205250 (UMLS CUI [2,4])
C1265611 (UMLS CUI [2,5])
HIV Seropositivity
Item
no known hiv positivity
boolean
C0019699 (UMLS CUI [1])
Peripheral Neuropathy | CTCAE Grades
Item
no peripheral neuropathy ≥ grade 2
boolean
C0031117 (UMLS CUI [1])
C1516728 (UMLS CUI [2])
Hypersensitivity bortezomib | Hypersensitivity Boron | Mannitol allergy
Item
no hypersensitivity to bortezomib, boron, or mannitol
boolean
C0020517 (UMLS CUI [1,1])
C1176309 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0006030 (UMLS CUI [2,2])
C0571922 (UMLS CUI [3])
Prior Therapy
Item
prior concurrent therapy:
boolean
C1514463 (UMLS CUI [1])
bortezomib
Item
no prior bortezomib
boolean
C1176309 (UMLS CUI [1])
Regimen Duration
Item
more than 28 days since prior regimens with a duration of > 1 week but ≤ 2 weeks
boolean
C0040808 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
Steroids
Item
no steroids within 14 days prior to study entry
boolean
C0038317 (UMLS CUI [1])
Adrenal Cortex Hormones | Therapeutic procedure Nonmalignant Conditions
Item
no concurrent corticosteroids except for the treatment of a nonmalignant condition
boolean
C0001617 (UMLS CUI [1])
C0087111 (UMLS CUI [2,1])
C0032927 (UMLS CUI [2,2])
Prednisone Dosage Equivalent
Item
may not exceed the equivalent dose of prednisone 10 mg/day
boolean
C0032952 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0205163 (UMLS CUI [1,3])
Chemotherapy | Immunotherapy | Therapeutic radiology procedure | Operative Surgical Procedures
Item
no concurrent chemotherapy, immunotherapy, radiotherapy, or surgery
boolean
C0392920 (UMLS CUI [1])
C0021083 (UMLS CUI [2])
C1522449 (UMLS CUI [3])
C0543467 (UMLS CUI [4])
Investigational New Drugs
Item
no other concurrent investigational agents
boolean
C0013230 (UMLS CUI [1])
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