ID

30877

Description

Treatment With Velcade (Bortezomib) Plus Dexamethasone (VD) or VD Plus Cyclophosphamide or VD Plus Lenalidomide in Patients With Multiple Myeloma Stabilized After 4 Cycles of VD; ODM derived from: https://clinicaltrials.gov/show/NCT00908232

Lien

https://clinicaltrials.gov/show/NCT00908232

Mots-clés

Versions (1)
  1. 29/06/2018 29/06/2018 -
Détendeur de droits

See clinicaltrials.gov

Téléchargé le

29 juin 2018

DOI

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Licence

Creative Commons BY 4.0
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Eligibility Multiple Myeloma NCT00908232

Anglais

Eligibility Multiple Myeloma NCT00908232

1 Formulaires  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
patient has relapsed/progressed or is refractory for multiple myeloma following 1 previous line of therapy
Description

Recurrent multiple myeloma | Multiple Myeloma Progressive | Refractory multiple myeloma | Status post Line of Therapy Quantity

Type de données

boolean

Alias
UMLS CUI [1]
C1370446
UMLS CUI [2,1]
C0026764
UMLS CUI [2,2]
C0205329
UMLS CUI [3]
C0278620
UMLS CUI [4,1]
C0231290
UMLS CUI [4,2]
C4524693
UMLS CUI [4,3]
C1265611
measurable secretory multiple myeloma: measurable disease for secretory multiple myeloma is defined by at least one of the following measurements: serum monoclonal protein greater than or equal to 1 g/dl (> 10 gm/l) [10g/l], urine m-protein of ≥200 mg/24 hours
Description

Multiple Myeloma | Measurable Disease | Serum Monoclonal Protein Measurement | Urine Monoclonal Protein Measurement

Type de données

boolean

Alias
UMLS CUI [1]
C0026764
UMLS CUI [2]
C1513041
UMLS CUI [3,1]
C0229671
UMLS CUI [3,2]
C2984963
UMLS CUI [4,1]
C0042036
UMLS CUI [4,2]
C2984963
patient has a karnofsky performance status of ≥ 60
Description

Karnofsky Performance Status

Type de données

boolean

Alias
UMLS CUI [1]
C0206065
patient has a life expectancy estimated at screening of at least 6 months
Description

Life Expectancy

Type de données

boolean

Alias
UMLS CUI [1]
C0023671
patient fulfills defined pretreatment laboratory requirements at and within 14 days before baseline
Description

Laboratory Procedures pre treatment Fulfill

Type de données

boolean

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C2709094
UMLS CUI [1,3]
C1550543
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
patient received more than 1 previous line of therapy for multiple myeloma
Description

Line of Therapy Quantity Multiple Myeloma

Type de données

boolean

Alias
UMLS CUI [1,1]
C4524693
UMLS CUI [1,2]
C1265611
UMLS CUI [1,3]
C0026764
patient has known allergy or hypersensitivity to bortezomib, dexamethasone and/or cyclophosphamide and/or lenalidomide or any of the constituent compounds such as boron, mannitol, or lactose
Description

Hypersensitivity Bortezomib | Dexamethasone allergy | Hypersensitivity Cyclophosphamide | Hypersensitivity Lenalidomide | Hypersensitivity Boron | Mannitol allergy | FOOD ALLERGY TO LACTOSE

Type de données

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C1176309
UMLS CUI [2]
C0571611
UMLS CUI [3,1]
C0020517
UMLS CUI [3,2]
C0010583
UMLS CUI [4,1]
C0020517
UMLS CUI [4,2]
C1144149
UMLS CUI [5,1]
C0020517
UMLS CUI [5,2]
C0006030
UMLS CUI [6]
C0571922
UMLS CUI [7]
C0744078
patient has oligosecretory or non-secretory multiple myeloma
Description

Multiple Myeloma M Protein Very low | Non-secretory myeloma

Type de données

boolean

Alias
UMLS CUI [1,1]
C0026764
UMLS CUI [1,2]
C0700271
UMLS CUI [1,3]
C0442811
UMLS CUI [2]
C0456845
patient received nitrosoureas or any other chemotherapy (including thalidomide), clarithromycin, interferon within 6 weeks before enrolment. note: subjects can have received thalidomide or interferon as maintenance therapy, according to local standard of care
Description

Nitrosoureas | Chemotherapy | Thalidomide | Clarithromycin | Interferon | Thalidomide Maintenance therapy allowed | Interferon Maintenance therapy allowed

Type de données

boolean

Alias
UMLS CUI [1]
C0028210
UMLS CUI [2]
C0392920
UMLS CUI [3]
C0039736
UMLS CUI [4]
C0055856
UMLS CUI [5]
C0021747
UMLS CUI [6,1]
C0039736
UMLS CUI [6,2]
C0677908
UMLS CUI [6,3]
C0683607
UMLS CUI [7,1]
C0021747
UMLS CUI [7,2]
C0677908
UMLS CUI [7,3]
C0683607
patient received corticosteroids (> 10 mg/day prednisone or equivalent) within 3 weeks before enrolment. note: subjects can have received steroids (dexamethasone or equivalent) as maintenance therapy according to local standard of care. in addition, subjects can have received a cumulative dose of up to 160 mg of dexamethasone or equivalent as emergency therapy within 3 weeks prior to study entry.
Description

Adrenal Cortex Hormones | Prednisone U/day | Prednisone Equivalent | Steroids Maintenance therapy allowed | Dexamethasone Maintenance therapy allowed | Dexamethasone Cumulative Dose Emergency treatment allowed

Type de données

boolean

Alias
UMLS CUI [1]
C0001617
UMLS CUI [2,1]
C0032952
UMLS CUI [2,2]
C0456683
UMLS CUI [3,1]
C0032952
UMLS CUI [3,2]
C0205163
UMLS CUI [4,1]
C0038317
UMLS CUI [4,2]
C0677908
UMLS CUI [4,3]
C0683607
UMLS CUI [5,1]
C0011777
UMLS CUI [5,2]
C0677908
UMLS CUI [5,3]
C0683607
UMLS CUI [6,1]
C0011777
UMLS CUI [6,2]
C2986497
UMLS CUI [6,3]
C0013969
UMLS CUI [6,4]
C0683607
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Similar models

Eligibility Multiple Myeloma NCT00908232

1 Formulaires
Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
C1512693 (UMLS CUI)
Recurrent multiple myeloma | Multiple Myeloma Progressive | Refractory multiple myeloma | Status post Line of Therapy Quantity
Item
patient has relapsed/progressed or is refractory for multiple myeloma following 1 previous line of therapy
boolean
C1370446 (UMLS CUI [1])
C0026764 (UMLS CUI [2,1])
C0205329 (UMLS CUI [2,2])
C0278620 (UMLS CUI [3])
C0231290 (UMLS CUI [4,1])
C4524693 (UMLS CUI [4,2])
C1265611 (UMLS CUI [4,3])
Multiple Myeloma | Measurable Disease | Serum Monoclonal Protein Measurement | Urine Monoclonal Protein Measurement
Item
measurable secretory multiple myeloma: measurable disease for secretory multiple myeloma is defined by at least one of the following measurements: serum monoclonal protein greater than or equal to 1 g/dl (> 10 gm/l) [10g/l], urine m-protein of ≥200 mg/24 hours
boolean
C0026764 (UMLS CUI [1])
C1513041 (UMLS CUI [2])
C0229671 (UMLS CUI [3,1])
C2984963 (UMLS CUI [3,2])
C0042036 (UMLS CUI [4,1])
C2984963 (UMLS CUI [4,2])
Karnofsky Performance Status
Item
patient has a karnofsky performance status of ≥ 60
boolean
C0206065 (UMLS CUI [1])
Life Expectancy
Item
patient has a life expectancy estimated at screening of at least 6 months
boolean
C0023671 (UMLS CUI [1])
Laboratory Procedures pre treatment Fulfill
Item
patient fulfills defined pretreatment laboratory requirements at and within 14 days before baseline
boolean
C0022885 (UMLS CUI [1,1])
C2709094 (UMLS CUI [1,2])
C1550543 (UMLS CUI [1,3])
Item Group
C0680251 (UMLS CUI)
Line of Therapy Quantity Multiple Myeloma
Item
patient received more than 1 previous line of therapy for multiple myeloma
boolean
C4524693 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0026764 (UMLS CUI [1,3])
Hypersensitivity Bortezomib | Dexamethasone allergy | Hypersensitivity Cyclophosphamide | Hypersensitivity Lenalidomide | Hypersensitivity Boron | Mannitol allergy | FOOD ALLERGY TO LACTOSE
Item
patient has known allergy or hypersensitivity to bortezomib, dexamethasone and/or cyclophosphamide and/or lenalidomide or any of the constituent compounds such as boron, mannitol, or lactose
boolean
C0020517 (UMLS CUI [1,1])
C1176309 (UMLS CUI [1,2])
C0571611 (UMLS CUI [2])
C0020517 (UMLS CUI [3,1])
C0010583 (UMLS CUI [3,2])
C0020517 (UMLS CUI [4,1])
C1144149 (UMLS CUI [4,2])
C0020517 (UMLS CUI [5,1])
C0006030 (UMLS CUI [5,2])
C0571922 (UMLS CUI [6])
C0744078 (UMLS CUI [7])
Multiple Myeloma M Protein Very low | Non-secretory myeloma
Item
patient has oligosecretory or non-secretory multiple myeloma
boolean
C0026764 (UMLS CUI [1,1])
C0700271 (UMLS CUI [1,2])
C0442811 (UMLS CUI [1,3])
C0456845 (UMLS CUI [2])
Nitrosoureas | Chemotherapy | Thalidomide | Clarithromycin | Interferon | Thalidomide Maintenance therapy allowed | Interferon Maintenance therapy allowed
Item
patient received nitrosoureas or any other chemotherapy (including thalidomide), clarithromycin, interferon within 6 weeks before enrolment. note: subjects can have received thalidomide or interferon as maintenance therapy, according to local standard of care
boolean
C0028210 (UMLS CUI [1])
C0392920 (UMLS CUI [2])
C0039736 (UMLS CUI [3])
C0055856 (UMLS CUI [4])
C0021747 (UMLS CUI [5])
C0039736 (UMLS CUI [6,1])
C0677908 (UMLS CUI [6,2])
C0683607 (UMLS CUI [6,3])
C0021747 (UMLS CUI [7,1])
C0677908 (UMLS CUI [7,2])
C0683607 (UMLS CUI [7,3])
Adrenal Cortex Hormones | Prednisone U/day | Prednisone Equivalent | Steroids Maintenance therapy allowed | Dexamethasone Maintenance therapy allowed | Dexamethasone Cumulative Dose Emergency treatment allowed
Item
patient received corticosteroids (> 10 mg/day prednisone or equivalent) within 3 weeks before enrolment. note: subjects can have received steroids (dexamethasone or equivalent) as maintenance therapy according to local standard of care. in addition, subjects can have received a cumulative dose of up to 160 mg of dexamethasone or equivalent as emergency therapy within 3 weeks prior to study entry.
boolean
C0001617 (UMLS CUI [1])
C0032952 (UMLS CUI [2,1])
C0456683 (UMLS CUI [2,2])
C0032952 (UMLS CUI [3,1])
C0205163 (UMLS CUI [3,2])
C0038317 (UMLS CUI [4,1])
C0677908 (UMLS CUI [4,2])
C0683607 (UMLS CUI [4,3])
C0011777 (UMLS CUI [5,1])
C0677908 (UMLS CUI [5,2])
C0683607 (UMLS CUI [5,3])
C0011777 (UMLS CUI [6,1])
C2986497 (UMLS CUI [6,2])
C0013969 (UMLS CUI [6,3])
C0683607 (UMLS CUI [6,4])
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