ID

21964

Descrição

A Phase 2 Study to Evaluate Efficacy and Safety of Masitinib in Patients With Relapse or Refractory Multiple Myeloma With t(4/14) Translocation Expressing or Not FGFR3; ODM derived from: https://clinicaltrials.gov/show/NCT00866138

Link

https://clinicaltrials.gov/show/NCT00866138

Palavras-chave

Versões (1)
  1. 10/05/2017 10/05/2017 -
Transferido a

10 de maio de 2017

DOI

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Licença

Creative Commons BY 4.0
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Eligibility Multiple Myeloma NCT00866138

Inglês

Eligibility Multiple Myeloma NCT00866138

1 Formulários  
Inclusion Criteria
Descrição

Inclusion Criteria

Alias
UMLS CUI
C1512693
confirmed multiple myeloma with a t (4; 14) translocation by fish and pcr, expressing or not expressing fgfr3 identified by facs
Descrição

Multiple Myeloma | t(4;14) Fluorescent in Situ Hybridization | t(4;14) Polymerase Chain Reaction | fibroblast growth factor receptor 3 Fluorescence-Activated Cell Sorting | fibroblast growth factor receptor 3 Expression Fluorescence-Activated Cell Sorting

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0026764
UMLS CUI [2,1]
C2986942
UMLS CUI [2,2]
C0162789
UMLS CUI [3,1]
C2986942
UMLS CUI [3,2]
C0032520
UMLS CUI [4,1]
C0117718
UMLS CUI [4,2]
C0079366
UMLS CUI [5,1]
C0117718
UMLS CUI [5,2]
C1171362
UMLS CUI [5,3]
C0079366
patients with multiple myeloma progressing or relapsing after at least two prior therapies (including conventional chemotherapy and/or high dose therapy) or who get a reduction of m-protein less than 75% within 3 months after a high dose treatment (melphalan 200mg/m2) or after the plateau obtained for 3 months duration following to a conventional chemotherapy
Descrição

Multiple Myeloma Progressing | Multiple Myeloma Relapsing | Therapeutic procedure Quantity | Chemotherapy | high-dose chemotherapy | M Protein Percentage Reduction | Melphalan

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0026764
UMLS CUI [1,2]
C0205329
UMLS CUI [2,1]
C0026764
UMLS CUI [2,2]
C0035020
UMLS CUI [3,1]
C0087111
UMLS CUI [3,2]
C1265611
UMLS CUI [4]
C0392920
UMLS CUI [5]
C1328050
UMLS CUI [6,1]
C0700271
UMLS CUI [6,2]
C0439165
UMLS CUI [6,3]
C0392756
UMLS CUI [7]
C0025241
life expectancy > 3 months
Descrição

Life Expectancy

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0023671
patient with rapidly progressive disease with cytopenia and / or renal failure have to be stabilized with chemotherapy (if possible 3 cycles of vtd ( bortezomib/thalidomide/dexamethasone) or high dose melphalan regimen followed by a 4 weeks washout period before the inclusion in the study.
Descrição

Rapidly progressive disorder | Cytopenia | Kidney Failure | Chemotherapy Quantity | bortezomib | Thalidomide | Dexamethasone | Melphalan High dose | Washout Period

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1850776
UMLS CUI [2]
C0010828
UMLS CUI [3]
C0035078
UMLS CUI [4,1]
C0392920
UMLS CUI [4,2]
C1265611
UMLS CUI [5]
C1176309
UMLS CUI [6]
C0039736
UMLS CUI [7]
C0011777
UMLS CUI [8,1]
C0025241
UMLS CUI [8,2]
C0444956
UMLS CUI [9]
C1710661
patients must have a clearly detectable and quantifiable monoclonal m- component value (>5 g/l) in the serum and / or urine light chain excretion (>0,5 g/d)
Descrição

M Protein monoclonal Value Serum | M Protein monoclonal Value Urine light chain measurement

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0700271
UMLS CUI [1,2]
C0746619
UMLS CUI [1,3]
C1522609
UMLS CUI [1,4]
C0229671
UMLS CUI [2,1]
C0700271
UMLS CUI [2,2]
C0746619
UMLS CUI [2,3]
C1522609
UMLS CUI [2,4]
C1445962
ecog = 0 -2
Descrição

ECOG performance status

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1520224
Exclusion Criteria
Descrição

Exclusion Criteria

Alias
UMLS CUI
C0680251
prior corticosteroids within two weeks before enrolment
Descrição

Adrenal Cortex Hormones

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0001617
prior local irradiation within two weeks before enrolment
Descrição

Therapeutic radiology procedure Local

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1522449
UMLS CUI [1,2]
C0205276
prior experimental or standard treatment (other than steroids and local irradiation) within 30 days before enrolment
Descrição

Therapies, Investigational | Therapeutic procedure | Steroids | Therapeutic radiology procedure Local

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0949266
UMLS CUI [2]
C0087111
UMLS CUI [3]
C0038317
UMLS CUI [4,1]
C1522449
UMLS CUI [4,2]
C0205276
contra-indication to high dose steroids (including ongoing active infection)
Descrição

Medical contraindication Steroids High dose

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0038317
UMLS CUI [1,3]
C0444956
patient treated for a cancer other than mm within 5 years before enrolment, with the exception of basal cell carcinoma or cervical cancer in situ
Descrição

Cancer treatment | Multiple Myeloma | Basal cell carcinoma | Carcinoma in situ of uterine cervix

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0920425
UMLS CUI [2]
C0026764
UMLS CUI [3]
C0007117
UMLS CUI [4]
C0851140
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Similar models

Eligibility Multiple Myeloma NCT00866138

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
C1512693 (UMLS CUI)
Multiple Myeloma | t(4;14) Fluorescent in Situ Hybridization | t(4;14) Polymerase Chain Reaction | fibroblast growth factor receptor 3 Fluorescence-Activated Cell Sorting | fibroblast growth factor receptor 3 Expression Fluorescence-Activated Cell Sorting
Item
confirmed multiple myeloma with a t (4; 14) translocation by fish and pcr, expressing or not expressing fgfr3 identified by facs
boolean
C0026764 (UMLS CUI [1])
C2986942 (UMLS CUI [2,1])
C0162789 (UMLS CUI [2,2])
C2986942 (UMLS CUI [3,1])
C0032520 (UMLS CUI [3,2])
C0117718 (UMLS CUI [4,1])
C0079366 (UMLS CUI [4,2])
C0117718 (UMLS CUI [5,1])
C1171362 (UMLS CUI [5,2])
C0079366 (UMLS CUI [5,3])
Multiple Myeloma Progressing | Multiple Myeloma Relapsing | Therapeutic procedure Quantity | Chemotherapy | high-dose chemotherapy | M Protein Percentage Reduction | Melphalan
Item
patients with multiple myeloma progressing or relapsing after at least two prior therapies (including conventional chemotherapy and/or high dose therapy) or who get a reduction of m-protein less than 75% within 3 months after a high dose treatment (melphalan 200mg/m2) or after the plateau obtained for 3 months duration following to a conventional chemotherapy
boolean
C0026764 (UMLS CUI [1,1])
C0205329 (UMLS CUI [1,2])
C0026764 (UMLS CUI [2,1])
C0035020 (UMLS CUI [2,2])
C0087111 (UMLS CUI [3,1])
C1265611 (UMLS CUI [3,2])
C0392920 (UMLS CUI [4])
C1328050 (UMLS CUI [5])
C0700271 (UMLS CUI [6,1])
C0439165 (UMLS CUI [6,2])
C0392756 (UMLS CUI [6,3])
C0025241 (UMLS CUI [7])
Life Expectancy
Item
life expectancy > 3 months
boolean
C0023671 (UMLS CUI [1])
Rapidly progressive disorder | Cytopenia | Kidney Failure | Chemotherapy Quantity | bortezomib | Thalidomide | Dexamethasone | Melphalan High dose | Washout Period
Item
patient with rapidly progressive disease with cytopenia and / or renal failure have to be stabilized with chemotherapy (if possible 3 cycles of vtd ( bortezomib/thalidomide/dexamethasone) or high dose melphalan regimen followed by a 4 weeks washout period before the inclusion in the study.
boolean
C1850776 (UMLS CUI [1])
C0010828 (UMLS CUI [2])
C0035078 (UMLS CUI [3])
C0392920 (UMLS CUI [4,1])
C1265611 (UMLS CUI [4,2])
C1176309 (UMLS CUI [5])
C0039736 (UMLS CUI [6])
C0011777 (UMLS CUI [7])
C0025241 (UMLS CUI [8,1])
C0444956 (UMLS CUI [8,2])
C1710661 (UMLS CUI [9])
M Protein monoclonal Value Serum | M Protein monoclonal Value Urine light chain measurement
Item
patients must have a clearly detectable and quantifiable monoclonal m- component value (>5 g/l) in the serum and / or urine light chain excretion (>0,5 g/d)
boolean
C0700271 (UMLS CUI [1,1])
C0746619 (UMLS CUI [1,2])
C1522609 (UMLS CUI [1,3])
C0229671 (UMLS CUI [1,4])
C0700271 (UMLS CUI [2,1])
C0746619 (UMLS CUI [2,2])
C1522609 (UMLS CUI [2,3])
C1445962 (UMLS CUI [2,4])
ECOG performance status
Item
ecog = 0 -2
boolean
C1520224 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Adrenal Cortex Hormones
Item
prior corticosteroids within two weeks before enrolment
boolean
C0001617 (UMLS CUI [1])
Therapeutic radiology procedure Local
Item
prior local irradiation within two weeks before enrolment
boolean
C1522449 (UMLS CUI [1,1])
C0205276 (UMLS CUI [1,2])
Therapies, Investigational | Therapeutic procedure | Steroids | Therapeutic radiology procedure Local
Item
prior experimental or standard treatment (other than steroids and local irradiation) within 30 days before enrolment
boolean
C0949266 (UMLS CUI [1])
C0087111 (UMLS CUI [2])
C0038317 (UMLS CUI [3])
C1522449 (UMLS CUI [4,1])
C0205276 (UMLS CUI [4,2])
Medical contraindication Steroids High dose
Item
contra-indication to high dose steroids (including ongoing active infection)
boolean
C1301624 (UMLS CUI [1,1])
C0038317 (UMLS CUI [1,2])
C0444956 (UMLS CUI [1,3])
Cancer treatment | Multiple Myeloma | Basal cell carcinoma | Carcinoma in situ of uterine cervix
Item
patient treated for a cancer other than mm within 5 years before enrolment, with the exception of basal cell carcinoma or cervical cancer in situ
boolean
C0920425 (UMLS CUI [1])
C0026764 (UMLS CUI [2])
C0007117 (UMLS CUI [3])
C0851140 (UMLS CUI [4])
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