ID

21964

Beskrivning

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

Länk

https://clinicaltrials.gov/show/NCT00866138

Nyckelord

Versioner (1)
  1. 2017-05-10 2017-05-10 -
Uppladdad den

10 maj 2017

DOI

För en begäran logga in.

Licens

Creative Commons BY 4.0
Modellkommentarer :

Här kan du kommentera modellen. Med hjälp av pratbubblor i Item-grupperna och Item kan du lägga in specifika kommentarer.

Tillbaka till modellkommentarer
Itemgroup-kommentar för :

Item-kommentar för :

Du måste vara inloggad för att kunna ladda ner formulär. Var vänlig logga in eller registrera dig utan kostnad.

Eligibility Multiple Myeloma NCT00866138

Engelsk

Eligibility Multiple Myeloma NCT00866138

1 Formulär  
Inclusion Criteria
Beskrivning

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
Beskrivning

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

Datatyp

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
Beskrivning

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

Datatyp

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
Beskrivning

Life Expectancy

Datatyp

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.
Beskrivning

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

Datatyp

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)
Beskrivning

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

Datatyp

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
Beskrivning

ECOG performance status

Datatyp

boolean

Alias
UMLS CUI [1]
C1520224
Exclusion Criteria
Beskrivning

Exclusion Criteria

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

Adrenal Cortex Hormones

Datatyp

boolean

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

Therapeutic radiology procedure Local

Datatyp

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
Beskrivning

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

Datatyp

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)
Beskrivning

Medical contraindication Steroids High dose

Datatyp

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
Beskrivning

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

Datatyp

boolean

Alias
UMLS CUI [1]
C0920425
UMLS CUI [2]
C0026764
UMLS CUI [3]
C0007117
UMLS CUI [4]
C0851140
Tillbaka till toppen

Similar models

Eligibility Multiple Myeloma NCT00866138

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
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])
Tillbaka till toppen 

Kontakt

Använd detta formulär för feedback, frågor och förslag på förbättringar.

Fält markerade med * är obligatoriska.

Hjälp

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial