ID

30831

Beskrivning

Fludarabine, Busulfan, Antithymocyte Globulin, and Donor Stem Cell Transplant in Treating Patients With Multiple Myeloma That Has Not Responded to Treatment; ODM derived from: https://clinicaltrials.gov/show/NCT00802568

Länk

https://clinicaltrials.gov/show/NCT00802568

Nyckelord

Versioner (1)
  1. 2018-06-25 2018-06-25 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

25 juni 2018

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Multiple Myeloma and Plasma Cell Neoplasm NCT00802568

Engelsk

Eligibility Multiple Myeloma and Plasma Cell Neoplasm NCT00802568

1 Formulär  
Criteria
Beskrivning

Criteria

diagnosis of multiple myeloma, meeting 1 of the following criteria:
Beskrivning

Multiple Myeloma | Criteria Fulfill

Datatyp

boolean

Alias
UMLS CUI [1]
C0026764
UMLS CUI [2,1]
C0243161
UMLS CUI [2,2]
C1550543
stage i disease with a bone lesion
Beskrivning

Disease Tumor stage | Bone lesion

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C1300072
UMLS CUI [2]
C0238792
stage ii or iii disease meeting any of the following criteria:
Beskrivning

Disease Tumor stage | Criteria Fulfill

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C1300072
UMLS CUI [2,1]
C0243161
UMLS CUI [2,2]
C1550543
elevated beta-2 microglobulin
Beskrivning

Beta 2 microglobulin increased

Datatyp

boolean

Alias
UMLS CUI [1]
C0855565
deletion of chromosome 13
Beskrivning

Loss of Chromosome 13

Datatyp

boolean

Alias
UMLS CUI [1]
C1517957
refractory or relapsed disease
Beskrivning

Refractory Disease | Recurrent disease

Datatyp

boolean

Alias
UMLS CUI [1]
C1514815
UMLS CUI [2]
C0277556
presence of an evaluable monoclonal component
Beskrivning

Presence Component monoclonal

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0150312
UMLS CUI [1,2]
C1179435
UMLS CUI [1,3]
C0746619
must have achieved reduction of primary tumor after receiving prior intensified chemotherapy with high-dose melphalan and cyclosporine with autologous transplantation
Beskrivning

Primary tumor Reduction | Chemotherapy intense | Melphalan High dose | Cyclosporine High dose | Transplantation, Autologous

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0677930
UMLS CUI [1,2]
C0392756
UMLS CUI [2,1]
C0392920
UMLS CUI [2,2]
C0522510
UMLS CUI [3,1]
C0025241
UMLS CUI [3,2]
C0444956
UMLS CUI [4,1]
C0010592
UMLS CUI [4,2]
C0444956
UMLS CUI [5]
C0040736
hla identical family donor available
Beskrivning

Availability of Family Donor | Donor HLA Identical

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0470187
UMLS CUI [1,2]
C0015576
UMLS CUI [1,3]
C0013018
UMLS CUI [2,1]
C0013018
UMLS CUI [2,2]
C0019721
UMLS CUI [2,3]
C0205280
bone marrow transplantation is allowed in case hematopoietic stem cell collection fails
Beskrivning

Bone Marrow Transplantation allowed | Hematopoietic stem cells Collection fails

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0005961
UMLS CUI [1,2]
C0683607
UMLS CUI [2,1]
C0018956
UMLS CUI [2,2]
C0200345
UMLS CUI [2,3]
C0231175
patient characteristics:
Beskrivning

Client Characteristics

Datatyp

boolean

Alias
UMLS CUI [1]
C0815172
karnofsky 70-100%
Beskrivning

Karnofsky Performance Status

Datatyp

boolean

Alias
UMLS CUI [1]
C0206065
no contraindications to allogeneic transplantation
Beskrivning

Medical contraindication Absent Allogeneic Stem Cell Transplantation

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0332197
UMLS CUI [1,3]
C2242529
no contraindications to drugs used in conditioning regimen
Beskrivning

Medical contraindication Absent Pharmaceutical Preparations Transplantation Conditioning

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0332197
UMLS CUI [1,3]
C0013227
UMLS CUI [1,4]
C0376450
no psychiatric illness
Beskrivning

Exclusion | Mental disorders

Datatyp

boolean

Alias
UMLS CUI [1]
C2828389
UMLS CUI [2]
C0004936
no other cancer within the past 5 years except basal cell skin cancer or epithelioma in situ of the cervix
Beskrivning

Exclusion | Cancer Other | Exception Basal cell carcinoma | Exception Carcinoma in situ of uterine cervix

Datatyp

boolean

Alias
UMLS CUI [1]
C2828389
UMLS CUI [2]
C1707251
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0007117
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0851140
no serious and uncontrolled infection
Beskrivning

Exclusion | Communicable Disease Serious Uncontrolled

Datatyp

boolean

Alias
UMLS CUI [1]
C2828389
UMLS CUI [2,1]
C0009450
UMLS CUI [2,2]
C0205404
UMLS CUI [2,3]
C0205318
not pregnant or nursing
Beskrivning

Exclusion Criteria | Pregnancy | Breast Feeding

Datatyp

boolean

Alias
UMLS CUI [1]
C0680251
UMLS CUI [2]
C0032961
UMLS CUI [3]
C0006147
fertile patients must use effective contraception
Beskrivning

Fertility Contraceptive methods

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0015895
UMLS CUI [1,2]
C0700589
prior concurrent therapy:
Beskrivning

Therapeutic procedure

Datatyp

boolean

Alias
UMLS CUI [1]
C0087111
see disease characteristics
Beskrivning

ID.21

Datatyp

boolean

at least 1 month since participation in another prior clinical trial
Beskrivning

Study Subject Participation Status

Datatyp

boolean

Alias
UMLS CUI [1]
C2348568
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Similar models

Eligibility Multiple Myeloma and Plasma Cell Neoplasm NCT00802568

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
Multiple Myeloma | Criteria Fulfill
Item
diagnosis of multiple myeloma, meeting 1 of the following criteria:
boolean
C0026764 (UMLS CUI [1])
C0243161 (UMLS CUI [2,1])
C1550543 (UMLS CUI [2,2])
Disease Tumor stage | Bone lesion
Item
stage i disease with a bone lesion
boolean
C0012634 (UMLS CUI [1,1])
C1300072 (UMLS CUI [1,2])
C0238792 (UMLS CUI [2])
Disease Tumor stage | Criteria Fulfill
Item
stage ii or iii disease meeting any of the following criteria:
boolean
C0012634 (UMLS CUI [1,1])
C1300072 (UMLS CUI [1,2])
C0243161 (UMLS CUI [2,1])
C1550543 (UMLS CUI [2,2])
Beta 2 microglobulin increased
Item
elevated beta-2 microglobulin
boolean
C0855565 (UMLS CUI [1])
Loss of Chromosome 13
Item
deletion of chromosome 13
boolean
C1517957 (UMLS CUI [1])
Refractory Disease | Recurrent disease
Item
refractory or relapsed disease
boolean
C1514815 (UMLS CUI [1])
C0277556 (UMLS CUI [2])
Presence Component monoclonal
Item
presence of an evaluable monoclonal component
boolean
C0150312 (UMLS CUI [1,1])
C1179435 (UMLS CUI [1,2])
C0746619 (UMLS CUI [1,3])
Primary tumor Reduction | Chemotherapy intense | Melphalan High dose | Cyclosporine High dose | Transplantation, Autologous
Item
must have achieved reduction of primary tumor after receiving prior intensified chemotherapy with high-dose melphalan and cyclosporine with autologous transplantation
boolean
C0677930 (UMLS CUI [1,1])
C0392756 (UMLS CUI [1,2])
C0392920 (UMLS CUI [2,1])
C0522510 (UMLS CUI [2,2])
C0025241 (UMLS CUI [3,1])
C0444956 (UMLS CUI [3,2])
C0010592 (UMLS CUI [4,1])
C0444956 (UMLS CUI [4,2])
C0040736 (UMLS CUI [5])
Availability of Family Donor | Donor HLA Identical
Item
hla identical family donor available
boolean
C0470187 (UMLS CUI [1,1])
C0015576 (UMLS CUI [1,2])
C0013018 (UMLS CUI [1,3])
C0013018 (UMLS CUI [2,1])
C0019721 (UMLS CUI [2,2])
C0205280 (UMLS CUI [2,3])
Bone Marrow Transplantation allowed | Hematopoietic stem cells Collection fails
Item
bone marrow transplantation is allowed in case hematopoietic stem cell collection fails
boolean
C0005961 (UMLS CUI [1,1])
C0683607 (UMLS CUI [1,2])
C0018956 (UMLS CUI [2,1])
C0200345 (UMLS CUI [2,2])
C0231175 (UMLS CUI [2,3])
Client Characteristics
Item
patient characteristics:
boolean
C0815172 (UMLS CUI [1])
Karnofsky Performance Status
Item
karnofsky 70-100%
boolean
C0206065 (UMLS CUI [1])
Medical contraindication Absent Allogeneic Stem Cell Transplantation
Item
no contraindications to allogeneic transplantation
boolean
C1301624 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C2242529 (UMLS CUI [1,3])
Medical contraindication Absent Pharmaceutical Preparations Transplantation Conditioning
Item
no contraindications to drugs used in conditioning regimen
boolean
C1301624 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0013227 (UMLS CUI [1,3])
C0376450 (UMLS CUI [1,4])
Exclusion | Mental disorders
Item
no psychiatric illness
boolean
C2828389 (UMLS CUI [1])
C0004936 (UMLS CUI [2])
Exclusion | Cancer Other | Exception Basal cell carcinoma | Exception Carcinoma in situ of uterine cervix
Item
no other cancer within the past 5 years except basal cell skin cancer or epithelioma in situ of the cervix
boolean
C2828389 (UMLS CUI [1])
C1707251 (UMLS CUI [2])
C1705847 (UMLS CUI [3,1])
C0007117 (UMLS CUI [3,2])
C1705847 (UMLS CUI [4,1])
C0851140 (UMLS CUI [4,2])
Exclusion | Communicable Disease Serious Uncontrolled
Item
no serious and uncontrolled infection
boolean
C2828389 (UMLS CUI [1])
C0009450 (UMLS CUI [2,1])
C0205404 (UMLS CUI [2,2])
C0205318 (UMLS CUI [2,3])
Exclusion Criteria | Pregnancy | Breast Feeding
Item
not pregnant or nursing
boolean
C0680251 (UMLS CUI [1])
C0032961 (UMLS CUI [2])
C0006147 (UMLS CUI [3])
Fertility Contraceptive methods
Item
fertile patients must use effective contraception
boolean
C0015895 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
Therapeutic procedure
Item
prior concurrent therapy:
boolean
C0087111 (UMLS CUI [1])
ID.21
Item
see disease characteristics
boolean
Study Subject Participation Status
Item
at least 1 month since participation in another prior clinical trial
boolean
C2348568 (UMLS CUI [1])
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