ID

30830

Beskrivning

Bortezomib, Thalidomide, and Dexamethasone After Melphalan and Stem Cell Transplant in Treating Patients With Stage I-III Multiple Myeloma; ODM derived from: https://clinicaltrials.gov/show/NCT00792142

Länk

https://clinicaltrials.gov/show/NCT00792142

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 NCT00792142

Engelsk

Eligibility Multiple Myeloma and Plasma Cell Neoplasm NCT00792142

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
multiple myeloma patients with symptomatic disease, stage ii or iii at diagnosis or progressive stage i requiring chemotherapy and/or radiation therapy (by salmon-durie classification), who are not eligible for tandem transplant study using tmi; because of previous radiation or eligibility criteria; documentation of disease staging by both salmon-durie classification and international staging system (iss) is required
Beskrivning

Multiple Myeloma Symptomatic Tumor stage | Multiple Myeloma Progressive Durie/Salmon Stage | Patient need for Chemotherapy | Patient need for Therapeutic radiology procedure | Ineligibility Tandem Hematopoietic Stem Cell Transplantation Study | Ineligibility Total Marrow Irradiation | Disease Documentation International Staging System for Myeloma

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0026764
UMLS CUI [1,2]
C0231220
UMLS CUI [1,3]
C1300072
UMLS CUI [2,1]
C0026764
UMLS CUI [2,2]
C0205329
UMLS CUI [2,3]
C4528204
UMLS CUI [3,1]
C0686904
UMLS CUI [3,2]
C0392920
UMLS CUI [4,1]
C0686904
UMLS CUI [4,2]
C1522449
UMLS CUI [5,1]
C1512714
UMLS CUI [5,2]
C3897372
UMLS CUI [5,3]
C2603343
UMLS CUI [6,1]
C1512714
UMLS CUI [6,2]
C2348809
UMLS CUI [7,1]
C0012634
UMLS CUI [7,2]
C0920316
UMLS CUI [7,3]
C2346508
patients with non-secretory myeloma should have measurable serum free-light chain protein by the free-lite test or measurable disease such as a soft tissue myeloma
Beskrivning

Non-secretory myeloma | Serum Free Immunoglobulin Light Chain Measurable | Other Coding | Measurable Disease | Soft tissue Myeloma

Datatyp

boolean

Alias
UMLS CUI [1]
C0456845
UMLS CUI [2,1]
C2827352
UMLS CUI [2,2]
C1513040
UMLS CUI [3]
C3846158
UMLS CUI [4]
C1513041
UMLS CUI [5,1]
C0225317
UMLS CUI [5,2]
C0026764
a minimum of 4 x 10^6 of cd 34 positive cell/kg has been harvested
Beskrivning

Minimum Cell positive for CD34 antigen Quantity Per Kilogram

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1524031
UMLS CUI [1,2]
C0882849
UMLS CUI [1,3]
C1265611
UMLS CUI [1,4]
C4054209
a karnofsky performance status (kps) of >= 70% is required unless the kps is impaired due to bone disease
Beskrivning

Karnofsky Performance Status | Exception Impairment Due to Bone Diseases

Datatyp

boolean

Alias
UMLS CUI [1]
C0206065
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0221099
UMLS CUI [2,3]
C0678226
UMLS CUI [2,4]
C0005940
no contraindication to the collection of a minimum of 4 x 10^6 cd34+ cells/kg by apheresis
Beskrivning

Medical contraindication Absent Collection Cell positive for CD34 antigen | Cell positive for CD34 antigen Quantity Per Kilogram Apheresis

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0332197
UMLS CUI [1,3]
C0200345
UMLS CUI [1,4]
C0882849
UMLS CUI [2,1]
C0882849
UMLS CUI [2,2]
C1265611
UMLS CUI [2,3]
C4054209
UMLS CUI [2,4]
C0005791
all patients must have signed a voluntary, informed consent in accordance with institutional and federal guidelines
Beskrivning

Informed Consent

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
bilirubin =< 1.5 mg/dl
Beskrivning

Serum total bilirubin measurement

Datatyp

boolean

Alias
UMLS CUI [1]
C1278039
serum glutamic oxaloacetic transaminase (sgot) and serum glutamic pyruvate transaminase (sgpt) < 2.5 x upper limits of normal
Beskrivning

Aspartate aminotransferase measurement | Alanine aminotransferase measurement

Datatyp

boolean

Alias
UMLS CUI [1]
C0201899
UMLS CUI [2]
C0201836
creatinine clearance of >= 40cc/min
Beskrivning

Creatinine clearance measurement

Datatyp

boolean

Alias
UMLS CUI [1]
C0373595
absolute neutrophil count of > 1000/ul
Beskrivning

Absolute neutrophil count

Datatyp

boolean

Alias
UMLS CUI [1]
C0948762
platelet count of > 100,000/ul
Beskrivning

Platelet Count measurement

Datatyp

boolean

Alias
UMLS CUI [1]
C0032181
cardiac ejection fraction >= 45% by multigated acquisition (muga) scan and/or by echocardiogram
Beskrivning

Cardiac ejection fraction MUGA scan | Cardiac ejection fraction Echocardiography

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0232174
UMLS CUI [1,2]
C0521317
UMLS CUI [2,1]
C0232174
UMLS CUI [2,2]
C0013516
diffusing capacity of the lung for carbon monoxide (dlco) >= 50% of predicted lower limit
Beskrivning

Carbon Monoxide Diffusing Capability Test

Datatyp

boolean

Alias
UMLS CUI [1]
C1516251
human immunodeficiency virus (hiv) antibody tests negative
Beskrivning

HIV antibody negative

Datatyp

boolean

Alias
UMLS CUI [1]
C1142096
no other medical, or psychosocial problems which in the opinion of the primary physician or principal investigator would place the patient at unacceptably high risk from this treatment regimen
Beskrivning

Patient Problem Absent | Psychosocial problem Absent | High risk Due to Therapeutic procedure

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1254481
UMLS CUI [1,2]
C0332197
UMLS CUI [2,1]
C0740697
UMLS CUI [2,2]
C0332197
UMLS CUI [3,1]
C0332167
UMLS CUI [3,2]
C0678226
UMLS CUI [3,3]
C0087111
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
presence of peripheral neuropathy >= grade ii
Beskrivning

Peripheral Neuropathy CTCAE Grades

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0031117
UMLS CUI [1,2]
C1516728
patients with evidence of disease progression (with >= 25% increase in m protein) on bortezomib and or thalidomide therapy prior to transplant
Beskrivning

Disease Progression | Increase M Protein Percentage | Bortezomib | Thalidomide

Datatyp

boolean

Alias
UMLS CUI [1]
C0242656
UMLS CUI [2,1]
C0442805
UMLS CUI [2,2]
C0700271
UMLS CUI [2,3]
C0439165
UMLS CUI [3]
C1176309
UMLS CUI [4]
C0039736
pregnant or nursing women, as well as women of child bearing age, who are unwilling to use a dual method of contraception and men who are unwilling to use condom
Beskrivning

Pregnancy | Breast Feeding | Childbearing Potential Contraceptive methods Double Unwilling | Gender Male Condoms Unwilling

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3,1]
C3831118
UMLS CUI [3,2]
C0700589
UMLS CUI [3,3]
C0205173
UMLS CUI [3,4]
C0558080
UMLS CUI [4,1]
C0079399
UMLS CUI [4,2]
C0009653
UMLS CUI [4,3]
C0558080
patients with history of hypersensitivity to bortezomib, boron or mannitol
Beskrivning

Hypersensitivity Bortezomib | Hypersensitivity Boron | Mannitol allergy

Datatyp

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
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Similar models

Eligibility Multiple Myeloma and Plasma Cell Neoplasm NCT00792142

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Multiple Myeloma Symptomatic Tumor stage | Multiple Myeloma Progressive Durie/Salmon Stage | Patient need for Chemotherapy | Patient need for Therapeutic radiology procedure | Ineligibility Tandem Hematopoietic Stem Cell Transplantation Study | Ineligibility Total Marrow Irradiation | Disease Documentation International Staging System for Myeloma
Item
multiple myeloma patients with symptomatic disease, stage ii or iii at diagnosis or progressive stage i requiring chemotherapy and/or radiation therapy (by salmon-durie classification), who are not eligible for tandem transplant study using tmi; because of previous radiation or eligibility criteria; documentation of disease staging by both salmon-durie classification and international staging system (iss) is required
boolean
C0026764 (UMLS CUI [1,1])
C0231220 (UMLS CUI [1,2])
C1300072 (UMLS CUI [1,3])
C0026764 (UMLS CUI [2,1])
C0205329 (UMLS CUI [2,2])
C4528204 (UMLS CUI [2,3])
C0686904 (UMLS CUI [3,1])
C0392920 (UMLS CUI [3,2])
C0686904 (UMLS CUI [4,1])
C1522449 (UMLS CUI [4,2])
C1512714 (UMLS CUI [5,1])
C3897372 (UMLS CUI [5,2])
C2603343 (UMLS CUI [5,3])
C1512714 (UMLS CUI [6,1])
C2348809 (UMLS CUI [6,2])
C0012634 (UMLS CUI [7,1])
C0920316 (UMLS CUI [7,2])
C2346508 (UMLS CUI [7,3])
Non-secretory myeloma | Serum Free Immunoglobulin Light Chain Measurable | Other Coding | Measurable Disease | Soft tissue Myeloma
Item
patients with non-secretory myeloma should have measurable serum free-light chain protein by the free-lite test or measurable disease such as a soft tissue myeloma
boolean
C0456845 (UMLS CUI [1])
C2827352 (UMLS CUI [2,1])
C1513040 (UMLS CUI [2,2])
C3846158 (UMLS CUI [3])
C1513041 (UMLS CUI [4])
C0225317 (UMLS CUI [5,1])
C0026764 (UMLS CUI [5,2])
Minimum Cell positive for CD34 antigen Quantity Per Kilogram
Item
a minimum of 4 x 10^6 of cd 34 positive cell/kg has been harvested
boolean
C1524031 (UMLS CUI [1,1])
C0882849 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
C4054209 (UMLS CUI [1,4])
Karnofsky Performance Status | Exception Impairment Due to Bone Diseases
Item
a karnofsky performance status (kps) of >= 70% is required unless the kps is impaired due to bone disease
boolean
C0206065 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0221099 (UMLS CUI [2,2])
C0678226 (UMLS CUI [2,3])
C0005940 (UMLS CUI [2,4])
Medical contraindication Absent Collection Cell positive for CD34 antigen | Cell positive for CD34 antigen Quantity Per Kilogram Apheresis
Item
no contraindication to the collection of a minimum of 4 x 10^6 cd34+ cells/kg by apheresis
boolean
C1301624 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0200345 (UMLS CUI [1,3])
C0882849 (UMLS CUI [1,4])
C0882849 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
C4054209 (UMLS CUI [2,3])
C0005791 (UMLS CUI [2,4])
Informed Consent
Item
all patients must have signed a voluntary, informed consent in accordance with institutional and federal guidelines
boolean
C0021430 (UMLS CUI [1])
Serum total bilirubin measurement
Item
bilirubin =< 1.5 mg/dl
boolean
C1278039 (UMLS CUI [1])
Aspartate aminotransferase measurement | Alanine aminotransferase measurement
Item
serum glutamic oxaloacetic transaminase (sgot) and serum glutamic pyruvate transaminase (sgpt) < 2.5 x upper limits of normal
boolean
C0201899 (UMLS CUI [1])
C0201836 (UMLS CUI [2])
Creatinine clearance measurement
Item
creatinine clearance of >= 40cc/min
boolean
C0373595 (UMLS CUI [1])
Absolute neutrophil count
Item
absolute neutrophil count of > 1000/ul
boolean
C0948762 (UMLS CUI [1])
Platelet Count measurement
Item
platelet count of > 100,000/ul
boolean
C0032181 (UMLS CUI [1])
Cardiac ejection fraction MUGA scan | Cardiac ejection fraction Echocardiography
Item
cardiac ejection fraction >= 45% by multigated acquisition (muga) scan and/or by echocardiogram
boolean
C0232174 (UMLS CUI [1,1])
C0521317 (UMLS CUI [1,2])
C0232174 (UMLS CUI [2,1])
C0013516 (UMLS CUI [2,2])
Carbon Monoxide Diffusing Capability Test
Item
diffusing capacity of the lung for carbon monoxide (dlco) >= 50% of predicted lower limit
boolean
C1516251 (UMLS CUI [1])
HIV antibody negative
Item
human immunodeficiency virus (hiv) antibody tests negative
boolean
C1142096 (UMLS CUI [1])
Patient Problem Absent | Psychosocial problem Absent | High risk Due to Therapeutic procedure
Item
no other medical, or psychosocial problems which in the opinion of the primary physician or principal investigator would place the patient at unacceptably high risk from this treatment regimen
boolean
C1254481 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0740697 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0332167 (UMLS CUI [3,1])
C0678226 (UMLS CUI [3,2])
C0087111 (UMLS CUI [3,3])
Item Group
C0680251 (UMLS CUI)
Peripheral Neuropathy CTCAE Grades
Item
presence of peripheral neuropathy >= grade ii
boolean
C0031117 (UMLS CUI [1,1])
C1516728 (UMLS CUI [1,2])
Disease Progression | Increase M Protein Percentage | Bortezomib | Thalidomide
Item
patients with evidence of disease progression (with >= 25% increase in m protein) on bortezomib and or thalidomide therapy prior to transplant
boolean
C0242656 (UMLS CUI [1])
C0442805 (UMLS CUI [2,1])
C0700271 (UMLS CUI [2,2])
C0439165 (UMLS CUI [2,3])
C1176309 (UMLS CUI [3])
C0039736 (UMLS CUI [4])
Pregnancy | Breast Feeding | Childbearing Potential Contraceptive methods Double Unwilling | Gender Male Condoms Unwilling
Item
pregnant or nursing women, as well as women of child bearing age, who are unwilling to use a dual method of contraception and men who are unwilling to use condom
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C3831118 (UMLS CUI [3,1])
C0700589 (UMLS CUI [3,2])
C0205173 (UMLS CUI [3,3])
C0558080 (UMLS CUI [3,4])
C0079399 (UMLS CUI [4,1])
C0009653 (UMLS CUI [4,2])
C0558080 (UMLS CUI [4,3])
Hypersensitivity Bortezomib | Hypersensitivity Boron | Mannitol allergy
Item
patients with history of 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])
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