ID

15510

Beschrijving

A Phase II Trial of Oncolytic Virotherapy by Systemic Administration of Edmonston Strain of Measles Virus; ODM derived from: https://clinicaltrials.gov/show/NCT02192775

Link

https://clinicaltrials.gov/show/NCT02192775

Trefwoorden

Versies (1)
  1. 02-06-16 02-06-16 -
Geüploaded op

2 juni 2016

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Multiple Myeloma NCT02192775

Engels

Eligibility Multiple Myeloma NCT02192775

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
relapsed patients must have a confirmed mm diagnosis with high-risk disease as defined by gep70 risk score ≥ 0.66 or gep80 gene score of ≥ 2.48 or metaphase cytogenetic abnormalities or ldh ≥ 360 u/l due to mm (rule out hemolysis, infection and contact pi for clarification if any doubt). patients must have relapsed after auto-pbsct followed by further chemotherapy
Beschrijving

Multiple Myeloma | Recurrent disease | Disease High risk | Gene Expression Profiling | Metaphase Chromosome Aberrations | Lactate Dehydrogenase | Hemolysis | Communicable Diseases | Peripheral Stem Cell Transplantation Autologous | Chemotherapy Regimen

Datatype

boolean

Alias
UMLS CUI [1]
C0026764
UMLS CUI [2]
C0277556
UMLS CUI [3,1]
C0012634
UMLS CUI [3,2]
C0332167
UMLS CUI [4]
C0752248
UMLS CUI [5,1]
C1621812
UMLS CUI [5,2]
C0008625
UMLS CUI [6]
C0022917
UMLS CUI [7]
C0019054
UMLS CUI [8]
C0009450
UMLS CUI [9,1]
C0242602
UMLS CUI [9,2]
C0439859
UMLS CUI [10]
C0392920
≥2 months must have elapsed after the last peripheral blood stem cell transplant prior to enrollment
Beschrijving

Peripheral Stem Cell Transplantation Last | Elapsed Time

Datatype

boolean

Alias
UMLS CUI [1,1]
C0242602
UMLS CUI [1,2]
C1517741
UMLS CUI [2]
C2826303
zubrod ≤ 2, unless solely due to symptoms of mm-related (bone) disease
Beschrijving

Zubrod Performance Status | Symptoms Bone Disease Due to Multiple Myeloma

Datatype

boolean

Alias
UMLS CUI [1]
C3714786
UMLS CUI [2,1]
C1457887
UMLS CUI [2,2]
C0005940
UMLS CUI [2,3]
C0678226
UMLS CUI [2,4]
C0026764
patients must have a platelet count of ≥ 20,000/µl within 45 days of registration, unless lower levels are explained by extensive bm plasmacytosis or extensive prior therapy
Beschrijving

Platelet Count measurement | Plasmacytosis Bone Marrow Extensive | Prior Therapy Extensive

Datatype

boolean

Alias
UMLS CUI [1]
C0032181
UMLS CUI [2,1]
C0085663
UMLS CUI [2,2]
C0005953
UMLS CUI [2,3]
C0205231
UMLS CUI [3,1]
C1514463
UMLS CUI [3,2]
C0205231
patients must be at least 18 years of age and not older than 75 years of age at the time of registration
Beschrijving

Age

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
participants must have preserved renal function as defined by a serum creatinine level of ≤ 3 mg/dl within 45 days of registration
Beschrijving

Renal function | Serum creatinine level

Datatype

boolean

Alias
UMLS CUI [1]
C0232804
UMLS CUI [2]
C0600061
participants must have an ejection fraction by echo or muga scan ≥ 40% within 45 days prior to registration
Beschrijving

Ejection fraction | Echoencephalography | Multiple gated acquisition scanning

Datatype

boolean

Alias
UMLS CUI [1]
C0489482
UMLS CUI [2]
C0013526
UMLS CUI [3]
C0521317
patients must have adequate pulmonary function studies > 50% of predicted on mechanical aspects (fev1, etc) and diffusion capacity (dlco) > 50% of predicted within 45 days prior to registration. if the patient is unable to complete pulmonary function tests due to mm related pain or condition, exception may be granted
Beschrijving

Pulmonary function | FEV1 | DLCO

Datatype

boolean

Alias
UMLS CUI [1]
C0231921
UMLS CUI [2]
C0748133
UMLS CUI [3]
C1516251
patients must have signed an irb-approved informed consent and health insurance portability and accountability act (hipaa) authorization form
Beschrijving

Informed Consent IRB Approval | HIPAA

Datatype

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C2346499
UMLS CUI [2]
C0600593
patients must have anti-mv igg titer of ≤ 0.5u/ml (mayo clinic assay). mayo clinic will also assay the patients' igm titer and perform a neutralizing antibody plaque-assay to determine recent mv exposure and the ability of the patients'
Beschrijving

Measles virus IgG Titer | Mayo Clinic Cancer Center | Measles virus IgM Titer | Measles virus

Datatype

boolean

Alias
UMLS CUI [1,1]
C0553471
UMLS CUI [1,2]
C0475208
UMLS CUI [2]
C1513038
UMLS CUI [3,1]
C0553472
UMLS CUI [3,2]
C0475208
UMLS CUI [4]
C0025011
circulating antibodies to inhibit mv propagation on vero cells, respectively. while these tests are additional indicators of patient eligibility, final enrollment decision will be determined by igg levels
Beschrijving

Measurement of Measles virus antibody | Vero Cells | Measles IgG level

Datatype

boolean

Alias
UMLS CUI [1]
C0523315
UMLS CUI [2]
C0042542
UMLS CUI [3]
C1277842
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients may not be positive for the human immunodeficiency virus (hiv)
Beschrijving

HIV Seropositivity

Datatype

boolean

Alias
UMLS CUI [1]
C0019699
history of poorly controlled hypertension, diabetes mellitus, or any other serious medical illness or psychiatric illness that could potentially interfere with the completion of treatment according to this protocol or could be considered to be an exclusion criterion deemed by the pi
Beschrijving

Hypertensive disease Poorly controlled | Diabetes Mellitus | Illness Serious | Mental disorders | Compliance behavior Limited

Datatype

boolean

Alias
UMLS CUI [1,1]
C0020538
UMLS CUI [1,2]
C3853134
UMLS CUI [2]
C0011849
UMLS CUI [3,1]
C0221423
UMLS CUI [3,2]
C0205404
UMLS CUI [4]
C0004936
UMLS CUI [5,1]
C1321605
UMLS CUI [5,2]
C0439801
patients must not have prior malignancy, except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer for which the patient has not received treatment for one year prior to enrollment. other cancers will only be acceptable if the patient's life expectancy exceeds three years as determined by the pi
Beschrijving

Malignant Neoplasms Previous | Basal cell carcinoma | Squamous cell carcinoma of skin | Carcinoma in situ of uterine cervix | Cancer treatment | Life Expectancy

Datatype

boolean

Alias
UMLS CUI [1,1]
C0006826
UMLS CUI [1,2]
C0205156
UMLS CUI [2]
C0007117
UMLS CUI [3]
C0553723
UMLS CUI [4]
C0851140
UMLS CUI [5]
C0920425
UMLS CUI [6]
C0023671
pregnant or nursing women may not participate. women of childbearing potential must have a negative pregnancy test documented within one week of registration. women/men of reproductive potential may not participate unless they have agreed to use an effective contraceptive method
Beschrijving

Pregnancy | Breast Feeding | Childbearing Potential Pregnancy test negative | Reproductive potential Contraceptive methods

Datatype

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3,1]
C3831118
UMLS CUI [3,2]
C0427780
UMLS CUI [4,1]
C4034483
UMLS CUI [4,2]
C0700589
exposure to household contacts ≤ 15 months old or household contact with known immunodeficiency
Beschrijving

Household Contact Exposure to | Household Contact Immunologic Deficiency Syndromes

Datatype

boolean

Alias
UMLS CUI [1,1]
C3640861
UMLS CUI [1,2]
C0332157
UMLS CUI [2,1]
C3640861
UMLS CUI [2,2]
C0021051
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Similar models

Eligibility Multiple Myeloma NCT02192775

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Multiple Myeloma | Recurrent disease | Disease High risk | Gene Expression Profiling | Metaphase Chromosome Aberrations | Lactate Dehydrogenase | Hemolysis | Communicable Diseases | Peripheral Stem Cell Transplantation Autologous | Chemotherapy Regimen
Item
relapsed patients must have a confirmed mm diagnosis with high-risk disease as defined by gep70 risk score ≥ 0.66 or gep80 gene score of ≥ 2.48 or metaphase cytogenetic abnormalities or ldh ≥ 360 u/l due to mm (rule out hemolysis, infection and contact pi for clarification if any doubt). patients must have relapsed after auto-pbsct followed by further chemotherapy
boolean
C0026764 (UMLS CUI [1])
C0277556 (UMLS CUI [2])
C0012634 (UMLS CUI [3,1])
C0332167 (UMLS CUI [3,2])
C0752248 (UMLS CUI [4])
C1621812 (UMLS CUI [5,1])
C0008625 (UMLS CUI [5,2])
C0022917 (UMLS CUI [6])
C0019054 (UMLS CUI [7])
C0009450 (UMLS CUI [8])
C0242602 (UMLS CUI [9,1])
C0439859 (UMLS CUI [9,2])
C0392920 (UMLS CUI [10])
Peripheral Stem Cell Transplantation Last | Elapsed Time
Item
≥2 months must have elapsed after the last peripheral blood stem cell transplant prior to enrollment
boolean
C0242602 (UMLS CUI [1,1])
C1517741 (UMLS CUI [1,2])
C2826303 (UMLS CUI [2])
Zubrod Performance Status | Symptoms Bone Disease Due to Multiple Myeloma
Item
zubrod ≤ 2, unless solely due to symptoms of mm-related (bone) disease
boolean
C3714786 (UMLS CUI [1])
C1457887 (UMLS CUI [2,1])
C0005940 (UMLS CUI [2,2])
C0678226 (UMLS CUI [2,3])
C0026764 (UMLS CUI [2,4])
Platelet Count measurement | Plasmacytosis Bone Marrow Extensive | Prior Therapy Extensive
Item
patients must have a platelet count of ≥ 20,000/µl within 45 days of registration, unless lower levels are explained by extensive bm plasmacytosis or extensive prior therapy
boolean
C0032181 (UMLS CUI [1])
C0085663 (UMLS CUI [2,1])
C0005953 (UMLS CUI [2,2])
C0205231 (UMLS CUI [2,3])
C1514463 (UMLS CUI [3,1])
C0205231 (UMLS CUI [3,2])
Age
Item
patients must be at least 18 years of age and not older than 75 years of age at the time of registration
boolean
C0001779 (UMLS CUI [1])
Renal function | Serum creatinine level
Item
participants must have preserved renal function as defined by a serum creatinine level of ≤ 3 mg/dl within 45 days of registration
boolean
C0232804 (UMLS CUI [1])
C0600061 (UMLS CUI [2])
Ejection fraction | Echoencephalography | Multiple gated acquisition scanning
Item
participants must have an ejection fraction by echo or muga scan ≥ 40% within 45 days prior to registration
boolean
C0489482 (UMLS CUI [1])
C0013526 (UMLS CUI [2])
C0521317 (UMLS CUI [3])
Pulmonary function | FEV1 | DLCO
Item
patients must have adequate pulmonary function studies > 50% of predicted on mechanical aspects (fev1, etc) and diffusion capacity (dlco) > 50% of predicted within 45 days prior to registration. if the patient is unable to complete pulmonary function tests due to mm related pain or condition, exception may be granted
boolean
C0231921 (UMLS CUI [1])
C0748133 (UMLS CUI [2])
C1516251 (UMLS CUI [3])
Informed Consent IRB Approval | HIPAA
Item
patients must have signed an irb-approved informed consent and health insurance portability and accountability act (hipaa) authorization form
boolean
C0021430 (UMLS CUI [1,1])
C2346499 (UMLS CUI [1,2])
C0600593 (UMLS CUI [2])
Measles virus IgG Titer | Mayo Clinic Cancer Center | Measles virus IgM Titer | Measles virus
Item
patients must have anti-mv igg titer of ≤ 0.5u/ml (mayo clinic assay). mayo clinic will also assay the patients' igm titer and perform a neutralizing antibody plaque-assay to determine recent mv exposure and the ability of the patients'
boolean
C0553471 (UMLS CUI [1,1])
C0475208 (UMLS CUI [1,2])
C1513038 (UMLS CUI [2])
C0553472 (UMLS CUI [3,1])
C0475208 (UMLS CUI [3,2])
C0025011 (UMLS CUI [4])
Measurement of Measles virus antibody | Vero Cells | Measles IgG level
Item
circulating antibodies to inhibit mv propagation on vero cells, respectively. while these tests are additional indicators of patient eligibility, final enrollment decision will be determined by igg levels
boolean
C0523315 (UMLS CUI [1])
C0042542 (UMLS CUI [2])
C1277842 (UMLS CUI [3])
Item Group
C0680251 (UMLS CUI)
HIV Seropositivity
Item
patients may not be positive for the human immunodeficiency virus (hiv)
boolean
C0019699 (UMLS CUI [1])
Hypertensive disease Poorly controlled | Diabetes Mellitus | Illness Serious | Mental disorders | Compliance behavior Limited
Item
history of poorly controlled hypertension, diabetes mellitus, or any other serious medical illness or psychiatric illness that could potentially interfere with the completion of treatment according to this protocol or could be considered to be an exclusion criterion deemed by the pi
boolean
C0020538 (UMLS CUI [1,1])
C3853134 (UMLS CUI [1,2])
C0011849 (UMLS CUI [2])
C0221423 (UMLS CUI [3,1])
C0205404 (UMLS CUI [3,2])
C0004936 (UMLS CUI [4])
C1321605 (UMLS CUI [5,1])
C0439801 (UMLS CUI [5,2])
Malignant Neoplasms Previous | Basal cell carcinoma | Squamous cell carcinoma of skin | Carcinoma in situ of uterine cervix | Cancer treatment | Life Expectancy
Item
patients must not have prior malignancy, except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer for which the patient has not received treatment for one year prior to enrollment. other cancers will only be acceptable if the patient's life expectancy exceeds three years as determined by the pi
boolean
C0006826 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
C0007117 (UMLS CUI [2])
C0553723 (UMLS CUI [3])
C0851140 (UMLS CUI [4])
C0920425 (UMLS CUI [5])
C0023671 (UMLS CUI [6])
Pregnancy | Breast Feeding | Childbearing Potential Pregnancy test negative | Reproductive potential Contraceptive methods
Item
pregnant or nursing women may not participate. women of childbearing potential must have a negative pregnancy test documented within one week of registration. women/men of reproductive potential may not participate unless they have agreed to use an effective contraceptive method
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C3831118 (UMLS CUI [3,1])
C0427780 (UMLS CUI [3,2])
C4034483 (UMLS CUI [4,1])
C0700589 (UMLS CUI [4,2])
Household Contact Exposure to | Household Contact Immunologic Deficiency Syndromes
Item
exposure to household contacts ≤ 15 months old or household contact with known immunodeficiency
boolean
C3640861 (UMLS CUI [1,1])
C0332157 (UMLS CUI [1,2])
C3640861 (UMLS CUI [2,1])
C0021051 (UMLS CUI [2,2])
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