ID

14560

Beskrivning

A Study of Autologous Expanded Natural Killer Cell Therapy for Asymptomatic Multiple Myeloma; ODM derived from: https://clinicaltrials.gov/show/NCT01884688

Länk

https://clinicaltrials.gov/show/NCT01884688

Nyckelord

Versioner (1)
  1. 2016-04-21 2016-04-21 -
Uppladdad den

21 april 2016

DOI

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Creative Commons BY 4.0
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Eligibility Asymptomatic Multiple Myeloma NCT01884688

Engelsk

Eligibility Asymptomatic Multiple Myeloma NCT01884688

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
the study population will be participants with amm being seen at myeloma institute for research and therapy (mirt), and under continuing followup with standard clinical care testing .
Beskrivning

Asymptomatic multiple myeloma

Datatyp

boolean

Alias
UMLS CUI [1]
C2585107
participants must have a diagnosis of amm as defined in staging criteria (section 3.0) and gep-70 score >-0.26.
Beskrivning

Asymptomatic multiple myeloma | Gene Expression Profiling Score

Datatyp

boolean

Alias
UMLS CUI [1]
C2585107
UMLS CUI [2,1]
C0752248
UMLS CUI [2,2]
C0449820
participant (male or female) from any race or ethnicity must be at least 18 years of age and not older than 75 years of age at the time of registration.
Beskrivning

Age | Racial group | Ethnic group

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2]
C0034510
UMLS CUI [3]
C0015031
participants must have a performance status of 0 - 2 by zubrod criteria
Beskrivning

Zubrod Performance Status 0 | Zubrod Performance Status 1 | performance status 2

Datatyp

boolean

Alias
UMLS CUI [1]
C1518966
UMLS CUI [2]
C1518967
UMLS CUI [3]
C0278956
participants must have signed an institutional review board (irb)-approved informed consent and health insurance portability and accountability act (hipaa) authorization form.
Beskrivning

Informed Consent Institutional Review Board Approval | Health Insurance Portability and Accountability Act Authorization documentation

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C2346499
UMLS CUI [2,1]
C0600593
UMLS CUI [2,2]
C1524004
must be fit to undergo leukapheresis for enk cell generation as determined by pi.
Beskrivning

Ability Leukapheresis | Expanded Natural Killer Cells

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0085732
UMLS CUI [1,2]
C0023416
UMLS CUI [2,1]
C0205229
UMLS CUI [2,2]
C0022688
must be a suitable candidate for insertion of apheresis catheter. participants with unusual anatomy or vascular anomalies preventing insertion of apheresis catheter will not qualify.
Beskrivning

Appropriate Patient | Apheresis Catheter device

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1548787
UMLS CUI [1,2]
C0030705
UMLS CUI [2,1]
C0005791
UMLS CUI [2,2]
C0085590
patients must have previous test results indicating adequate pulmonary function studies (pft) > 50% of predicted on mechanical aspects (fev1, forced vital capacity(fvc), etc) and diffusion capacity (dlco) > 50% of predicted.
Beskrivning

Pulmonary function tests | FEV1 | Forced vital capacity - finding | Diffusion capacity of lung, function

Datatyp

boolean

Alias
UMLS CUI [1]
C0024119
UMLS CUI [2]
C0748133
UMLS CUI [3]
C1287681
UMLS CUI [4]
C0231971
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
participants must not have received prior treatment for their disease. prior use of bisphosphonates is permitted.
Beskrivning

Prior Therapy | prior use of medications Diphosphonates

Datatyp

boolean

Alias
UMLS CUI [1]
C1514463
UMLS CUI [2,1]
C2114648
UMLS CUI [2,2]
C0012544
no other prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated stage i or ii cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease-free for 2 years.
Beskrivning

Malignant Neoplasms | Basal cell carcinoma | Squamous cell carcinoma of skin | Carcinoma in situ of uterine cervix | malignant neoplasm stage i | Malignant Neoplasms Clinical stage II

Datatyp

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2]
C0007117
UMLS CUI [3]
C0553723
UMLS CUI [4]
C0851140
UMLS CUI [5]
C3250643
UMLS CUI [6,1]
C0006826
UMLS CUI [6,2]
C0205571
may not have 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.
Beskrivning

Poorly controlled hypertensive disease | poorly controlled diabetes mellitus | Serious Disease | Mental disorders | Compliance behavior Limited

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3853134
UMLS CUI [1,2]
C0020538
UMLS CUI [2]
C0554876
UMLS CUI [3,1]
C0205404
UMLS CUI [3,2]
C0012634
UMLS CUI [4]
C0004936
UMLS CUI [5,1]
C1321605
UMLS CUI [5,2]
C0439801
pregnant or nursing women may not participate. women of childbearing potential must have a negative pregnancy test documented within 10 to 14 days of enrollment. women/men of reproductive potential may not participate unless they have either agreed to practice true abstinence, when this is in line with the preferred and usual lifestyle of the participant. (periodic abstinence [eg,calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception.) or begin two reliable methods of birth control: 1 highly effective method and 1 additional effective method at the same time, at least 28 days before starting study treatment through 30 days after the last dose of study treatment.
Beskrivning

Pregnancy | Breast Feeding | Childbearing Potential | Pregnancy test negative | Sexual Abstinence | Natural Family Planning Methods | Rhythm method of contraception | Oral contraception | Temperature method of contraception | Withdrawal - birth control | Contraceptive methods

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3]
C3831118
UMLS CUI [4]
C0427780
UMLS CUI [5]
C0036899
UMLS CUI [6]
C1256761
UMLS CUI [7]
C0035513
UMLS CUI [8]
C0029151
UMLS CUI [9]
C0419534
UMLS CUI [10]
C3812880
UMLS CUI [11]
C0700589
serologic evaluation will be used to assess exposure to syphilis, west nile virus, chagas, cytomegalovirus (cmv), immunoglobulin g (igg), hepatitis b, and c, hiv i and ii, and human t cell lymphoma virus (htlv) i/ii. participants may not be hepatitis b or c (+) unless positive due to previous vaccination or positive but has received therapy and is negative for hepatitis b or c by rapid test polymerase chain reaction (rt-pcr). an hiv-i/ii(+) and htlv-1/ii (+) participant will be rejected on medical grounds. participants serologically positive for syphilis, west nile virus, chagas, cmv, are only excluded if they are being treated for active infection.
Beskrivning

Serologic Evaluation | Exposure to Syphilis | Exposure to West Nile virus | Exposure to Chagas Disease | Exposure to Cytomegalovirus | Exposure to Immunoglobulin G | Exposure to Hepatitis B | Exposure to Hepatitis C | Exposure to HIV-1 | Exposure to Human immunodeficiency virus 2 (HIV-2) | Exposure to Human T-lymphotropic virus 1 | Exposure to Human T-lymphotropic virus 2

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0205473
UMLS CUI [1,2]
C0220825
UMLS CUI [2,1]
C0332157
UMLS CUI [2,2]
C0039128
UMLS CUI [3,1]
C0332157
UMLS CUI [3,2]
C0043125
UMLS CUI [4,1]
C0332157
UMLS CUI [4,2]
C0041234
UMLS CUI [5,1]
C0332157
UMLS CUI [5,2]
C0010825
UMLS CUI [6,1]
C0332157
UMLS CUI [6,2]
C0020852
UMLS CUI [7,1]
C0332157
UMLS CUI [7,2]
C0019163
UMLS CUI [8,1]
C0332157
UMLS CUI [8,2]
C0019196
UMLS CUI [9,1]
C0332157
UMLS CUI [9,2]
C0019704
UMLS CUI [10,1]
C0332157
UMLS CUI [10,2]
C0019707
UMLS CUI [11,1]
C0332157
UMLS CUI [11,2]
C0020094
UMLS CUI [12,1]
C0332157
UMLS CUI [12,2]
C0020099
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Similar models

Eligibility Asymptomatic Multiple Myeloma NCT01884688

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Asymptomatic multiple myeloma
Item
the study population will be participants with amm being seen at myeloma institute for research and therapy (mirt), and under continuing followup with standard clinical care testing .
boolean
C2585107 (UMLS CUI [1])
Asymptomatic multiple myeloma | Gene Expression Profiling Score
Item
participants must have a diagnosis of amm as defined in staging criteria (section 3.0) and gep-70 score >-0.26.
boolean
C2585107 (UMLS CUI [1])
C0752248 (UMLS CUI [2,1])
C0449820 (UMLS CUI [2,2])
Age | Racial group | Ethnic group
Item
participant (male or female) from any race or ethnicity 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])
C0034510 (UMLS CUI [2])
C0015031 (UMLS CUI [3])
Zubrod Performance Status 0 | Zubrod Performance Status 1 | performance status 2
Item
participants must have a performance status of 0 - 2 by zubrod criteria
boolean
C1518966 (UMLS CUI [1])
C1518967 (UMLS CUI [2])
C0278956 (UMLS CUI [3])
Informed Consent Institutional Review Board Approval | Health Insurance Portability and Accountability Act Authorization documentation
Item
participants must have signed an institutional review board (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 [2,1])
C1524004 (UMLS CUI [2,2])
Ability Leukapheresis | Expanded Natural Killer Cells
Item
must be fit to undergo leukapheresis for enk cell generation as determined by pi.
boolean
C0085732 (UMLS CUI [1,1])
C0023416 (UMLS CUI [1,2])
C0205229 (UMLS CUI [2,1])
C0022688 (UMLS CUI [2,2])
Appropriate Patient | Apheresis Catheter device
Item
must be a suitable candidate for insertion of apheresis catheter. participants with unusual anatomy or vascular anomalies preventing insertion of apheresis catheter will not qualify.
boolean
C1548787 (UMLS CUI [1,1])
C0030705 (UMLS CUI [1,2])
C0005791 (UMLS CUI [2,1])
C0085590 (UMLS CUI [2,2])
Pulmonary function tests | FEV1 | Forced vital capacity - finding | Diffusion capacity of lung, function
Item
patients must have previous test results indicating adequate pulmonary function studies (pft) > 50% of predicted on mechanical aspects (fev1, forced vital capacity(fvc), etc) and diffusion capacity (dlco) > 50% of predicted.
boolean
C0024119 (UMLS CUI [1])
C0748133 (UMLS CUI [2])
C1287681 (UMLS CUI [3])
C0231971 (UMLS CUI [4])
Item Group
C0680251 (UMLS CUI)
Prior Therapy | prior use of medications Diphosphonates
Item
participants must not have received prior treatment for their disease. prior use of bisphosphonates is permitted.
boolean
C1514463 (UMLS CUI [1])
C2114648 (UMLS CUI [2,1])
C0012544 (UMLS CUI [2,2])
Malignant Neoplasms | Basal cell carcinoma | Squamous cell carcinoma of skin | Carcinoma in situ of uterine cervix | malignant neoplasm stage i | Malignant Neoplasms Clinical stage II
Item
no other prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated stage i or ii cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease-free for 2 years.
boolean
C0006826 (UMLS CUI [1])
C0007117 (UMLS CUI [2])
C0553723 (UMLS CUI [3])
C0851140 (UMLS CUI [4])
C3250643 (UMLS CUI [5])
C0006826 (UMLS CUI [6,1])
C0205571 (UMLS CUI [6,2])
Poorly controlled hypertensive disease | poorly controlled diabetes mellitus | Serious Disease | Mental disorders | Compliance behavior Limited
Item
may not have 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
C3853134 (UMLS CUI [1,1])
C0020538 (UMLS CUI [1,2])
C0554876 (UMLS CUI [2])
C0205404 (UMLS CUI [3,1])
C0012634 (UMLS CUI [3,2])
C0004936 (UMLS CUI [4])
C1321605 (UMLS CUI [5,1])
C0439801 (UMLS CUI [5,2])
Pregnancy | Breast Feeding | Childbearing Potential | Pregnancy test negative | Sexual Abstinence | Natural Family Planning Methods | Rhythm method of contraception | Oral contraception | Temperature method of contraception | Withdrawal - birth control | Contraceptive methods
Item
pregnant or nursing women may not participate. women of childbearing potential must have a negative pregnancy test documented within 10 to 14 days of enrollment. women/men of reproductive potential may not participate unless they have either agreed to practice true abstinence, when this is in line with the preferred and usual lifestyle of the participant. (periodic abstinence [eg,calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception.) or begin two reliable methods of birth control: 1 highly effective method and 1 additional effective method at the same time, at least 28 days before starting study treatment through 30 days after the last dose of study treatment.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C3831118 (UMLS CUI [3])
C0427780 (UMLS CUI [4])
C0036899 (UMLS CUI [5])
C1256761 (UMLS CUI [6])
C0035513 (UMLS CUI [7])
C0029151 (UMLS CUI [8])
C0419534 (UMLS CUI [9])
C3812880 (UMLS CUI [10])
C0700589 (UMLS CUI [11])
Serologic Evaluation | Exposure to Syphilis | Exposure to West Nile virus | Exposure to Chagas Disease | Exposure to Cytomegalovirus | Exposure to Immunoglobulin G | Exposure to Hepatitis B | Exposure to Hepatitis C | Exposure to HIV-1 | Exposure to Human immunodeficiency virus 2 (HIV-2) | Exposure to Human T-lymphotropic virus 1 | Exposure to Human T-lymphotropic virus 2
Item
serologic evaluation will be used to assess exposure to syphilis, west nile virus, chagas, cytomegalovirus (cmv), immunoglobulin g (igg), hepatitis b, and c, hiv i and ii, and human t cell lymphoma virus (htlv) i/ii. participants may not be hepatitis b or c (+) unless positive due to previous vaccination or positive but has received therapy and is negative for hepatitis b or c by rapid test polymerase chain reaction (rt-pcr). an hiv-i/ii(+) and htlv-1/ii (+) participant will be rejected on medical grounds. participants serologically positive for syphilis, west nile virus, chagas, cmv, are only excluded if they are being treated for active infection.
boolean
C0205473 (UMLS CUI [1,1])
C0220825 (UMLS CUI [1,2])
C0332157 (UMLS CUI [2,1])
C0039128 (UMLS CUI [2,2])
C0332157 (UMLS CUI [3,1])
C0043125 (UMLS CUI [3,2])
C0332157 (UMLS CUI [4,1])
C0041234 (UMLS CUI [4,2])
C0332157 (UMLS CUI [5,1])
C0010825 (UMLS CUI [5,2])
C0332157 (UMLS CUI [6,1])
C0020852 (UMLS CUI [6,2])
C0332157 (UMLS CUI [7,1])
C0019163 (UMLS CUI [7,2])
C0332157 (UMLS CUI [8,1])
C0019196 (UMLS CUI [8,2])
C0332157 (UMLS CUI [9,1])
C0019704 (UMLS CUI [9,2])
C0332157 (UMLS CUI [10,1])
C0019707 (UMLS CUI [10,2])
C0332157 (UMLS CUI [11,1])
C0020094 (UMLS CUI [11,2])
C0332157 (UMLS CUI [12,1])
C0020099 (UMLS CUI [12,2])
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