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])
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])