Multiple Myeloma Treatment required for | Smoldering myeloma | Progressive Disease Requirement Chemotherapy
Item
1. patients must have the diagnosis of active mm requiring treatment. patients with a previous history of smoldering myeloma will be eligible if there is evidence of progressive disease requiring chemotherapy.
boolean
C0026764 (UMLS CUI [1,1])
C0332121 (UMLS CUI [1,2])
C1531608 (UMLS CUI [2])
C1335499 (UMLS CUI [3,1])
C1514873 (UMLS CUI [3,2])
C0392920 (UMLS CUI [3,3])
Protein Criteria Present | M component present IgG | M component present IgA | M component present IgD | M component present IgE | Urine kappa light chain measurement | Urine lambda light chain measurement | Bence Jones Protein | Free kappa light chain | Free lambda light chain | Response Evaluation | Non-secretory myeloma | Plasmacytosis Percentage MRI | Plasmacytoma Focal Multiple MRI | Lesion Focal Multiple MRI
Item
2. protein criteria must be present (quantifiable m-component of igg, iga, igd, or ige and/or urinary kappa or lambda light chain, bence-jones protein, or free kappa light chain or free lambda light chain) in order to evaluate response. non-secretory patients are eligible provided the patient has > 20% plasmacytosis or multiple (>3) focal plasmacytomas or focal lesions on mri.
boolean
C0033684 (UMLS CUI [1,1])
C0243161 (UMLS CUI [1,2])
C0150312 (UMLS CUI [1,3])
C2363751 (UMLS CUI [2,1])
C0020852 (UMLS CUI [2,2])
C2363751 (UMLS CUI [3,1])
C0020835 (UMLS CUI [3,2])
C2363751 (UMLS CUI [4,1])
C0020843 (UMLS CUI [4,2])
C2363751 (UMLS CUI [5,1])
C0020846 (UMLS CUI [5,2])
C1445960 (UMLS CUI [6])
C1445961 (UMLS CUI [7])
C0004965 (UMLS CUI [8])
C0443743 (UMLS CUI [9])
C0443744 (UMLS CUI [10])
C1704632 (UMLS CUI [11,1])
C1261322 (UMLS CUI [11,2])
C0456845 (UMLS CUI [12])
C0085663 (UMLS CUI [13,1])
C0439165 (UMLS CUI [13,2])
C0024485 (UMLS CUI [13,3])
C0032131 (UMLS CUI [14,1])
C0205234 (UMLS CUI [14,2])
C0439064 (UMLS CUI [14,3])
C0024485 (UMLS CUI [14,4])
C0221198 (UMLS CUI [15,1])
C0205234 (UMLS CUI [15,2])
C0439064 (UMLS CUI [15,3])
C0024485 (UMLS CUI [15,4])
Prior Chemotherapy | Prior radiation therapy
Item
3. patients must have received no more than 12 months of prior chemotherapy for this disease. patients may have received prior radiotherapy provided approval has been obtained by the principal investigator.
boolean
C1514457 (UMLS CUI [1])
C0279134 (UMLS CUI [2])
Age
Item
4. patients must be 18-75 years of age at the time of initial registration.
boolean
C0001779 (UMLS CUI [1])
Cardiac ejection fraction Echocardiography | Cardiac ejection fraction MUGA scan
Item
5. ejection fraction by echo or muga ≥ 40% performed within 60 days prior to registration.
boolean
C0232174 (UMLS CUI [1,1])
C0013516 (UMLS CUI [1,2])
C0232174 (UMLS CUI [2,1])
C0521317 (UMLS CUI [2,2])
Pulmonary function tests | FEV1 | FVC | Diffusion capacity of lung, function | Carbon Monoxide Diffusing Capability Test | Exception Therapeutic procedure High dose Anticipated
Item
6. patients must have adequate pulmonary function studies > 50% of predicted on mechanical aspects (fev1, fvc) and diffusion capacity (dlco) > 50% of predicted, within 60 days of registration. if the patient is unable to complete pulmonary function tests due to mm related pain or condition, exception may be granted if the principal investigator documents that the patient is a candidate for high dose therapy.
boolean
C0024119 (UMLS CUI [1])
C0849974 (UMLS CUI [2])
C3714541 (UMLS CUI [3])
C0231971 (UMLS CUI [4])
C1516251 (UMLS CUI [5])
C1705847 (UMLS CUI [6,1])
C0087111 (UMLS CUI [6,2])
C0444956 (UMLS CUI [6,3])
C3840775 (UMLS CUI [6,4])
Creatinine measurement, serum | Creatinine clearance measurement
Item
7. patients must have a creatinine < 3 mg/dl and a creatinine clearance >30ml/min
boolean
C0201976 (UMLS CUI [1])
C0373595 (UMLS CUI [2])
Performance status SWOG Criteria | Poor performance status Relationship Bone pain
Item
8. patients must have a performance status of 0-2 based on swog criteria. patients with a poor performance status (3-4), based solely on bone pain will be eligible.
boolean
C1518965 (UMLS CUI [1,1])
C1519429 (UMLS CUI [1,2])
C0243161 (UMLS CUI [1,3])
C1831741 (UMLS CUI [2,1])
C0439849 (UMLS CUI [2,2])
C0151825 (UMLS CUI [2,3])
Informed Consent
Item
9. all patients must be informed of the investigational nature of this study and must have signed an irb-approved informed consent in accordance with institutional and federal guidelines.
boolean
C0021430 (UMLS CUI [1])
Platelet Count measurement | Exception Relationship Myeloma
Item
1. platelet count < 30 x 109/l, unless myeloma-related.
boolean
C0032181 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0439849 (UMLS CUI [2,2])
C0026764 (UMLS CUI [2,3])
Peripheral Neuropathy CTCAE Grades
Item
2. greater than a grade 2 peripheral neuropathy.
boolean
C0031117 (UMLS CUI [1,1])
C1516728 (UMLS CUI [1,2])
Hypersensitivity Bortezomib | Hypersensitivity Boron | Mannitol allergy
Item
3. 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])
Diabetic - poor control
Item
4. uncontrolled diabetes.
boolean
C0421258 (UMLS CUI [1])
Myocardial Infarction | Angina, Unstable | Congestive heart failure CONTROL DIFFICULT | Uncontrolled hypertension | Cardiac Arrhythmia CONTROL DIFFICULT
Item
5. recent (< 6 months) myocardial infarction, unstable angina, difficult to control congestive heart failure, uncontrolled hypertension, or difficult to control cardiac arrhythmias.
boolean
C0027051 (UMLS CUI [1])
C0002965 (UMLS CUI [2])
C0018802 (UMLS CUI [3,1])
C0742800 (UMLS CUI [3,2])
C1868885 (UMLS CUI [4])
C0003811 (UMLS CUI [5,1])
C0742800 (UMLS CUI [5,2])
Chronic Obstructive Airway Disease | Restrictive lung disease chronic
Item
6. evidence of chronic obstructive or chronic restrictive pulmonary disease.
boolean
C0024117 (UMLS CUI [1])
C0085581 (UMLS CUI [2,1])
C0205191 (UMLS CUI [2,2])
Kidney Failure Relationship Light chain disease | Creatinine measurement, serum
Item
7. patients must not have light chain deposition disease-related renal failure or creatinine > 3 mg/dl.
boolean
C0035078 (UMLS CUI [1,1])
C0439849 (UMLS CUI [1,2])
C0238239 (UMLS CUI [1,3])
C0201976 (UMLS CUI [2])
Malignant Neoplasms | Exception Basal cell carcinoma Treated | Exception Squamous cell carcinoma of skin Treated | Exception Carcinoma in situ of uterine cervix Treated | Exception Cancer Other Untreated Duration | Life Expectancy
Item
8. 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 five years.
boolean
C0006826 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0007117 (UMLS CUI [2,2])
C1522326 (UMLS CUI [2,3])
C1705847 (UMLS CUI [3,1])
C0553723 (UMLS CUI [3,2])
C1522326 (UMLS CUI [3,3])
C1705847 (UMLS CUI [4,1])
C0851140 (UMLS CUI [4,2])
C1522326 (UMLS CUI [4,3])
C1705847 (UMLS CUI [5,1])
C1707251 (UMLS CUI [5,2])
C0332155 (UMLS CUI [5,3])
C0449238 (UMLS CUI [5,4])
C0023671 (UMLS CUI [6])
Comorbidity Significant | Communicable Disease Life Threatening Uncontrolled
Item
9. patients must not have significant co-morbid medical conditions or uncontrolled life threatening infection.
boolean
C0009488 (UMLS CUI [1,1])
C0750502 (UMLS CUI [1,2])
C0009450 (UMLS CUI [2,1])
C2826244 (UMLS CUI [2,2])
C0205318 (UMLS CUI [2,3])
Pregnancy | Breast Feeding | Childbearing Potential Pregnancy test negative | Females & males of reproductive potential Contraceptive methods
Item
10. pregnant or nursing women. women of child-bearing potential must have a negative pregnancy test documented within one week of registration. women and 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])