Multiple Myeloma Symptomatic
Item
patients must have a confirmed diagnosis of symptomatic myeloma in accordance with international myeloma working group (imwg) criteria
boolean
C0026764 (UMLS CUI [1,1])
C0231220 (UMLS CUI [1,2])
BONE MARROW PLASMACYTOSIS | Plasma Cells | Plasmacytoma | Biopsy
Item
bone marrow plasmacytosis with > 10% plasma cells or sheets of plasma cells or biopsy proven plasmacytoma
boolean
C0238803 (UMLS CUI [1])
C0032112 (UMLS CUI [2])
C0032131 (UMLS CUI [3])
C0005558 (UMLS CUI [4])
Disease Symptomatic | end organ damage Due to Multiple Myeloma | Anemia | Hypercalcemia | Bone Diseases | Lytic lesion | Pathological fracture | Renal dysfunction
Item
symptomatic disease, i.e., end-organ damage due to multiple myeloma (mm) including at least one of the following: anemia, hypercalcemia, bone disease (lytic bone lesions or pathologic fracture), or renal dysfunction
boolean
C0012634 (UMLS CUI [1,1])
C0231220 (UMLS CUI [1,2])
C0743496 (UMLS CUI [2,1])
C0678226 (UMLS CUI [2,2])
C0026764 (UMLS CUI [2,3])
C0002871 (UMLS CUI [3])
C0020437 (UMLS CUI [4])
C0005940 (UMLS CUI [5])
C0221204 (UMLS CUI [6])
C0016663 (UMLS CUI [7])
C3279454 (UMLS CUI [8])
Absolute neutrophil count
Item
absolute neutrophil count (anc) >= 1000 cells/mm^3 (without use of growth factors)
boolean
C0948762 (UMLS CUI [1])
Platelet Count measurement
Item
platelets >= 50,000 cells/mm^3
boolean
C0032181 (UMLS CUI [1])
Bilirubin, direct measurement | Increased bilirubin level Due to Gilbert Disease | Increased bilirubin level Due to Hemolysis
Item
direct bilirubin =< 1.5 x upper limit of normal (uln); elevated bilirubin is permissible if patient has a known history of elevated bilirubin due to gilbert's or if elevated bilirubin is due to hemolysis
boolean
C0201916 (UMLS CUI [1])
C0311468 (UMLS CUI [2,1])
C0678226 (UMLS CUI [2,2])
C0017551 (UMLS CUI [2,3])
C0311468 (UMLS CUI [3,1])
C0678226 (UMLS CUI [3,2])
C0019054 (UMLS CUI [3,3])
Alanine aminotransferase measurement
Item
alanine aminotransferase (alt) (serum glutamate pyruvate transaminase [sgpt]) =< 1.5 x uln
boolean
C0201836 (UMLS CUI [1])
Informed consent
Item
subjects must have the ability to understand and the willingness to sign a written informed consent document
boolean
C0021430 (UMLS CUI [1])
Prior Therapy | Multiple Myeloma Neoadjuvant Therapy
Item
prior treatment with > 1 cycle of any plasma cell myeloma (pcm) induction regimen (maximum 6 weeks of prior treatment)
boolean
C1514463 (UMLS CUI [1])
C0026764 (UMLS CUI [2,1])
C0600558 (UMLS CUI [2,2])
prior radiation therapy
Item
prior radiation therapy is allowed
boolean
C0279134 (UMLS CUI [1])
Prior Therapy Malignant Neoplasms Other | physiological aspects Hematopoietic | organ function | Chemotherapy Malignant Neoplasm Other
Item
prior treatment for other cancers is allowed as long as patient meets criteria for adequate hematopoietic and organ function and is not actively on chemotherapy for another cancer
boolean
C1514463 (UMLS CUI [1,1])
C0006826 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C0031843 (UMLS CUI [2,1])
C0229601 (UMLS CUI [2,2])
C0678852 (UMLS CUI [3])
C3665472 (UMLS CUI [4,1])
C0006826 (UMLS CUI [4,2])
C0205394 (UMLS CUI [4,3])
Peripheral Neuropathy
Item
grade >= 2 peripheral neuropathy
boolean
C0031117 (UMLS CUI [1])
Neoplasms, Second Primary | Chemotherapy | Therapeutic radiology procedure | Hormone Therapy Breast Carcinoma | Hormone Therapy Prostate carcinoma
Item
second malignancy currently undergoing chemotherapy or radiotherapy; hormonal therapy for breast or prostate cancer is allowed
boolean
C0085183 (UMLS CUI [1])
C0392920 (UMLS CUI [2])
C1522449 (UMLS CUI [3])
C0279025 (UMLS CUI [4,1])
C0678222 (UMLS CUI [4,2])
C0279025 (UMLS CUI [5,1])
C0600139 (UMLS CUI [5,2])
Investigational New Drugs Other
Item
patients may not be receiving any other investigational agents
boolean
C0013230 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
Allergic Reaction bortezomib | Allergic Reaction Cyclophosphamide | Allergic Reaction Dexamethasone | Allergic Reaction Investigational New Drugs
Item
history of allergic reactions attributed to compounds of similar chemical or biologic composition to bortezomib, cyclophosphamide, dexamethasone or other agents used in this study
boolean
C1527304 (UMLS CUI [1,1])
C1176309 (UMLS CUI [1,2])
C1527304 (UMLS CUI [2,1])
C0010583 (UMLS CUI [2,2])
C1527304 (UMLS CUI [3,1])
C0011777 (UMLS CUI [3,2])
C1527304 (UMLS CUI [4,1])
C0013230 (UMLS CUI [4,2])
Comorbidity Compliance behavior Limited | Communicable Diseases | Symptomatic congestive heart failure | Angina, Unstable | Cardiac Arrhythmia | Mental disorders | social situation
Item
patients with uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
boolean
C0009488 (UMLS CUI [1,1])
C1321605 (UMLS CUI [1,2])
C0439801 (UMLS CUI [1,3])
C0009450 (UMLS CUI [2])
C0742758 (UMLS CUI [3])
C0002965 (UMLS CUI [4])
C0003811 (UMLS CUI [5])
C0004936 (UMLS CUI [6])
C0748872 (UMLS CUI [7])