Smoldering myeloma
Item
diagnosis of smoldering multiple myeloma (smm) for <4 years
boolean
C1531608 (UMLS CUI [1])
High risk Smoldering myeloma | Bone marrow plasma cells Percentage | Serum Monoclonal Protein Measurement | Free Light Chain Ratio Measurement Abnormal
Item
diagnosis of high-risk smm (defined as bone marrow plasma cells >=10% and either serum monoclonal protein >=3 g/dl, or abnormal free light chain ratio <0.126 or >8 and serum m-protein <3 g/dl but >=1 g/dl)
boolean
C4319571 (UMLS CUI [1,1])
C1531608 (UMLS CUI [1,2])
C2238293 (UMLS CUI [2,1])
C0439165 (UMLS CUI [2,2])
C0229671 (UMLS CUI [3,1])
C2984963 (UMLS CUI [3,2])
C3274398 (UMLS CUI [4,1])
C0205161 (UMLS CUI [4,2])
Laboratory Results Study Protocol
Item
patients must be within certain limits for protocol-specified laboratory tests
boolean
C1254595 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])
ECOG performance status
Item
eastern cooperative oncology group (ecog) performance status score of 0 or 1
boolean
C1520224 (UMLS CUI [1])
Postmenopausal state | Female Sterilization | Pregnancy Unable
Item
women not of childbearing potential must be postmenopausal, permanently sterilized, or otherwise incapable of pregnancy
boolean
C0232970 (UMLS CUI [1])
C0015787 (UMLS CUI [2])
C0032961 (UMLS CUI [3,1])
C1299582 (UMLS CUI [3,2])
Childbearing Potential Contraceptive methods | Childbearing Potential Egg Donation Absent | Childbearing Potential Pregnancy test negative
Item
women of childbearing potential must agree to use adequate birth control measures and agree to not donate eggs for the purpose of assisted reproduction during the study and for 3 months after receiving the last dose of study agent, and must have a negative pregnancy test at screening
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C3831118 (UMLS CUI [2,1])
C4053456 (UMLS CUI [2,2])
C0332197 (UMLS CUI [2,3])
C3831118 (UMLS CUI [3,1])
C0427780 (UMLS CUI [3,2])
Gender | Barrier Contraception Double | Sperm donation Absent
Item
men must agree to use a double-barrier method of birth control and to not donate sperm during the study and for 3 months after receiving the last dose of study agent
boolean
C0079399 (UMLS CUI [1])
C0004764 (UMLS CUI [2,1])
C0205173 (UMLS CUI [2,2])
C0871414 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
Multiple Myeloma Symptomatic | Lytic lesion | Severe osteopenia | Pathological fracture | Hypercalcemia | Renal Insufficiency | Hyperviscosity Symptomatic | Bacterial Infections Serious Recurrent | Pneumonia
Item
having symptomatic multiple myeloma, defined by any of the following (if due to myeloma): lytic bone lesions, severe osteopenia (low bone density), pathologic fractures, hypercalcemia (too much calcium in the blood), kidney insufficiency; symptomatic hyperviscosity of the blood, or recurrent serious bacterial infections such as pneumonia
boolean
C0026764 (UMLS CUI [1,1])
C0231220 (UMLS CUI [1,2])
C0221204 (UMLS CUI [2])
C1970459 (UMLS CUI [3])
C0016663 (UMLS CUI [4])
C0020437 (UMLS CUI [5])
C1565489 (UMLS CUI [6])
C0221104 (UMLS CUI [7,1])
C0231220 (UMLS CUI [7,2])
C0004623 (UMLS CUI [8,1])
C0205404 (UMLS CUI [8,2])
C2945760 (UMLS CUI [8,3])
C0032285 (UMLS CUI [9])
Primary amyloidosis
Item
primary systemic amyloid light (al) chain amyloidosis (a build-up of amyloid light chain proteins in the blood)
boolean
C0268381 (UMLS CUI [1])
Therapy Multiple Myeloma | Investigational Therapy Multiple Myeloma | Diphosphonates Stable allowed | Denosumab Stable allowed | Steroids Stable allowed | Erythropoiesis-stimulating Agent
Item
prior or concurrent exposure to approved or investigational multiple myeloma treatments (concurrent treatment with bone-protecting agents (eg, bisphosphonates, denosumab), or steroids (not exceeding 10 mg prednisone per day or equivalent) are only allowed if given in a stable dose and for a nonmalignant condition; concurrent treatment with erythropoietin-stimulating agents (esas) are not allowed.)
boolean
C0087111 (UMLS CUI [1,1])
C0026764 (UMLS CUI [1,2])
C0949266 (UMLS CUI [2,1])
C0026764 (UMLS CUI [2,2])
C0012544 (UMLS CUI [3,1])
C0205360 (UMLS CUI [3,2])
C0683607 (UMLS CUI [3,3])
C1690432 (UMLS CUI [4,1])
C0205360 (UMLS CUI [4,2])
C0683607 (UMLS CUI [4,3])
C0038317 (UMLS CUI [5,1])
C0205360 (UMLS CUI [5,2])
C0683607 (UMLS CUI [5,3])
C2917382 (UMLS CUI [6])
Pharmacologic Substance Targeting Interleukin-6 | Pharmacologic Substance Targeting Interleukin 6 Receptor
Item
prior exposure to agents targeting interleukin 6 (il 6) or the il 6 receptor
boolean
C1254351 (UMLS CUI [1,1])
C1521840 (UMLS CUI [1,2])
C0021760 (UMLS CUI [1,3])
C1254351 (UMLS CUI [2,1])
C1521840 (UMLS CUI [2,2])
C0063717 (UMLS CUI [2,3])
Cancer Other | Exception Basal cell carcinoma Treated | Exception Squamous cell carcinoma of skin Treated | Exception Cervix carcinoma Treated | Exception Cervix carcinoma TNM clinical staging Treated
Item
other malignancy within the past 3 years, except for the following, if treated and not active: basal cell or nonmetastatic (non-spreading) squamous cell carcinoma of the skin, cervical carcinoma or international federation of gynecology and obstetrics stage 1 carcinoma of the cervix
boolean
C1707251 (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])
C0302592 (UMLS CUI [4,2])
C1522326 (UMLS CUI [4,3])
C1705847 (UMLS CUI [5,1])
C0302592 (UMLS CUI [5,2])
C3258246 (UMLS CUI [5,3])
C1522326 (UMLS CUI [5,4])