Smoldering multiple myeloma
Item
diagnosis of smoldering multiple myeloma (smm) for less than 5 years
boolean
C1531608 (UMLS CUI [1])
Smoldering multiple myeloma Intermediate | Smoldering multiple myeloma High risk | ECOG performance status
Item
have a confirmed diagnosis of intermediate or high-risk smm, and an eastern cooperative oncology group (ecog) performance status score of 0 or 1.
boolean
C1531608 (UMLS CUI [1,1])
C0205103 (UMLS CUI [1,2])
C1531608 (UMLS CUI [2,1])
C0332167 (UMLS CUI [2,2])
C1520224 (UMLS CUI [3])
Multiple Myeloma Requirement Therapeutic procedure
Item
active multiple myeloma,requiring treatment as defined by the study protocol
boolean
C0026764 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C0087111 (UMLS CUI [1,3])
Primary amyloidosis of light chain type Systemic
Item
primary systemic al (immunoglobulin light chain) amyloidosis
boolean
C0342606 (UMLS CUI [1,1])
C0205373 (UMLS CUI [1,2])
Exposure to Following | Therapeutic procedure Smoldering multiple myeloma | Therapeutic procedure Multiple Myeloma | daratumumab | Steroid therapy | Prednisone | Bisphosphonate drugs affecting bone structure and mineralization | Diphosphonates | denosumab | Investigational New Drugs | INVESTIGATIONAL VACCINES | Investigational Medical Device
Item
prior or concurrent exposure to any of the following: approved or investigational treatments for smm or/and multiple myeloma, daratumumab or other anti cd-38 therapies, treatment with corticosteroids with a dose greater than (>) 10 milligram (mg) prednisone per day or equivalent and bone-protecting agents (eg, bisphosphonates, denosumab) or are only allowed if given in a stable dose and for a nonmalignant condition, or received an investigational drug (including investigational vaccines) or used an invasive investigational medical device within 4 weeks before cycle 1, day 1
boolean
C0332157 (UMLS CUI [1,1])
C0332282 (UMLS CUI [1,2])
C0087111 (UMLS CUI [2,1])
C1531608 (UMLS CUI [2,2])
C0087111 (UMLS CUI [3,1])
C0026764 (UMLS CUI [3,2])
C2346801 (UMLS CUI [4])
C0149783 (UMLS CUI [5])
C0032952 (UMLS CUI [6])
C3541401 (UMLS CUI [7])
C0012544 (UMLS CUI [8])
C1690432 (UMLS CUI [9])
C0013230 (UMLS CUI [10])
C1875384 (UMLS CUI [11])
C2346570 (UMLS CUI [12])
Malignant Neoplasms Other | Basal cell carcinoma | Squamous cell carcinoma of skin | Carcinoma in situ of uterine cervix | Noninfiltrating Intraductal Carcinoma | Cervix carcinoma stage I
Item
history of malignancy (other than smm) within 3 years before the date of randomization, except for the following if treated and not active: basal cell or nonmetastatic squamous cell carcinoma of the skin, cervical carcinoma in situ, ductal carcinoma in situ of breast, or international federation of gynecology and obstetrics (figo) stage 1 carcinoma of the cervix
boolean
C0006826 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C0007117 (UMLS CUI [2])
C0553723 (UMLS CUI [3])
C0851140 (UMLS CUI [4])
C0007124 (UMLS CUI [5])
C0278575 (UMLS CUI [6])
Chronic Obstructive Airway Disease | Moderate persistent asthma | Severe persistent asthma
Item
known chronic obstructive pulmonary disease (copd) or moderate or severe persistent asthma within the past 2 years
boolean
C0024117 (UMLS CUI [1])
C1960047 (UMLS CUI [2])
C1960048 (UMLS CUI [3])
Comorbidity Interferes with Study Protocol | Comorbidity Interferes with research results | Comorbidity At risk Study Subject Participation Status | Autoimmune Diseases | Systemic disease | Myelodysplasia
Item
any concurrent medical or psychiatric condition or disease (eg, autoimmune disease, active systemic disease, myelodysplasia) that is likely to interfere with the study procedures or results, or that in the opinion of the investigator, would constitute a hazard for participating in this study
boolean
C0009488 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C2348563 (UMLS CUI [1,3])
C0009488 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C0683954 (UMLS CUI [2,3])
C0009488 (UMLS CUI [3,1])
C1444641 (UMLS CUI [3,2])
C2348568 (UMLS CUI [3,3])
C0004364 (UMLS CUI [4])
C0442893 (UMLS CUI [5])
C0026985 (UMLS CUI [6])