Consent
Item
written informed consent obtained before starting any study-specific procedure.
boolean
C0021430 (UMLS CUI [1])
Multiple myeloma diagnosis EBMT Criteria
Item
symptomatic elderly MM newly diagnosed by ebmt criteria older than 65 years.
boolean
C0231220 (UMLS CUI [1,1])
C0026764 (UMLS CUI [1,2])
C3826859 (UMLS CUI [1,3])
C0001779 (UMLS CUI [1,4])
ECOG
Item
performance status (ecog) ≤ 2.
boolean
C1520224 (UMLS CUI [1])
Lab values
Item
have pre-treatment clinical laboratory values meeting the following criteria within 14 days of randomization: - platelet count ≥ 75x109/L - haemoglobin ≥ 8g/dL - absolute neutrophil count (ANC) ≥ 1.0x109/L - Serum bilirubin ≤ 1.5 mg/dL and alkaline phosphatise ≤ 2.5 x ULN AST, ALT ≤ 2.5 x ULN - Serum creatinine ≤2,5 mg/dl
boolean
C1527021 (UMLS CUI [1,1])
C1948041 (UMLS CUI [1,2])
C0022877 (UMLS CUI [1,3])
C0032181 (UMLS CUI [2])
C0518015 (UMLS CUI [3])
C0948762 (UMLS CUI [4])
C1278039 (UMLS CUI [5,1])
C0201850 (UMLS CUI [5,2])
C0201976 (UMLS CUI [6])
Previous treatment
Item
patient previously received treatment with velcade or revlimid.
boolean
C0087111 (UMLS CUI [1,1])
C1174739 (UMLS CUI [1,2])
C0087111 (UMLS CUI [2,1])
C1135145 (UMLS CUI [2,2])
Pre-treatment for multiple myeloma
Item
patient previously received treatment for multiple myeloma.
boolean
C0026764 (UMLS CUI [1,1])
C1514463 (UMLS CUI [1,2])
Peripheral neuropathy CTCAE
Item
patient has ≥ grade 2 peripheral neuropathy within 14 days before enrolment.
boolean
C0031117 (UMLS CUI [1,1])
C1516728 (UMLS CUI [1,2])
C0521116 (UMLS CUI [1,3])
Hypersensitivity
Item
patient has hypersensitivity to bortezomib, boron, mannitol or lenalidomide.
boolean
C0020517 (UMLS CUI [1,1])
C1176309 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0006030 (UMLS CUI [2,2])
C0020517 (UMLS CUI [3,1])
C0024730 (UMLS CUI [3,2])
C0020517 (UMLS CUI [4,1])
C1144149 (UMLS CUI [4,2])
Other investigational drugs
Item
patient has received other investigational drugs with 28 days before enrolment.
boolean
C0013230 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C0332152 (UMLS CUI [1,3])
C2348568 (UMLS CUI [1,4])
Cardiac function
Item
patient had a myocardial infarction within 6 months of enrolment or has new york heart association (nyha) class iii or iv heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities.
boolean
C0027051 (UMLS CUI [1])
C1275491 (UMLS CUI [2,1])
C0018801 (UMLS CUI [2,2])
C0205318 (UMLS CUI [3,1])
C0002965 (UMLS CUI [3,2])
C0085612 (UMLS CUI [4])
C3900108 (UMLS CUI [5])
C0151236 (UMLS CUI [6])
Other clinical research study
Item
patient currently is enrolled in another clinical research study and/or is receiving an investigational agent for any reason.
boolean
C0008972 (UMLS CUI [1,1])
C2348568 (UMLS CUI [1,2])
C0013230 (UMLS CUI [2,1])
C3840932 (UMLS CUI [2,2])
Radiation therapy
Item
radiation therapy within 30 days before randomization, at least patient has had antialgic radiation. radiation therapy will be afterwards permitted during the treatment period if it is indicated due to the presence of plasmacytomas
boolean
C1522449 (UMLS CUI [1,1])
C0030193 (UMLS CUI [1,2])
C0436323 (UMLS CUI [1,3])
C1705847 (UMLS CUI [2,1])
C0347984 (UMLS CUI [2,2])
C0087111 (UMLS CUI [2,3])
C0032131 (UMLS CUI [2,4])
C1444656 (UMLS CUI [2,5])