Age
Item
patient is 65 years of age or older at the time of signing the informed consent.
boolean
C0001779 (UMLS CUI [1])
Protocol Compliance
Item
patient is, in the investigator(s) opinion willing and able to comply with the protocol requirements.
boolean
C0525058 (UMLS CUI [1])
Informed Consent
Item
patient has given voluntary written informed consent before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to their future medical care.
boolean
C0021430 (UMLS CUI [1])
Gender Contraceptive methods | Condoms, Male | Sexual Abstinence | Lenalidomide Discontinuation
Item
male patient agrees to use an acceptable method for contraception (i.e., condom or abstinence) during study drug therapy (including dose interruption) and for 4 weeks after discontinuation of lenalidomide therapy.
boolean
C0079399 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0009653 (UMLS CUI [2])
C0036899 (UMLS CUI [3])
C1144149 (UMLS CUI [4,1])
C1444662 (UMLS CUI [4,2])
Postmenopausal state | Female Sterilization | Gender Sexual Abstinence | Gender Contraceptive methods Double | Intrauterine Devices | Contraceptives, Oral, Hormonal | Contraceptive injection | Contraceptive implant | Tubal Ligation | Partner had vasectomy | Latex condom | Vaginal contraceptive diaphragm | CERVICAL CAP FOR CONTRACEPTIVE USE | Lenalidomide Discontinuation
Item
female patient is either post-menopausal for 24 consecutive months or surgically sterilised or agree to continuous abstinence from heterosexual sexual contact or willing to use two acceptable method of birth control at the same time (one highly effective method and one additional effective method)(highly effective methods: intrauterine device -iud-; hormonal -birth control pills, injections, implants-; tubal ligation; partner's vasectomy; additional effective methods: latex condom; diaphragm; cervical cap) for 4 weeks prior to beginning study drug therapy, during study drug therapy (including dose interruption) and for 4 weeks after discontinuation of lenalidomide therapy.
boolean
C0232970 (UMLS CUI [1])
C0015787 (UMLS CUI [2])
C0079399 (UMLS CUI [3,1])
C0036899 (UMLS CUI [3,2])
C0079399 (UMLS CUI [4,1])
C0700589 (UMLS CUI [4,2])
C0205173 (UMLS CUI [4,3])
C0021900 (UMLS CUI [5])
C0009907 (UMLS CUI [6])
C1656586 (UMLS CUI [7])
C1657106 (UMLS CUI [8])
C0520483 (UMLS CUI [9])
C0420842 (UMLS CUI [10])
C3873750 (UMLS CUI [11])
C0042241 (UMLS CUI [12])
C0493327 (UMLS CUI [13])
C1144149 (UMLS CUI [14,1])
C1444662 (UMLS CUI [14,2])
Multiple Myeloma
Item
patient was a newly diagnosed multiple myeloma based on standard criteria
boolean
C0026764 (UMLS CUI [1])
Measurable Disease | Multiple Myeloma | Serum M Protein Measurement | M Protein Immunoglobulin G measurement | M Protein Immunoglobulin A measurement | Urine light chain measurement 24 Hour Test | Non-secretory myeloma | Plasma Cells Bone marrow Percentage | Plasmacytoma Size Quantity Clinical examination | Plasmacytoma Size Quantity Radiography | Plasmacytoma Size Quantity MRI | Plasmacytoma Size Quantity CT scan
Item
patient has measurable disease, defined as follows: - secretory myeloma: any quantifiable serum monoclonal protein value (generally, but not necessarily, greater than 1 g/dl of igg m-protein and greater than 0.5 g/dl of iga m-protein) and, where applicable, urine light-chain excretion of >200 mg/24 hours; - non-secretory myeloma: > 30% plasma cells in the bone marrow and at least one plasmacytoma > 2 cm as determined by clinical examination or applicable radiographs (i.e., mri or ct scan).
boolean
C1513041 (UMLS CUI [1])
C0026764 (UMLS CUI [2])
C0229671 (UMLS CUI [3,1])
C0700271 (UMLS CUI [3,2])
C0242485 (UMLS CUI [3,3])
C0700271 (UMLS CUI [4,1])
C0202087 (UMLS CUI [4,2])
C0700271 (UMLS CUI [5,1])
C0202083 (UMLS CUI [5,2])
C1445962 (UMLS CUI [6,1])
C1255149 (UMLS CUI [6,2])
C0456845 (UMLS CUI [7])
C1994776 (UMLS CUI [8,1])
C0439165 (UMLS CUI [8,2])
C0032131 (UMLS CUI [9,1])
C0456389 (UMLS CUI [9,2])
C1265611 (UMLS CUI [9,3])
C1456356 (UMLS CUI [9,4])
C0032131 (UMLS CUI [10,1])
C0456389 (UMLS CUI [10,2])
C1265611 (UMLS CUI [10,3])
C0034571 (UMLS CUI [10,4])
C0032131 (UMLS CUI [11,1])
C0456389 (UMLS CUI [11,2])
C1265611 (UMLS CUI [11,3])
C0024485 (UMLS CUI [11,4])
C0032131 (UMLS CUI [12,1])
C0456389 (UMLS CUI [12,2])
C1265611 (UMLS CUI [12,3])
C0040405 (UMLS CUI [12,4])
Karnofsky Performance Status
Item
patient has a karnofsky performance status ≥ 50%.
boolean
C0206065 (UMLS CUI [1])
Life Expectancy
Item
patient has a life-expectancy >3 months.
boolean
C0023671 (UMLS CUI [1])
Medical condition Serious Preventing Informed Consent | Laboratory test result abnormal Preventing Informed Consent | Mental disorders Preventing Informed Consent | Medical condition Serious Study Subject Participation Status At risk | Laboratory test result abnormal Study Subject Participation Status At risk | Mental disorders Study Subject Participation Status At risk
Item
any serious medical condition, laboratory abnormality or psychiatric illness that prevented the subject from signing the informed consent form or placed the subjects at unacceptable risk.
boolean
C3843040 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C1292733 (UMLS CUI [1,3])
C0021430 (UMLS CUI [1,4])
C0438215 (UMLS CUI [2,1])
C1292733 (UMLS CUI [2,2])
C0021430 (UMLS CUI [2,3])
C0004936 (UMLS CUI [3,1])
C1292733 (UMLS CUI [3,2])
C0021430 (UMLS CUI [3,3])
C3843040 (UMLS CUI [4,1])
C0205404 (UMLS CUI [4,2])
C2348568 (UMLS CUI [4,3])
C1444641 (UMLS CUI [4,4])
C0438215 (UMLS CUI [5,1])
C2348568 (UMLS CUI [5,2])
C1444641 (UMLS CUI [5,3])
C0004936 (UMLS CUI [6,1])
C2348568 (UMLS CUI [6,2])
C1444641 (UMLS CUI [6,3])
Prior Therapy Multiple Myeloma | Exception Therapeutic radiology procedure | Exception Diphosphonates | Exception Steroids Dosage | Equivalent Dexamethasone U/day
Item
previous treatment with anti-myeloma therapy (does not include radiotherapy, bisphosphonates, or a single short course of steroid; < to the equivalent of dexamethasone 40 mg/day for 4 days).
boolean
C1514463 (UMLS CUI [1,1])
C0026764 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C1522449 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0012544 (UMLS CUI [3,2])
C1705847 (UMLS CUI [4,1])
C0038317 (UMLS CUI [4,2])
C0178602 (UMLS CUI [4,3])
C0205163 (UMLS CUI [5,1])
C0011777 (UMLS CUI [5,2])
C0456683 (UMLS CUI [5,3])
Pregnancy | Breast Feeding
Item
pregnant or lactating females
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
HIV Seropositivity | Hepatitis A | Hepatitis B | Hepatitis C
Item
known positive for hiv or active infectious hepatitis type a, b or c
boolean
C0019699 (UMLS CUI [1])
C0019159 (UMLS CUI [2])
C0019163 (UMLS CUI [3])
C0019196 (UMLS CUI [4])