Multiple Myeloma | Progressive Disease | Second line treatment Patient need for | Third line treatment Patient need for | M Protein Percentage Increased | Lytic lesion New | Lytic lesion Worsening | malignant plasmacytoma of soft tissue | Hypercalcemia | Serum calcium measurement | In complete remission Relapse | bortezomib | Dexamethasone | Thalidomide | Adrenal Cortex Hormones | Revlimid
Item
patient was previously diagnosed with multiple myeloma based on standard criteria and currently requires second or *third line therapy because of pd, defined as a 25% increase in m-protein, or development of new or worsening of existing lytic bone lesions or soft tissue plasmacytomas, or hypercalcemia (serum calcium >11.5 mg/dl), or relapse from cr.*patients will only be eligible for bortezomib as 3rd line therapy if they have received dexamethasone alone, thalidomide alone (or with corticosteroids) or revlimid alone (or with corticosteroids) as one of the 2 prior therapies.
boolean
C0026764 (UMLS CUI [1])
C1335499 (UMLS CUI [2])
C1710038 (UMLS CUI [3,1])
C0686904 (UMLS CUI [3,2])
C2986605 (UMLS CUI [4,1])
C0686904 (UMLS CUI [4,2])
C0700271 (UMLS CUI [5,1])
C0439165 (UMLS CUI [5,2])
C0205217 (UMLS CUI [5,3])
C0221204 (UMLS CUI [6,1])
C0205314 (UMLS CUI [6,2])
C0221204 (UMLS CUI [7,1])
C0332271 (UMLS CUI [7,2])
C2211566 (UMLS CUI [8])
C0020437 (UMLS CUI [9])
C0728876 (UMLS CUI [10])
C0677874 (UMLS CUI [11,1])
C0035020 (UMLS CUI [11,2])
C1176309 (UMLS CUI [12])
C0011777 (UMLS CUI [13])
C0039736 (UMLS CUI [14])
C0001617 (UMLS CUI [15])
C1135145 (UMLS CUI [16])
Age Legal consent
Item
patient is of a legally consenting age, as defined by local regulations.
boolean
C0001779 (UMLS CUI [1,1])
C0814676 (UMLS CUI [1,2])
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performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to their future medical care.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])
Postmenopausal state | Female Sterilization | Gender Contraceptive methods | Hormonal contraception | Intrauterine Devices | Vaginal contraceptive diaphragm | Vaginal Spermicides | Female Condoms | Sexual Abstinence
Item
female patient is either post-menopausal or surgically sterilized or willing to use an acceptable method of birth control (i.e., a hormonal contraceptive, intrauterine device, diaphragm with spermicide, condom with spermicide, or abstinence) for the duration of the study.
boolean
C0232970 (UMLS CUI [1])
C0015787 (UMLS CUI [2])
C0079399 (UMLS CUI [3,1])
C0700589 (UMLS CUI [3,2])
C2985296 (UMLS CUI [4])
C0021900 (UMLS CUI [5])
C0042241 (UMLS CUI [6])
C0087145 (UMLS CUI [7])
C0221829 (UMLS CUI [8])
C0036899 (UMLS CUI [9])
Gender Contraceptive methods
Item
male patient agrees to use an acceptable method for contraception for the duration of the study.
boolean
C0079399 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
Measurable Disease
Item
patient has measurable disease
boolean
C1513041 (UMLS CUI [1])
Karnofsky Performance Status
Item
patient has a karnofsky performance status ≥60%.
boolean
C0206065 (UMLS CUI [1])
Life Expectancy
Item
patient has a life-expectancy >3 months.
boolean
C0023671 (UMLS CUI [1])
Resistance Primary Dexamethasone
Item
primary dexamethasone resistance
boolean
C1514892 (UMLS CUI [1,1])
C0205225 (UMLS CUI [1,2])
C0011777 (UMLS CUI [1,3])
bortezomib
Item
prior therapy with bortezomib
boolean
C1176309 (UMLS CUI [1])
Allergic Reaction Severe bortezomib | Allergic Reaction Severe Velcade | Allergic Reaction Severe Boron | Mannitol allergy Severe
Item
prior severe allergic reactions to bortezomib (velcade), boron or mannitol
boolean
C1527304 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C1176309 (UMLS CUI [1,3])
C1527304 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
C1174739 (UMLS CUI [2,3])
C1527304 (UMLS CUI [3,1])
C0205082 (UMLS CUI [3,2])
C0006030 (UMLS CUI [3,3])
C0571922 (UMLS CUI [4,1])
C0205082 (UMLS CUI [4,2])
Painful Neuropathy CTCAE Grades
Item
neuropathy > grade 2 with pain by nci-ctcae criteria
boolean
C1850383 (UMLS CUI [1,1])
C1516728 (UMLS CUI [1,2])