Candidate for melphalan prednisone treatment
Item
male or female patient for whom standard melphalan prednisone (mp) treatment is indicated and who is not a candidate for high-dose therapy plus stem cell transplantation (hdt-sct) for 1 of the following reasons: the patient is 65 years of age or older or the patient is less than 65 years of age but has significant comorbid condition(s) that are likely to have a negative impact on tolerability of hdt-sct
boolean
C3146298 (UMLS CUI [1,1])
C0025241 (UMLS CUI [1,2])
C0032952 (UMLS CUI [1,3])
C0444956 (UMLS CUI [2,1])
C0010858 (UMLS CUI [2,2])
C1831743 (UMLS CUI [2,3])
C1272460 (UMLS CUI [2,4])
C0001779 (UMLS CUI [2,5])
C0009488 (UMLS CUI [2,6])
Diagnosis of multiple myeloma
Item
symptomatic multiple myeloma or asymptomatic myeloma with myeloma-related organ damage diagnosed according to standard criteria
boolean
C0026764 (UMLS CUI [1])
Measureable myeloma
Item
measurable disease as specified in study protocol
boolean
C1513041 (UMLS CUI [1])
ECOG
Item
eastern cooperative oncology group (ecog) performance status of 0 to 2
boolean
C1520224 (UMLS CUI [1])
Organ function
Item
must have adequate hematologic, liver, and renal function
boolean
C0221130 (UMLS CUI [1,1])
C0232804 (UMLS CUI [1,2])
C0232741 (UMLS CUI [1,3])
No pregnancy
Item
female patients who are post menopausal, surgically sterile, or agree to practice 2 effective methods of contraception or agree to abstain from heterosexual intercourse
boolean
C0232970 (UMLS CUI [1])
C0015787 (UMLS CUI [2])
C0700589 (UMLS CUI [3,1])
C0036899 (UMLS CUI [3,2])
C0009253 (UMLS CUI [3,3])
Contraception - male patients
Item
male patients who agree to practice effective barrier contraception or agree to abstain from heterosexual intercourse
boolean
C0004764 (UMLS CUI [1])
C0036899 (UMLS CUI [2])
Consent
Item
voluntary written consent
boolean
C0021430 (UMLS CUI [1])
Peripheral neuropathy
Item
peripheral neuropathy that is greater or equal to grade 2
boolean
C0031117 (UMLS CUI [1])
Pregnancy and breastfeeding
Item
female patients who are lactating or pregnant
boolean
C0032961 (UMLS CUI [1,1])
C0006147 (UMLS CUI [1,2])
Pretreatment
Item
major surgery or radiotherapy within 14 days before the first dose of study drug
boolean
C0679637 (UMLS CUI [1,1])
C0521116 (UMLS CUI [1,2])
C1522449 (UMLS CUI [2,1])
C0521116 (UMLS CUI [2,2])
Infection
Item
uncontrolled infection requiring systematic antibiotics
boolean
C0009450 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
Diarrhea
Item
diarrhea (> grade 1)
boolean
C0011991 (UMLS CUI [1])
Prior systemic therapy
Item
prior systemic therapy for multiple myeloma, including investigational drugs (prior treatment with corticosteroids or localized radiation therapy dose not disqualify the patient)
boolean
C1515119 (UMLS CUI [1,1])
C0026764 (UMLS CUI [1,2])
C1514463 (UMLS CUI [1,3])
C0013230 (UMLS CUI [2])
CNS
Item
central nervous system involvement
boolean
C4050309 (UMLS CUI [1])
Cardiac status
Item
cardiac status as described in protocol
boolean
C1999091 (UMLS CUI [1])
Absorption and tolerance of ixazomib
Item
known gastrointestinal condition or procedure that could interfere with swallowing or the oral absorption or tolerance of ixazomib - diagnosis of smoldering multiple myeloma, waldenstrom's macroglobulinemia, poems syndrome, plasma cell leukemia, primary amyloidosis, myelodysplastic syndrome, or myeloproliferative syndrome
boolean
C0017178 (UMLS CUI [1,1])
C0524722 (UMLS CUI [1,2])
C0521102 (UMLS CUI [1,3])
C0392678 (UMLS CUI [1,4])
C0237442 (UMLS CUI [1,5])
C0175795 (UMLS CUI [1,6])
C3273711 (UMLS CUI [1,7])
Infection and immunodeficiency
Item
known human immunodeficiency virus (hiv) positive, hepatitis b surface antigen-positive status, or known or suspected active hepatitis c infection
boolean
C0019699 (UMLS CUI [1])
C0149709 (UMLS CUI [2])
C0019196 (UMLS CUI [3,1])
C0009450 (UMLS CUI [3,2])
C0205177 (UMLS CUI [3,3])
Other malignancy
Item
diagnosed or treated for another malignancy within 2 years before the first dose or previously diagnosed with another malignancy and have any evidence of residual disease with the exception of nonmelanoma skin cancer or any completely resected carcinoma in situ
boolean
C0262926 (UMLS CUI [1,1])
C0006826 (UMLS CUI [1,2])
C0543478 (UMLS CUI [2])
C1705847 (UMLS CUI [3,1])
C0699893 (UMLS CUI [3,2])
C1705847 (UMLS CUI [4,1])
C0007099 (UMLS CUI [4,2])
C1522326 (UMLS CUI [4,3])
Comorbidities
Item
serious medical or psychiatric illness that could, in the investigator's opinion, potentially interfere with the completion of treatment according to the protocol
boolean
C0221423 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C0004936 (UMLS CUI [1,3])