Tandem Transplantation | Melphalan High dose | Autologous peripheral blood stem cell transplant
Item
patient having received tandem transplants with high-dose melphalan and autologous pbsct within 3-6 months prior to inclusion into this protocol
boolean
C3897372 (UMLS CUI [1])
C0025241 (UMLS CUI [2,1])
C0444956 (UMLS CUI [2,2])
C1960579 (UMLS CUI [3])
Measurable Disease Residual Minimal | Very Good Partial Response | partial response | Stable Disease
Item
patients with measurable minimal residual disease (very good partial remission [vgpr]) or patients in partial remission (pr) or patients with stable disease (sd) at the time of inclusion in the study
boolean
C1513041 (UMLS CUI [1,1])
C1609982 (UMLS CUI [1,2])
C0547040 (UMLS CUI [1,3])
C4053871 (UMLS CUI [2])
C1521726 (UMLS CUI [3])
C0677946 (UMLS CUI [4])
Informed Consent
Item
patient must agree to participate in the study.
boolean
C0021430 (UMLS CUI [1])
Contraceptive methods Agree
Item
patient agrees to use an appropriate method of contraception.
boolean
C0700589 (UMLS CUI [1,1])
C3641827 (UMLS CUI [1,2])
Protocol Compliance
Item
willingness and ability to comply with the study protocol for the duration of the study
boolean
C0525058 (UMLS CUI [1])
Disease Progression Signs
Item
patient showing signs of disease progression
boolean
C0242656 (UMLS CUI [1,1])
C0311392 (UMLS CUI [1,2])
Platelet Count measurement
Item
patient has a platelet count < 100 x 10^9/l within 14 days before enrollment.
boolean
C0032181 (UMLS CUI [1])
Absolute neutrophil count
Item
patient has an absolute neutrophil count < 1.0 x 10^9/l within 14 days before enrollment.
boolean
C0948762 (UMLS CUI [1])
Estimation of creatinine clearance by Cockcroft-Gault formula | Creatinine clearance measurement
Item
patient has a calculated or measured creatinine clearance < 30 ml/minute within 14 days before enrollment.
boolean
C2711451 (UMLS CUI [1])
C0373595 (UMLS CUI [2])
Peripheral Neuropathy CTCAE Grades
Item
patient has >= grade 2 peripheral neuropathy within 14 days before enrollment.
boolean
C0031117 (UMLS CUI [1,1])
C1516728 (UMLS CUI [1,2])
Hypersensitivity bortezomib | Hypersensitivity Boron | Mannitol allergy
Item
patient has hypersensitivity to bortezomib, boron, or mannitol.
boolean
C0020517 (UMLS CUI [1,1])
C1176309 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0006030 (UMLS CUI [2,2])
C0571922 (UMLS CUI [3])
bortezomib
Item
patient has received prior treatment with bortezomib
boolean
C1176309 (UMLS CUI [1])
Pregnancy | Breast Feeding
Item
patient is pregnant or nursing
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Investigational New Drugs
Item
patient has received other investigational drugs within 14 days before enrollment
boolean
C0013230 (UMLS CUI [1])
Progressive Disease
Item
patient has progressive disease
boolean
C1335499 (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 of < 3 months
boolean
C0023671 (UMLS CUI [1])
Pharmaceutical Preparations Disease Modification | Transplantation of autologous hematopoietic stem cell | aminobisphosphonate | Interferon-alpha | Glucocorticoids
Item
patient has received disease modifying agents following autologous stem cell transplantation other than aminobisphosphonates such as interferon-alpha or glucocorticosteroids
boolean
C0013227 (UMLS CUI [1,1])
C0012634 (UMLS CUI [1,2])
C0392747 (UMLS CUI [1,3])
C1831743 (UMLS CUI [2])
C2091830 (UMLS CUI [3])
C0002199 (UMLS CUI [4])
C0017710 (UMLS CUI [5])
Study Subject Participation Status | Reagents Investigational
Item
patient currently enrolled in another clinical research study and/or receiving an investigational reagent for any reason.
boolean
C2348568 (UMLS CUI [1])
C0034760 (UMLS CUI [2,1])
C1517586 (UMLS CUI [2,2])