Multiple Myeloma
Item
1. a confirmed diagnosis of multiple myeloma
boolean
C0026764 (UMLS CUI [1])
Melphalan Dose intense | Disease Progression | Paraprotein Decrease Percentage
Item
2. show progression of disease after a previous cycle of dose-intense melphalan, or less than 25% decrease in paraprotein measured at 8 weeks after a prior cycle of dose-intense melphalan
boolean
C0025241 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0522510 (UMLS CUI [1,3])
C0242656 (UMLS CUI [2])
C0700271 (UMLS CUI [3,1])
C0547047 (UMLS CUI [3,2])
C0439165 (UMLS CUI [3,3])
Melphalan Dose intense | Interventional procedure Disease Progression
Item
may have received intervening therapies for disease progression after dose-intense melphalan and enrollment in this protocol
boolean
C0025241 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0522510 (UMLS CUI [1,3])
C0184661 (UMLS CUI [2,1])
C0242656 (UMLS CUI [2,2])
Age
Item
3. age:18yrs-76yrs at time of melphalan administration
boolean
C0001779 (UMLS CUI [1])
Gender
Item
4. gender: there is no gender restriction
boolean
C0079399 (UMLS CUI [1])
Peripheral blood stem cell Autologous CD34 positive Available | Donor Syngeneic | Donation Syngeneic Criteria Fulfill
Item
5. availability of >2x10^6 autologous peripheral blood cd34+ cells/kg or a syngeneic donor meeting eligibility criteria for syngeneic donation
boolean
C1518999 (UMLS CUI [1,1])
C0439859 (UMLS CUI [1,2])
C0882849 (UMLS CUI [1,3])
C0470187 (UMLS CUI [1,4])
C0040288 (UMLS CUI [2,1])
C2348628 (UMLS CUI [2,2])
C0680854 (UMLS CUI [3,1])
C2348628 (UMLS CUI [3,2])
C0243161 (UMLS CUI [3,3])
C1550543 (UMLS CUI [3,4])
Syngeneic transplantation preferred
Item
syngeneic transplantation is preferred
boolean
C0520485 (UMLS CUI [1,1])
C0558295 (UMLS CUI [1,2])
Peripheral blood stem cell Autologous CD34 positive Storage | Peripheral blood stem cell Syngeneic CD34 positive Storage
Item
for patients enrolled in the phase i part of this study, >1x10^6 autologous or syngeneic peripheral blood cd34+ cells/kg remaining in storage as "backup" in case of engraftment failure
boolean
C1518999 (UMLS CUI [1,1])
C0439859 (UMLS CUI [1,2])
C0882849 (UMLS CUI [1,3])
C1698986 (UMLS CUI [1,4])
C1518999 (UMLS CUI [2,1])
C2348628 (UMLS CUI [2,2])
C0882849 (UMLS CUI [2,3])
C1698986 (UMLS CUI [2,4])
Salvage Therapy Complication Patient recovered
Item
6. recovery from complications of salvage therapy, if administered -
boolean
C0085405 (UMLS CUI [1,1])
C0009566 (UMLS CUI [1,2])
C1115804 (UMLS CUI [1,3])
Diagnosis Except Multiple Myeloma
Item
1. diagnosis other than multiple myeloma
boolean
C0011900 (UMLS CUI [1,1])
C0332300 (UMLS CUI [1,2])
C0026764 (UMLS CUI [1,3])
Chemotherapy | Therapeutic radiology procedure
Item
2. chemotherapy or radiotherapy within 28 days of initiating treatment in this study
boolean
C0392920 (UMLS CUI [1])
C1522449 (UMLS CUI [2])
Therapeutic procedure Dose intense
Item
3. prior dose-intense therapy within 56 days of initiating treatment in this study
boolean
C0087111 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0522510 (UMLS CUI [1,3])
Bacterial Infections Uncontrolled | Virus Diseases Uncontrolled | Mycoses Uncontrolled | Parasitic infection Uncontrolled
Item
4. uncontrolled bacterial,viral,fungal or parasitic infections
boolean
C0004623 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0042769 (UMLS CUI [2,1])
C0205318 (UMLS CUI [2,2])
C0026946 (UMLS CUI [3,1])
C0205318 (UMLS CUI [3,2])
C0747256 (UMLS CUI [4,1])
C0205318 (UMLS CUI [4,2])
CNS metastases Uncontrolled
Item
5. uncontrolled cns metastases
boolean
C0686377 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
Amyloid deposition Heart
Item
6. known amyloid deposition in heart
boolean
C0011560 (UMLS CUI [1,1])
C0018787 (UMLS CUI [1,2])
Single organ dysfunction
Item
7. organ dysfunction
boolean
C0349410 (UMLS CUI [1])
Left ventricular ejection fraction | Heart failure Unresponsive to Treatment
Item
lvef<40% or cardiac failure not responsive to therapy
boolean
C0428772 (UMLS CUI [1])
C0018801 (UMLS CUI [2,1])
C0205269 (UMLS CUI [2,2])
Forced vital capacity | FEV1 | Carbon Monoxide Diffusing Capability Test | Oxygen supplementation
Item
fvc,fev1,or dlco<50% of predicted and/or receiving supplementary continuous oxygen
boolean
C1287681 (UMLS CUI [1])
C0748133 (UMLS CUI [2])
C1516251 (UMLS CUI [3])
C0919655 (UMLS CUI [4])
Liver Dysfunction | Elevated total bilirubin | Aspartate aminotransferase increased
Item
evidence of hepatic synthetic dysfunction, or total bilirubin>2x or ast>3x uln
boolean
C0086565 (UMLS CUI [1])
C0741494 (UMLS CUI [2])
C0151904 (UMLS CUI [3])
Creatinine clearance measurement
Item
measured creatinine clearance <20ml/min
boolean
C0373595 (UMLS CUI [1])
Sensory neuropathy CTCAE Grades
Item
sensory peripheral neuropathy grade 4
boolean
C0151313 (UMLS CUI [1,1])
C1516728 (UMLS CUI [1,2])
Karnofsky Performance Status | Bone Disease caused by Myeloma
Item
8. karnofsky score<70% unless a result of bone disease directly caused by myeloma
boolean
C0206065 (UMLS CUI [1])
C0005940 (UMLS CUI [2,1])
C0015127 (UMLS CUI [2,2])
C0026764 (UMLS CUI [2,3])
Comorbidity Life Expectancy Limited
Item
9. life expectancy limited by another co-morbid illness
boolean
C0009488 (UMLS CUI [1,1])
C0023671 (UMLS CUI [1,2])
C0439801 (UMLS CUI [1,3])
Cancer in remission | Basal cell carcinoma Excluded
Item
10. history of another malignancy in remission <2yrs (other than basal cell carcinoma)
boolean
C0687702 (UMLS CUI [1])
C0007117 (UMLS CUI [2,1])
C2828389 (UMLS CUI [2,2])
Pregnancy | Contraceptive methods Unwilling
Item
11. pregnant (women)or unwilling to use acceptable birth control methods (men or women) for twelve months after treatment
boolean
C0032961 (UMLS CUI [1])
C0700589 (UMLS CUI [2,1])
C0558080 (UMLS CUI [2,2])
Melphalan allergy | Hypersensitivity Bortezomib | Hypersensitivity Melphalan Component | Hypersensitivity Bortezomib Component
Item
12. documented hypersensitivity to melphalan or bortezomib or any components of the formulation
boolean
C0570673 (UMLS CUI [1])
C0020517 (UMLS CUI [2,1])
C1176309 (UMLS CUI [2,2])
C0020517 (UMLS CUI [3,1])
C0025241 (UMLS CUI [3,2])
C1705248 (UMLS CUI [3,3])
C0020517 (UMLS CUI [4,1])
C1176309 (UMLS CUI [4,2])
C1705248 (UMLS CUI [4,3])
Informed Consent Unable | Informed Consent Unwilling
Item
13. patients unable or unwilling to provide consent
boolean
C0021430 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
C0021430 (UMLS CUI [2,1])
C0558080 (UMLS CUI [2,2])