Multiple Myeloma
Item
diagnosis of mm as per imwg criteria
boolean
C0026764 (UMLS CUI [1])
Age
Item
age greater than 17 years
boolean
C0001779 (UMLS CUI [1])
Therapeutic procedure Quantity
Item
have received at least 2 but no more than 4 prior lines of therapy
boolean
C0087111 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
Multiple Myeloma Absent response to treatment | Progressive Disease
Item
have failed to respond to the most recently administered anti-mm therapy or have demonstrably progressive disease as defined by accepted standard criteria
boolean
C0026764 (UMLS CUI [1,1])
C0438286 (UMLS CUI [1,2])
C1335499 (UMLS CUI [2])
Life Expectancy
Item
have a life expectancy of at least 3 months
boolean
C0023671 (UMLS CUI [1])
ECOG performance status
Item
ecog performance status < 3
boolean
C1520224 (UMLS CUI [1])
Results Hematologic
Item
at registration haematological values within the following limits:
boolean
C1254595 (UMLS CUI [1,1])
C0205488 (UMLS CUI [1,2])
Absolute neutrophil count
Item
1. absolute neutrophil count (anc) > 1.0 x 109/l
boolean
C0948762 (UMLS CUI [1])
Platelet Count measurement
Item
2. platelet count > 50 x 109/l unsupported
boolean
C0032181 (UMLS CUI [1])
Results Biochemical
Item
at registration biochemical values within the following limits
boolean
C1254595 (UMLS CUI [1,1])
C0205474 (UMLS CUI [1,2])
Serum total bilirubin measurement | Transaminases | Serum total bilirubin measurement Secondary to Infiltration Myeloma Liver | Transaminases Secondary to Infiltration Myeloma Liver
Item
1. bilirubin < 1.5 x upper limit of normal (uln) and transaminases < 2 x uln unless considered secondary to hepatic myelomatous infiltration
boolean
C1278039 (UMLS CUI [1])
C0002594 (UMLS CUI [2])
C1278039 (UMLS CUI [3,1])
C0175668 (UMLS CUI [3,2])
C0332448 (UMLS CUI [3,3])
C0026764 (UMLS CUI [3,4])
C0023884 (UMLS CUI [3,5])
C0002594 (UMLS CUI [4,1])
C0175668 (UMLS CUI [4,2])
C0332448 (UMLS CUI [4,3])
C0026764 (UMLS CUI [4,4])
C0023884 (UMLS CUI [4,5])
Creatinine measurement, serum
Item
2. serum creatinine < 0.19mmol/l
boolean
C0201976 (UMLS CUI [1])
Informed Consent
Item
written informed consent
boolean
C0021430 (UMLS CUI [1])
Indication Contraceptive methods | Childbearing Potential Criteria Fulfill
Item
must agree to use adequate contraceptive measures if indicated. specifically, women of childbearing potential (wocbp) may participate provided they meet the following conditions:
boolean
C3146298 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C3831118 (UMLS CUI [2,1])
C0243161 (UMLS CUI [2,2])
C1550543 (UMLS CUI [2,3])
Childbearing Potential Contraceptive methods Quantity
Item
1. agree to use at least 2 effective contraceptive methods throughout the study and for 30 days following the study
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
Childbearing Potential Serum pregnancy test negative
Item
2. have a negative serum pregnancy test within 24 hours of commencing on study medication
boolean
C3831118 (UMLS CUI [1,1])
C0430061 (UMLS CUI [1,2])
Gender Contraceptive methods Quantity | Partner Childbearing Potential
Item
3. male participants with female partners that are wocbp must agree to use 2 effective contraceptive methods throughout the study and for 30 days following the study
boolean
C0079399 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
C0682323 (UMLS CUI [2,1])
C3831118 (UMLS CUI [2,2])
Monoclonal Gammopathy of Undetermined Significance | Indolent multiple myeloma | Smoldering myeloma
Item
patients with monoclonal gammopathy of undetermined significance (mgus) or indolent/smouldering mm
boolean
C0026470 (UMLS CUI [1])
C2049069 (UMLS CUI [2])
C1531608 (UMLS CUI [3])
Hypersensitivity Azathioprine | Mannitol allergy | Hypersensitivity Azathioprine Suspected | Mannitol allergy Suspected
Item
known or suspected hypersensitivity to aza or mannitol
boolean
C0020517 (UMLS CUI [1,1])
C0004482 (UMLS CUI [1,2])
C0571922 (UMLS CUI [2])
C0020517 (UMLS CUI [3,1])
C0004482 (UMLS CUI [3,2])
C0750491 (UMLS CUI [3,3])
C0571922 (UMLS CUI [4,1])
C0750491 (UMLS CUI [4,2])
General condition of patient Therapeutic procedure With intensity Inappropriate | Heart Disease | Lung disease
Item
patients whose general condition makes them unsuitable for intensive treatment e.g. significant cardiac or pulmonary disease
boolean
C0424449 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
C0522510 (UMLS CUI [1,3])
C1548788 (UMLS CUI [1,4])
C0018799 (UMLS CUI [2])
C0024115 (UMLS CUI [3])
Communicable Diseases Exclude Chemotherapy | Illness Excludes Chemotherapy | Communicable Diseases Exclude Compliance behavior | Illness Excludes Compliance behavior
Item
active infections or other illnesses that precludes chemotherapy administration or patient compliance
boolean
C0009450 (UMLS CUI [1,1])
C0332196 (UMLS CUI [1,2])
C0392920 (UMLS CUI [1,3])
C0221423 (UMLS CUI [2,1])
C0332196 (UMLS CUI [2,2])
C0392920 (UMLS CUI [2,3])
C0009450 (UMLS CUI [3,1])
C0332196 (UMLS CUI [3,2])
C1321605 (UMLS CUI [3,3])
C0221423 (UMLS CUI [4,1])
C0332196 (UMLS CUI [4,2])
C1321605 (UMLS CUI [4,3])
HIV Infection | Hepatitis B | Hepatitis C
Item
active viral infection with known human immunodeficiency virus (hiv) or viral hepatitis type b or c
boolean
C0019693 (UMLS CUI [1])
C0019163 (UMLS CUI [2])
C0019196 (UMLS CUI [3])
Pregnancy | Breast Feeding
Item
pregnant or lactating women
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])