Multiple Myeloma
Item
previously diagnosed with multiple myeloma
boolean
C0026764 (UMLS CUI [1])
Refractory multiple myeloma Primary | Recurrent multiple myeloma Post Line of Therapy Quantity
Item
primary refractory multiple myeloma or relapsed following 1 to 3 previous lines of therapy
boolean
C0278620 (UMLS CUI [1,1])
C0205225 (UMLS CUI [1,2])
C1370446 (UMLS CUI [2,1])
C0687676 (UMLS CUI [2,2])
C4524693 (UMLS CUI [2,3])
C1265611 (UMLS CUI [2,4])
Karnofsky Performance Status
Item
karnofsky performance status must be equal to 60 percentage (ie, better or equal performance than requiring some help and taking care of most personal requirements)
boolean
C0206065 (UMLS CUI [1])
Life Expectancy
Item
has life expectancy estimated at screening must be of at least 6 months
boolean
C0023671 (UMLS CUI [1])
Contraceptive methods Willing
Item
agrees to protocol-defined use of effective contraception
boolean
C0700589 (UMLS CUI [1,1])
C0600109 (UMLS CUI [1,2])
Line of Therapy Quantity Multiple Myeloma
Item
not received more than three previous lines of therapy for multiple myeloma
boolean
C4524693 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0026764 (UMLS CUI [1,3])
Nitrosoureas Multiple Myeloma | Chemotherapy Multiple Myeloma | Immunotherapy Multiple Myeloma | Antibody therapy Multiple Myeloma | Plasmapheresis
Item
not received nitrosoureas or any other chemotherapy or immunotherapy or antibody therapy for multiple myeloma within 6 to 8 weeks before enrolment. plasmapheresis must not be applied within 2 weeks before enrolment
boolean
C0028210 (UMLS CUI [1,1])
C0026764 (UMLS CUI [1,2])
C0392920 (UMLS CUI [2,1])
C0026764 (UMLS CUI [2,2])
C0021083 (UMLS CUI [3,1])
C0026764 (UMLS CUI [3,2])
C0281176 (UMLS CUI [4,1])
C0026764 (UMLS CUI [4,2])
C0032134 (UMLS CUI [5])
Peripheral Neuropathy CTCAE Grades | Peripheral neuropathic pain CTCAE Grades
Item
patients with peripheral neuropathy or neuropathic pain of grade 2 or greater intensity
boolean
C0031117 (UMLS CUI [1,1])
C1516728 (UMLS CUI [1,2])
C0458960 (UMLS CUI [2,1])
C1516728 (UMLS CUI [2,2])
Cardiovascular Diseases Poorly controlled | Vascular Diseases Poorly controlled | Lung diseases Poorly controlled | Gastrointestinal Diseases Poorly controlled | Endocrine System Diseases Poorly controlled | Nervous system disorder Poorly controlled | Mental disorders Poorly controlled | Liver diseases Poorly controlled | Kidney Diseases Poorly controlled | Metabolic Diseases Poorly controlled | Hematological Disease Poorly controlled
Item
patients with poorly controlled cardio vascular, vascular, pulmonary, gastro-intestinal, endocrine, neurological, psychiatric, hepatic, renal or metabolic diseases or hematological disorders
boolean
C0007222 (UMLS CUI [1,1])
C3853134 (UMLS CUI [1,2])
C0042373 (UMLS CUI [2,1])
C3853134 (UMLS CUI [2,2])
C0024115 (UMLS CUI [3,1])
C3853134 (UMLS CUI [3,2])
C0017178 (UMLS CUI [4,1])
C3853134 (UMLS CUI [4,2])
C0014130 (UMLS CUI [5,1])
C3853134 (UMLS CUI [5,2])
C0027765 (UMLS CUI [6,1])
C3853134 (UMLS CUI [6,2])
C0004936 (UMLS CUI [7,1])
C3853134 (UMLS CUI [7,2])
C0023895 (UMLS CUI [8,1])
C3853134 (UMLS CUI [8,2])
C0022658 (UMLS CUI [9,1])
C3853134 (UMLS CUI [9,2])
C0025517 (UMLS CUI [10,1])
C3853134 (UMLS CUI [10,2])
C0018939 (UMLS CUI [11,1])
C3853134 (UMLS CUI [11,2])
Multiple Myeloma M Protein Very low | Non-secretory myeloma
Item
not have oligosecretory or non-secretory multiple myeloma
boolean
C0026764 (UMLS CUI [1,1])
C0700271 (UMLS CUI [1,2])
C0442811 (UMLS CUI [1,3])
C0456845 (UMLS CUI [2])