Age
Item
age ≥ 18 years
boolean
C0001779 (UMLS CUI [1])
Multiple Myeloma | Recurrent disease | Response failed | Status post Systemic therapy Quantity | Exception Steroid therapy Single
Item
documented pathologic diagnosis of multiple myeloma that has relapsed or failed to respond after treatment with at least one prior systemic therapy (other than corticosteroid monotherapy)
boolean
C0026764 (UMLS CUI [1])
C0277556 (UMLS CUI [2])
C1704632 (UMLS CUI [3,1])
C0231175 (UMLS CUI [3,2])
C0231290 (UMLS CUI [4,1])
C1515119 (UMLS CUI [4,2])
C1265611 (UMLS CUI [4,3])
C1705847 (UMLS CUI [5,1])
C0149783 (UMLS CUI [5,2])
C0205171 (UMLS CUI [5,3])
Measurable Disease
Item
measurable disease
boolean
C1513041 (UMLS CUI [1])
Systemic therapy Quantity | Exception Adrenal Cortex Hormone Single
Item
at least one prior systemic therapy other than single-agent corticosteroids
boolean
C1515119 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C0001617 (UMLS CUI [2,2])
C0205171 (UMLS CUI [2,3])
Autologous bone marrow transplant | Patients Ineligible Transplantation
Item
european union patients must have had prior bone marrow transplant (autologous) or be ineligible for transplant
boolean
C0194037 (UMLS CUI [1])
C0030705 (UMLS CUI [2,1])
C1512714 (UMLS CUI [2,2])
C0040732 (UMLS CUI [2,3])
Bortezomib | Clinical Response | Stable Disease | Interval Progression Free of
Item
if previously received bortezomib, demonstration of clinical response of any duration or stable disease with progression-free interval of ≥ 6 months from the start of that therapy
boolean
C1176309 (UMLS CUI [1])
C4055223 (UMLS CUI [2])
C0677946 (UMLS CUI [3])
C1272706 (UMLS CUI [4,1])
C0242656 (UMLS CUI [4,2])
C0332296 (UMLS CUI [4,3])
Bortezomib | Toxicity Relationship Bortezomib | Patient recovered | Peripheral Neuropathy CTCAE Grades
Item
if previously received bortezomib, must have recovered from bortezomib-related toxicities and must have a peripheral neuropathy score of grade ≤ 1, according to the nci ctcae v3.0
boolean
C1176309 (UMLS CUI [1])
C0600688 (UMLS CUI [2,1])
C0439849 (UMLS CUI [2,2])
C1176309 (UMLS CUI [2,3])
C1115804 (UMLS CUI [3])
C0031117 (UMLS CUI [4,1])
C1516728 (UMLS CUI [4,2])
Autologous Transplantation Completion
Item
if applicable, completion of autologous transplant ≥ 12 weeks prior to day 1
boolean
C0040736 (UMLS CUI [1,1])
C0205197 (UMLS CUI [1,2])
Cancer treatment Discontinuation | Investigational Therapy Discontinuation | Administration Monoclonal Antibodies Discontinuation
Item
discontinuation of previous anticancer or investigational therapy for ≥ 21 days prior to treatment, or ≥ 90 days prior to treatment for previous monoclonal antibody administration
boolean
C0920425 (UMLS CUI [1,1])
C1444662 (UMLS CUI [1,2])
C0949266 (UMLS CUI [2,1])
C1444662 (UMLS CUI [2,2])
C1533734 (UMLS CUI [3,1])
C0003250 (UMLS CUI [3,2])
C1444662 (UMLS CUI [3,3])
Allogeneic bone marrow transplantation
Item
prior allogeneic bone marrow transplant
boolean
C0149615 (UMLS CUI [1])
Invasive cancer | Exception Basal cell carcinoma Treated | Exception Squamous cell carcinoma of skin Treated | Exception Carcinoma in situ of uterine cervix Treated | Exception Carcinoma in situ of female breast Treated | Exception Carcinoma in situ of prostate Treated | Exception Disease Free of
Item
other invasive malignancies within 3 years prior to day 1 except for adequately treated basal cell or squamous cell skin cancer; carcinoma in situ of the cervix, breast, or prostate; or other cancer of which the patient has been disease-free for ≥
boolean
C0677898 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0007117 (UMLS CUI [2,2])
C1522326 (UMLS CUI [2,3])
C1705847 (UMLS CUI [3,1])
C0553723 (UMLS CUI [3,2])
C1522326 (UMLS CUI [3,3])
C1705847 (UMLS CUI [4,1])
C0851140 (UMLS CUI [4,2])
C1522326 (UMLS CUI [4,3])
C1705847 (UMLS CUI [5,1])
C0686288 (UMLS CUI [5,2])
C1522326 (UMLS CUI [5,3])
C1705847 (UMLS CUI [6,1])
C0154088 (UMLS CUI [6,2])
C1522326 (UMLS CUI [6,3])
C1705847 (UMLS CUI [7,1])
C0012634 (UMLS CUI [7,2])
C0332296 (UMLS CUI [7,3])
ID.12
Item
3 years
boolean
Anaphylaxis Immune Globulin (Human)
Item
prior anaphylactic reaction to human immunoglobulin administration
boolean
C0002792 (UMLS CUI [1,1])
C0358321 (UMLS CUI [1,2])
Hyperviscosity syndrome Symptomatic
Item
symptomatic hyperviscosity syndrome
boolean
C0221030 (UMLS CUI [1,1])
C0231220 (UMLS CUI [1,2])
Communicable Disease Requirement Antibiotics Parenteral
Item
active infection requiring parenteral antibiotics within 14 days of day 1
boolean
C0009450 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C0003232 (UMLS CUI [1,3])
C1518896 (UMLS CUI [1,4])
Major surgery | Traumatic injury | Patient need for Major surgery
Item
major surgical procedure or significant traumatic injury within 28 days prior to day 1, or anticipation of need for major surgical procedure during the course of the study
boolean
C0679637 (UMLS CUI [1])
C3263723 (UMLS CUI [2])
C0686904 (UMLS CUI [3,1])
C0679637 (UMLS CUI [3,2])
Cardiac dysfunction | Organ dysfunction
Item
clinically significant cardiac dysfunction or other significant organ dysfunction
boolean
C3277906 (UMLS CUI [1])
C0349410 (UMLS CUI [2])