Eligibility Multiple Myeloma NCT02462525

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
ECOG performance status
Item
eastern cooperative oncology group performance status of 0 to 2
boolean
C1520224 (UMLS CUI [1])
Ineligibility Stem cell transplant | Ineligibility Bone Marrow Transplantation | Stem cell transplant Refused | Bone Marrow Transplantation Refused | Recurrent disease Post Autologous hematopoietic stem cell transplant | Recurrent disease Post Autologous bone marrow transplant | Recurrent disease Post Allogeneic hematopoietic stem cell transplant | Recurrent disease Post Allogeneic bone marrow transplantation
Item
not eligible for stem cell/bone marrow transplant or have refused stem cell/bone marrow transplant or have relapsed after autologous or allogeneic stem cell/bone marrow transplant
boolean
C1512714 (UMLS CUI [1,1])
C1504389 (UMLS CUI [1,2])
C1512714 (UMLS CUI [2,1])
C0005961 (UMLS CUI [2,2])
C1504389 (UMLS CUI [3,1])
C1705116 (UMLS CUI [3,2])
C0005961 (UMLS CUI [4,1])
C1705116 (UMLS CUI [4,2])
C0277556 (UMLS CUI [5,1])
C0687676 (UMLS CUI [5,2])
C2193200 (UMLS CUI [5,3])
C0277556 (UMLS CUI [6,1])
C0687676 (UMLS CUI [6,2])
C0194037 (UMLS CUI [6,3])
C0277556 (UMLS CUI [7,1])
C0687676 (UMLS CUI [7,2])
C4255274 (UMLS CUI [7,3])
C0277556 (UMLS CUI [8,1])
C0687676 (UMLS CUI [8,2])
C0149615 (UMLS CUI [8,3])
Eligibility Bone marrow aspirate
Item
eligible for and agree to bm aspirate prior to treatment start
boolean
C1548635 (UMLS CUI [1,1])
C1271729 (UMLS CUI [1,2])
Measurable Disease | M Protein Measurement Serum | M Protein Measurement In Urine 24 hour urine sample
Item
measurable disease m component in serum (≥ 0.5 g/dl) and/or urine (≥ 0.2 g excreted in a 24 hour collection sample)
boolean
C1513041 (UMLS CUI [1])
C2984963 (UMLS CUI [2,1])
C0229671 (UMLS CUI [2,2])
C2984963 (UMLS CUI [3,1])
C0042037 (UMLS CUI [3,2])
C0456209 (UMLS CUI [3,3])
Prior Therapy Quantity | Immunomodulators | Proteasome inhibitor | Disease Progression | Alkylating Agents
Item
received at least 2 prior therapies including an imid and a proteasome inhibitor and have demonstrated disease progression on or within 60 days of completion of the last therapy; participants previously treated with an alkylating agent, in addition to an imid or proteasome inhibitor, are allowed to enroll in the trial
boolean
C1514463 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C1527392 (UMLS CUI [2])
C1443643 (UMLS CUI [3])
C0242656 (UMLS CUI [4])
C0002073 (UMLS CUI [5])
Liver function | Renal function | Bone Marrow function
Item
participants must have adequate liver, kidney, and bone morrow function
boolean
C0232741 (UMLS CUI [1])
C0232804 (UMLS CUI [2])
C0005953 (UMLS CUI [3,1])
C0031843 (UMLS CUI [3,2])
Chronic heart failure | Left ventricular ejection fraction Echocardiography
Item
participants with a history of chronic heart failure must have cardiac echo indicating left ventricular ejection fraction (lvef) ≥ 45% within 21 days prior to first dose of study drug
boolean
C0264716 (UMLS CUI [1])
C0428772 (UMLS CUI [2,1])
C0013516 (UMLS CUI [2,2])
Item Group
C0680251 (UMLS CUI)
Cancer treatment | Chemotherapy | Immunotherapy | Therapeutic radiology procedure | Biological treatment | Therapy, Investigational | Phytotherapy
Item
received anti-cancer therapy including chemotherapy, immunotherapy, radiation, biologic, or any investigational therapy within a period of 21 days, herbal therapy within 7 days prior to the first dose of abbv-838, and have unresolved toxicities ≥
boolean
C0920425 (UMLS CUI [1])
C0392920 (UMLS CUI [2])
C0021083 (UMLS CUI [3])
C1522449 (UMLS CUI [4])
C1531518 (UMLS CUI [5])
C0949266 (UMLS CUI [6])
C0242388 (UMLS CUI [7])
Toxicity CTCAE Grades | Resolution Lacking
Item
grade 2
boolean
C0600688 (UMLS CUI [1,1])
C1516728 (UMLS CUI [1,2])
C1514893 (UMLS CUI [2,1])
C0332268 (UMLS CUI [2,2])
Solid Neoplasm metastatic
Item
concurrent metastatic solid tumors
boolean
C0280100 (UMLS CUI [1,1])
C1522484 (UMLS CUI [1,2])
M Protein Non-Measurable Serum | M Protein Non-Measurable In Urine | Serum Free Light Chain Measurable
Item
non-measurable m protein (serum or urine) and measurable sflc (< 100 mg/ml)
boolean
C0700271 (UMLS CUI [1,1])
C1518373 (UMLS CUI [1,2])
C0229671 (UMLS CUI [1,3])
C0700271 (UMLS CUI [2,1])
C1518373 (UMLS CUI [2,2])
C0042037 (UMLS CUI [2,3])
C2827352 (UMLS CUI [3,1])
C1513040 (UMLS CUI [3,2])
Major surgery
Item
major surgery within 21 days prior to the first dose of abbv-838
boolean
C0679637 (UMLS CUI [1])
Condition Clinical Significance Uncontrolled
Item
clinically significant uncontrolled condition(s) including but not limited to the following:
boolean
C0348080 (UMLS CUI [1,1])
C2826293 (UMLS CUI [1,2])
C0205318 (UMLS CUI [1,3])
Peripheral Neuropathy CTCAE Grades | Pain | Hypercalcemia Uncontrolled | Communicable Disease Uncontrolled | Symptomatic congestive heart failure | Angina, Unstable | Cardiac Arrhythmia | Mental disorders Limiting Protocol Compliance | Social situation Limiting Protocol Compliance
Item
grade ≥ 3 peripheral neuropathy or grade 2 peripheral neuropathy with pain uncontrolled hypercalcemia active uncontrolled infection symptomatic congestive heart failure unstable angina pectoris or cardiac arrhythmia psychiatric illness/social situation that would limit compliance with the study
boolean
C0031117 (UMLS CUI [1,1])
C1516728 (UMLS CUI [1,2])
C0030193 (UMLS CUI [2])
C0020437 (UMLS CUI [3,1])
C0205318 (UMLS CUI [3,2])
C0009450 (UMLS CUI [4,1])
C0205318 (UMLS CUI [4,2])
C0742758 (UMLS CUI [5])
C0002965 (UMLS CUI [6])
C0003811 (UMLS CUI [7])
C0004936 (UMLS CUI [8,1])
C0439801 (UMLS CUI [8,2])
C0525058 (UMLS CUI [8,3])
C0748872 (UMLS CUI [9,1])
C0439801 (UMLS CUI [9,2])
C0525058 (UMLS CUI [9,3])
Immunologic reaction Major Immunoglobulin G | Immunologic reaction Major Auristatin
Item
major immunologic reaction to any igg containing agent or auristatin based agent
boolean
C0301873 (UMLS CUI [1,1])
C0205164 (UMLS CUI [1,2])
C0020852 (UMLS CUI [1,3])
C0301873 (UMLS CUI [2,1])
C0205164 (UMLS CUI [2,2])
C2742798 (UMLS CUI [2,3])
CYP3A4 Inhibitors Strong
Item
participants who are taking strong cyp3a4 inhibitors
boolean
C3850053 (UMLS CUI [1,1])
C0442821 (UMLS CUI [1,2])
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