Eligibility Multiple Myeloma NCT02400242

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Multiple Myeloma | Multiple myeloma recurrent | Multiple myeloma recurrent Refractory | Status post Stable Disease | Therapeutic procedure Quantity | Progressive Disease
Item
must have a documented diagnosis of mm and have relapsed or relapsed-and-refractory disease. all patients must have relapsed after having achieved at least stable disease (sd) for at least 1 cycle of treatment to at least 1 prior regimen and then developed progressive disease (pd). relapsed-and-refractory patients also have documented evidence of pd during or within 60 days of completing last treatment
boolean
C0026764 (UMLS CUI [1])
C1370446 (UMLS CUI [2])
C1370446 (UMLS CUI [3,1])
C0205269 (UMLS CUI [3,2])
C0231290 (UMLS CUI [4,1])
C0677946 (UMLS CUI [4,2])
C0087111 (UMLS CUI [5,1])
C1265611 (UMLS CUI [5,2])
C1335499 (UMLS CUI [6])
Prior Therapy Quantity | lenalidomide | Proteasome inhibitor
Item
must have undergone prior treatment with at least 2 cycles of lenalidomide and at least 2 cycles of proteasome inhibitor unless not a candidate.
boolean
C1514463 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C1144149 (UMLS CUI [2])
C1443643 (UMLS CUI [3])
Prior Therapy | pomalidomide | Disease Response Pomalidomide | Minimal response Pomalidomide | Partial response Pomalidomide
Item
may have undergone prior treatment with pomalidomide if patient previously achieved a response of minimal response (mr) or better to pomalidomide.
boolean
C1514463 (UMLS CUI [1])
C2347624 (UMLS CUI [2])
C1704632 (UMLS CUI [3,1])
C2347624 (UMLS CUI [3,2])
C0184783 (UMLS CUI [4,1])
C2347624 (UMLS CUI [4,2])
C1521726 (UMLS CUI [5,1])
C2347624 (UMLS CUI [5,2])
Measurable Disease | Serum M Protein | Urine M Protein
Item
must have measurable disease (serum m-protein or urine m-protein).
boolean
C1513041 (UMLS CUI [1])
C0229671 (UMLS CUI [2,1])
C0700271 (UMLS CUI [2,2])
C0042036 (UMLS CUI [3,1])
C0700271 (UMLS CUI [3,2])
ECOG performance status
Item
must have eastern cooperative oncology group (ecog) performance score of 0, 1, or 2.
boolean
C1520224 (UMLS CUI [1])
Aspirin Low Dose | Heparin, Low-Molecular-Weight | Antithrombotic Agents Equivalent Daily | Anticoagulants Equivalent Daily | Prophylactic anticoagulation
Item
must be able to take low-dose aspirin, low molecular weight heparin, or other equivalent antithrombotic or anticoagulant daily as prophylactic anticoagulation.
boolean
C2608320 (UMLS CUI [1])
C0019139 (UMLS CUI [2])
C1704311 (UMLS CUI [3,1])
C0205163 (UMLS CUI [3,2])
C0332173 (UMLS CUI [3,3])
C0003280 (UMLS CUI [4,1])
C0205163 (UMLS CUI [4,2])
C0332173 (UMLS CUI [4,3])
C4304154 (UMLS CUI [5])
Exclusion Criteria Main
Item
key exclusion criteria:
boolean
C0680251 (UMLS CUI [1,1])
C1542147 (UMLS CUI [1,2])
Prior Therapy | pomalidomide | Response Progressive Disease | Response Stable Disease
Item
prior therapy with pomalidomide with best response of pd or sd.
boolean
C1514463 (UMLS CUI [1])
C2347624 (UMLS CUI [2])
C1704632 (UMLS CUI [3,1])
C1335499 (UMLS CUI [3,2])
C1704632 (UMLS CUI [4,1])
C0677946 (UMLS CUI [4,2])
Prior Therapy | Histone deacetylase inhibitor
Item
prior therapy with histone deacetylase (hdac) inhibitor.
boolean
C1514463 (UMLS CUI [1])
C1512474 (UMLS CUI [2])
Laboratory test result abnormal | Absolute neutrophil count | Platelet Count measurement | Nucleated cells Bone marrow Percentage Plasma Cells | Hemoglobin measurement | Estimation of creatinine clearance by Cockcroft-Gault formula | Estimation of creatinine clearance by Cockcroft-Gault formula 24 hour urine sample | Aspartate aminotransferase increased | Alanine aminotransferase increased | SERUM TOTAL BILIRUBIN ELEVATED | Hereditary Benign Hyperbilirubinemia
Item
any of the following laboratory abnormalities: absolute neutrophil count(anc) < 1,000/µl, platelet count < 75,000/µl or < 50,000/µl for patients in whom ≥ 50% of bone marrow nucleated cells are plasma cells, hemoglobin < 8 g/dl, creatinine clearance < 45 ml/min according to cockcroft-gault formula. if creatinine clearance calculated from the 24 hour urine sample is ≥ 45 ml/min, patient will qualify for the trial, aspartate transaminase (ast) or alanine transaminase (alt) > 3.0 × upper limited normal (uln), serum total bilirubin > 2.0 mg/dl or > 3.0 × uln for patients with hereditary benign hyperbilirubinaemia.
boolean
C0438215 (UMLS CUI [1])
C0948762 (UMLS CUI [2])
C0032181 (UMLS CUI [3])
C2738468 (UMLS CUI [4,1])
C0439165 (UMLS CUI [4,2])
C0032112 (UMLS CUI [4,3])
C0518015 (UMLS CUI [5])
C2711451 (UMLS CUI [6])
C2711451 (UMLS CUI [7,1])
C0456209 (UMLS CUI [7,2])
C0151904 (UMLS CUI [8])
C0151905 (UMLS CUI [9])
C0595866 (UMLS CUI [10])
C0020435 (UMLS CUI [11,1])
C0205183 (UMLS CUI [11,2])
Growth Factors Hematologic
Item
hematologic growth factors are not allowed at screening or during the first cycle of phase 1a or 1b.
boolean
C0018284 (UMLS CUI [1,1])
C0205488 (UMLS CUI [1,2])
Non-secretory myeloma | Serum Free Light Chain | Myeloma M Protein Very low
Item
nonsecretory myeloma or free light chain detected in serum only (ogliosecretory).
boolean
C0456845 (UMLS CUI [1])
C2827352 (UMLS CUI [2])
C0026764 (UMLS CUI [3,1])
C0700271 (UMLS CUI [3,2])
C0442811 (UMLS CUI [3,3])
Hypersensitivity Thalidomide | Hypersensitivity Lenalidomide | Hypersensitivity Pomalidomide | Dexamethasone allergy
Item
hypersensitivity to thalidomide, lenalidomide, pomalidomide, or dexamethasone
boolean
C0020517 (UMLS CUI [1,1])
C0039736 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C1144149 (UMLS CUI [2,2])
C0020517 (UMLS CUI [3,1])
C2347624 (UMLS CUI [3,2])
C0571611 (UMLS CUI [4])
Allogeneic bone marrow transplantation | Allogeneic peripheral blood stem cell transplant
Item
patients who received an allogeneic bone marrow or allogeneic peripheral blood stem cell transplant less than 12 months prior to initiation of study
boolean
C0149615 (UMLS CUI [1])
C1960580 (UMLS CUI [2])
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