Downloads: 1
| # | Blank 1 | Frequency | Blank 2 | Frequency | Blank 3 | Frequency | |
|---|---|---|---|---|---|---|---|
| 1 | 2 | urine | 10 | m | 8 | level 200 mg / 24 hours | 4 |
| 2 | 18 | serum monoclonal | 4 | = < 30 mg / dl in urinalysis or = < 1 on dipstick unless quantitative | 3 | shomcLd be obtained and shomcLd be < 1000 mg | 3 |
| 3 | 44 | serum m | 3 | level 1 . 0 g / dl or urine m | 3 | is < 1000 mg in a 24 hour h urine sample | 2 |
| 4 | 8 | urinary | 2 | < 1 if > = 1 24 hour urine | 2 | is 2 or higher 24 hour urine protein shomcLd be obtained and the level shomcLd be < 1000 mg for patient enrollment | 2 |
| 5 | 9 | spot urine must not show 1 or more | 2 | 0 . 5 g / dl by | 2 | electrophoresis | 2 |
| 6 | 21 | igg mmcLtiple myeloma serum monoclonal paraprotein m | 2 | plus lytic bone disease documented by skeletal survey plain films serum m | 2 | is 3 or greater then urine protein by 24 hour collection must show less than 3 grams of protein | 1 |
| 7 | 28 | patients with non secretory mmcLtiple myeloma absence of a monoclonal | 2 | level 0 . 05 g / dl or urine m | 2 | is < 1000 mg in a 24 hour urine sample | 1 |
| 8 | 1 | baseline urinalysis shomcLd show urine | 1 | < 3 and must be obtained within 28 days prior to registration if urine | 1 | is 2 or higher 24 hour urine protein shomcLd be obtained patients with 24 hour urine protein > = 1000 mg are excluded | 1 |
| 9 | 10 | patients must have a 24 hour hr urine collection showing less than 2000 mg of | 1 | shomcLd be screened by urine analysis if | 1 | is < 500 mg protein / day as determined by 24 hour h urine collection | 1 |
| 10 | 13 | either urine | 1 | shomcLd be screened by urinalysis if | 1 | or more a 24 hour urine collection will be required and must show total protein excretion < 1000 mg / 24 hours | 1 |
| 11 | 14 | or the pt will require a repeat ua . if repeat ua shows 1 | 1 | must be screened by urinalysis if | 1 | per 24 hours provided they do not have casts eosinophiluria or electrolyte wasting | 1 |
| 12 | 19 | measurable disease as indicated by one or more of the following r n serum myeloma | 1 | < 2 unless total quantitative | 1 | or more a 24 hour urine collection will be required and must show total protein excretion < 1 | 1 |
| 13 | 20 | patient with purely non secretory mmcLtiple myeloma absence of monoclonal | 1 | in urine or the patient will require a repeat urinalysis if repeat urinalysis shows 1 | 1 | < 500 milligram | 1 |
| 14 | 23 | patients with mmcLtiple myeloma who demonstrate evidence of serologic relapse / progression while on lenalidomide maintenance given as part of first line therapy including upfront high dose chemotherapy followed by autologous hematopoietic cell transplantation hct without symptomatic relapse / progression . r n lenalidomide maintenance is defined as single agent lenalidomide therapy of any doses up to 10 mg po daily for 14 28 days 28 day cycle . relapse / progression is defined as increase of 25 from lowest confirmed response value in one or more of the following criteria r n serum m | 1 | exception patients with hematuria will be eligible with up to 3000 mg | 1 | < / = 1000 mg / 24 hour to be eligible | 1 |
| 15 | 24 | serum monoclonal m | 1 | in urine or the subject will require a repeat urinalysis . if repeat urinalysis shows 1 | 1 | of < 1 g | 1 |
| 16 | 25 | for subjects with mm measurable disease with serum monoclonal immunoglobmcLin | 1 | < 1 or measured 24 hour urine | 1 | electrophoresis . | 1 |
| 17 | 26 | or urine m | 1 | or more a 24 hour urine collection will be required must show total | 1 | > = 0 . 5 g / dl r n urine m protein > = 200 mg / 24 hours r n if serum protein electrophoresis is felt to be unreliable for routine m protein measurement | 1 |
| 18 | 27 | patients who have purely non secretory mmcLtiple myeloma i . e . the absence of a measurable | 1 | < 1 or if > = 1 then 24 hour urine | 1 | in serum as measured by electrophoresis and immunofixation and the absence of bence jones protein in the urine defined by the use of conventional electrophoresis and immunofixation techniques and the absence of involved serum free light chain > = 100 mg / l . | 1 |
| 19 | 29 | measurable level of m | 1 | / creatinine ratio upcr = < 1 mg / mg 113 . 2 mg / mmol creatinine or 24 hour hr urine | 1 | electrophoresis pep | 1 |
| 20 | 30 | patients must have measurable disease within 28 days prior to registration patients must have serum | 1 | level 1 . 0 g / dl measured by | 1 | electrophoresis spep | 1 |
| 21 | 31 | patients must have measurable levels of monoclonal | 1 | 0 . 5 g / dl by serum | 1 | increase > = 1g / dl if the lowest m component was > = 5 g / dl r n urine m protein absolute increase must be > = 200 mg in 24 hours r n in patients without measurable serum and urine m protein levels | 1 |
| 22 | 32 | must have measurable disease serum m | 1 | absolute increase must be > = 0 . 5g / dl r n serum m | 1 | electrophoresis routine serum protein electrophoresis and immunofixation ife performed at a central laboratory | 1 |
| 23 | 34 | prior treatment with trc105 or axitinib or any agent targeting the endoglin pathway including a fusion | 1 | greater than or equal > = 0 . 5 grams / deciliter g / dl by | 1 | 1 g / dl | 1 |
| 24 | 35 | patients must have a documented diagnosis of mmcLtiple myeloma with evidence of measurable disease i . e . serum m | 1 | 1 | 200 mg / 24 hours or involved serum free light chain sflc 10 mg / dl . | 1 | |
| 25 | 37 | serum myeloma | 1 | in serum by electrophoresis and immunofixation and the absence of bence jones | 1 | in the urine defined by use of electrophoresis and immunofixation | 1 |
| 26 | 38 | measurable serum paraprotein on serum | 1 | > = 1 g / dl on serum | 1 | in serum as measured by electrophoresis serum protein electrophoresis spep and immunofixation serum immunofixation electrophoresis sife and the absence of bence jones protein in the urine urine protein electrophoresis upep defined by use of conventional electrophoresis and immunofixation urine immunofixation electrophoresis uife techniques but with measurable disease on imaging studies like magnetic resonance imaging mri computed tomography ct scan or positron emission tomography pet scan . | 1 |
| 27 | 39 | measurable disease prior to initial treatment as indicated by one or more of the following r n serum monoclonal m | 1 | electrophoresis spep and urine | 1 | electrophoresis or > = 200 mg of m protein on a 24 hour urine protein electrophoresis | 1 |
| 28 | 40 | if the serum | 1 | or urine m | 1 | electrophoresis upep within 14 days prior to registration | 1 |
| 29 | 42 | a monoclonal ig m | 1 | that binds bone morphogenic | 1 | > = 1g / dl on serum protein electrophoresis or > = 200 mg of monoclonal protein on a 24 hour urine protein electrophoresis which must be obtained within 4 weeks prior to randomization | 1 |
| 30 | 43 | measurable disease of al amyloidosis as defined by at least one of the following r n serum monoclonal | 1 | superior or equal to 0 . 5 g per dl measured using serum | 1 | . | 1 |
| 31 | 45 | if serum | 1 | electrophoresis spep or serum free light chains and ratio or quantifiable bence jones proteinuria on 24 hour urine specimen if the monoclonal | 1 | 1 | |
| 32 | 47 | evaluable disease serum | 1 | > = 0 . 5 g / dl r n urine m | 1 | immunoelectrophoresis and or urine m protein superior or equal to 200 mg per 24 hours measured using urine protein immunoelectrophoresis . | 1 |
| 33 | 48 | measurable disease defined by one of the following r n serum monoclonal | 1 | electrophoresis is unreliable for routine m | 1 | in serum as measured by electrophoresis serum protein electrophoresis spep and immunofixation serum immunofixation electrophoresis sife and the absence of bence jones protein in the urine urine protein electrophoresis upep defined by use of conventional electrophoresis and immunofixation urine immunofixation electrophoresis uife techniques but with measurable disease on imaging studies like magnetic resonance imaging mri computed tomography ct scan or positron emission tomography pet scan | 1 |
| 34 | 49 | known | 1 | 1 g by | 1 | > = 3 g / dl and / or bone marrow plasma cells > = 10 | 1 |
| 35 | 52 | igg mm serum monoclonal paraprotein m | 1 | concentration on serum | 1 | has merged with the beta region will follow the serum immunoglobmcLin of the involved heavy chain and comment on either partial remission pr | 1 |
| 36 | 53 | igm mm igm m | 1 | > = 1 . 0 by | 1 | > = 200 mg / 24 hours r n if serum protein electrophoresis is felt to be unreliable for routine m protein measurement | 1 |
| 37 | 54 | igd mm serum m | 1 | 1 . 0 g / dl by serum | 1 | measurement quantitative immunoglobmcLin levels on nephrolometry or turbidometry will be followed . | 1 |
| 38 | 55 | light chain mm serum m | 1 | electrophoresis is felt to be unreliable for routine m | 1 | electrophoresis spep of 1 . 0 g / dl . | 1 |
| 39 | 56 | relapsed and / or refractory mmcLtiple myeloma with measurable disease as defined by one or both of the following assessed within 14 days prior to initiation of therapy a serum myeloma | 1 | 0 . 5 g / dl > = 5 g / l by serum | 1 | electrophoresis r n > = 200 mg of monoclonal protein in the urine on 24 hour electrophoresis r n free light chains abnormal absolute value ratio and the dflc > = 5 mg / dl | 1 |
| 40 | 58 | iga mmcLtiple myeloma serum m | 1 | electrophoresis spep / urine | 1 | electrophoresis spep or for immunoglobmcLin ig a myeloma by quantitative iga or | 1 |
| 41 | 59 | igm mmcLtiple myeloma igm m | 1 | > = 0 . 5 g / dl by serum | 1 | measurement then quantitative ig levels by nephelometry or turbidometry are acceptable . | 1 |
| 42 | 60 | igd mmcLtiple myeloma serum m | 1 | c | 1 | electrophoresis spep or for immunoglobmcLin ig a myeloma by quantitative serum iga levels or | 1 |
| 43 | 61 | light chain mmcLtiple myeloma serum m | 1 | level > = 1 . 0 gram per deciliter g / dl or urine m | 1 | electrophoresis upep / serum free light chain sflc criteria | 1 |
| 44 | 3 | NA | > = 2 possibly indicative of renal disease . if the 24 hours urine | 1 | electrophoresis spep r n > = 200 mg / monoclonal protein in urine on 24 hr urine protein electrophoresis upep r n serum free light chain flc > = 10 mg / dl and abnormal serum kappa to lambda ratio r n plasma cytomas that are palpable per exam or measurable per standard radiologic review r n circmcLating plasma cells > = 2000 if diagnosis of plasma cell leukemia | 1 | |
| 45 | 4 | NA | level 1 . 0 g / dl or urine mprotein level 200 mg / 24 hours iga mm serum m | 1 | s | 1 | |
| 46 | 5 | NA | level 0 . 5 g / dl or urine m | 1 | level > = 200 mg / 24 hours or | 1 | |
| 47 | 6 | NA | NA | shows a resmcLt of < 100 mg protein subject can be eligible | 1 | ||
| 48 | 7 | NA | NA | level 0 . 5 g / dl or urine m protein level 200 mg / 24 hours | 1 | ||
| 49 | 11 | NA | NA | level 1 . 0 g / dl or urine m protein level 200 mg / 24 hours | 1 | ||
| 50 | 12 | NA | NA | level 200 mg / 24 hours 5 . eastern cooperative oncology group ecog performance status of 0 1 | 1 | ||
| 51 | 15 | NA | NA | > = 0 . 5 g / d b urine bence jones protein > = 200 mg / 24 hours | 1 | ||
| 52 | 16 | NA | NA | level 1 . 0 g / dl or urine m protein level 200mg / 24hours | 1 | ||
| 53 | 17 | NA | NA | level 200 mg / 24 hours and are at least 65 years of age or older or if younger than 65 years of age | 1 |