Serum monoclonal protein ? . g/dL by protein electrophoresis.
?  mg/ hours of monoclonal protein in the urine on -hour electrophoresis
Measurable serum and/or urine M-protein from prior to induction therapy documented and available; a positive serum free lite assay is acceptable
Patient with purely non-secretory multiple myeloma [absence of monoclonal protein (M protein) 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 > mg/L].
Serum monoclonal protein ? . g/dL by serum protein electrophoresis (SPEP)
?  mg/ hours of monoclonal protein in the urine on -hour urine electrophoresis (UPEP)
serum monoclonal (M)-protein greater than or equal (>=) . grams/deciliter (g/dL) by protein electrophoresis (routine serum protein electrophoresis and immunofixation [IFE] performed at a central laboratory)
Patients who have purely non-secretory multiple myeloma (i.e., the absence of a measurable protein in serum by electrophoresis and immunofixation and the absence of Bence-Jones protein in the urine defined by use of electrophoresis and immunofixation)
Patients must have histologically or cytologically confirmed symptomatic multiple myeloma (MM), Salmon-Durie stage II or III, or International Staging System II or III or fulfill the calcium, renal failure, anemia, and bone lesions (CRAB) criteria; patients should not have previously been treated; finally, patients must meet at least one of the following parameters of measurable disease:\r\n* Bone marrow plasmacytosis with > % plasma cells, or sheets of plasma cells, or biopsy proven plasmacytoma which must be obtained within  weeks prior to registration\r\n* Measurable levels of M-protein: >=  g/dL on serum protein electrophoresis (SPEP) or >=  mg of monoclonal light chain on a  hour urine protein electrophoresis (UPEP) or involved free light chain (FLC) >=  mg/dL (>=  mg/L) which must be obtained within  weeks prior to registration\r\nSerum and urine M-protein levels should be determined by electrophoresis rather than by quantitative immunoglobulin (Ig) measurement; exceptions are made in cases in which the M-spike value may be deemed to be unreliable (e.g. co-migrating M-spike); in these cases, quantitative Ig should be used; to assess response and progression, however, SPEP values should only be compared to SPEP values and quantitative Ig values only to quantitative Ig values
Patients with non-secretory multiple myeloma (absence of a monoclonal protein [M protein] 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.
Measurable level of M-protein >  g/dL on serum protein electrophoresis or >  mg of M-protein on a  hour urine protein electrophoresis
Patients must have measurable disease within  days prior to registration; patients must have serum protein electrophoresis (SPEP) and urine protein electrophoresis (UPEP) within  days prior to registration
Measurable disease defined as a quantitative IgM monoclonal protein of >\n                  mg/dL obtained within  days prior to registration
Inclusion Criteria:\n\n        Measurable MM based on modified IMWG guidelines. Defined by at least one of the following:\n\n          . Serum M-protein ? . g/dL by serum electrophoresis (SPEP) or for IgA myeloma, by\n             quantitative IgA\n\n          . Urinary M-protein excretion ?  mg/ hours\n\n          . Free Light Chain (FLC) ?  mg/L, provided that the FLC ratio is abnormal\n\n          . If serum protein electrophoresis is felt to be unreliable for routine M-protein\n             measurement, then quantitative Ig levels by nephelometry or turbidimetry are\n             acceptable\n\n               -  Must have previously received ?  anti-MM regimens including: an alkylating\n                  agent, lenalidomide, pomalidomide, bortezomib, carfilzomib, daratumumab, and a\n                  glucocorticoid. There is no upper limit on the number of prior therapies provided\n                  that all other inclusion/exclusion criteria are met.\n\n               -  MM refractory to previous treatment with one or more glucocorticoids, parenteral\n                  PI (i.e., bortezomib and/or carfilzomib), IMiD (i.e., lenalidomide and/or\n                  pomalidomide), and the anti-CD mAb, daratumumab. Refractory is defined as ? %\n                  response to therapy, or progression during therapy or progression within  days\n                  after completion of therapy.\n\n        Exclusion Criteria:\n\n          -  Active smoldering MM.\n\n          -  Active plasma cell leukemia.\n\n          -  Documented systemic amyloid light chain amyloidosis.\n\n          -  Active CNS MM.
Patients must have measurable levels of monoclonal protein (M-protein): >= g/dL on serum protein electrophoresis or >=  mg of monoclonal protein on a  hour urine protein electrophoresis which must be obtained within  weeks prior to randomization
Monoclonal protein present in the serum and/or urine
Serum monoclonal protein ? . g/dL by protein electrophoresis
? mg of monoclonal protein in the urine on -hour electrophoresis
Patients with non-secretory multiple myeloma (absence of a monoclonal protein [M protein] 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
Measurable serum paraprotein on serum protein electrophoresis (SPEP) or serum free light chains and ratio, or quantifiable Bence-Jones proteinuria on  hour urine specimen; if the monoclonal protein has merged with the beta region will follow the serum immunoglobulin of the involved heavy chain and comment on either partial remission (PR, as judged by two protocol investigators) or complete remission (CR, as defined by the achievement of PR as above and the resolution of the monoclonal protein by immunofixation in the serum and urine)
Measurable disease, prior to initial treatment as indicated by one or more of the following:\r\n* Serum monoclonal (M)-protein >= . g/dL\r\n* Urine M-protein >=  mg/ hours\r\n* If serum protein electrophoresis is felt to be unreliable for routine M-protein measurement, then quantitative immunoglobulin levels are acceptable
Must have documented diagnosis of multiple myeloma and have measureable disease by serum and urine protein electrophoresis.
Demonstrate measurable disease as defined by one or more of the following:\r\n* Serum monoclonal protein >= . g/dL by serum electrophoresis\r\n* Urine monoclonal protein >  mg/dL in a  hr urine electrophoresis\r\n* Demonstrate clonal population of plasma cells in the bone marrow or abnormal free light chain (FLC) ratio
If the serum protein electrophoresis is unreliable for routine M-protein measurement, quantitative immunoglobulin levels on nephrolometry or turbidometry will be followed.
Serum monoclonal protein ? g by protein electrophoresis
Urine monoclonal protein > mg on  hour electrophoresis
A monoclonal Ig (M-protein) concentration on serum protein electrophoresis (SPEP) of ? . g/dL.
Measurable urinary light chain secretion by quantitative analysis using urine protein electrophoresis (UPEP) of ?  mg/ hours.
Monoclonal protein present in the serum and/or urine
Measurable disease of AL amyloidosis as defined by at least ONE of the following:\r\n* Serum monoclonal protein >= . by protein electrophoresis\r\n* >  mg of monoclonal protein in the urine on  hour electrophoresis\r\n* Free light chains (abnormal absolute value, ratio and the dFLC >  mg/dL)
Serum M-protein ? . g/dL by serum protein electrophoresis (SPEP) or for immunoglobulin (Ig) A myeloma, by quantitative IgA; or
If serum protein electrophoresis is felt to be unreliable for routine M- protein measurement, then quantitative Ig levels by nephelometry or turbidometry are acceptable.
Monoclonal protein present in the serum and/or urine
Serum M-protein ? . g/dL (>  g/L) by serum protein electrophoresis (SPEP) or for immunoglobulin (Ig) A myeloma, by quantitative serum IgA levels; or
Patients unwilling or unable to comply with the protocol, including providing -hour urine samples for urine protein electrophoresis at the required time points.
Evaluable disease (serum protein electrophoresis [SPEP]/urine protein electrophoresis [UPEP]/serum free light chain [SFLC] criteria)
Measurable disease defined by one of the following:\r\n* Serum monoclonal protein >= . g/dL by serum protein electrophoresis (SPEP)\r\n* >=  mg/monoclonal protein in urine on  hr urine protein electrophoresis (UPEP)\r\n* Serum free light chain (FLC) >=  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* Circulating plasma cells >= , if diagnosis of plasma cell leukemia