STEP I: Patients must have measurable or evaluable disease as defined by having one or more of the following, obtained within  days prior to randomization:\r\n* >=  g/dL monoclonal protein (M-protein) on serum protein electrophoresis\r\n* >=  mg/ hours (hrs) of monoclonal protein on a  hour urine protein electrophoresis\r\n* Involved free light chain >=  mg/dL or >=  mg/L AND abnormal serum immunoglobulin kappa to lambda free light chain ratio (< . or > .)\r\n* Monoclonal bone marrow plasmacytosis >= % (evaluable disease)\r\n* Serum protein electrophoresis (SPEP), urine protein electrophoresis (UPEP), and serum free light chain (FLC) assay are required to be performed within  days prior to randomization; a bone marrow biopsy and/or aspirate is required within  days if bone marrow is being followed for response\r\n** NOTE: UPEP (on a -hour collection) is required, no substitute method is acceptable; urine must be followed monthly if the baseline urine M-spike is >=  mg/ hr; please note that if both serum and urine M-components are present, both must be followed in order to evaluate response\r\n** NOTE: The serum free light chain test is required to be done if the patient does not have measurable disease in the serum or urine; measurable disease in the serum is defined as having a serum M-spike >=  g/dL; measurable disease in the urine is defined as having a urine M-spike >=  mg/ hr
Patient must have measurable disease or non-measurable disease, defined as one or more of the following holding true:\r\n* Measurable disease:\r\n** Serum M-protein >= . g/dL (>= . g/dL for IgA or IgM myeloma) and/or\r\n** Urine M-protein >=  mg/ hours and/or\r\n** Involved serum free light chain level >=  mg/dL AND an abnormal serum free light chain ratio\r\n* For non-measurable disease:\r\n** Baseline marrow burden of myeloma of at least %
RE-REGISTRATION ELIGIBILITY CRITERIA (STEP ): Patient must have measurable disease or non-measurable disease after progression on pomalidomide + dexamethasone, defined as one or more of the following holding true:\r\n* Measurable disease:\r\n** Serum M-protein >= . g/dL and/or\r\n** Urine M-protein >=  mg/ hours and/or\r\n** Involved serum free light chain level >=  mg/dL AND an abnormal serum free light chain ratio\r\n* For non-measurable disease:\r\n** Marrow burden of myeloma of at least %
Inclusion criteria:\n\n        Part A\n\n          -  Patients must have a known diagnosis of multiple myeloma (MM) with evidence of\n             measurable disease, as defined below, and have evidence of disease progression based\n             on International Myeloma Working Group (IMWG) criteria:\n\n          -  Serum M-protein ?g/dL, or urine M-protein ? mg/ hours, OR\n\n          -  In the absence of measurable M-protein, serum immunoglobulin free light chain ?\n             mg/dL, and abnormal serum immunoglobulin kappa lambda free light chain ratio.\n\n          -  Patients must have received at least  prior lines of therapy for MM and must include\n             treatment with an immunomodulatory drug (IMiD) (for ? cycles or ? months of\n             treatment) and a proteasome inhibitor (for ? cycles or ? months of treatment).\n             Induction therapy and stem cell transplant ( maintenance) will be considered as one\n             regimen within a line, OR\n\n          -  Patients whose disease is double refractory to an IMiD and a proteasome inhibitor. For\n             patients who have received more than one type of IMiD and proteasome inhibitor, their\n             disease must be refractory to the most recent one.\n\n          -  Patients must have achieved a minimal response (MR) or better to at least one prior\n             line of therapy.\n\n          -  Patients must have received an alkylating agent (for ? cycles or ? months of\n             treatment) either alone or in combination with other MM treatments (history of stem\n             cell transplant is acceptable). Treatment with high-dose Melphalan for stem cell\n             transplantation meets this requirement.\n\n          -  Signed written informed consent and be willing and able to complete all study-related\n             procedures.\n\n        Part B\n\n          -  Patients must have a known diagnosis of multiple myeloma (MM) with evidence of\n             measurable disease, as defined below, and have evidence of disease progression based\n             on International Myeloma Working Group (IMWG) criteria:\n\n          -  Serum M-protein ?g/dL, or urine M-protein ? mg/ hours, OR\n\n          -  In the absence of measurable M-protein, serum immunoglobulin free light chain ?\n             mg/dL, and abnormal serum immunoglobulin kappa lambda free light chain ratio.\n\n          -  Patients must have received at least  cycles of daratumumab treatment with at least \n             weeks from the last treatment with daratumumab to the first study treatment OR at\n             least  cycles of daratumumab treatment in case another therapy is given between\n             daratumumab and isatuximab with at least  weeks from the last treatment with\n             daratumumab to the first study treatment.\n\n          -  Patients must have achieved MR or better to at least  prior line of therapy.\n\n          -  Signed written informed consent and be willing and able to complete all study-related\n             procedures.\n\n        Exclusion criteria:\n\n          -  Patients < years old.\n\n          -  Eastern Cooperative Oncology Group (ECOG) performance status >.\n\n          -  Poor bone marrow reserve.\n\n          -  Poor organ function.\n\n          -  Known intolerance/hypersensitivity to IMiDs, dexamethasone, boron or mannitol,\n             sucrose, histidine, or polysorbate .\n\n          -  Any serious active disease (including clinically significant infection that is\n             chronic, recurrent, or active) or comorbid condition, which, in the opinion of the\n             Investigator, could interfere with the safety, the compliance with the study, or with\n             the interpretation of the results.\n\n          -  Any severe underlying medical conditions including presence of laboratory\n             abnormalities, which could impair the ability to participate in the study or the\n             interpretation of its results.\n\n        The above information is not intended to contain all considerations relevant to a patient's\n        potential participation in a clinical trial.
Serum free light chain ?  mg/dL AND abnormal serum kappa to lambda free light chain ratio
Patients must have measurable disease according to International Myeloma Working Group (IMWG) criteria; measurable disease includes at least one of the following criteria:\r\n* Serum M-protein >= . g/dL, and/or\r\n* Urine M-protein >=  mg/ hours, and/or\r\n* Involved serum free light chain >=  mg/dL (>=  mg/L) AND an abnormal serum free light chain ratio, and/or\r\n* Baseline marrow burden or myeloma of at least %
Measurable disease, as indicated by one or more of the following:\r\n* Serum myeloma protein (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\r\n* Involved serum free light chains >=  mg/dL provided that free light chain ratio is abnormal
Measurable disease, as indicated by one or more of the following: Serum M-protein ? . g/dL Urine Bence Jones protein ?  mg/ hr Elevated Free Light Chain as per IMWG criteria, and abnormal ratio
Measureable disease, as defined by at least one of the following: serum M protein . g/dL or higher, urine M protein  mg/ hour or higher, and serum immunoglobulin free light chain  mg/dL or higher and abnormal serum immunoglobulin kappa lambda free light chain ratio
Patients must have measurable disease defined by at least  of the following measurements:\r\n* Serum M-protein >= . g/dL (>=  g/L) for an immunoglobulin (Ig)G myeloma, >= . g/dL for an IgD myeloma or . g/dL (>= g/L) for an IgA myeloma\r\n* Urine light chain >=  mg/ hours\r\n* Serum free light chain >=  mg/dL provided the free light chain (FLC) ratio is abnormal\r\n* Patients with oligo- or non-secretory disease must have bone marrow involvement with at least % plasmacytosis on aspiration
Patients must have measurable disease defined as any of the following:\r\n* Serum monoclonal protein >=  mg/dL by protein electrophoresis \r\n* >  mg of monoclonal protein in the urine on screening -hour electrophoresis \r\n* Serum immunoglobulin free light chain >=  mg/L AND abnormal serum immunoglobulin kappa to lambda free light chain ratio
Measurable disease of multiple myeloma as defined by at least ONE of the following:\r\n* Serum monoclonal protein >= . g/dL\r\n* >  mg of monoclonal protein in the urine on  hour electrophoresis\r\n* Serum immunoglobulin free light chain >=  mg/dL AND abnormal serum immunoglobulin kappa to lambda free light chain ratio
COHORT B ONLY: serum immunoglobulin free light chain >=  mg/dL AND abnormal serum immunoglobulin kappa to lambda free light chain ratio
Measurable disease at Screening: Serum monoclonal protein of at least . g/dL (g/L) by protein electrophoresis or at least  mg of monoclonal protein in the urine on -hr electrophoresis or serum immunoglobulin free light chain of at least  mg/dL and abnormal serum immunoglobulin kappa to lambda free light chain ratio.
Involved/un-involved light chain ratio must be < 
Measurable disease within the past  weeks defined by any one of the following:\r\n* Serum monoclonal protein >= . g/dl\r\n* Urine monoclonal protein >  mg/ hour\r\n* Serum immunoglobulin free light chain >  mg/dL AND abnormal kappa/lambda ratio (reference .-.)\r\n* NOTE: As of Amendment L, the primary endpoint is MRD(-) CR rate; therefore, per the discretion of the principal investigator, patients without measurable disease (e.g., M-spike < ) may also be enrolled; this is in line with the most recent International Myeloma Working Group Multiple Myeloma (IMWG MM) response criteria
Measurable disease defined by at least one of the following:\r\n* Serum monoclonal protein (serum protein electrophoresis [SPEP]) > gm/dL\r\n* Serum free light chain (sFLC): involved free light chain (FLC) >= mg/dL AND abnormal kappa to lambda serum free light chain ratio\r\n* >= mg of monoclonal protein in the urine on  hour electrophoresis (urine protein electrophoresis [UPEP])
Measurable disease of multiple myeloma as defined by at least ONE of the following:\r\n* Serum monoclonal protein ? . g/dL\r\n* ?  mg of monoclonal protein in the urine on  hour electrophoresis\r\n* Serum immunoglobulin free light chain ?  mg/dL AND abnormal serum immunoglobulin kappa to lambda free light chain ratio
Have measurable disease by International Myeloma Working Group (IMWG) criteria based on one or more of the following findings:\r\n* Serum monoclonal immunoglobulin (M-protein) ?  g/dL\r\n* Urine M-protein ?  mg/ hour\r\n* Involved serum free light chain (sFLC) level ?  mg/dL with abnormal kappa/lambda ratio\r\n* Measurable biopsy-proven plasmacytomas (?  lesion that has a single diameter ?  cm)\r\n* Bone marrow plasma cells ? %
Serum free light chain assay: involved free light chain level >  mg/dL (>  mg/L) provided the serum free light chain ratio is abnormal
Serum free light chain (SFLC) ?  mg/dL AND abnormal serum kappa to lambda free light chain ratio
Measurable disease with at least  of the following assessed within  days prior to cycle  day : \r\n* Serum M-protein >= . g/dL\r\n* Urine M-protein >=  mg/ hour\r\n* In subjects without detectable serum or urine M-protein, serum free light chain (SFLC) >  mg/dL (involved light chain) and an abnormal serum kappa lambda ratio
Patients with purely non-secretory MM [absence of a monoclonal protein (M protein) in serum as measured by electrophoresis and immunofixation and the absence of Bence Jones protein in the urine defined by use of conventional electrophoresis and immunofixation techniques and the absence of involved serum free light chain > mg/L]. Patients with light chain MM detected in the serum by free light chain assay are eligible.
Have measurable disease by International Myeloma Working Group (IMWG) criteria based on one or more of the following findings:\r\n* Serum M-protein >=  g/dL\r\n* Urine M-protein >=  mg/ hour\r\n* Involved serum free light chain (sFLC) level >=  mg/dL with abnormal ?/? ratio\r\n* Measurable biopsy-proven plasmacytomas (>=  lesion that has a single diameter >=  cm)\r\n* Bone marrow plasma cells >= %
Patients with evidence of progression, relapse or refractory disease from last line of therapy as defined by International Myeloma Working Group (IMWG) criteria; a line of therapy is defined as one or more cycles of a planned treatment program which may be one therapy or a sequence of treatments; a new line of therapy begins when a planned course of therapy is modified due to disease progression, relapse or toxicity or when a planned period of observation off therapy; measurable disease as defined by any of the following:\r\n* Serum M-protein >= . g/dl (>=  g/l)\r\n* Urine monoclonal protein >=  mg/ hour(h)\r\n* Involved free light chain (FLC) level >= mg/dl (>= mg/l) and an abnormal serum free light chain ratio (< ., or > .)\r\n* Measurable biopsy proven plasmacytoma (should be measured within  days of initial investigational agent dosing)
Evaluable MM with at least one of the following: (a) serum monoclonal component ? . g/dL; or (b) Bence Jones (BJ) proteinuria ?  mg/h; or (c) measurable plasmacytoma (not previously irradiated); or (d) involved serum free light chain ?  mg/dL with an abnormal free light chain ratio;
Diagnosis of primary systemic AL amyloidosis of tissue as determined by: a. Congo red staining of tissue showing apple green birefringence AND b. Clonal plasma cell disorder as determined by: i. Immunohistochemistry, in situ hybridization (ISH) or flow cytometry demonstrating kappa or lambda light chain restriction on bone marrow biopsy AND/OR ii. Monoclonal protein on serum or urine electrophoresis/immunofixation OR abnormal free light chain ratio
Measurable disease defined by: a. Monoclonal protein in the serum or urine by immunofixation OR plasmacytosis of bone marrow with monoclonal staining for kappa or lambda light-chain isotype b. dFLC >=  mg/L (dFLC=difference in involved and uninvolved serum free light-chain levels)
Light chain multiple myeloma without measurable disease in the serum or the urine: Serum immunoglobulin free light chain (FLC) >= mg/dL and abnormal serum immunoglobulin kappa lambda FLC ratio
Measurable myeloma disease (urine protein >  mg in  hours [hr] urine collection, serum free light chain ratio >  with an abnormal k/l ratio, serum M protein > . g/dl)
Measurable disease, as indicated by one of the following:\r\n* Serum monoclonal (M)-protein >= . g/dL\r\n* Elevated free light chain as per IMWG criteria, and abnormal ratio\r\n* Urine Bence Jones protein >  mg/ hr
Measurable hematologic disease as defined by:\r\n* Serum differential free light chain concentration (dFLC, difference between amyloid forming [involved] and non-amyloid forming [uninvolved] free light chain [FLC]) >=  mg/L)
Measurable disease, characterized by one of the following parameters:\r\n* Serum monoclonal (M) protein >=  g/dl by protein electrophoresis\r\n* >  mg of M protein in the urine on  hour electrophoresis\r\n* Serum immunoglobulin free light chain >=  mg/dL AND abnormal serum immunoglobulin kappa to lambda free light chain ratio
Patients with measurable disease defined as at least one of the following:\r\n* Serum monoclonal protein >= . g/dL by protein electrophoresis\r\n* >=  mg of monoclonal protein in the urine on -hour electrophoresis\r\n* Serum immunoglobulin free light chain >=  mg/dL AND abnormal serum immunoglobulin kappa to lambda free light chain ratio
Patients must have measurable disease, as defined by at least one of the following:\r\n* Serum monoclonal protein level >= . g/dL for IgG, IgA, or IgM disease\r\n* Monoclonal protein or total serum IgD >= . g/dL for IgD disease\r\n* Urinary M-protein excretion of >=  mg over a -hour period\r\n* Involved free light chain level >=  mg/dL, along with an abnormal free light chain ratio
M spike >= . g/dL or involved free light chain >=  mg/dL with an abnormal free light chain ratio
serum free light chain greater than or equal to (>=) . milligram/deciliter (mg/dL) with an abnormal kappa:lambda ratio or the difference between involved and uninvolved free light chains (dFLC) >=  mg/ dL
FOR MULTIPLE MYELOMA ONLY: Measurable disease of multiple myeloma as defined by at least ONE of the following:\r\n* Serum monoclonal protein >= . g/dL by protein electrophoresis\r\n* >=  mg of monoclonal protein in the urine on -hour electrophoresis\r\n* Serum immunoglobulin free light chain >=  mg/dL AND abnormal serum immunoglobulin kappa to lambda free light chain ratio
Measurable disease =<  days prior to registration, defined by at least one of the following:\r\n* Serum monoclonal protein >= . g/dL\r\n* >  mg of monoclonal protein in the urine on -hour electrophoresis\r\n* Serum immunoglobulin free light chain >  mg/dL AND abnormal serum immunoglobulin kappa to lambda free light chain ratio\r\n* Monoclonal bone marrow plasmacytosis > % (evaluable disease)
Measurable disease of multiple myeloma as defined by at least ONE of the following:\r\n* Serum monoclonal protein >= . g/dL \r\n* >=  mg of monoclonal protein in the urine on  hour electrophoresis\r\n* Serum immunoglobulin free light chain >=  mg/dL AND abnormal serum immunoglobulin kappa to lambda free light chain ratio
Measurable disease, prior to initial treatment as indicated by one or more of the following:\r\n* Serum 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 (>=  g/dL)\r\n* Involved serum free light chains >=  mg/dL provided that free light chain ratio is abnormal
High risk smoldering multiple myeloma (SMM), defined as follows by Mayo Clinic criteria:\r\n* Bone marrow plasma cells between % and %\r\n* Serum M-protein >=  g/dL (except IgA >=  g/dL) or urine M-protein >  mg per  hours\r\n* Serum free light chain ratio < . or > ; an involved to uninvolved ratio of >=  is permitted\r\n* Measurable disease, defined as: M-protein >=  g/dL OR Bence-Jones protein (BJP) >  mg/ hours (hr) OR involved free light chain >  mg/dL
For subjects with MM, measurable disease with serum monoclonal immunoglobulin protein (M-protein) ? g/dL, or urine M-protein protein ? mg/ hours, or involved serum free light chain (SFLC) ? mg/dL.
Presence of a plasma cell clone (any of the following):\r\n* Monoclonal protein in the serum or urine\r\n* Measurable light chains by free light chain assay\r\n* Measurable plasmacytoma\r\n* Monoclonal plasma cells in bone marrow
Subjects must have measurable disease by standard serum and urine tests to enable post-transplant monitoring for progression-free survival; any of the following criteria are sufficient to define measurable disease:\r\n* Serum monoclonal protein spike (M-spike) >= . g/dL\r\n*  hour urine M-spike >= mg\r\n* Involved serum free light chain (FLC) >=  mg/L with abnormal ratio\r\n* For immunoglobulin A (IgA) multiple myeloma, total serum IgA level elevated above normal range\r\nNote: Measurable disease does not need to be documented at enrollment but can be based on historical lab results obtained at or since diagnosis with multiple myeloma; for example, a patient who does not have measurable disease at enrollment due to complete remission after induction therapy is eligible if the disease was previously measurable by one of the above criteria
Have measurable disease as defined by at least one of the following:\r\n* Serum monoclonal (M) protein >= . g/dL by protein electrophoresis\r\n* >  mg of M protein in the urine on  hour electrophoresis\r\n* Serum immunoglobulin free light chain >=  mg/dL AND abnormal serum immunoglobulin kappa to lambda free light chain ratio\r\n* Monoclonal bone marrow plasmacytosis >= %
Measurable disease of multiple myeloma as defined by at least ONE of the following:\r\n* Serum monoclonal protein >= . g/dL\r\n* >  mg of monoclonal protein in the urine on  hour electrophoresis\r\n* Serum immunoglobulin free light chain >=  mg/dL AND abnormal serum immunoglobulin kappa to lambda free light chain ratio
Subjects must have relapsed and/or refractory myeloma with measurable disease, as defined by at least one of the following: \r\n* Serum myeloma (M)-protein level >= . g/dL for immunoglobulin G (IgG), immunoglobulin A (IgA), or immunoglobulin M (IgM) disease\r\n* M-protein or total serum immunoglobulin D (IgD) >= . g/dL for IgD disease\r\n* Urinary myeloma (M)-protein excretion of >=  mg over a -hour period\r\n* Involved free light chain level >=  mg/dL, along with an abnormal free light chain ratio
Have a confirmed diagnosis of MM with measurable disease, as defined by the presence of monoclonal immunoglobulin protein in serum electrophoreses of at least . g/dL for immunoglobulin G (IgG) or . g/dL for IgA, or measurable light chain in serum ( mg/L) or urinary excretion of at least  mg monoclonal light chain per  hours
Patients much have measurable disease, defined as one of the following within  days prior to registration:\r\n* Serum M-protein >= . g/dL\r\n* Urine M-protein >=  mg/ hour (hr)\r\n* Serum free light chain >=  mg/dL provided the free light chain (FLC) ratio is abnormal\r\n* % plasma cells in bone marrow
Serum immunoglobulin free light chains ?  mg/dL and abnormal serum immunoglobulin kappa/lambda free light chain ratio), or
Measurable disease of multiple myeloma at the time of baseline values for disease assessment as defined by at least one of the following:\r\n* Serum monoclonal protein >= . g/dL \r\n* >=  mg of monoclonal protein in the urine on  hour electrophoresis\r\n* Serum immunoglobulin free light chain (involved free light chain [FLC]) >= mg/dL AND abnormal serum immunoglobulin kappa to lambda free light chain ratio\r\n** NOTE: For patients with no relapse prior to transplant, measurable disease at the time of diagnosis\r\n** NOTE: For patients who have had a disease relapse prior to transplant, measurable disease at the time of the most recent relapse immediately prior to transplant; NOTE: if the patient had treatment for the relapsed disease prior to transplant, the patient must have measurable disease at the time of relapse prior to this therapy
Measurable disease, as indicated by one or more of the following:\r\n* Serum M protein >= . g/dL\r\n* Urine Bence Jones protein >  mg/ hr\r\n* Elevated free light chain as per International Myeloma Working Group (IMWG) criteria, and abnormal ratio
Patients with measurable disease defined as at least one of the following:\r\n* Serum monoclonal protein >= . g/dL by protein electrophoresis\r\n* >  mg of monoclonal protein in the urine on -hour electrophoresis\r\n* Serum immunoglobulin free light chain >=  mg/dL AND abnormal serum immunoglobulin kappa to lambda free light chain ratio
Measurable disease of multiple myeloma as defined by at least ONE of the following:\r\n* Serum monoclonal protein >= . g/dL\r\n* >  mg of monoclonal protein in the urine on  hour electrophoresis\r\n* Serum immunoglobulin free light chain >=  mg/dL AND abnormal serum immunoglobulin kappa to lambda free light chain ratio
In the absence of measurable M-protein, serum immunoglobulin free light chain ? mg/dL, and abnormal serum immunoglobulin kappa lambda free light chain ratio (<. or >.).
Participants with light chain and free light chain (FLC) only may be enrolled if they meet all the criteria for a diagnosis of MM.
in subjects without measurable serum or urine M- protein, serum free light chain (SFLC) ?  mg/L (involved light chain) and an abnormal serum kappa lambda ratio
Subject has measurable disease as defined by > . g/dL serum monoclonal protein, > mg/dL involved serum free light chain (either kappa or lambda) provided that the serum free light chain ratio is abnormal, >. g/ hrs urinary M-protein excretion, and/or measurable plasmacytoma(s) of at least cm in greatest dimension as measured by either CT scanning or MRI.
Subject has immeasurable MM (no measurable monoclonal protein, free light chains in blood or urine, or measureable plasmacytoma on radiologic scanning).
Measurable disease by IMWG as defined by at least one of the following:\r\n* Serum M-protein >= . g/dL\r\n* Urine M-protein >=  mg in a -hour collection\r\n* Serum free light chain level >=  mg/dL provided the free light chain ratio is abnormal\r\n* Measurable plasmacytoma; if plasmacytoma measurement is the only measurable disease, subject eligibility must be reviewed with lead principal investigator (PI) prior to signing consent
Measurable disease defined as at least one of the following: serum M-protein >/= grams/deciliter (g/dL), urine M-protein >/=  milligrams/ hours (mg/h), serum free light chain (SFLC) assay: involved SFLCs >/=  mg/dL (>/=  mg/L) and an abnormal SFLC ratio (<. or >.).
Measurable disease of multiple myeloma as defined by at least one of the following:\r\n* Serum monoclonal protein >= . g/dL\r\n* >=  mg of monoclonal protein in the urine on  hour electrophoresis\r\n* Serum free light chain >=  mg/L ( mg/dL) and abnormal serum free kappa to serum free kappa light chain ratio
Subjects must have measurable disease, as defined by at least one of the following:\r\n* Serum monoclonal protein M-protein level >= . g/dL \r\n* Urinary M-protein excretion of >=  mg over a -hour period\r\n* Involved free light chain level >=  mg/dL, along with an abnormal free light chain ratio
Serum immunoglobulin free light chain > mg/dL AND abnormal kappa/lambda ratio (reference .-.)
Patients with measurable disease as defined by any of the following:\r\n* Serum M-protein >= . g/dl (>=  mg/dL)\r\n* Urine monoclonal protein >=  mg/h\r\n* Involved free light chain (FLC) level >=  mg/dl (>=  mg/l) and an abnormal serum free light chain ratio (< ., or > .)
Measurable disease of multiple myeloma as defined by at least ONE of the following:\r\n* Serum monoclonal protein >= . g/dL\r\n* >  mg of monoclonal protein in the urine on  hour electrophoresis \r\n* Serum immunoglobulin free light chain >=  mg/dL AND abnormal serum immunoglobulin kappa to lambda free light chain ratio
Patients with MM must have measurable disease, defined as one or more of the following:\r\n* Serum M-protein >= . g/dL\r\n* Urine M-protein >=  mg/ hr\r\n* Serum immunoglobulin free light chain (FLC) >=  mg/L ( mg/dL) and abnormal serum immunoglobulin kappa to lambda FLC ratio\r\n** IgA patients must have serum quantitative immunoglobulin >=  mg/dL\r\n** Patients with oligosecretory or non-secretory disease must have a documented abnormal free light chain ratio (normal value . to .) or a value beyond the laboratory calculation range
Had measurable disease of MM at diagnosis, defined as:\r\n* A monoclonal immunoglobulin spike on serum electrophoresis of at least . g/dL and/or\r\n* Urine monoclonal protein levels of at least  mg/ hours\r\n* For subjects without measurable serum or urine M-protein levels, an abnormal free light chain ratio (normal value: .-.) with involved free light chain (FLC) level >=  mg/dL (>=  mg/L)\r\n* Measurable disease is NOT required at the time of enrollment; final determination of measurable disease requirement is at principal investigator's (PIs) discretion
Must have measurable disease defined as any of the following: serum m-spike >=  g/dL,  hour (h) urine m-spike of at least  mg/d, involved serum free light chains >=  mg/L with abnormal serum free light chain ratio, bone marrow plasma cells of at least %
Patients must have serum protein electrophoresis (SPEP) and kappa and lambda light chain testing performed within  days prior to registration in order to establish baseline measurements
Measurable disease, as defined by at least one of the following: Serum M protein . g/dL or higher, Urine M protein  mg/ hr or higher, Serum free light chain (SFLC)  mg/dL or higher, and Abnormal SFLC ratio.
Must have measurable disease as defined by m-protein or serum free light chain.
Measurable disease as defined by serum differential free light chain concentration (dFLC, difference between amyloid forming [involved] and nonamyloid forming [uninvolved] free light chain [FLC]) ?  mg/L.
Serum free light chain (SFLC): involved FLC ? mg/dL (? mg/L) AND abnormal kappa to lambda serum free light chain ratio
Abnormal serum free light-chain ratio ? (involved kappa) or < . (involved lambda)
Nonsecretory myeloma or free light chain detected in serum only (ogliosecretory).
Serum immunoglobulin free light chain ? mg/dL AND abnormal serum immunoglobulin kappa to lambda free light chain ratio
Free Light Chain measurable disease only.
Measureable disease by Serum M protein, or Urine M protein, or serum free light chain (SFLC) and an abnormal serum kappa lambda ratio (for subjects without detectable serum or urine M-protein), or Serum quantitative immunoglobulin A (qlgA) (for immunoglobulin (Ig) A subjects whose disease can only be reliable measured by qlgA).
Absence of involved: uninvolved serum free light chain ratio >= 
Within the past  weeks: Serum immunoglobulin free light chain >  mg/dL AND abnormal kappa/lambda ratio (reference .-.)
Participants must also have measurable disease according to the Standard Diagnostic Criteria:\r\n* Serum immunoglobulin (Ig)G, IgA, or IgM M-protein >= . g/dL, or\r\n* Serum IgD M-protein >= . g/dL, or\r\n* Urinary M-protein excretion of more than  mg/ hours, or\r\n* Serum free light chains of at least  mg/L with an abnormal free light chains (FLC) ratio
In subjects without detectable serum or urine M-protein, serum free light chain (SFLC) >  mg/L (involved light chain) and an abnormal serum kappa lambda ratio
Participants must also have measurable disease according to the Standard Diagnostic Criteria:\r\n* Serum immunoglobulin (Ig)G, IgA, or IgM M-protein >= . g/dL, or\r\n* Serum IgD M-protein >= . g/dL, or\r\n* Urinary M-protein excretion of more than  mg/ hours, or\r\n* Serum free light chains of at least  mg/dL with an abnormal free light chain (FLC) ratio
Patients must have measurable myeloma paraprotein levels in serum (>= . g/dL) or urine (>= . g excreted in a -hour urine collection sample) or by free light chain (involved free light chain greater than  mg/L)
Patients must have measurable disease defined as one of the following:\r\n* Serum M protein >= . g/dL\r\n* Urine M protein >=  mg/ hours\r\n* Serum free light chain >=  mg/dL provided the free light chain (FLC) ratio is abnormal
Measurable disease, as defined by one or all of the following (assessed within  days prior to initiation of therapy): a) serum M-protein >= . g/d; b) urine Bence-Jones protein >=  mg/ hours; c) patients with light chain only myeloma are eligible; the involved free light chain level  mg/L with abnormal serum free light chain ratio
Patients with evidence of relapse or refractory disease as defined by International Myeloma Working Group (IMWG) criteria and measurable disease as defined by any of the following:\r\n* Serum M-protein >= . g/dl (>=  g/l)\r\n* Urine monoclonal protein >=  mg/ h\r\n* Involved free light chain (FLC) level >=  mg/dl (>=  mg/l) and an abnormal serum free light chain ratio (< ., or > .)\r\n* Measurable biopsy proven plasmacytoma (should be measured within  days of registration to study)
For patients without measurable serum or urine M protein, serum free light chain (SFLC): Involved free light chain (FLC) concentration ?  mg/dL provided SFLC ratio is abnormal
Measurable disease as defined by any of the following International Myeloma Working Group Criteria\r\n* Monoclonal serum peak of greater than . gms per deciliter\r\n* Measurable urine peak as defined by urine protein electrophoresis of greater than  mg per  hours\r\n* Involved light chain versus uninvolved light chain ratio of greater than 
Patients must not have measurable disease at the time of enrollment. Measurable disease is defined as follows-\r\n* Serum monoclonal protein >  gm/dL\r\n* Urine monoclonal protein >  mg/ hours\r\n* Involved serum free light chain >  mg/dL
Newly diagnosed patients with histologically confirmed multiple myeloma (MM) based on the following criteria:\r\n* Clonal plasma cells in the bone marrow\r\n* Measurable disease within the past  weeks defined by any one of the following:\r\n** Serum monoclonal protein >= . g/dL\r\n** Urine monoclonal protein >  mg/ hour\r\n** Involved serum immunoglobulin free light chain >  mg/dL AND abnormal kappa/lambda ratio
Measurable disease of multiple myeloma as defined by at least ONE of the following:\r\n* Serum monoclonal protein >= . g/dL\r\n* >=  mg of monoclonal protein in the urine on  hour electrophoresis\r\n* Serum immunoglobulin free light chain >=  mg/dL AND abnormal serum immunoglobulin kappa to lambda free light chain ratio\r\n* Monoclonal plasmacytosis >= % (evaluable disease)\r\n* Measurable plasmacytoma that has not been radiated
Patients with light chain only myeloma are eligible; the involved free light chain level >=  mg/L with abnormal serum free light chain ratio
Patients must have measurable disease on study entry. Measurable disease may include quantifiable or detectable levels of serum or urine paraprotein. For patients with minimally secretory disease on study entry, serum free kappa or lambda light chain levels, or the serum free light chain ratio may be measured and used for disease monitoring if abnormal.
Protein criteria must be present at diagnosis (quantifiable M-component of immunoglobulin [Ig]G, IgA, IgD, or IgE and/or urinary kappa or lambda light chain, Bence-Jones protein, or free kappa light chain or free lambda light chain) in order to evaluate response; non-secretory participants are eligible provided the participant has >= % plasmacytosis OR multiple (>= ) plasmacytomas or lesions on magnetic resonance imaging (MRI) at the time of diagnosis or study enrollment, OR the presence of lesions on positron emission tomography (PET)/computed tomography (CT) scan or skeletal survey at diagnosis or study enrollment
Measurable disease of multiple myeloma at the time of baseline values for disease assessment as defined by at least one of the following:\r\n* Serum monoclonal protein >= . g/dL\r\n* >=  mg of monoclonal protein in the urine on  hour electrophoresis\r\n* Serum immunoglobulin free light chain >= mg/dL AND abnormal serum immunoglobulin kappa to lambda free light chain ratio\r\n* Bone marrow plasma cells >= %\r\n* NOTE: For patients with no relapse prior to transplant, measurable disease at the time of diagnosis\r\n* NOTE: For patients who have had a disease relapse prior to transplant, measurable disease at the time of the most recent relapse immediately prior to transplant; NOTE: If the patient had treatment for the relapsed disease prior to transplant, the patient must have measurable disease at the time of relapse prior to this therapy
Non-secretory or hyposecretory multiple myeloma, prior to initial treatment defined as < . g/dL M-protein in serum, <  mg/ hour (hr) urine M-protein, or disease only measured by serum free light chain
Measurable disease at Screening: Serum monoclonal protein greater than or equal to  g/dL by protein electrophoresis, or greater than or equal to  mg monoclonal protein in the urine on -hr electrophoresis, or serum immunoglobulin free light chain greater than or equal to  mg/dL and abnormal serum immunoglobulin kappa to lambda free light chain ratio.
Patients must have measurable disease as defined by the International Uniform Response Criteria, defined as any of the following:\r\n* Serum M-protein >=  mg/dL\r\n* Urine M-protein of >=  mg/ hours\r\n* Involved free light chain >=  mg/dL provided serum free light chain ratio is abnormal
Measurable light chain elevation, as defined by:\r\n* A difference between the involved immunoglobulin free light chain and uninvolved light chain and uninvolved light chain (dFLC) of >=  mg/dL AND abnormal serum immunoglobulin kappa lambda free light chain ratio\r\n* EXCEPTION: during the DOSE ESCALATION PORTION of the study only, a measurable M-protein (>= . g/dL) on serum protein electrophoresis (SPEP) or a measurable urinary light chain (>=  mg/ hrs) by urine protein electrophoresis (UPEP) without a dFLC meeting the above criteria is acceptable; subjects without a dFLC >=  mg/dL treated at the MTD will not count towards the expansion cohort
Diagnosis of high-risk SMM (defined as bone marrow plasma cells >=% and either serum monoclonal protein >= g/dL, or abnormal free light chain ratio <. or > and serum M-protein < g/dL but >= g/dL)
Measurable disease of multiple myeloma as defined by at least ONE of the following:\r\n* Serum monoclonal protein >= . g/dL\r\n* >=  mg of monoclonal protein in the urine on  hour electrophoresis\r\n* Serum immunoglobulin free light chain >=  mg/dL AND abnormal serum immunoglobulin kappa to lambda free light chain ratio
Serum monoclonal protein >.g/dL and/or .g/hr urine light chain excretion
Must have a detectable serum or urine M-Protein by protein electrophoresis that is at least  mg/dL (serum) or  gm/ hours (urine), respectively, or serum free light chain level > mg/l for the involved free light chain.
Measurable disease defined as at least one of the following: Serum m-spike >= g/dL, urine m-spike >= mg/hrs, serum free light chains >= mg/L (provided the kappa/lambda ratio is abnormal), or bone marrow plasma cells >= %
Newly diagnosed patients with histologically confirmed multiple myeloma (MM) based on the following criteria:\r\n* Clonal plasma cells in the bone marrow\r\n* Measurable disease within the past  weeks defined by any one of the following:\r\n** Serum monoclonal protein >= . g/dL\r\n** Urine monoclonal protein >  mg/ hour \r\n** Involved serum immunoglobulin free light chain >  mg/dL AND abnormal kappa/lambda ratio
Patients with measurable disease as defined by a history of an elevated myeloma protein (M component) in plasma, urine, or free kappa/lambda light chains in the serum
Monoclonal protein in the serum of >= . gm/dL or monoclonal light chain in the urine protein electrophoresis of >=  mg/  hours, or measurable light chains by free light chain assay of >=  mg/dL, or measurable plasmacytoma
Serum immunoglobulin free light chain ? mg/dL AND abnormal serum immunoglobulin kappa to lambda free light chain ratio
Multiple myeloma showing signs of biochemical progression while taking lenalidomide or lenalidomide plus dexamethasone maintenance therapy after autologous hematopoietic stem cell transplantation; (progression is defined solely based on serum or urine M-protein, or in patients without measurable serum and urine M-protein levels; the difference between involved and uninvolved serum free light chain level)
Patients with biochemical progression only with at least >= % increase from the baseline in any of the following parameters on at least  occasions; and when the treating physician deems a change in therapy is necessary: a. serum M-protein; b. urine M-protein; or, c. in patients without measurable serum and urine M-protein levels; the difference between involved and uninvolved free light chain levels
Patients must have evaluable multiple myeloma with, at least one of the following, assessed within  days prior to randomization:\r\n* Serum M-protein >= . g/dL, or\r\n* Urine M-protein >=  mg/ hour, or\r\n* In patients without detectable serum or urine M-protein, serum free light chain (SFLC) >  mg/L (involved light chain) and/or an abnormal kappa/lambda ratio (> : or < :), or\r\n* Monoclonal plasma cells in a bone marrow biopsy/aspirate of >  %
In subjects without detectable serum or urine M-protein, serum free light chain (SFLC) >  mg/L (involved light chain) and an abnormal kappa lambda ratio (SFLC kappa lambda ratio < . or > .)
Measurable disease of multiple myeloma as defined by at least ONE of the following:\r\n* Serum monoclonal protein >= . g/dL\r\n* >=  mg of monoclonal protein in the urine on  hour electrophoresis\r\n* Serum immunoglobulin free light chain >=  mg/dL AND abnormal serum immunoglobulin kappa to lambda free light chain ratio\r\n* Monoclonal bone marrow plasmacytosis >= % (evaluable disease)
Patients must have clonal disease measureable by serum free light chain (FreeliteTM) assay:
For the dose-escalation cohort: this is defined as having any elevation in the amyloidogenic (i.e. clonal) light chain with an abnormal free kappa:lambda ratio
Subjects must have measurable disease, defined as one or both of the following:\r\n* Serum M-protein >= . g/dL\r\n* Urine M-protein >=  mg/ hours\r\n* Free light chains: Only in patients without measurable serum and urine M-protein levels: the difference between involved and uninvolved free light chain (FLC) levels must be at least  mg/dl
Multiple myeloma (MM) diagnosed according to the following standard criteria (all three criteria must be met):\r\n* Monoclonal plasma cells in bone marrow >= % and/or presence of biopsy-proven plasmacytoma\r\n* Monoclonal protein (M-protein) present in serum and/or urine, defined as serum M-protein of >= g/dL OR urine M-protein of >=  mg/ hours; patients with no M-protein must have serum free light chain assay with involved light chain >=  mg/dL and abnormal serum free light chain ratio\r\n* MM-related organ dysfunction ( or more)\r\n** (C) calcium elevation in blood (serum calcium > . mg/L or upper limit of normal [ULN])\r\n** (R) renal insufficiency (serum creatinine [SCr] >  mg/dL)\r\n** (A) anemia (hemoglobin <  g/dL or g < normal)\r\n** (B) lytic bone lesions or osteoporosis
Measureable disease as indicated by monoclonal protein in the serum of greater than or equal to (?)  grams per deciliter (g/dL), involved serum free light chain assay ? mg/dL (? mg/L) provided the serum free light chain ratio is abnormal; monoclonal light chain in the urine protein electrophoresis of ?  mg/ hours, or measurable plasmacytoma
Measurable disease of multiple myeloma as defined by at least ONE of the following:\r\n* Serum monoclonal protein >=  g/dL\r\n* >=  mg of monoclonal protein in the urine on  hour electrophoresis\r\n* Serum immunoglobulin free light chain >=  mg/dL and abnormal serum immunoglobulin kappa to lambda free light chain ratio\r\n* Monoclonal bone marrow plasmacytosis >= % (evaluable disease)
Measurable disease of multiple myeloma as defined by at least ONE of the following:\r\n* Serum monoclonal protein >= . g/dL\r\n* >  mg of monoclonal protein in the urine on  hour electrophoresis\r\n* Serum immunoglobulin free light chain >=  mg/dL AND abnormal serum immunoglobulin kappa to lambda free light chain ratio
In patients without detectable serum or urine M-protein, serum free light chain (SFLC) >  mg/L (involved light chain) and an abnormal serum kappa/lamda ratio, or
Histologically confirmed diagnosis of multiple myeloma with a measurable disease parameter at time of screening; a measurable disease parameter is defined as one or more of the following:\r\n* Serum monoclonal protein >= . g/dl\r\n*  hour urine monoclonal protein >= . g/ hour\r\n* Serum free light chain ratio >  x normal ratio with an absolute difference of mg/dl between the involved and uninvolved free light chain\r\n* Soft tissue plasmacytoma >=  cm measurable by either physical examination and/or applicable radiographs (e.g. magnetic resonance imaging [MRI], computed tomography [CT], etc)\r\n* Bone marrow plasma cells >= %
Measurable monoclonal (M-) protein component in serum (? . g/dL) and/or urine (if present), (? . g excreted in a  hour collection sample). Subjects with free light chain only disease are excluded.
Patients with multiple myeloma must have measurable disease; measurable disease may be paraprotein in serum or urine or the presence of free light chains in serum or urine defined by one or more of the following criteria: \r\n* Presence of serum M-protein concentration >  g/dL\r\n* Urine M-protein excretion >  mg in -hour urine collection\r\n* Serum free light chain concentration >=  mg/dL and abnormal kappa/lambda ratio\r\n* Urine free light chain concentration >=  mg/L and abnormal kappa/lambda ratio
Nonsecretory multiple myeloma based upon standard M-component criteria (ie, measurable serum/urine M-component) unless the baseline serum free light chain level is elevated
Measurable disease based on either of a) serum monoclonal protein by protein electrophoresis (SPEP), b) monoclonal protein in the urine on -hour urine electrophoresis (UPEP), and/or c) serum immunoglobulin free light chain combined with abnormal serum immunoglobulin kappa to lambda free light chain ratio