Measureable disease, as defined by at least one of the following: serum M protein 0.5 g/dL or higher, urine M protein 200 mg/24 hour or higher, and serum immunoglobulin free light chain 10 mg/dL or higher and abnormal serum immunoglobulin kappa lambda free light chain ratio
Measurable disease at the time of relapse, defined as a monoclonal immunoglobulin spike on serum electrophoresis of >= 1 gm/dL (immunoglobulin [IG]G) or >= 0.5 gm/dL (IGA) and/or urine monoclonal immunoglobulin spike of > 200 mg/24 hours and/ or involved free light chain (FLC) level >= 10 mg/dl and the serum FLC ratio is abnormal
Patients must have measurable disease defined as any of the following:\r\n* Serum monoclonal protein >= 500 mg/dL by protein electrophoresis \r\n* > 200 mg of monoclonal protein in the urine on screening 24-hour electrophoresis \r\n* Serum immunoglobulin free light chain >= 100 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 >= 1.0 g/dL\r\n* > 200 mg of monoclonal protein in the urine on 24 hour electrophoresis\r\n* Serum immunoglobulin free light chain >= 10 mg/dL AND abnormal serum immunoglobulin kappa to lambda free light chain ratio
COHORT B ONLY: serum immunoglobulin free light chain >= 5 mg/dL AND abnormal serum immunoglobulin kappa to lambda free light chain ratio
Measurable disease at Screening: Serum monoclonal protein of at least 1.0 g/dL (10g/L) by protein electrophoresis or at least 200 mg of monoclonal protein in the urine on 24-hr electrophoresis or serum immunoglobulin free light chain of at least 10 mg/dL and abnormal serum immunoglobulin kappa to lambda free light chain ratio.
Measurable disease within the past 4 weeks defined by any one of the following:\r\n* Serum monoclonal protein >= 1.0 g/dl\r\n* Urine monoclonal protein > 200 mg/24 hour\r\n* Serum immunoglobulin free light chain > 10 mg/dL AND abnormal kappa/lambda ratio (reference 0.26-1.65)\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 < 1) may also be enrolled; this is in line with the most recent International Myeloma Working Group Multiple Myeloma (IMWG MM) response criteria
Measurable disease of multiple myeloma as defined by at least ONE of the following:\r\n* Serum monoclonal protein ? 1.0 g/dL\r\n* ? 200 mg of monoclonal protein in the urine on 24 hour electrophoresis\r\n* Serum immunoglobulin free light chain ? 10 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) ? 1 g/dL\r\n* Urine M-protein ? 200 mg/24 hour\r\n* Involved serum free light chain (sFLC) level ? 10 mg/dL with abnormal kappa/lambda ratio\r\n* Measurable biopsy-proven plasmacytomas (? 1 lesion that has a single diameter ? 2 cm)\r\n* Bone marrow plasma cells ? 30%
Light chain multiple myeloma without measurable disease in the serum or the urine: Serum immunoglobulin free light chain (FLC) >=10 mg/dL and abnormal serum immunoglobulin kappa lambda FLC ratio
Measurable disease, characterized by one of the following parameters:\r\n* Serum monoclonal (M) protein >= 1 g/dl by protein electrophoresis\r\n* > 200 mg of M protein in the urine on 24 hour electrophoresis\r\n* Serum immunoglobulin free light chain >= 10 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 >= 1.0 g/dL by protein electrophoresis\r\n* >= 200 mg of monoclonal protein in the urine on 24-hour electrophoresis\r\n* Serum immunoglobulin free light chain >= 10 mg/dL AND abnormal serum immunoglobulin kappa to lambda free light chain ratio
Participants must have a confirmed diagnosis of multiple myeloma as defined by the following criteria:\r\n* Monoclonal plasma cells in the bone marrow greater than or equal to 10% and/or presence of a biopsy-proven plasmacytoma\r\n* Monoclonal protein present in the serum and/or urine\r\n* Measurable disease as defined by the following:\r\n** Immunoglobulin G (IgG) multiple myeloma: Serum monoclonal paraprotein (M-protein) level greater than or equal to 0.5 g/dL or urine M-protein level greater than or equal to 200 mg/24 hours\r\n** Immunoglobulin A (IgA) multiple myeloma: Serum M-protein level greater than or equal to 0.5 g/dL or urine M-protein level greater than or equal to 200 mg/24 hours\r\n** Immunoglobulin D (IgD) multiple myeloma: Serum M-protein level greater than or equal to 0.5 g/dL or urine M-protein level greater than or equal to 200 mg/24 hours\r\n** Light chain multiple myeloma: Serum immunoglobulin free light chain >= 10 mg/dL and abnormal serum immunoglobulin kappa lambda free light chain ratio
FOR MULTIPLE MYELOMA ONLY: Measurable disease of multiple myeloma as defined by at least ONE of the following:\r\n* Serum monoclonal protein >= 1.0 g/dL by protein electrophoresis\r\n* >= 200 mg of monoclonal protein in the urine on 24-hour electrophoresis\r\n* Serum immunoglobulin free light chain >= 10 mg/dL AND abnormal serum immunoglobulin kappa to lambda free light chain ratio
Measurable disease =< 28 days prior to registration, defined by at least one of the following:\r\n* Serum monoclonal protein >= 1.0 g/dL\r\n* > 200 mg of monoclonal protein in the urine on 24-hour electrophoresis\r\n* Serum immunoglobulin free light chain > 10 mg/dL AND abnormal serum immunoglobulin kappa to lambda free light chain ratio\r\n* Monoclonal bone marrow plasmacytosis > 30% (evaluable disease)
Measurable disease of multiple myeloma as defined by at least ONE of the following:\r\n* Serum monoclonal protein >= 1.0 g/dL \r\n* >= 200 mg of monoclonal protein in the urine on 24 hour electrophoresis\r\n* Serum immunoglobulin free light chain >= 10 mg/dL AND abnormal serum immunoglobulin kappa to lambda free light chain ratio
Have measurable disease as defined by at least one of the following:\r\n* Serum monoclonal (M) protein >= 0.5 g/dL by protein electrophoresis\r\n* > 200 mg of M protein in the urine on 24 hour electrophoresis\r\n* Serum immunoglobulin free light chain >= 10 mg/dL AND abnormal serum immunoglobulin kappa to lambda free light chain ratio\r\n* Monoclonal bone marrow plasmacytosis >= 30%
Measurable disease of multiple myeloma as defined by at least ONE of the following:\r\n* Serum monoclonal protein >= 1.0 g/dL\r\n* > 200 mg of monoclonal protein in the urine on 24 hour electrophoresis\r\n* Serum immunoglobulin free light chain >= 10 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 >= 0.5 g/dL for immunoglobulin G (IgG), immunoglobulin A (IgA), or immunoglobulin M (IgM) disease\r\n* M-protein or total serum immunoglobulin D (IgD) >= 0.5 g/dL for IgD disease\r\n* Urinary myeloma (M)-protein excretion of >= 200 mg over a 24-hour period\r\n* Involved free light chain level >= 10 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 0.5 g/dL for immunoglobulin G (IgG) or 0.25 g/dL for IgA, or measurable light chain in serum (100 mg/L) or urinary excretion of at least 200 mg monoclonal light chain per 24 hours
Serum immunoglobulin free light chains ? 10 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 >= 1.0 g/dL \r\n* >= 200 mg of monoclonal protein in the urine on 24 hour electrophoresis\r\n* Serum immunoglobulin free light chain (involved free light chain [FLC]) >=10 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
Patients with measurable disease defined as at least one of the following:\r\n* Serum monoclonal protein >= 1.0 g/dL by protein electrophoresis\r\n* > 200 mg of monoclonal protein in the urine on 24-hour electrophoresis\r\n* Serum immunoglobulin free light chain >= 10 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 >= 1.0 g/dL\r\n* > 200 mg of monoclonal protein in the urine on 24 hour electrophoresis\r\n* Serum immunoglobulin free light chain >= 10 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 ?10 mg/dL, and abnormal serum immunoglobulin kappa lambda free light chain ratio (<0.26 or >1.65).
Measurable disease of multiple myeloma as defined by at least one of the following:\r\n* Serum monoclonal protein >= 0.5 g/dL\r\n* >= 200 mg of monoclonal protein in the urine on 24 hour electrophoresis\r\n* Serum free light chain >= 100 mg/L (10 mg/dL) and abnormal serum free kappa to serum free kappa light chain ratio
Serum immunoglobulin free light chain >10 mg/dL AND abnormal kappa/lambda ratio (reference 0.26-1.65)
Measurable disease of multiple myeloma as defined by at least ONE of the following:\r\n* Serum monoclonal protein >= 1.0 g/dL\r\n* > 200 mg of monoclonal protein in the urine on 24 hour electrophoresis \r\n* Serum immunoglobulin free light chain >= 10 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 >= 0.5 g/dL\r\n* Urine M-protein >= 200 mg/24 hr\r\n* Serum immunoglobulin free light chain (FLC) >= 100 mg/L (10 mg/dL) and abnormal serum immunoglobulin kappa to lambda FLC ratio\r\n** IgA patients must have serum quantitative immunoglobulin >= 750 mg/dL\r\n** Patients with oligosecretory or non-secretory disease must have a documented abnormal free light chain ratio (normal value 0.26 to 1.65) or a value beyond the laboratory calculation range
Participant must have documented multiple myeloma satisfying the CRAB (calcium elevation, renal insufficiency, anemia and bone abnormalities) criteria, monoclonal plasma cells in the bone marrow greater than or equal to (>=) 10 percent (%) or presence of a biopsy proven plasmacytoma and measurable disease as defined by any of the following: (a) immunoglobulin (Ig) G myeloma (serum monoclonal paraprotein [M-protein] level >=1.0 gram/deciliter [g/dL] or urine M-protein level >=200 milligram[mg]/24 hours[hrs]; or (b) IgA, IgM, IgD, or IgE multiple myeloma (serum M-protein level >=0.5 g/dL or urine M-protein level >=200 mg/24 hrs); or (c) light chain multiple myeloma without measurable disease in serum or urine (serum immunoglobulin free light chain >=10 mg/dL and abnormal serum immunoglobulin kappa lambda free light chain ratio)
Serum immunoglobulin free light chain ?10 mg/dL AND abnormal serum immunoglobulin kappa to lambda free light chain ratio
Measurable disease as defined by any of the following: (a) immunoglobulin (Ig) G myeloma (serum monoclonal paraprotein [M-protein] level >=1.0 gram/deciliter [g/dL] or urine M-protein level greater than or equal to (>=) 200 milligram[mg]/24 hours[hrs]; or (b) IgA, IgD, or IgE multiple myeloma (serum M-protein level >= 0.5 g/dL or urine M-protein level >= 200 mg/24 hrs); or (c) light chain multiple myeloma (serum immunoglobulin free light chain >=10 mg/dL and abnormal serum immunoglobulin kappa lambda free light chain ratio)
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).
Within the past 4 weeks: Serum immunoglobulin free light chain > 10 mg/dL AND abnormal kappa/lambda ratio (reference 0.26-1.65)
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 4 weeks defined by any one of the following:\r\n** Serum monoclonal protein >= 1.0 g/dL\r\n** Urine monoclonal protein > 200 mg/24 hour\r\n** Involved serum immunoglobulin free light chain > 10 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 >= 1.0 g/dL\r\n* >= 200 mg of monoclonal protein in the urine on 24 hour electrophoresis\r\n* Serum immunoglobulin free light chain >= 10 mg/dL AND abnormal serum immunoglobulin kappa to lambda free light chain ratio\r\n* Monoclonal plasmacytosis >= 30% (evaluable disease)\r\n* Measurable plasmacytoma that has not been radiated
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 >= 1.0 g/dL\r\n* >= 200 mg of monoclonal protein in the urine on 24 hour electrophoresis\r\n* Serum immunoglobulin free light chain >=10 mg/dL AND abnormal serum immunoglobulin kappa to lambda free light chain ratio\r\n* Bone marrow plasma cells >= 30%\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 at Screening: Serum monoclonal protein greater than or equal to 1 g/dL by protein electrophoresis, or greater than or equal to 200 mg monoclonal protein in the urine on 24-hr electrophoresis, or serum immunoglobulin free light chain greater than or equal to 10 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 >= 1.0 g/dL\r\n* >= 200 mg of monoclonal protein in the urine on 24 hour electrophoresis\r\n* Serum immunoglobulin free light chain >= 10 mg/dL AND abnormal serum immunoglobulin kappa to lambda free light chain ratio
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 4 weeks defined by any one of the following:\r\n** Serum monoclonal protein >= 1.0 g/dL\r\n** Urine monoclonal protein > 200 mg/24 hour \r\n** Involved serum immunoglobulin free light chain > 10 mg/dL AND abnormal kappa/lambda ratio
Serum immunoglobulin free light chain ?10 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 >= 1.0 g/dL\r\n* >= 200 mg of monoclonal protein in the urine on 24 hour electrophoresis\r\n* Serum immunoglobulin free light chain >= 10 mg/dL AND abnormal serum immunoglobulin kappa to lambda free light chain ratio\r\n* Monoclonal bone marrow plasmacytosis >= 30% (evaluable disease)
Measurable disease of multiple myeloma as defined by at least ONE of the following:\r\n* Serum monoclonal protein >= 1 g/dL\r\n* >= 200 mg of monoclonal protein in the urine on 24 hour electrophoresis\r\n* Serum immunoglobulin free light chain >= 10 mg/dL and abnormal serum immunoglobulin kappa to lambda free light chain ratio\r\n* Monoclonal bone marrow plasmacytosis >= 30% (evaluable disease)
Measurable disease of multiple myeloma as defined by at least ONE of the following:\r\n* Serum monoclonal protein >= 1.0 g/dL\r\n* > 200 mg of monoclonal protein in the urine on 24 hour electrophoresis\r\n* Serum immunoglobulin free light chain >= 10 mg/dL AND abnormal serum immunoglobulin kappa to lambda free light chain ratio
Measurable disease based on either of a) serum monoclonal protein by protein electrophoresis (SPEP), b) monoclonal protein in the urine on 24-hour urine electrophoresis (UPEP), and/or c) serum immunoglobulin free light chain combined with abnormal serum immunoglobulin kappa to lambda free light chain ratio