Baseline urinalysis should show urine protein < 3+ and must be obtained within 28 days prior to registration; if urine protein is 3+ or greater, then urine protein by 24 hour collection must show less than 3 grams of protein
Urine protein: =< 30 mg/dl in urinalysis or =< 1+ on dipstick, unless quantitative protein is < 1000 mg in a 24 hour (h) urine sample
? 200 mg/24 hours of monoclonal protein in the urine on 24-hour electrophoresis
Urine protein: =< 30 mg/dl in urinalysis or =< 1+ on dipstick, unless quantitative protein is < 1000 mg in a 24 hour (h) urine sample
? 200 mg/24 hours of monoclonal protein in the urine on 24-hour urine electrophoresis (UPEP)
Urine protein =< 30 mg/g
Urine/protein creatinine ratio spot-check < 0.5 mg/mg
Urine protein =< 30 mg/dL in urinalysis or =< 1+ on dipstick, unless quantitative protein is < 1000 mg in a 24 hour urine sample
Or 24-hour urine protein < 1 g
Urine protein should be screened by urine analysis; if protein is 2+ or higher, 24-hour urine protein should be obtained; patients with 24-hour urine protein >= 1000 mg are excluded
Urinary protein excretion =< 500 mg/day
Urine M-protein ? 200 mg/24h
Urine monoclonal protein >200 mg/24 hour
Urine protein should be screened by urinalysis; if protein is 2+ or higher, 24 hour urine protein should be obtained and the level should be < 1000 mg for patient enrollment
Urine M-protein ?200 mg/24 hrs
Urine monoclonal protein (UPEP) ?200 mg by 24 hour urine.
?200 mg of monoclonal protein in the urine on 24-hour electrophoresis
Urine protein must be screened by urinalysis; if protein is 2+ or higher, 24-hour urine protein should be obtained and the level should be < 1000 mg for patient enrollment
Within the past 4 weeks: Urine monoclonal protein > 200 mg/24 hour
Urine M-protein ? 200 mg/24 h
Urinary protein < 2+ (unless total quantitative protein is < 500 mg protein/day as determined by 24 hour [H] urine collection)
Spot urine must not show 1+ or more protein in urine or the patient will require a repeat urinalysis; if repeat urinalysis shows 1+ protein or more, a 24-hour urine collection will be required and must show total protein excretion < 1000 mg/24 hours
Patients must have a 24 hour (hr) urine collection showing less than 2000 mg of protein; EXCEPTION: patients with hematuria will be eligible with up to 3000 mg protein per 24 hours provided they do not have casts, eosinophiluria or electrolyte wasting
Spot urine must not show 1+ or more protein in urine or the subject will require a repeat urinalysis. If repeat urinalysis shows 1+ protein or more, a 24-hour urine collection will be required and must show total protein excretion <1,000 mg per 24 hours.
Participants with urine protein ?1 gram/24 hour
Urine protein < 1+; if >= 1+, 24 hour urine protein should be obtained and should be < 1000 mg
Significant proteinuria: urinary protein/creatinine ratio >0.5 mg/mg in a non first void urine sample
Either urine protein < 1+ or measured 24 hour urine protein < 500 milligram
Continued from Inclusion #8: Serum creatinine </= 1.5 ULN or creatinine clearance (CrCl) >/= 45 mL/min (CrCl = Wt (kg) x (140-age)/72 x Cr level, female x 0.85) for pts w/ creatinine levels above institutional normal; Amylase & lipase < 1.5 x the ULN; Urinalysis (UA) must show less than 1+ protein in urine, or the pt will require a repeat UA. If repeat UA shows 1+ protein or more, a 24 hour urine collection will be required & must show total protein </= 1000 mg/24 hour to be eligible
Non-Measurable M Protein (serum or urine) and measurable sFLC (< 100 mg/mL)
mGPS of 1: C-reactive protein >10 mg/L and albumin ?35 g/L
mGPS of 2: C-reactive protein >10 mg/L and albumin <35 g/L
Urine M-protein ? 200 mg/24 hr, or
Urine protein/creatinine < 1 mg/mg
Urine protein < 1+; if >= 1+, 24 hour urine protein should be obtained and should be < 1000 mg
mGPS of 2: C-reactive protein (CRP) > 10 mg/L and albumin < 35 g/L
mGPS of 1: C-reactive protein (CRP) > 10 mg/L and albumin ? 35 g/L
C-reactive protein >10 mg/L AND albumin ?35 g/L; Score = 1
C-reactive protein >10 mg L AND albumin <35 g/L; Score = 2
Urine M-protein ? 200 mg/24 h
Urine protein < 1+; or if >= 1+ then 24 hour urine protein should be obtained and should be < 1000 mg
Urine monoclonal protein >200 mg on 24 hour electrophoresis
Kidney: albuminuria ? 500 mg/day in a 24-hour urine specimen
Urine Bence Jones protein ? 200 mg/24 hr
Urine protein/creatinine ratio (UPCR) =< 1 mg/mg (113.2 mg/mmol) creatinine or 24-hour (hr) urine protein of < 1 g
Urine M-protein ? 200 mg/24 hour, or
Urine M ?200 mg per 24hr
Urine M protein ?200 mg per 24hr
Urine M protein ?200 mg per 24hr
Subjects must have a C-reactive protein (CRP) > 3 mg/L
Have detectable disease measured by a specific protein in your blood and/or urine
Patients unwilling or unable to comply with the protocol, including providing 24-hour urine samples for urine protein electrophoresis at the required time points.
C-reactive protein > 3 mg/L
Serum M-Protein >=1.0 g/dL (>=10 g/L), OR
Serum M- protein ?0.5 g/dL for IgG, IgM, IgA, or ?0.05 g/dL for IgD; or
Serum monoclonal protein ? 0.5 g/dL by protein electrophoresis.
Measurable serum and/or urine M-protein from prior to induction therapy documented and available; a positive serum free lite assay is acceptable
Measurable disease, as indicated by one or more of the following:\r\n* Serum myeloma protein (M-protein) >= 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, then quantitative immunoglobulin levels are acceptable\r\n* Involved serum free light chains >= 10 mg/dL provided that free light chain ratio is abnormal
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 >100 mg/L].
Serum M-protein defined by the following:
IgG multiple myeloma: Serum monoclonal paraprotein (M-protein) level ?1.0 g/dL (measured by protein electrophoresis [PEP]);
Serum M-protein > 0.5 g/dL
Serum monoclonal protein ? 0.5 g/dL by serum protein electrophoresis (SPEP)
Patients with multiple 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 –protein (absolute increase must be >= 0.5g/dl)\r\n** Serum M-protein 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, the difference between involved and uninvolved free light chain (FLC) levels (absolute increase must be > 10 mg/dl)\r\n * For patients relapsing from complete remission, relapse is defined as: reappearance of serum or serum M-protein by immunofixation or electrophoresis
Serum M-protein ?1 g/dL (?10 g/L), OR
Serum M-protein ? 0.5 g/dL OR
serum monoclonal (M)-protein greater than or equal (>=) 0.5 grams/deciliter (g/dL) by protein electrophoresis (routine serum protein electrophoresis and immunofixation [IFE] performed at a central laboratory)
Non-secretory or hyposecretory multiple myeloma, prior to initial treatment defined as < 1.0 g/dL M-protein in serum, < 200 mg/24 hr urine M-protein, and no measurable disease as per IMWG by Freelite
For subjects with MM, measurable disease with serum monoclonal immunoglobulin protein (M-protein) ?1 g/dL, or urine M-protein protein ?200 mg/24 hours, or involved serum free light chain (SFLC) ?10 mg/dL.
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)
Serum M-protein ?1 g/dL (?0.5 g/dL in case of immunoglobulin A [IgA] disease), AND/OR
Presence of serum and/or urinary monoclonal protein
Serum M-protein ? 1 g/dL
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.
Serum monoclonal protein ? 0.5 g/dL
Serum M protein ? 0.5 /dL (? 5 g/L)
Measurable level of M-protein > 1 g/dL on serum protein electrophoresis or > 200 mg of M-protein on a 24 hour urine protein electrophoresis
Patients must have measurable disease within 28 days prior to registration; patients must have serum protein electrophoresis (SPEP) and urine protein electrophoresis (UPEP) within 14 days prior to registration
Measurable disease defined as a quantitative IgM monoclonal protein of >500\n                  mg/dL obtained within 28 days prior to registration
Patients must have measurable levels of monoclonal protein (M-protein): >= 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
Serum monoclonal protein (SPEP) ?1 g/dL
Monoclonal protein present in the serum and/or urine
Serum M protein ?0.5 g/dL (?5 g/L);
Serum monoclonal protein (SPEP) ?1 g/dL.
Must have measurable disease (serum M-protein or urine M-protein).
Serum monoclonal protein ? 0.5 g/dL by protein electrophoresis
Prior treatment with TRC105 or axitinib or any agent targeting the endoglin pathway (including a fusion protein that binds bone morphogenic protein)
Patients must have a documented diagnosis of multiple myeloma with evidence of measurable disease i.e. serum M protein superior or equal to 0.5 g per dL measured using serum protein immunoelectrophoresis and or urine M protein superior or equal to 200 mg per 24 hours measured using urine protein immunoelectrophoresis.
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
Serum myeloma protein (M-protein) >= 3 g/dl and/or bone marrow plasma cells >= 10 %
Within the past 4 weeks: Serum monoclonal protein >= 1.0 g/dl
Serum M-protein ? 0.5 g/dL
Measurable serum paraprotein on serum protein electrophoresis (SPEP) or serum free light chains and ratio, or quantifiable Bence-Jones proteinuria on 24 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)
Serum M-protein ? 500 mg/dL
Measurable disease, prior to initial treatment as indicated by one or more of the following:\r\n* Serum monoclonal (M)-protein >= 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, then quantitative immunoglobulin levels are acceptable
Serum M-protein ? 1 g/dL (? 10 g/L).
Serum M-protein ? 0.5 g/dL
Total protein > 6.4
Serum M-protein ? 0.5g/dL of IgA or ? 1 g/dL of IgG, or
Serum M-protein ? 0.5 g/dl (? 5 g/l)
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 ?1 g by protein electrophoresis
Serum M-protein ? 0.5 g/dL
A monoclonal Ig (M-protein) concentration on serum protein electrophoresis (SPEP) of ? 1.0 g/dL.
Serum M-protein ? 0.5 g/dL, or
Serum M-protein ? 1.0 g/dL
Serum M-protein ? 0.5 g/dL, or
Serum M-protein ? 0.5 g/dL
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 >= 1.0 by protein 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)
Serum M-protein ? 1.0 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
Total protein within 2 x ULN
Serum M-protein ? 0.5 g/dL (> 5 g/L) by serum protein electrophoresis (SPEP) or for immunoglobulin (Ig) A myeloma, by quantitative serum IgA levels; or
Serum M-protein >=500 mg/dL (>=5 gram per liter [g/L]).
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 >= 0.5 g/dL by serum protein 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* Circulating plasma cells >= 2,000 if diagnosis of plasma cell leukemia
Known protein C, protein S, or anti-thrombin deficiency or other known thrombophilic disorders
Urine M-Protein >= 200 mg/24 hours, OR
Urine M-protein ?200 mg/24 hours ; or
Urine M-protein level >= 200 milligram per 24 hours (mg/24 hours); or
Urine M-protein ?200 mg/24 hours (any immunoglobulin heavy chain type measured by PEP).
Urine M-protein > 200 mg/24 hours
Serum M-protein level >=1.0 gram per deciliter (g/dL) or urine M-protein level >=200 mg/24 hours; or
Urine M-protein ?200 mg/24 hours and must have documented MM isotype by immunofixation (central laboratory).
Urine M-protein ? 200 mg/24 hours OR
Urine M protein ? 200 mg/24 hours), or
Urine M-protein =< 1 g/24 hours (MM patients only)
urine M-protein ?200 mg/24 hours.
Urine M-protein ?200 mg/24 hours, OR
urine M-protein ? 200 mg/24 hours,
Urinary protein >2+ possibly indicative of renal disease. If the 24 hours urine protein shows a result of < 100 mg protein, subject can be eligible;
Urine M protein ? 200 mg/24 hours
IgG MM: Serum monoclonal paraprotein (M-protein) level ? 1.0 g/dl or urine Mprotein level ? 200 mg/24 hours- IgA MM: Serum M-protein level ? 0.5 g/dl or urine M-protein level ? 200 mg/24 hours
IgM MM (IgM M-protein plus lytic bone disease documented by skeletal survey plain films): Serum M-protein level ? 1.0 g/dl or urine M-protein level ? 200 mg/24 hours
IgD MM: Serum M-protein level ? 0.05 g/dl or urine M-protein level ? 200 mg/24 hours
Light chain MM: Serum M-protein level ? 1.0 g/dl or urine M-protein level ? 200 mg/24 hours 5. Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2 6. Females of childbearing potential (FCBP1) must:
Urine M protein ?200 mg/24 hours;
Urine protein =< 1+ on urine dipstick (if 2+ seen on first test, re-test at least 24 hours later), within 14 days of study registration
Urine M-protein ? 200 mg/24 hours
Relapsed and/or refractory multiple 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 protein (M-protein) >= 0.5 g/d; b) urine Bence-Jones protein >= 200 mg/24 hours
Urine M-protein ? 200 mg/24 hours.
Urine M-protein ? 200 mg/24 hours
Urine M-protein ? 200 mg/24 hours OR
Urine M-protein ? 200 mg/24 hours, or
Urine Bence-Jones protein ? 200 mg/24 hours
IgG multiple myeloma: Serum monoclonal paraprotein (M-protein) level ? 1.0 g/dl or urine M-protein level ? 200 mg/24 hours
IgA multiple myeloma: Serum M-protein level ? 0.5 g/dl or urine M-protein level ? 200 mg/24 hours
IgM multiple myeloma (IgM M-protein plus lytic bone disease documented by skeletal survey plain films): Serum M-protein level ? 1.0 g/dl or urine M-protein level ? 200mg/24hours
IgD multiple myeloma: Serum M-protein level ? 0.05 g/dl or urine M-protein level ? 200 mg/24 hours
Light chain multiple myeloma: Serum M-protein level ? 1.0 g/dl or urine M-protein level ? 200 mg/24 hours AND are at least 65 years of age or older or, if younger than 65 years of age, are not candidates for stem cell transplantation because:
Urinary M-protein excretion at least 200 mg/24 hours; or
Urinary M-protein excretion at least 200 mg/24 hours; or
Urine protein =< 1+ on urine dipstick (if 2+ seen on first test, re-test at least 24 hours later) (within 14 days of study registration)
Urine M-protein >=200 mg/24 hours.