[c09aa8]: / clusters / ordered9kclusters / clust_2493.txt

Download this file

67 lines (66 with data), 9.8 kB

 1
 2
 3
 4
 5
 6
 7
 8
 9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
26
27
28
29
30
31
32
33
34
35
36
37
38
39
40
41
42
43
44
45
46
47
48
49
50
51
52
53
54
55
56
57
58
59
60
61
62
63
64
65
66
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