[c09aa8]: / clusters / ordered9kclusters / clust_1144.txt

Download this file

50 lines (49 with data), 15.8 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
Participants must have disease that is measurable by either serum or urine evaluation of the monoclonal component or by assay of serum free light chains or by minimal residual detection; measurable disease is defined as one or more of the following:\r\n* Serum M protein > 0.5 G/DL, or\r\n* Urine M protein > 200 MG/24H, and/or\r\n* Serum free light chain (FLC) assay: involved FLC level > 10 MG/DL with abnormal serum FLC ratio\r\n* >= 50 plasma cells detectable by multicolor flow cytometry, at a sensitive level of 10^-4 (determined by central review)
Serum free light chain (FLC) >= 10 mg/dL, provided serum FLC ratio is abnormal in participants who do not have measurable disease by Serum Protein Electrophoresis (SPEP) or Urine Protein Electrophoresis (UPEP) criteria.
Serum free light chain (FLC) assay: involved FLC level ?10 mg/dL and an abnormal serum FLC ratio (<0.26 or >1.65).
Patients must have measurable disease defined as at least one of the following:\r\n* Serum M-protein >= 0.5 g/dl (>= 5 g/l)\r\n* Urine M-protein >= 200 mg/24 hours (h)\r\n* Serum free light chain (FLC) assay: involved FLC level >= 10 mg/dl (>= 100 mg/l) and an abnormal serum free light chain ratio (< 0.26 or > 1.65)\r\n* Quantitative immunoglobulin > 500 mg/dL, only for immunoglobulin (Ig)A and IgD myeloma when the protein electrophoresis under-represents disease burden\r\n* Biopsy proven plasmacytoma > 1x1 cm (should be measured within 28 days prior to initial investigational agent dosing)
Measurable disease defined by any of following: Serum M-protein > 1 g/dL; Urine M-protein > 200 mg/24h; Serum free light chain (FLC) assay: involved FLC level > or equal to 10 mg/dL provided serum FLC ratio is abnormal; subjects who are non-secretors will be considered on a case-by-case basis
Light chain multiple myeloma (MM), for participants without measurable disease in the serum or urine: serum Immunoglobulin (Ig) free light chain (FLC) >= 10 mg/dL and abnormal FLC ratio
Serum free light chain (FLC) ?10 mg/dL with abnormal ratio in subjects with unmeasurable disease by serum or urine PEP.
Serum free light chain (FLC) > 100 mg/L of involved FLC
Participants must have myeloma that is measurable by either serum or urine evaluation of the monoclonal component or by assay of serum free light chains; measurable disease is defined as one or more of the following: serum M-protein >= 0.5 g/dL, urine M-protein >= 200 mg/24 hour (h), and/or serum free light chain (FLC) assay: involved FLC level >= 10 mg/dL with abnormal serum FLC ratio
Measurable disease defined by serum M-protein ?1 g/dL, or urine light chain ?200 mg/24 hours, or abnormal serum FLC ratio with involved FLC > 10 mg/dL provided serum FLC ratio is abnormal
The subject has measurable disease with at least one of the following: Serum M-protein >=0.5 gram per deciliter (g/dL) (>=5 gram per Liter [g/L]); Urine M-protein >=200 milligram per 24 hours (mg/24h); Serum Free light chain (FLC) assay: Involved FLC level >=10 mg/dL (>=100 mg/L) and an abnormal serum free light chain ratio (<0.26 or >1.65).
Must have at least ONE aspect of measurable disease, defined as one the following: Urine M-protein excretion >=200 milligram (mg)/24 hours, or; Serum M-protein concentration >=0.5 gram (g)/deciliter (dL) (>=5.0 g/Liter), or; Serum free light chain (FLC) assay: involved FLC level >=10 mg/dL (>=100 mg/L) and an abnormal serum FLC ratio (<0.26 or >1.65).
Serum free light chain (FLC) assay: involved FLC assay ? 10 mg/dL (? 100 mg/L) and an abnormal serum FLC ratio (< 0.26 or > 1.65)
High risk disease defined by all of the following:\r\n* >= 10% bone marrow plasma cells AND\r\n* Abnormal serum free light chain (FLC) ratio (< 0.26 or > 1.65) by serum FLC assay AND\r\n* Monotypic plasma cell S-phase >= 0.3%
Patient is at higher than average risk of progression to active MM, defined as having 2 or more of the following features:\r\n* Serum M-protein >= 3 g/dL\r\n* BMPC > 10% and < 60%\r\n* Abnormal serum free light chains (FLC) ratio (0.26-1.65)
Patients must have measurable MM as defined by at least one of the criteria below\r\n* One or more of these abnormalities defines measurable disease:\r\n* Serum M-protein greater or equal to 0.4 g/dl (10 g/l)\r\n* Urine M-protein greater or equal to 200 mg/24 hour (h)\r\n* Serum free light chain (FLC) assay: involved FLC level greater or equal to 10 mg/dl (100 mg/l) provided serum FLC ratio is abnormal\r\n* A biopsy-proven plasmacytoma
Patients must have measurable disease as defined as at least one of the following (these baseline laboratory studies for determining eligibility must be obtained within 28 days prior to enrollment):\r\n* Serum M-protein >= 0.5 g/dl (>= 5 g/l)\r\n* Urine M-protein >= 200 mg/24 h\r\n* Serum free light chains (FLC) assay: involved FLC level >= 10 mg/dl (>= 100 mg/l) and an abnormal serum free light chain ratio (< 0.26 or > 1.65)\r\n* Biopsy proven plasmacytoma (should be measured within 28 days of first study drug administration); prior biopsy is acceptable\r\n* If the serum protein electrophoresis is unreliable for routine M-protein measurement, quantitative immunoglobulin levels on nephelometry or turbidimetry will be followed
Criteria for cohort A (recently diagnosed subjects to receive AHCT)\r\n* Must have presence of clonal plasma cells in the bone marrow greater or equal to 10% or biopsy proven plasmacytoma\r\n* Must have either (a) presence of myeloma protein (M-component) (immunoglobulin [Ig]G or IgA) in serum greater or equal to 1 g/dl or in urine greater or equal to 200 mg/24 hours (h); or (b) presence of an abnormal serum free light chain (FLC) ratio on the serum FLC assay
Participants must have myeloma that is measurable by either serum or urine evaluation of the monoclonal component or by assay of serum free light chains; measurable disease is defined as one or more of the following: serum M-protein >= 1 g/dl (except patients with immunoglobulin [Ig] D or IgA myeloma), urine M-protein >= 200 mg/24 hour (h), and/or serum free light chain (FLC) assay: involved FLC level >= 10 mg/dl with abnormal serum FLC ratio; for patients with IgD or IgA myeloma, a serum M-protein of greater than or equal to 0.5 g/dl will suffice; free light chain patients not measurable by urine or serum evaluation may be considered for inclusion
Subjects must have measurable disease including at least one of the criteria below: Serum M-protein greater or equal to 0.5 g/dL Urine M-protein greater or equal to 200 mg/24 h Serum free light chain (FLC) assay: involved FLC level greater or equal to 10 mg/dL (100 mg/L) provided serum FLC ratio is abnormal -Women of child-bearing potential (WCBP) must have a negative serum pregnancy test prior to treatment. All sexually active WCBP and all sexually active male subjects must agree to use effective methods of birth control throughout the study Part A: Diagnosis of MM with relapsed or refractory disease and have had at least 3 different prior lines of therapy including proteasome inhibitor (e.g., bortezomib or carfilzomib) and immunomodulatory therapy (IMiD; e.g., lenalidomide or pomalidomide), or have \double refractory\ disease to a proteasome inhibitor and IMiD, defined as progression on or within 60 days of treatment with these agents
Patients with measurable disease defined as one or more of the following: serum M-protein >= 1.0 g/dl, urine M-protein >= 200 mg/24 hour (h), and/or serum free light chain (FLC) assay: involved FLC level >= 10 mg/dl with abnormal serum FLC ratio
Serum free light chain (FLC) assay: Involved FLC assay ?10 mg/dL (?100 mg/L) and an abnormal serum FLC ratio (<0.26 or >1.65).
Participant has measurable disease at Screening, defined as at least one of the following: Serum M-protein greater than or equal to 0.5 g/dL, OR Urine M-protein greater than or equal to 200 mg in 24-hours, OR serum immunoglobulin free light chain (FLC) greater than or equal to 10 mg/dL provided serum FLC ratio is abnormal.
Measurable disease as defined by one or more of the following criteria (assessed within 28 days prior to registration):\r\n* Serum paraprotein >= 5 g/L (for immunoglobulin A [IgA] patients whose disease can only be reliably measured by serum quantitative immunoglobulin [IgA]: >= 7.5 g/L)\r\n* Urine Bence Jones protein: >= 200 mg/24 hours (h) \r\n* Serum light chain assay: Involved free light chain (FLC) level >= 100 mg/L, provided serum FLC ratio is abnormal
Patients must currently have measurable disease, as defined as:\r\n* Serum M protein >= 0.5 g/dl\r\n* Urine M protein >= 200 mg/24h\r\n* Serum free light chain assay: involved free light chain (FLC) level >= 10 mg/dl (>= 100 mg/l) provided serum FLC ratio is abnormal\r\n* If no monoclonal protein is detected (non-secretory disease), then > 30% monoclonal bone marrow plasma cells
Measurable MM disease, defined as one of the following:\r\n* A monoclonal immunoglobulin (Ig) concentration on serum electrophoresis of >= 0.5 g/dL for an IgG myeloma, >= 0.1 g/dL for an IgD myeloma or >= 0.5 g/dL for an IgA myeloma\r\n* Measurable urinary light chain secretion by quantitative analysis of >= 200 mg/24 hours\r\n* Involved serum free light chain (FLC) level >= 10 mg/dL, provided the serum FLC ratio is abnormal\r\n* Patients with oligo- or non-secretory disease must have bone marrow involvement with at least 30% plasmacytosis on aspiration
Participants must have myeloma that is measurable; measurable disease is 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 hour (h), and/or\r\n* Serum free light chain (FLC) assay: involved FLC level >= 10 mg/dl with abnormal serum FLC ratio
Measurable disease for phase IIa portion only\r\n* Lymphoma (includes cutaneous T-cell lymphoma [CTCL] patients who have no evidence of disease [NED] in skin): computed tomography (CT) or positron emission tomography (PET)/CT by modified Cheson criteria with incorporation of PET\r\n* Multiple myeloma: patient must have measurable disease and therefore must have at least one of the following:\r\n** Serum myeloma protein (M-protein) >= 0.5 gm/dL (>= 5 gm/L)\r\n** Urine M-protein >= 200 mg/24 hours (hr)\r\n** Serum free light chain (FLC) assay: involved FLC >= 10 mg/dL (>= 100 mg/L) provided serum FLC ratio is abnormal\r\n* CTCL: Modified Severity-Weighted Assessment Tool (mSWAT) > 0 or absolute Sezary count >= 1,000 cells/uL
Serum free light chain (FLC) assay: involved FLC level ? 10 mg/dL (? 100 mg/L), provided that the serum FLC ratio was abnormal.
Serum free light chain (FLC) > 100 mg/L of involved FLC
Measurable MM disease, defined as one of the following: \r\n* A monoclonal immunoglobulin (Ig) concentration on serum electrophoresis of >= 0.5 g/dL for an IgG myeloma, >= 0.1 g/dL for an IgD myeloma or 0.5 g/dL for an IgA myeloma\r\n* Measurable urinary light chain secretion by quantitative analysis of >= 200 mg/24 hours\r\n* Involved serum free light chain (FLC) level >= 10 mg/dL, provided the serum FLC ratio is abnormal\r\n* Patients with oligo- or non-secretory disease must have bone marrow involvement with at least 30% plasmacytosis
Measurable multiple myeloma disease, defined as meeting at least 1 of the following criteria within 14 days prior to registration: \r\n* A monoclonal Ig (M-protein) concentration on serum protein electrophoresis (SPEP) of >= 0.5 g/dL\r\n* Measurable urinary light chain secretion by quantitative analysis using urine protein electrophoresis (UPEP) of >= 200 mg/24 hours\r\n* Involved serum free light chain (FLC) level >= 10 mg/dL, provided the serum FLC ratio is abnormal\r\n* Presence of extramedullary plasmacytomas
Involved FLC assay > 10 mg/dL with abnormal FLC ratio.
Serum free light chains (FLC) assay: Involved FLC level ? 10 mg/dl (? 100 mg/l) and an abnormal serum free light chain ratio (< 0.26 or > 1.65)
Must have measurable disease, defined by one or more of following: (i) a serum M protein > 0.5 g/dl measured by serum protein electrophoresis; (ii) urinary M protein excretion > 200 mg/24 hours; (iii) serum free light chain (FLC) measurement > 10 mg/dl, provided that the serum FLC ratio is abnormal
Serum free light chain (FLC) > 100 mg/L of involved FLC
Involved serum free light chain (FLC) level ? 10 mg/dL, provided the serum FLC ratio is abnormal.
Patients must currently have measurable disease, as defined as:\r\n* Serum M protein >= 1.0 g/dl (>= 10000 mg/l) unless IgA >= 0.5 g/dL\r\n* Urine M protein >= 200 mg/24h\r\n* Serum free light chain assay: involved free light chain (FLC) level >= 10mg/dl (>= 100 mg/l) provided serum FLC ratio is abnormal\r\n* If no monoclonal protein is detected (non-secretory disease), then > 30% monoclonal bone marrow plasma cells
Patients with measureable disease defined as at least one of the following:\r\n* Serum M-protein >= 0.5 g/dl (>= 5 g/l)\r\n* Urine M-protein >= 200 mg/24 h\r\n* Serum free light chain (FLC) assay: involved FLC level >= 10 mg/dl (>= 100 mg/l) and an abnormal serum free light chain ratio (< 0.26 or > 1.65)\r\n* Measurable plasmacytoma (prior biopsy is acceptable, should be measured within 28 days of first study drug administration)
Involved FLC ?10 mg/dL and abnormal FLC ratio in serum (<0.26 or >1.65)
Involved FLC level ?10 mg/dL and abnormal FLC ratio in serum (<0.26 or >1.65)
Involved FLC level ?10 mg/dL and an abnormal FLC ratio in serum (<0.26 or >1.65)
Serum FLC ? 100 mg/L, provided that the serum FLC ratio is abnormal.
MM that does not express M-protein or serum FLC (i.e., non-secretory MM is excluded; plasmacytomas without M-protein or serum FLC are excluded).
Part 1/dose escalation; Histologically or cytologically confirmed diagnosis of Multiple Myeloma in a subject who fulfills all of the following: has undergone stem cell transplant, or is considered transplant ineligible, has been pretreated with at least the 3 following classes of anti-myeloma drugs: alkylators, proteasome inhibitors and immunomodulators, has demonstrated progression on, or within 60 days of completion of the last therapy. Part 2 /MM cohort; Histologically or cytologically confirmed diagnosis of: Multiple Myeloma in a subject who fulfills all of the following: has undergone stem cell transplant, or is considered transplant ineligible, has been pretreated with at least the 3 following classes of anti-myeloma drugs: alkylators, proteasome inhibitors and immunomodulators, has demonstrated progression on, or within 60 days of completion of the last therapy, and has measurable disease with at least one of the following: serum M-protein >=0.5 gram (g)/decilitre (dL) (>=5 g/Litre (L)), urine M-protein >=200 milligram (mg)/24hour (h). Serum free light chain (FLC) assay: Involved FLC level >=5 mg/dL (>=50 mg/L) and an abnormal serum FLC ratio (<0.26 or >1.65) and biopsy proven plasmacytoma (should be measured within 28 days of Screening Visit).
Diagnosis of high risk smoldering multiple myeloma (SMM) (per International Myeloma Working Group [IMWG] criteria) for less than or equal to (<=)5 years with measurable disease, defined as clonal bone marrow plasma cells (BMPCs) greater than or equal to (>=)10 percent (%) but less than (<)60% and 1 of the following: serum M-protein >=10 gram per liter (g/L) or urine M-protein >=200 milligram per 24 hours (mg/24 hours) or involved serum free light chain (FLC) >=100 milligram per liter (mg/L) and abnormal serum FLC ratio
Serum FLC ratio (involved:uninvolved) >=100 (the involved FLC must be >=100 mg/L)
Serum free light chain (FLC) ? 100 mg/L, provided that the serum FLC ratio is abnormal.
In participants without measurable M-protein in serum protein electrophoresis (SPEP) or urine protein electrophoresis (UPEP), a serum FLC assay result with involved FLC level >=10 mg/dL (>=100 milligram per liter [mg/L]), provided serum FLC ratio is abnormal.