--- a +++ b/clusters/9knumclustersv2/clust_1258.txt @@ -0,0 +1,53 @@ +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 > . G/DL, or\r\n* Urine M protein > MG/H, and/or\r\n* Serum free light chain (FLC) assay: involved FLC level > MG/DL with abnormal serum FLC ratio\r\n* >= plasma cells detectable by multicolor flow cytometry, at a sensitive level of ^- (determined by central review) +Serum free light chain (FLC) >= 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 ? mg/dL and an abnormal serum FLC ratio (<. or >.). +Patients must have measurable disease defined as at least one of the following:\r\n* Serum M-protein >= . g/dl (>= g/l)\r\n* Urine M-protein >= mg/ hours (h)\r\n* Serum free light chain (FLC) assay: involved FLC level >= mg/dl (>= mg/l) and an abnormal serum free light chain ratio (< . or > .)\r\n* Quantitative immunoglobulin > mg/dL, only for immunoglobulin (Ig)A and IgD myeloma when the protein electrophoresis under-represents disease burden\r\n* Biopsy proven plasmacytoma > x cm (should be measured within days prior to initial investigational agent dosing) +Measurable disease defined by any of following: Serum M-protein > g/dL; Urine M-protein > mg/h; Serum free light chain (FLC) assay: involved FLC level > or equal to 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) >= mg/dL and abnormal FLC ratio +Serum free light chain (FLC) ? mg/dL with abnormal ratio in subjects with unmeasurable disease by serum or urine PEP. +Measurable disease at the time of relapse, defined as a monoclonal immunoglobulin spike on serum electrophoresis of >= gm/dL (immunoglobulin [IG]G) or >= . gm/dL (IGA) and/or urine monoclonal immunoglobulin spike of > mg/ hours and/ or involved free light chain (FLC) level >= mg/dl and the serum FLC ratio is abnormal +Serum free light chain (FLC) > 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 >= . g/dL, urine M-protein >= mg/ hour (h), and/or serum free light chain (FLC) assay: involved FLC level >= mg/dL with abnormal serum FLC ratio +Measurable disease defined by serum M-protein ? g/dL, or urine light chain ? mg/ hours, or abnormal serum FLC ratio with involved FLC > mg/dL provided serum FLC ratio is abnormal +The subject has measurable disease with at least one of the following: Serum M-protein >=. gram per deciliter (g/dL) (>= gram per Liter [g/L]); Urine M-protein >= milligram per hours (mg/h); Serum Free light chain (FLC) assay: Involved FLC level >= mg/dL (>= mg/L) and an abnormal serum free light chain ratio (<. or >.). +Must have at least ONE aspect of measurable disease, defined as one the following: Urine M-protein excretion >= milligram (mg)/ hours, or; Serum M-protein concentration >=. gram (g)/deciliter (dL) (>=. g/Liter), or; Serum free light chain (FLC) assay: involved FLC level >= mg/dL (>= mg/L) and an abnormal serum FLC ratio (<. or >.). +Serum free light chain (FLC) assay: involved FLC assay ? mg/dL (? mg/L) and an abnormal serum FLC ratio (< . or > .) +High risk disease defined by all of the following:\r\n* >= % bone marrow plasma cells AND\r\n* Abnormal serum free light chain (FLC) ratio (< . or > .) by serum FLC assay AND\r\n* Monotypic plasma cell S-phase >= .% +Patient is at higher than average risk of progression to active MM, defined as having or more of the following features:\r\n* Serum M-protein >= g/dL\r\n* BMPC > % and < %\r\n* Abnormal serum free light chains (FLC) ratio (.-.) +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 . g/dl ( g/l)\r\n* Urine M-protein greater or equal to mg/ hour (h)\r\n* Serum free light chain (FLC) assay: involved FLC level greater or equal to mg/dl ( 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 days prior to enrollment):\r\n* Serum M-protein >= . g/dl (>= g/l)\r\n* Urine M-protein >= mg/ h\r\n* Serum free light chains (FLC) assay: involved FLC level >= mg/dl (>= mg/l) and an abnormal serum free light chain ratio (< . or > .)\r\n* Biopsy proven plasmacytoma (should be measured within 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 % 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 g/dl or in urine greater or equal to mg/ 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 >= g/dl (except patients with immunoglobulin [Ig] D or IgA myeloma), urine M-protein >= mg/ hour (h), and/or serum free light chain (FLC) assay: involved FLC level >= mg/dl with abnormal serum FLC ratio; for patients with IgD or IgA myeloma, a serum M-protein of greater than or equal to . g/dl will suffice; free light chain patients not measurable by urine or serum evaluation may be considered for inclusion +Patients must be diagnosed with asymptomatic high-risk smoldering multiple myeloma (SMM) within the past months, as confirmed by both of the following:\r\n* Bone marrow plasmacytosis with >= % plasma cells or sheets of plasma cells at any time before initiating study treatment, including a marrow which must be obtained by bone marrow aspiration and/or biopsy within weeks prior to randomization\r\n* Abnormal serum free light chain ratio (< . or > .) by serum free light chain (FLC) assay; FLC assay must be performed within days of randomization +Subjects must have measurable disease including at least one of the criteria below: Serum M-protein greater or equal to . g/dL Urine M-protein greater or equal to mg/ h Serum free light chain (FLC) assay: involved FLC level greater or equal to mg/dL ( 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 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 days of treatment with these agents +Patients with measurable disease defined as one or more of the following: serum M-protein >= . g/dl, urine M-protein >= mg/ hour (h), and/or serum free light chain (FLC) assay: involved FLC level >= mg/dl with abnormal serum FLC ratio +Serum free light chain (FLC) assay: Involved FLC assay ? mg/dL (? mg/L) and an abnormal serum FLC ratio (<. or >.). +Participant has measurable disease at Screening, defined as at least one of the following: Serum M-protein greater than or equal to . g/dL, OR Urine M-protein greater than or equal to mg in -hours, OR serum immunoglobulin free light chain (FLC) greater than or equal to mg/dL provided serum FLC ratio is abnormal. +? prior systemic hematologic therapy for a free light chain (FLC) producing hematologic malignancy underlying the initial diagnosis of AL amyloidosis with at least a partial FLC response (PR, VGPR, CR) to treatment deemed stable and not requiring further treatment +Measurable disease as defined by one or more of the following criteria (assessed within days prior to registration):\r\n* Serum paraprotein >= g/L (for immunoglobulin A [IgA] patients whose disease can only be reliably measured by serum quantitative immunoglobulin [IgA]: >= . g/L)\r\n* Urine Bence Jones protein: >= mg/ hours (h) \r\n* Serum light chain assay: Involved free light chain (FLC) level >= mg/L, provided serum FLC ratio is abnormal +Patients must currently have measurable disease, as defined as:\r\n* Serum M protein >= . g/dl\r\n* Urine M protein >= mg/h\r\n* Serum free light chain assay: involved free light chain (FLC) level >= mg/dl (>= mg/l) provided serum FLC ratio is abnormal\r\n* If no monoclonal protein is detected (non-secretory disease), then > % 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 >= . g/dL for an IgG myeloma, >= . g/dL for an IgD myeloma or >= . g/dL for an IgA myeloma\r\n* Measurable urinary light chain secretion by quantitative analysis of >= mg/ hours\r\n* Involved serum free light chain (FLC) level >= 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 % 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 >= . g/dl,\r\n* Urine M-protein >= mg/ hour (h), and/or\r\n* Serum free light chain (FLC) assay: involved FLC level >= 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) >= . gm/dL (>= gm/L)\r\n** Urine M-protein >= mg/ hours (hr)\r\n** Serum free light chain (FLC) assay: involved FLC >= mg/dL (>= mg/L) provided serum FLC ratio is abnormal\r\n* CTCL: Modified Severity-Weighted Assessment Tool (mSWAT) > or absolute Sezary count >= , cells/uL +Serum free light chain (FLC) assay: involved FLC level ? mg/dL (? mg/L), provided that the serum FLC ratio was abnormal. +Serum free light chain (FLC) > 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 >= . g/dL for an IgG myeloma, >= . g/dL for an IgD myeloma or . g/dL for an IgA myeloma\r\n* Measurable urinary light chain secretion by quantitative analysis of >= mg/ hours\r\n* Involved serum free light chain (FLC) level >= 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 % plasmacytosis +Measurable multiple myeloma disease, defined as meeting at least of the following criteria within days prior to registration: \r\n* A monoclonal Ig (M-protein) concentration on serum protein electrophoresis (SPEP) of >= . g/dL\r\n* Measurable urinary light chain secretion by quantitative analysis using urine protein electrophoresis (UPEP) of >= mg/ hours\r\n* Involved serum free light chain (FLC) level >= mg/dL, provided the serum FLC ratio is abnormal\r\n* Presence of extramedullary plasmacytomas +Involved FLC assay > mg/dL with abnormal FLC ratio. +Serum free light chains (FLC) assay: Involved FLC level ? mg/dl (? mg/l) and an abnormal serum free light chain ratio (< . or > .) +Must have measurable disease, defined by one or more of following: (i) a serum M protein > . g/dl measured by serum protein electrophoresis; (ii) urinary M protein excretion > mg/ hours; (iii) serum free light chain (FLC) measurement > mg/dl, provided that the serum FLC ratio is abnormal +Serum free light chain (FLC) > mg/L of involved FLC +Involved serum free light chain (FLC) level ? mg/dL, provided the serum FLC ratio is abnormal. +Patients must currently have measurable disease, as defined as:\r\n* Serum M protein >= . g/dl (>= mg/l) unless IgA >= . g/dL\r\n* Urine M protein >= mg/h\r\n* Serum free light chain assay: involved free light chain (FLC) level >= mg/dl (>= mg/l) provided serum FLC ratio is abnormal\r\n* If no monoclonal protein is detected (non-secretory disease), then > % monoclonal bone marrow plasma cells +Patients with measureable disease defined as at least one of the following:\r\n* Serum M-protein >= . g/dl (>= g/l)\r\n* Urine M-protein >= mg/ h\r\n* Serum free light chain (FLC) assay: involved FLC level >= mg/dl (>= mg/l) and an abnormal serum free light chain ratio (< . or > .)\r\n* Measurable plasmacytoma (prior biopsy is acceptable, should be measured within days of first study drug administration) +Involved FLC ? mg/dL and abnormal FLC ratio in serum (<. or >.) +Involved FLC level ? mg/dL and abnormal FLC ratio in serum (<. or >.) +Involved FLC level ? mg/dL and an abnormal FLC ratio in serum (<. or >.) +Serum FLC ? 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). +MM\r\n* Absence of monoclonal protein in serum and urine by immunofixation with no current evidence of soft tissue plasmacytoma\r\n* Bone marrow aspirate and biopsy must demonstrate less than percent clonal plasma cells\r\n* In patients who lack measurable M proteins in the serum and urine being monitored using the free light chain (FLC) levels, the definition of complete response (CR) requires a normalization of the FLC ratio in addition to the above criteria +Part /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 following classes of anti-myeloma drugs: alkylators, proteasome inhibitors and immunomodulators, has demonstrated progression on, or within days of completion of the last therapy. Part /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 following classes of anti-myeloma drugs: alkylators, proteasome inhibitors and immunomodulators, has demonstrated progression on, or within days of completion of the last therapy, and has measurable disease with at least one of the following: serum M-protein >=. gram (g)/decilitre (dL) (>= g/Litre (L)), urine M-protein >= milligram (mg)/hour (h). Serum free light chain (FLC) assay: Involved FLC level >= mg/dL (>= mg/L) and an abnormal serum FLC ratio (<. or >.) and biopsy proven plasmacytoma (should be measured within 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 (<=) years with measurable disease, defined as clonal bone marrow plasma cells (BMPCs) greater than or equal to (>=) percent (%) but less than (<)% and of the following: serum M-protein >= gram per liter (g/L) or urine M-protein >= milligram per hours (mg/ hours) or involved serum free light chain (FLC) >= milligram per liter (mg/L) and abnormal serum FLC ratio +Serum FLC ratio (involved:uninvolved) >= (the involved FLC must be >= mg/L) +Serum free light chain (FLC) ? 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 >= mg/dL (>= milligram per liter [mg/L]), provided serum FLC ratio is abnormal.