[c09aa8]: / clusters / 9knumclustersv2 / clust_1780.txt

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Serum or plasma creatinine =< . x ULN measured within days prior to randomization
Patients with undetectable pre-treatment plasma EBV DNA
Has active hemolytic anemia, plasma cell leukemia, Waldenstrom's macroglobulinemia, POEMS syndrome, amyloidosis, significant autoimmune, CNS or other malignant disease
Concurrent symptomatic amyloidosis or plasma cell leukemia
Active or prior plasma cell leukemia (defined as either % of peripheral WBC comprised of plasma/CD+ cells or an absolute count of x ^/L).
Solitary bone or solitary extramedullary plasmacytoma as the only evidence of plasma cell dyscrasia.
Previously treated myeloma, currently with extramedullary disease (defined as plasmacytoma outside bone marrow that is not contiguous with a bone lesion) with at least one lesion that has a single diameter of >= cm or plasma cell leukemia (defined as circulating plasma cells exceeding % of peripheral blood leukocytes or . X ^/L or cells/ events by flow cytometry)
Concurrent symptomatic amyloidosis or plasma cell leukemia
Patients with non-secretory multiple myeloma, active plasma cell leukemia, defined as either having % of peripheral white blood cells comprised of CD+ plasma cells, or an absolute plasma cell count of x ^/L, known amyloidosis, or known POEMS syndrome (plasma cell dyscrasia with polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes)
PRIOR TO LYMPHODEPLETION: Patients on strong inhibitors of CYPA (e.g., fluvoxamine, ciprofloxacin) as these may increase plasma concentrations of bendamustine, and decrease plasma concentrations of its metabolites
Active plasma cell leukemia (defined as either % of peripheral white blood cells comprised of plasma/CD+ cells or an absolute plasma cell count of x ^/L)
Multiple myeloma specific:\r\n* Active or prior plasma cell leukemia (defined as either % of peripheral white blood cell [WBC] comprised of plasma/cluster of differentiation [CD]+ cells or an absolute count of x ^/L)\r\n* Solitary bone or solitary extramedullary plasmacytoma as the only evidence of plasma cell dyscrasia
Evidence of end-organ damage that can be attributed to the underlying plasma cell proliferative disorder, specifically:
The subject must have a documented CMV infection in whole blood or plasma, with a screening value of greater than or equal to (>=) international units per milliliter (IU/mL) in whole blood or >= IU/mL in plasma in consecutive assessments, separated by at least day, as determined by local or central speciality laboratory quantitative polymerase chain reaction (qPCR) or comparable quantitative CMV DNA results. Both samples should be taken within days prior to randomization with second sample obtained within days prior to randomization. The same laboratory and same sample type (whole blood or plasma) must be used for these assessments.
Diagnosed with plasma cell leukemia, POEMS syndrome or amyloidosis.
Less than % plasma cells in the peripheral blood leukocytes
Subjects who have plasma cell leukemia or clinically significant amyloidosis
Plasma cell leukemia, primary amyloidosis or POEMS syndrome
Plasma cell leukemia, primary amyloidosis or POEMS syndrome
Patient has concurrent symptomatic amyloidosis or plasma cell leukemia
Subjects with solitary bone or extramedullary plasmacytoma as the only evidence of plasma cells dyscrasia
Clonal bone marrow plasma cells >= % or biopsy-proven bony or extramedullary plasmacytoma and any one or more of the following defining events: \r\n* End organ damage that can be attributed to the underlying plasma cell proliferative disorder, specifically:
Plasma phosphate >= . and < . mg/dL
Bone marrow consistent with plasma cell dyscrasia
? prior systemic plasma cell dyscrasia therapy with at least a partial hematologic response
Received Plasma cell directed chemotherapy within months
Multiple myeloma: solitary bone or solitary extramedullary plasmacytoma as the only evidence of plasma cell dyscrasia
Active or prior plasma cell leukemia (defined as either % of peripheral WBC comprised of plasma/CD+ cells or an absolute count of x ^/L).
Solitary bone or solitary extramedullary plasmacytoma as the only evidence of plasma cell dyscrasia.
Serum or plasma HCV RNA level >= , IU/mL
Plasma creatinine =< .
Concurrent symptomatic amyloidosis or plasma cell leukemia
Patients with plasma alanine aminotransferase greater than IU/dL
Patients with plasma aspartate aminotransferase greater than IU/dL
CRITERIA FOR PLASMA GENOTYPING