Oncotherapeutics
This is a phase 1, multicenter, open-label study evaluating the safety and efficacy of ruxolitinib, steroids and lenalidomide among MM patients who currently show progressive disease.
Multiple myeloma (MM), a plasma cell dyscrasia, is the most common primary malignancy of the bone marrow.The etiology of myeloma is largely unknown, although genetic predisposition and environmental factors have been speculated. MM arises from malignant plasma cells that clonally expand and accumulate in the bone marrow. These clonal plasma cells produce high levels of monoclonal immunoglobulins. Plasma cell dyscrasias are classified as monoclonal gammopathy of undetermined significance, solitary plasmacytoma, smoldering myeloma, active myeloma, extra-skeletal myeloma, or plasma cell leukemia.…
Inclusion Criteria: Subjects must meet all of the following inclusion criteria to be eligible to enroll in this study. 1\. Has a diagnosis of MM based on standard criteria as follows: Major criteria: 1. Plasmacytomas on tissue biopsy. 2. Bone marrow plasmacytosis (greater than 30% plasma cells). 3. Monoclonal immunoglobulin spike on serum electrophoresis IgG greater than 3.5 g/dL or IgA greater than 2.0 g/dL or kappa or lambda light chain excretion greater than 1 g/day on 24 hour urine protein electrophoresis. Minor criteria: 1. bone marrow plasmacytosis (10% to 30% plasma cells) 2. mono…
Ruxolitinib will be administered on days 1-28 of the treatment cycle.
Lenalidomide will be administered on Days 1-21 of the treatment cycle.
Methyl-prednisolone will be administered on Days 1-28 of the treatment cycle.