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.
Plasmacytomas on tissue biopsy.
Bone marrow plasmacytosis (greater than 30% plasma cells).
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.
bone marrow plasmacytosis (10% to 30% plasma cells)
POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes)
Plasma cell leukemia (> 2.0 × 10E9/L circulating plasma cells by standard differential)
Primary amyloidosis
Non-hematologic malignancy within the past 5 years with the exception of a) adequately treated basal cell carcinoma, squamous cell skin cancer, or thyroid cancer; b) carcinoma in situ of the cervix or breast; c) prostate cancer of Gleason Grade 6 or less with stable prostate-specific antigen levels; or d) cancer considered cured by surgical resection or unlikely to impact survival during the duration of the study, such as localized transitional cell carcinoma of the bladder or benign tumors of the adrenal or pancreas
Sequential
Ruxolitinib Oral Tablet [Jakafi]
DrugRuxolitinib will be administered on days 1-28 of the treatment cycle.
Lenalidomide
DrugLenalidomide will be administered on Days 1-21 of the treatment cycle.
Methylprednisolone
DrugMethyl-prednisolone will be administered on Days 1-28 of the treatment cycle.
Determination of maximum tolerated dose (MTD) of ruxolitinib in combination with steroids and lenalidomide [Tolerability].
MTD will be determined by measuring incidence of the dose-limiting toxicities (DLTs) per dose level, of ruxolitinib in combination with steroids and lenalidomide for MM patients currently with progressive disease.
Incidence of Treatment-Emergent Adverse Events [Safety]
Safety will be measured by counting the occurrence of adverse events throughout the study, graded via Common Terminology Criteria for Adverse Events (CTCAE) v 4.03 criteria
Overall response rate (ORR) as a measure of efficacy
Overall response rate (ORR) is defined as CR + VGPR + PR
Clinical benefit rate (CBR) as a measure of efficacy
Clinical benefit rate is defined as ORR + MR
Progression Free Survival (PFS)
Progression-free survival will be measured in months as the time from initiation of therapy to progressive disease or death from any cause, whichever occurs first
Assessment of the time to response as a measure of efficacy (TTR)
Time to response, defined as the time from the initiation of therapy to the first evidence of confirmed clinical benefit defined as \> minimal response (MR, including patients who achieved a complete response (CR), very good partial response (VGPR), partial response (PR), or MR
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Oncotherapeutics
Lead sponsor
Incyte Corporation
Collaborator
