Treatment of Patients with Relapsed/Refractory Multiple Myeloma with Ruxolitinib, Methylprednisolone and Lenalidomide: Using Changes in Serum B-Cell Maturation Antigen (BCMA) or International Multiple Working Group (IMWG) Criteria to Determine Disease Progression in Order to Add Lenalidomide to Those Failing the Ruxolitinib/Methylprednisolone Combination
Oncotherapeutics
Summary
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 using BCMA to test progression.
Description
In recent years, new and more effective drugs have become available for the treatment of multiple myeloma (MM), resulting in a dramatic increase in median overall survival (OS).1 Therapeutic options have expanded to include immune-based approaches such as daratumumab and elotuzumab.2 The clinical course of MM is highly variable, and relapsing/refractory (RR)MM more so, with periods of response followed by periods of relapse. Improvements in predicting and determining individual patient outcome would allow for more effective and timely treatment interventions. Over the last several years, we h…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Subjects must meet all 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. BM 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. BM plasmacytosis (10% to 30%…
Interventions
- DrugRuxolitinib Oral Tablet [Jakafi]
Ruxolitinib will be administered on days 1-28 of the treatment cycle.
- DrugLenalidomide
Lenalidomide will be administered on Days 1-21 of the treatment cycle.
- DrugMethylprednisolone
Methyl-prednisolone will be administered on Days 1-28 of the treatment cycle.
Location
- Berenson Cancer CenterWest Hollywood, California