NCT03110822
A Phase 1 Study of Ruxolitinib, Steroids and Lenalidomide for Relapsed/Refractory Multiple Myeloma (RRMM) Patients
Recruiting · Phase 1 · Oncotherapeutics · registry updated 2023-11-01
Inclusion and exclusion lines below are quoted from ClinicalTrials.gov. No match score is shown, because a score needs a person's age, biomarkers, and treatment dates. Confirm the record with the study team.
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.
Inclusion
- Subjects must meet all of the following inclusion criteria to be eligible to enroll in this study.
- \. Has a diagnosis of MM based on standard criteria as follows:
- Major criteria:
- 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.
Exclusion
- Subjects meeting any of the following exclusion criteria are not to be enrolled in the study:
- 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 dura