Pilot Study Using Changes in Serum BCMA to Determine Disease Progression in Multiple Myeloma
ConditionMultiple Myeloma
Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorOncotherapeutics
About this trial
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.
Eligibility criteria
Qualifiers
Subjects must meet all the following inclusion criteria to be eligible to enroll in this study.
Plasmacytomas on tissue biopsy
BM 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
Disqualifiers
POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes)
Plasma cell leukemia (> 2.0 × 109/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
Trial design
Treatments tested in this trial
- Ruxolitinib Oral Tablet [Jakafi]
- Lenalidomide
- Methylprednisolone
Treatment groups
30 Participants
are divided into 2 treatment groupsSponsors and collaborators
Oncotherapeutics
Lead sponsor
Incyte Corporation
Collaborator
Source ClinicalTrials.gov