Pilot Study Using Changes in Serum BCMA to Determine Disease Progression in Multiple Myeloma (NCT06209606) | Clinical Trial Compass
RecruitingEarly Phase 1
Pilot Study Using Changes in Serum BCMA to Determine Disease Progression in Multiple Myeloma
United States30 participantsStarted 2022-12-08
Plain-language 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.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Has a diagnosis of MM based on standard criteria as follows:
✓. 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
✓. BM plasmacytosis (10% to 30% plasma cells)
✓. Monoclonal immunoglobulin present but of lesser magnitude than given under major criteria
✓. Lytic bone lesions
✓. Normal IgM less than 50 mg/dL, IgA less than 100 mg/dL, or IgG less than 600 mg/dL
✕. 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
✕. Impaired cardiac function or clinically significant cardiac diseases, including any one of the following:
✕. Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form
✕. Any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study