Phase II Randomized Study of High Dose Interleukin-2 Versus Stereotactic Body Radiation (SBRT) and High Dose Interleukin-2 (IL-2) in Patients with Metastatic Renal Cancer
This is a Phase 3, open-label, multicenter study designed to evaluate the safety and efficacy of venetoclax and dexamethasone compared with pomalidomide and dexamethasone in subjects with t(11;14)- positive R/R MM. The study will consist of Screening, a Treatment Period, and Follow-Up.
• Documented diagnosis of MM based on standard IMWG criteria.
• Has received at least 2 prior lines of therapy, had documented disease progression on or within 60 days after completion of the last therapy, are refractory to the IMiD lenalidomide, and have previously failed treatment with a PI.
• Has t(11;14)-positive status determined by an analytically validated FISH assay per centralized laboratory testing
Subjects should have laboratory values meeting the following criteria:
• alanine aminotransferase (ALT) ≤ 3 × the upper limit of normal (ULN)
• aspartate aminotransferase (AST) ≤ 3 × ULN
• total bilirubin ≤ 1.5 × ULN (subjects with documented Gilbert's syndrome may be allowed if total bilirubin > 1.5 × ULN)
• creatinine clearance ≥ 30 mL/min, measured by 24-hour urine collection or calculated using the Cockcroft-Gault formula
• serum calcium corrected for albumin ≤ 14.0 mg/dL (≤ 3.5 mmol/L)
• absolute neutrophil count (ANC) ≥ 1,000/μL (growth factor support is allowed to achieve eligibility criteria)
• hemoglobin ≥ 8.0 g/dL within 2 weeks prior to randomization (subject may receive blood transfusion in accordance with institutional guidelines to meet this criteria)
Brendan Curti, M.D.
Earle A Chiles Research Institute (EACRI)
- Oncology and Hematology Care Eastside