A Phase 3, Two-Stage, Randomized, Multicenter, Open-Label Study Comparing Mezigdomide (CC-92480), Bortezomib And Dexamethasone (MeziVd) Versus Pomalidomide, Bortezomib And Dexamethasone (PVd) In Subjects With Relapsed Or Refractory Multiple Myeloma (RRMM): Successor-1 - CA057-001

Celgene Corp.0 个研究点目标入组 874 人开始时间: 2024年4月25日最近更新: 2024年8月21日

适应症

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•Subject has documented diagnosis of MM and measurable disease, defined as: —M-protein = 0.5 g/dL by serum protein electrophoresis (sPEP), or = 200 mg/24-hour urine collection by urine protein electrophoresis (uPEP) or —For subjects without measurable disease in sPEP or uPEP: serum free light chain (sFLC) levels > 100 mg/L (10 mg/dL) involved light chain and an abnormal kappa/lambda FLC ratio, Subject has received 1 to 3 prior anti-myeloma lines of therapy, Subject must have received prior treatment with a lenalidomide containing regimen. For country-specific requirements, see APPENDIX I, Subject achieved a minimal response [MR] or better to at least 1 prior antimyeloma therapy, Subject must have documented disease progression during or after their last antimyeloma regimen, Subject has an Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1 or 2.

•Subject has had prior treatment with mezigdomide or pomalidomide, Subject has had progression during treatment or within 60 days of the last dose of a proteasome inhibitor, except as noted below: a. Subjects who progressed while being treated with, or within 60 days of last dose of bortezomib maintenance given once every 2 weeks or less are not excluded., Subject discontinued prior treatment with bortezomib due to toxicity, Any of the following laboratory abnormalities: —ANC < 1,000/µL (no GCSF allowed within 7 days prior to the CBC; which will be used to determine eligibility or within 14 prior days for pegfilgrastim) —Platelet : < 75,000/µL for subjects in whom < 50% of bone marrow nucleated cells are plasma cells; or a platelet count < 50,000/µL for subjects in whom = 50% of bone marrow nucleated cells are plasma cells (transfusions are not permitted within 7 days prior to the CBC which will be used to determine eligibility) —Hemoglobin < 8 g/dL (< 4.9 mmol/L). Not applicable for Protocol Amendment 4 and later. —eGFR < 30 mL/min/1.73m2 or requiring dialysis —Corrected serum calcium > 13.5 mg/dL (> 3.4 mmol/L) —AST or ALT > 2.5 × ULN —Serum total bilirubin > 1.5 × ULN, or for subjects with documented Gilbert's syndrome > 3.0 mg/d

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