进行中(不再招募) NCT05552976

评估 Mezigdomide 联合 carfilzomib 及 dexamethasone(MeziKD)对比 carfilzomib 及 dexamethasone(Kd)用于复发性或难治性多发性骨髓瘤患者的研究(SUCCESSOR-2)

骨髓瘤Phase III

本研究旨在比较 Mezigdomide(CC-92480/BMS-986348)联合 carfilzomib 及 dexamethasone(MeziKD)与 carfilzomib 及 dexamethasone(Kd)在复发性或难治性多发性骨髓瘤(RRMM)治疗中的效果:SUCCESSOR-2。

适应症:Relapsed or Refractory Multiple Myeloma

入组条件

纳入标准

  • \- Participant has documented diagnosis of multiple myeloma and measurable disease, defined as any of the following:.
  • i) Myeloma-protein (M-protein) ≥ 0.5 grams/deciliter (g/dL) by serum protein electrophoresis (sPEP), or.
  • ii) M-protein ≥ 200 milligrams (mg)/24-hour urine collection by urine protein electrophoresis (uPEP) or,.
  • iii) For participants without measurable disease in sPEP or uPEP: serum free light chain levels \> 100 mg/liter (L) (10 mg/dL) involved light chain and an abnormal κ/λ free light chain ratio.
  • Participant has received at least one prior line of anti-myeloma therapy. Note: One line can contain several phases (e.g., induction, \[with or without\] hematopoietic stem cell transplant, (with or without) consolidation, and/or \[with or without\] maintenance therapy).
  • Participant must have received prior treatment with lenalidomide and at least 2 cycles of an anti-CD38 monoclonal antibody (mAb) (participants who were intolerant of an anti-CD38 mAb and received \< 2 cycles are still eligible).
  • Participant achieved minimal response or better to at least 1 prior anti-myeloma therapy.
  • Participant must have documented disease progression during or after their last antimyeloma regimen.

排除标准

  • Participant who has had prior treatment with mezigdomide or carfilzomib.
  • Participant has previously received allogeneic stem cell transplant at any time or received autologous stem cell transplant within 12 weeks of initiating study treatment.

入组条件维持 ClinicalTrials.gov 原始英文登记资料,实际入组资格以研究团队的正式评估与受试者知情同意书为准。资料来源:ClinicalTrials.gov,每两周自动更新,最后同步:2026年10月8日。