A Phase 3, Two-stage, Randomized, Multicenter, Open-label Study Comparing CC-92480 (BMS-986348), Carfilzomib, and Dexamethasone (480Kd) Versus Carfilzomib and Dexamethasone (Kd) in Participants with Relapsed or Refractory Multiple Myeloma (RRMM) - NI

BRISTOL MYERS SQUIBB INDIA PRIVATE LIMITED0 个研究点目标入组 0 人开始时间: 待定最近更新: 2024年7月22日

试验速览

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•? Participant has documented diagnosis of multiple myeloma (MM) and measurable disease,
•defined as any of the following:
•? M-protein = 0.5 g/dL by serum protein electrophoresis (sPEP), or
•? M-protein = 200 mg/24-hour urine collection by urine protein electrophoresis (uPEP) or,
•? For participants 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 ?/? FLC ratio.
•? Participant has received at least one prior line of anti-myeloma therapy. Note: One line can
•contain several phases (eg, 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. Note: Patients who were intolerant of an anti-CD38 mAb and
•received < 2 cycles are still eligible.
•? Participant achieved minimal response [MR] or better to at least 1 prior anti-myeloma therapy.
•? Participant must have documented disease progression during or after their last antimyeloma

•1. Participant who has had prior treatment with CC-92480 or carfilzomib.
•2. Participant has previously received allogeneic stem cell transplant at any time or received
•autologous stem cell transplant within 12 weeks of initiating study treatment.
•3. Participant has any of the following laboratory values at screening:
•i. Absolute neutrophil count (ANC) < 1.0 × 109 /L ( < 1,000/ µL) without growth factor
•support within 7 days prior to screening complete blood count (CBC) (14 days if
•pegfilgrastim is used)
•ii. Platelets < 75 × 109 /L ( < 75,000/µL) and no platelet transfusions within the 7-day period
•leading up to screening CBC ? Hemoglobin < 8 g/dL ( < 4.9 mmol/L)
•iii. Corrected serum calcium > 13.5 mg/dL ( > 3.4 mmol/L)
•iv. Estimated glomerular filtration rate (eGFR) < 30 mL/min or requiring dialysis.

发起方

BRISTOL MYERS SQUIBB INDIA PRIVATE LIMITED