An Exploratory Phase 1b/2a Multicenter, Open-Label, Novel-Novel Combination Study toAssess the Safety, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of CC-92480(BMS-986348) in Novel Therapeutic Combinations in Participants with Relapsed or RefractoryMultiple Myeloma

Celgene Corporation0 个研究点目标入组 60 人开始时间: 2022年5月24日最近更新: 2024年7月8日

适应症

试验速览

暂无简介。

•Participants are eligible to be included in the study only if all of the following criteria apply:
•1.Signed written informed consent prior to any study procedure.
•2.= 18 years of age the time of signing the ICF.
•3.Relapsed or refractory multiple myeloma (MM) and must:
•a.have documented disease progression during or after their last myeloma therapy
•b. be refractory to, intolerant to, or not a candidate for available, established therapies known to provide clinical benefit in MM
•4.Must have measurable disease.
•5.Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1.
•6.Agree to follow the CC-92480 Pregnancy Prevention Plan (PPP)
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 24
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 36

•Participants are excluded from the study if any of the following criteria apply:
•1.Known active or history of central nervous system (CNS) involvement of MM.
•2.Plasma cell leukemia; Waldenstrom’s macroglobulinemia; polyneuropathy, organomegaly, endocrinopathy, M-protein, and skin changes (POEMS) syndrome; or clinically significant light-chain amyloidosis.
•3.Impaired cardiac function or clinically significant cardiac disease.
•4.Participant has previous SARS-CoV-2 infection within 14 days for asymptomatic or mild symptomatic infections or 28 days for severe/critical illness prior to Cycle 1 Day 1 (C1D1)
•5.For Part 1: received prior therapy with CC-92480.
•6.For Part 2: received prior therapy with CC-92480, tazemetostat, BMS-986158, or trametinib.
•7.Previously received allogeneic stem-cell transplant at any time or received autologous stem-cell transplant within 12 weeks of initiating study treatment
•8.Received any of the following within 14 days prior to initiating study treatment:
•a.Plasmapheresis
•b.Major surgery
•c.Radiation therapy other than local therapy for myeloma associated bone lesions
•d.Use of any systemic anti-myeloma drug therapy
•9.Used any investigational agents within 28 days or 5 half-lives (whichever is shorter) prior to initiating study treatment.
•10.COVID-19 vaccine within 14 days prior to C1D1

发起方