CTIS2023-509384-25-00招募中1 期
An Exploratory Phase 1b/2a Multicenter, Open-Label, Novel-Novel Combination Study to Assess the Safety, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of CC-92480 (BMS-986348) in Novel Therapeutic Combinations in Participants with Relapsed or Refractory Multiple Myeloma - CA057-003
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 60
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 65+（—）
- 性别
- All
入选标准
- •Signed written informed consent prior to any study procedure., = 18 years of age the time of signing the ICF., 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, Must have measurable disease., Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1., Agree to follow the CC-92480 Pregnancy Prevention Plan (PPP)
排除标准
- •Known active or history of central nervous system (CNS) involvement of MM., COVID-19 vaccine within 14 days prior to C1D1, Plasma cell leukemia; Waldenstrom's macroglobulinemia; polyneuropathy, organomegaly, endocrinopathy, M-protein, and skin changes (POEMS) syndrome; or clinically significant light-chain amyloidosis., Impaired cardiac function or clinically significant cardiac disease., 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), For Part 1: received prior therapy with CC-92480., For Part 2: received prior therapy with CC-92480, tazemetostat, BMS- 986158, or trametinib., Previously received allogeneic stem-cell transplant at any time or received autologous stem-cell transplant within 12 weeks of initiating study treatment, 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, Used any investigational agents within 28 days or 5 half-lives (whichever is shorter) prior to initiating study treatment.
研究者
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