NCT05372354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
Bristol-Myers Squibb17 个研究点 分布在 5 个国家目标入组 260 人开始时间: 2022年10月18日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 260
- 试验地点
- 17
- 主要终点
- Number of participants with adverse events (AEs)
研究概览
简要总结
The purpose of this study is to assess the safety, tolerability and preliminary effectiveness of CC-92480 (BMS-986348) in novel therapeutic combinations for the treatment of Relapsed or Refractory Multiple Myeloma (RRMM).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Relapsed or refractory multiple myeloma (MM) and must:
- •Have documented disease progression during or after their last myeloma therapy.
- •For Part 1 Dose Finding: Be refractory to, intolerant to, or not a candidate for available, established therapies known to provide clinical benefit in MM; For Part 2 Dose Expansion: Be refractory to or have relapsed after the protocol specified number of prior lines of therapy that include an immunomodulatory drug (IMiD), a proteasome inhibitor, an anti-CD38 mAb, and a T-cell redirecting therapy (TRT, eg, a CAR-T or T-cell engaging bispecific treatment) unless the participant is not a candidate for TRT.
- •Must have measurable disease.
- •Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or
- •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
- •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
- •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:
- •Plasmapheresis
- •Major surgery
- •Radiation therapy other than local therapy for myeloma associated bone lesions
- •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
- •COVID-19 vaccine within 14 days prior to C1D1
- •Other protocol-defined inclusion/exclusion criteria apply
研究组 & 干预措施
Part 1 Arm A: Dose Finding
Experimental
干预措施: CC-92480 (Drug)
Part 1 Arm A: Dose Finding
Experimental
干预措施: Tazemetostat (Drug)
Part 1 Arm A: Dose Finding
Experimental
干预措施: Dexamethasone (Drug)
Part 1 Arm B: Dose Finding
Experimental
干预措施: CC-92480 (Drug)
Part 1 Arm B: Dose Finding
Experimental
干预措施: BMS-986158 (Drug)
Part 1 Arm B: Dose Finding
Experimental
干预措施: Dexamethasone (Drug)
Part 1 Arm C: Dose Finding
Experimental
干预措施: CC-92480 (Drug)
Part 1 Arm C: Dose Finding
Experimental
干预措施: Trametinib (Drug)
Part 1 Arm C: Dose Finding
Experimental
干预措施: Dexamethasone (Drug)
Part 2 Arm D: Dose Expansion
Active Comparator
干预措施: CC-92480 (Drug)
Part 2 Arm D: Dose Expansion
Active Comparator
干预措施: Dexamethasone (Drug)
Part 2 Arm E: Dose Expansion
Experimental
干预措施: CC-92480 (Drug)
Part 2 Arm E: Dose Expansion
Experimental
干预措施: Tazemetostat (Drug)
Part 2 Arm E: Dose Expansion
Experimental
干预措施: Dexamethasone (Drug)
Part 2 Arm G: Dose Expansion
Experimental
干预措施: CC-92480 (Drug)
Part 2 Arm G: Dose Expansion
Experimental
干预措施: Trametinib (Drug)
Part 2 Arm G: Dose Expansion
Experimental
干预措施: Dexamethasone (Drug)
结局指标
主要结局
Number of participants with adverse events (AEs)
时间窗: From first participant first visit until 28 days after the last participant discontinues study treatment, up to approximately 4 years
Number of participants with Serious AEs
时间窗: Up to approximately 4 years
Number of participants with AEs meeting protocol-defined DLT criteria
时间窗: Up to approximately 4 years
Number of participants with AEs leading to discontinuation
时间窗: Up to approximately 4 years
Number of deaths
时间窗: Up to approximately 4 years
Establish recommended Phase 2 dose (RP2D)
时间窗: Up to approximately 2 years
Establish dosing schedule of each combination for Part 2 Dose Expansion
时间窗: Up to approximately 2 years
次要结局
- Overall response rate (ORR)(Up to approximately 4 years)
- Very good partial response rate (VGPRR)(Up to approximately 4 years)
- Complete response rate (CRR)(Up to approximately 4 years)
- Time-to-response (TTR)(Up to approximately 4 years)
- Duration of response (DOR)(Up to approximately 4 years)
- Progression-free survival (PFS)(Up to approximately 4 years)
- Maximum observed plasma concentration (Cmax)(Up to approximately 28 days)
- Time to maximum plasma concentration (Tmax)(Up to approximately 28 days)
- Area under the concentration-time curve (AUC)(Up to approximately 28 days)
- Terminal Half-Life (T-Half)(Up to approximately 28 days)
- Apparent total body clearance (CLT/F)(Up to approximately 28 days)
- Apparent volume of distribution (Vz/F)(Up to approximately 28 days)
研究者
研究点 (17)
Loading locations...
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