jRCT2031230660进行中（未招募）不适用
AN OPEN-LABEL, MULTICENTER, PHASE Ib TRIAL EVALUATING THE SAFETY, PHARMACOKINETICS, AND ACTIVITY OF CEVOSTAMAB AS MONOTHERAPY AND CEVOSTAMAB PLUS POMALIDOMIDE AND DEXAMETHASONE OR CEVOSTAMAB PLUS DARATUMUMAB AND DEXAMETHASONE IN PATIENTS WITH RELAPSED OR
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 126
- 主要终点
- safety
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomized Controlled Trial
- 干预模型
- Parallel Assignment
- 主要目的
- Treatment Purpose
- 盲法
- Open(masking Not Used)
入排标准
- 年龄范围
- 18age old over 至 No limit（—）
- 性别
- All
入选标准
- •Participants with R/R MM who have received at least 1 prior line of treatment
- •Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
- •Measurable disease
- •Agreement to provide bone marrow biopsy and aspirate samples
- •Resolution of adverse events from prior anti-cancer therapy to Grade <=1
- •Meet the other eligibility criteria as defined in the protocol.
排除标准
- •Inability to comply with protocol-mandated hospitalization and activities restrictions
- •Prior allogeneic SCT
- •Circulating plasma cell count exceeding 500/uL or 5% of the peripheral blood white cells
- •History of other malignancy within 2 years before screening
- •Positive and quantifiable EBV PCR or CMV PCR before first study treatment
- •Significant cardiovascular disease
- •Prior use of any monoclonal antibody, radioimmunoconjugate, or antibody-drugconjugate as anti-cancer therapy within 4 weeks before first study treatment, except for the use of non-myeloma therapy
- •Prior treatment with systemic immunotherapeutic agents, including, but not limited to, cytokine therapy and anti-CTLA4, anti-PD-1, and antiPD-L1 therapeutic antibodies within 12 weeks or 5 half-lives of the drug, whichever is shorter, before first study treatment
- •Prior treatment with CAR T-cell therapy within 12 weeks before first study treatment
- •Treatment with radiotherapy within 4 weeks (systemic) or 14 days (focal) before first study treatment
- •Treatment with any chemotherapeutic agent or other anti-cancer agent within 4 weeks or 5 half-lives of the drug, whichever is shorter, prior to first study treatment
- •ASCT within 100 days before first study treatment
- •Meet the other exclusion criteria as defined in the protocol
结局指标
主要结局
safety
- Adverse events; NCI CTCAE v5.0, ASTCT Consensus Grading
efficacy
- Response Rates; International Myeloma Working Group (IMWG) Criteria
phamacokinetics
- Observation/Inspection
次要结局
- Immunogenicity
- Exporatory
研究者
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