EUCTR2015-002509-13-IT进行中（未招募）1 期
A phase III study of Pomalidomide and low dose Dexamethasone with or without Pembrolizumab (MK3475) in refractory or relapsed and refractory Multiple Myeloma (rrMM) (KEYNOTE 183) - A phase III study of Pomalidomide and Dexamethasone with or without Pembrolizumab in rrMM
MERCK SHARP & DOHME CORP. UNA SUSSIDIARIA DI MERCK & CO. INC.0 个研究点目标入组 300 人开始时间: 2018年2月8日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 300
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Must have undergone prior treatment with = 2 treatment lines of anti-myeloma therapy and must have failed their last line of treatment defined as documented disease progression during or within 60 days of completing their last anti-myeloma therapy (refractory to last line of treatment).
- •2. Prior anti-myeloma treatments must have included an IMiD (lenalidomide or thalidomide) AND proteasome inhibitor (bortezomib or carfilzomib) alone or in combination and subject must have failed therapy with an IMiD OR proteasome inhibitor defined as one of the following:
- •Refractory: Documented progressive disease on or within 60 days of completing treatment with an IMiD and/or proteasome inhibitor OR
- •Relapsed and refractory: In case of prior response [= partial response (PR)] to an IMiD or proteasome inhibitor, subjects must have relapsed within 6 months after stopping treatment with and IMiD and/or proteasome inhibitor containing regimens
- •3. Confirmed diagnosis of active MM and measurable disease defined as:
- •Serum monoclonal protein (M-protein) levels = 0.5 g/dL or
- •Urine monoclonal protein (M-protein) levels =200 mg/24-hours or
- •Subjects without measurable serum and urine M-protein levels, an abnormal serum free light chain ratio (FLC ?/?) with involved FLC level =100 mg/L. (Normal serum FLC ?/? value: 0.26 - 1.65)
- •Presence of CRAB features
- •4. Provide, archival (=60 days) or newly obtained bone marrow biopsy or aspirate material for disease assessment and biomarker analysis.
- •5. Performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Scale.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 1
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 75
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 225
排除标准
- •1. Subjects with non-secretory or oligo-secretory myeloma, smoldering multiple myeloma (SMM), monoclonal gammopathy of undetermined significance (MGUS), plasma cell leukemia or Waldenström's macroglobulinemia.
- •2. History of repeated infections, primary amyloidosis, hyperviscosity or POEMS syndrome.
- •3. Has had a prior monoclonal antibody within 4 weeks prior to study Day 1 or who has not recovered (i.e. = Grade 1 or at baseline) from adverse events due to agents administered more than 4 weeks earlier.
- •4. Has had prior anti-myeloma therapy including but not limited to dexamethasone, IMiDs, proteasome inhibitors, chemotherapy, or radiation therapy within 2 weeks prior to Study Day 1 who has not recovered (i.e. = Grade 1 or at baseline) from adverse events due to a previously administered agent.
- •5. Has undergone prior allogeneic hematopoetic stem cell transplantation within the last 5 years. (Subjects who have had a transplant greater than 5 years ago are eligible as long as there are no symptoms of Graft versus Host Disease (GVHD).
- •6. Has received autologous stem cell transplant (auto-SCT) within 12 weeks before the first infusion or are planning for or are eligible for auto-SCT.
- •7. Has known hypersensitivity to thalidomide, lenalidomide or dexamethasone.
- •8. Has received previous therapy with pomalidomide.
- •9. Subjects unable or unwilling to undergo antithrombotic prophylactic treatment.
- •10. Subjects with peripheral neuropathy = Grade 2.
- •11. Has evidence of active, non-infectious pneumonitis.
- •12. Has received prior therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-Cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4) antibody.
研究者
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