A Phase 2, Multiple Cohort Study of Elotuzumab in Combination With Pomalidomide and Low-Dose Dexamethasone (EPd), and in Combination With Nivolumab (EN), in Patients With Multiple Myeloma Relapsed or Refractory to Prior Treatment With Lenalidomide.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 74
- 试验地点
- 22
- 主要终点
- Progression Free Survival (PFS)
研究概览
简要总结
Study of elotuzumab in combination with pomalidomide and low dose dexamethasone (EPd Cohort) and elotuzumab in combination with nivolumab (EN Cohort) to assess the safety and efficacy of these combination therapies for treatment of relapsed or refractory MM patients.
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
- •All subjects must have documented disease progression per IMWG criteria during or after their last anti-myeloma therapy.
- •ECOG Performance Status less than or equal to 2
- •Subject Re-enrollment: This study permits the re-enrollment of a subject that has discontinued the study as a pre-treatment failure (ie, has not been treated). If re-enrolled, the subject must be re-consented.
- •EPd Cohort:
- •must have received at least 1 but no greater than 2 prior lines of therapy (note: induction and stem cell transplants with or without maintenance therapy is considered 1 line of therapy)
- •Subjects must have received prior treatment with a lenalidomide-containing regimen for at least 2 consecutive cycles (full therapeutic dose) and must have been deemed as relapsed, refractory, or intolerant. Refractory is defined as progressing on-treatment or within 60 days of the last dose.
- •Subjects must have received at least 3 prior lines of therapy including a proteasome inhibitor (PI) and an immunomodulatory (IMID) agent OR were double-refractory to both an IMID and a PI. Refractory is defined as progressing on-treatment or within 60 days of the last dose.
排除标准
- •Subjects with solitary bone or extramedullary plasmacytoma as the only evidence of plasma cells dyscrasia
- •Subjects with monoclonal gammopathy of undetermined significance (MGUS), smoldering multiple myeloma (SMM), primary amyloidosis, Waldenstrom's macroglobulinemia, or POEMS syndrome (plasma cell dyscrasia with poly neuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes)
- •Subjects with Central Nervous System involvement with multiple myeloma
- •Other protocol defined inclusion/exclusion criteria could apply.
研究组 & 干预措施
Elotuzumab + Pomalidamide + Low Dose Dexamethasone (EPd)
patients will receive treatment with elotuzumab in combination with pomalidomide and low-dose dexamethasone. Patients are eligible to receive Nivolumab at progression.
干预措施: Elotuzumab (Drug)
Elotuzumab + Pomalidamide + Low Dose Dexamethasone (EPd)
patients will receive treatment with elotuzumab in combination with pomalidomide and low-dose dexamethasone. Patients are eligible to receive Nivolumab at progression.
干预措施: Pomalidomide (Drug)
Elotuzumab + Pomalidamide + Low Dose Dexamethasone (EPd)
patients will receive treatment with elotuzumab in combination with pomalidomide and low-dose dexamethasone. Patients are eligible to receive Nivolumab at progression.
干预措施: Dexamethasone (Drug)
Elotuzumab + Pomalidamide + Low Dose Dexamethasone (EPd)
patients will receive treatment with elotuzumab in combination with pomalidomide and low-dose dexamethasone. Patients are eligible to receive Nivolumab at progression.
干预措施: Nivolumab (Drug)
Elotuzumab + Nivolumab (EN)
Patients will receive treatment with a combination of elotuzumab and nivolumab
干预措施: Elotuzumab (Drug)
Elotuzumab + Nivolumab (EN)
Patients will receive treatment with a combination of elotuzumab and nivolumab
干预措施: Nivolumab (Drug)
结局指标
主要结局
Progression Free Survival (PFS)
时间窗: From first dose to study completion date (up to approximately 50 months)
PFS is defined as the time from first dosing date to the date of the first documented progression or death due to any cause, whichever occurs first. Progression is determined per International Myeloma Working Group (IMWG) uniform criteria. Participants who die without a reported prior progression were considered to have progressed on the date of their death. Participants who did not progress or die were censored on the date of their last evaluable assessment. Participants who did not have any on study efficacy assessments and did not die were censored on the first dosing date. Participants who switched to subsequent therapy prior to documented progression were censored on the date of the last evaluable assessment prior to the initiation of the new therapy.
Objective Response Rate (ORR)
时间窗: From first dose to study completion date (up to approximately 50 months)
ORR is defined as the percent of participants with best overall response of partial response (PR) or better. Response is determined per IMWG uniform criteria.
次要结局
- Objective Response Rate (ORR)(From first dose to study completion date (up to approximately 50 months))
- Progression Free Survival (PFS)(From first dose to study completion date (up to approximately 50 months))
- Overall Survival (OS)(From first dose to study completion date (up to approximately 50 months))