A Phase 2, Multicenter, Single Arm, Open Label Study of Venetoclax Plus Lenalidomide and Dexamethasone for the Treatment of Newly Diagnosed t(11;14)-Positive Multiple Myeloma in Subjects Who Are Ineligible for High-Dose Therapy
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 发起方
- 试验地点
- 22
- 主要终点
- Percentage of Participates Who Achieve CR
研究概览
简要总结
This study will evaluate the safety and preliminary efficacy of venetoclax when combined with lenalidomide and dexamethasone for participants with newly diagnosed, active t(11;14) positive multiple myeloma (MM).
This study will consist of 2 parts: Part 1 Dose Escalation and Part 2 Dose Expansion.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Must have documented, confirmed active multiple myeloma (MM) with greater than or equal to 10% clonal bone marrow plasma cells or biopsy-proven bone or extramedullary plasmacytoma and any one or more of the following myeloma-defining events:
- •Evidence of end organ damage attributed to the underlying plasma cell proliferative disorder and satisfying at least one of the protocol specified laboratory criteria for calcium elevation, renal failure, anemia, or lytic bone lesions; OR
- •One or more of the biomarkers of malignancy as described in the protocol.
- •Must have MM positive for the t(11;14) translocation, as determined by methods described in the protocol.
- •Must have measurable disease defined by at least one of the following criteria:
- •Serum M-protein ≥ 1.0 g/dL (immunoglobulin [Ig]G myeloma) or greater than or equal to 0.5 g/dL (IgA, IgM, IgD, or IgE myeloma);
- •Urine M-protein greater than or equal to 200 mg/24 hours;
- •Serum free light chain (FLC) greater than or equal to 10 mg/dL (100 mg/L) provided serum FLC ratio is abnormal.
- •Newly diagnosed and not considered a candidate for high-dose therapy and hematopoietic stem cell transplantation (HSCT)
- •Must have Eastern Cooperative Oncology Group performance status less than or equal to 2.
排除标准
- •Has a co-existing condition as specified in the protocol.
- •Has history of other active malignancies, including myelodysplastic syndromes (MDS) within the past 3 years with specific exceptions detailed in the protocol.
- •Has been treated with or received any of the following:
- •Prior or current systemic therapy or hematopoietic stem cell transplantation (HSCT) for MM (a short course of treatment with corticosteroids equivalent to dexamethasone 40 mg/day for a maximum of 4 days is allowed before treatment); use of systemic strong or moderate inhibitor or inducer of cytochrome P450(CYP)3A within 7 days before the first dose of study drug.
- •Radiation therapy within 2 weeks of dosing
- •Plasmapheresis within 4 weeks of dosing
- •Immunization with live vaccine within 8 weeks of dosing
- •Has a contraindication or inability to comply with antithrombotic prophylaxis.
研究组 & 干预措施
Venetoclax + Lenalidomide + Dexamethasone
Venetoclax up to 800 mg orally every day (QD) QD on Days 1 - 28 plus lenalidomide up to 25 mg orally QD on Days 1 - 21 (28 day cycle) plus dexamethasone up to 40 mg orally once weekly (QW).
干预措施: venetoclax (Drug)
Venetoclax + Lenalidomide + Dexamethasone
Venetoclax up to 800 mg orally every day (QD) QD on Days 1 - 28 plus lenalidomide up to 25 mg orally QD on Days 1 - 21 (28 day cycle) plus dexamethasone up to 40 mg orally once weekly (QW).
干预措施: lenalidomide (Drug)
Venetoclax + Lenalidomide + Dexamethasone
Venetoclax up to 800 mg orally every day (QD) QD on Days 1 - 28 plus lenalidomide up to 25 mg orally QD on Days 1 - 21 (28 day cycle) plus dexamethasone up to 40 mg orally once weekly (QW).
干预措施: dexamethasone (Drug)
结局指标
主要结局
Percentage of Participates Who Achieve CR
时间窗: From baseline up to approximately 24 months
Complete response (CR) is defined as negative immunofixation of serum and urine, and disappearance of any soft tissue plasmacytomas, and \< 5% plasma cells in bone marrow.
次要结局
- Percent of Participants Who Achieve MRD Negativity(From baseline up to approximately 24 months)
- Duration of response (DOR)(Approximately 7 years)
- Overall Response Rate (ORR)(From baseline up to approximately 24 months)
- Overall Survival (OS) Rate(Approximately 7 years)
- Percent of Participants Who Achieve VGPR or Better(From baseline up to approximately 24 months)
- Progression-free Survival (PFS)(Approximately 7 years)
- Time to Disease Progression (TTP)(Approximately 7 years)
- Time to Next Treatment (TTNT)(Approximately 7 years)
- Time to Response (TTR)(From baseline up to approximately 24 months)
- Minimal Residual Disease (MRD) Negativity Rate at 12 Months(Approximately 12 months after initial dose of study drug)