A Randomized Parallel Phase 2 Study of Elotuzumab Plus Lenalidomide (Elo/Rev) for the Treatment of Serologic Relapse/Progression While on Lenalidomide Maintenance for Multiple Myeloma
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Percentage of Participants With Progression Free Survival (PFS)
研究概览
简要总结
The purpose of this study is determine Time-to-Progression with elotuzumab plus lenalidomide when elotuzumab is added to multiple myeloma participants with serologic relapse/progression while receiving lenalidomide maintenance for each study arm.
详细描述
This is a randomized parallel 2-cohort phase 2 study of elotuzumab given at 10 mg/kg weekly during induction in combination with lenalidomide (either 25 mg or 10 mg) in patients with multiple myeloma who progress or relapse serologically while on single agent lenalidomide maintenance.
The combination therapy with elotuzumab and lenalidomide will be continued until further progression of myeloma (based on response criteria) or intolerability.
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
- •Patients with multiple myeloma who demonstrate evidence of serologic relapse/progression while on lenalidomide maintenance given as part of first line therapy (including upfront high-dose chemotherapy followed by autologous hematopoietic cell transplantation (HCT)) without symptomatic relapse/progression. Lenalidomide maintenance is defined as single agent lenalidomide therapy of any doses up to 10 mg PO daily for up to 28 days (28-day cycle).
- •Male or female patients aged ≥ 18 years old
- •Ability to provide written informed consent obtained prior to participation in the study and any related procedures being performed
- •Measurable disease as outlined in protocol guidelines
- •Participants must meet laboratory criteria as outlined in protocol guidelines
排除标准
- •Prior Elotuzumab
- •Patients with clinical relapse/progression as per the International Myeloma Working Group (IMWG) Uniform Response Criteria for Multiple Myeloma defined as one or more of the following criteria:
- •Development of new soft tissue plasmacytomas or bone lesions (osteoporotic fractures do not constitute progression)
- •Definite increase in the size of existing plasmacytomas or bone lesions. A definite increase is defined as a 50% (and ≥1 cm) increase as measured serially of the measurable lesion
- •Hypercalcemia (>11 mg/dL);
- •Decrease in hemoglobin of ≥2 g/dL not related to therapy or other non-myeloma-related conditions;
- •Rise in serum creatinine by 2 mg/dL or more from the start of the therapy and attributable to myeloma
- •Hyperviscosity related to serum paraprotein
- •Women who are pregnant or breast feeding or women of childbearing potential (WOCBP) not using an effective method of birth control. Women of childbearing potential must have a negative serum pregnancy testing within 7 days prior to the administration of drug.
- •Male patients whose sexual partners are WOCBP not using effective birth control
- •Patients with a prior malignancy with in the last 5 years (except for basal or squamous cell carcinoma, or in situ cancer of the cervix)
- •Patients with known positivity for human immunodeficiency virus (HIV)) or hepatitis C; baseline testing for HIV and hepatitis C is not required
- •Patients with a diagnosis of POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes) or plasma cell leukemia (> 2.0 × 10^9/L circulating plasma cells by standard differential)
研究组 & 干预措施
A: Elotuzumab + Lenalidomide at 25 mg
Elotuzumab 10 mg/kg intravenously (IV) weekly (days 1, 8, 15 and 22) for 2 cycles, then 20 mg/kg every 4 weeks. Dexamethasone will be administered as premedication for elotuzumab.
Lenalidomide 25 mg by mouth (PO) daily days 1-21 out of a 28-day schedule.
干预措施: Elotuzumab (Drug)
A: Elotuzumab + Lenalidomide at 25 mg
Elotuzumab 10 mg/kg intravenously (IV) weekly (days 1, 8, 15 and 22) for 2 cycles, then 20 mg/kg every 4 weeks. Dexamethasone will be administered as premedication for elotuzumab.
Lenalidomide 25 mg by mouth (PO) daily days 1-21 out of a 28-day schedule.
干预措施: Lenalidomide (Drug)
A: Elotuzumab + Lenalidomide at 25 mg
Elotuzumab 10 mg/kg intravenously (IV) weekly (days 1, 8, 15 and 22) for 2 cycles, then 20 mg/kg every 4 weeks. Dexamethasone will be administered as premedication for elotuzumab.
Lenalidomide 25 mg by mouth (PO) daily days 1-21 out of a 28-day schedule.
干预措施: Dexamethasone (Drug)
B: Elotuzumab + Lenalidomide at 10 mg
Elotuzumab 10 mg/kg IV weekly (days 1, 8, 15 and 22) for 2 cycles, then 20 mg/kg every 4 weeks. Dexamethasone will be administered as premedication for elotuzumab.
Lenalidomide 10 mg PO daily days 1-21 out of a 28-day schedule.
干预措施: Elotuzumab (Drug)
B: Elotuzumab + Lenalidomide at 10 mg
Elotuzumab 10 mg/kg IV weekly (days 1, 8, 15 and 22) for 2 cycles, then 20 mg/kg every 4 weeks. Dexamethasone will be administered as premedication for elotuzumab.
Lenalidomide 10 mg PO daily days 1-21 out of a 28-day schedule.
干预措施: Lenalidomide (Drug)
B: Elotuzumab + Lenalidomide at 10 mg
Elotuzumab 10 mg/kg IV weekly (days 1, 8, 15 and 22) for 2 cycles, then 20 mg/kg every 4 weeks. Dexamethasone will be administered as premedication for elotuzumab.
Lenalidomide 10 mg PO daily days 1-21 out of a 28-day schedule.
干预措施: Dexamethasone (Drug)
结局指标
主要结局
Percentage of Participants With Progression Free Survival (PFS)
时间窗: An average of 8 months
Progression free survival (PFS) is defined as the time of randomization to date of death from any cause, date of relapse/progression, or the last follow-up date, whichever comes first. The Kaplan-Meier method will be used to estimate PFS for each Study Arm. The method of Brookmeyer and Crowley will be used to construct 95% confidence interval.
次要结局
- Overall Response(Up to 60 days post last study treatment)
- Minimum Response (MR)(Up to 60 days post last study treatment)