A Phase II Study of Steroid Sparing Treatment With Daratumumab and Lenalidomide in Newly Diagnosed Transplant Ineligible Patients With Multiple Myeloma
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 28
- 试验地点
- 2
- 主要终点
- Daratumumab Related Infusion Reactions
研究概览
简要总结
The purpose of this study is to determine the effects of daratumumab and lenalidomide without steroids for treating patients with multiple myeloma.
详细描述
This is an open label, phase 2 study consisting of daratumumab, lenalidomide and dexamethasone, given upfront in newly diagnosed, transplant ineligible patients with myeloma. Patients participating in the study will be recruited from the Wilmot Cancer Institute, University of Rochester in Rochester, New York and all University of Rochester community affiliates.
Patients will be treated with 1800 milligrams of Daratumumab subcutaneously or 16 milligrams/kilograms daratumumab intravenously (IV) weekly for 8 treatments, followed by every 2 weeks for 8 treatments, followed by every 4 weeks. Patients will be treated with 25 milligrams of Lenalidomide days 1-21 out of a 28 day cycle (dose adjustments for creatinine clearance) and 20 milligrams of Dexamethasone at least 60 minutes prior to first infusion of daratumumab. Each cycle consists of 28 days (4 weeks).
Response assessments by International Myeloma Working Group criteria for myeloma will be performed every 4 weeks while on therapy.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of multiple myeloma with diagnosis
- •Must not have received previous therapy for multiple myeloma
- •Newly diagnosed and not considered candidate for high-dose chemotherapy
- •Adequate organ system function
- •A performance status ≤ 3
- •Ability to swallow and retain oral medication
- •Female subjects of child bearing potential must be surgically sterile, be post-menopausal
排除标准
- •A diagnosis of primary amyloidosis; monoclonal gammopathy of undetermined significance, smoldering multiple myeloma; non-secretory myeloma
- •A diagnosis of Waldenström's disease
- •Receiving cancer therapy
- •Radiation therapy within 14 days of enrollment
- •Major surgery within 2 weeks before enrollment
- •Human immunodeficiency virus -infected patients must be on effective anti-retroviral therapy with undetectable viral load within the past 6 months
- •Seropositive for hepatitis B, or seropositive for hepatitis C
- •Ongoing systemic bacterial, fungal or viral infection
- •Severe and/or uncontrolled medical conditions
- •Malignancy within 2 years of study enrollment
- •Women who are pregnant or lactating
- •Contraindications to required prophylaxis for deep vein thrombosis and pulmonary embolism.
研究组 & 干预措施
Experimental Arm: Cycle 1-4 All subjects
Subjects will be treated with the following:
- Daratumumab 16 milligrams/kilograms intravenously weekly for 8 treatments, followed by every 2 weeks for 8 treatments, followed by every 4 weeks
- Lenalidomide 25 milligrams by mouth daily days 1-21 out of a 28 day cycle
- Dexamethasone 20 milligrams by mouth or intravenously at least 60 minutes prior to first infusion of daratumumab
干预措施: Daratumumab (Drug)
Experimental Arm: Cycle 5+ Partial Response or Better
Subjects will be treated the following:
- Daratumumab 16 milligrams/kilograms intravenously weekly for 8 treatments, followed by every 2 weeks for 8 treatments, followed by every 4 weeks
- Lenalidomide 25 milligrams/kilograms daily days 1-21 out of a 28 day cycle
干预措施: Daratumumab (Drug)
Experimental Arm: Cycle 1-4 All subjects
Subjects will be treated with the following:
- Daratumumab 16 milligrams/kilograms intravenously weekly for 8 treatments, followed by every 2 weeks for 8 treatments, followed by every 4 weeks
- Lenalidomide 25 milligrams by mouth daily days 1-21 out of a 28 day cycle
- Dexamethasone 20 milligrams by mouth or intravenously at least 60 minutes prior to first infusion of daratumumab
干预措施: Lenalidomide (Drug)
Experimental Arm: Cycle 1-4 All subjects
Subjects will be treated with the following:
- Daratumumab 16 milligrams/kilograms intravenously weekly for 8 treatments, followed by every 2 weeks for 8 treatments, followed by every 4 weeks
- Lenalidomide 25 milligrams by mouth daily days 1-21 out of a 28 day cycle
- Dexamethasone 20 milligrams by mouth or intravenously at least 60 minutes prior to first infusion of daratumumab
干预措施: Dexamethasone (Drug)
Experimental Arm: Cycle 5+ Partial Response or Better
Subjects will be treated the following:
- Daratumumab 16 milligrams/kilograms intravenously weekly for 8 treatments, followed by every 2 weeks for 8 treatments, followed by every 4 weeks
- Lenalidomide 25 milligrams/kilograms daily days 1-21 out of a 28 day cycle
干预措施: Lenalidomide (Drug)
Experimental Arm: Cycle 5+ Less than Partial Response
Subjects will be treated the following:
- Daratumumab 16 milligrams/kilograms intravenously weekly for 8 treatments, followed by every 2 weeks for 8 treatments, followed by every 4 weeks
- Lenalidomide 25 milligrams by mouth daily days 1-21 out of a 28 day cycle
- Dexamethasone 20 milligrams by mouth or intravenously at least 60 minutes prior to first infusion of daratumumab
干预措施: Lenalidomide (Drug)
Experimental Arm: Cycle 5+ Less than Partial Response
Subjects will be treated the following:
- Daratumumab 16 milligrams/kilograms intravenously weekly for 8 treatments, followed by every 2 weeks for 8 treatments, followed by every 4 weeks
- Lenalidomide 25 milligrams by mouth daily days 1-21 out of a 28 day cycle
- Dexamethasone 20 milligrams by mouth or intravenously at least 60 minutes prior to first infusion of daratumumab
干预措施: Daratumumab (Drug)
Experimental Arm: Cycle 5+ Less than Partial Response
Subjects will be treated the following:
- Daratumumab 16 milligrams/kilograms intravenously weekly for 8 treatments, followed by every 2 weeks for 8 treatments, followed by every 4 weeks
- Lenalidomide 25 milligrams by mouth daily days 1-21 out of a 28 day cycle
- Dexamethasone 20 milligrams by mouth or intravenously at least 60 minutes prior to first infusion of daratumumab
干预措施: Dexamethasone (Drug)
结局指标
主要结局
Daratumumab Related Infusion Reactions
时间窗: 28 days
To determine the rate of daratumumab related infusion reactions in patients treated for myeloma without steroids compared to historical controls.
次要结局
- Determination of Response Rates(28 days)
研究者
Frank Passero
Professor of Hematology/Oncology
University of Rochester