A Phase II Pilot Study of Avelumab in Combination With Hypofractionated Radiotherapy in Patients With Relapsed Refractory Multiple Myeloma
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 4
- 试验地点
- 2
- 主要终点
- Overall Response Rate (ORR)
研究概览
简要总结
Background:
Multiple myeloma is a cancer that forms from plasma cells which normally produce important immune response antibodies. It cannot be cured. Researchers hope the combination of radiation combined with the drug avelumab causes the immune system to kill myeloma cells more effectively.
Objective:
To see if avelumab given with radiation treatment helps treat multiple myeloma. Also to see if giving the treatments together is safe.
Eligibility:
People ages 18 and older with multiple myeloma that has come back after treatment and has spread to other parts of the body
Design:
Participants will be screened with:
Medical history
Physical exam
Blood, urine, and heart tests
Possible tumor biopsy
Bone marrow testing: A needle will be stuck into the participants hipbone to take out a small amount of marrow.
Positron emission tomography (PET)/Computed tomography (CT) scan and magnetic resonance imaging (MRI): Participants will lie in a machine that takes pictures of the body.
Participants will get avelumab through an intravenous (IV). An IV is a small plastic tube put into an arm vein. They will get avelumab every 2 weeks for 2 doses. Then they will get radiation each day for 5 days. They will continue to get avelumab every 2 weeks as long as they do not have bad side effects and the treatment is helping their disease.
Participants will have blood and urine tests, bone marrow biopsies, scans, and X-rays repeated during the study.
Participants will have a follow-up visit 30 days after their last treatment dose. Then they will have visits every 3-6 months for up to 5 years....
详细描述
Background:
- Multiple Myeloma (MM) is a hematologic neoplasm of the plasma cells defined by an M- protein greater than or equal to 3.0 g/dL or bone marrow plasma cells greater than or equal to 10% and presence of end-organ disease.
- Although significant advances in treatment have been made in the past decade, MM remains incurable with median survivals of 5-8 years.
- While therapeutic strides have been made with approvals of immunomodulatory drugs (IMiDs), proteasome inhibitors, and monoclonal antibodies, treatment of relapsed refractory MM (RRMM) remains an unmet need for patients who have exhausted available therapies.
- Extramedullary plasmacytomas arising either from focal bone involvement or from hematogenous spread occur in 7-18% of newly diagnosed MM (NDMM) with an additional 6-20% in RRMM.
- Immune checkpoint inhibitors are being evaluated in combination regimens and evidence exists that radiation therapy (XRT) may synergize with immune checkpoint inhibitors.
Objectives:
- To assess the response rate of avelumab in combination with XRT (BavXRT) in RRMM patients with plasmacytomas or lytic lesions
Eligibility:
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
- 未提供
排除标准
- 未提供
结局指标
主要结局
Overall Response Rate (ORR)
时间窗: up to end of study, an average of 11 months
ORR is defined as participants who experience a partial response (PR), very good partial response (VGPR), complete response (CR), or stringent complete response (sCR) per International Myeloma Working Group Criteria (IMWG) 2016 criteria. Complete Response is defined as negative immunofixation on the serum and urine and disappearance of any soft tissue plasmacytomas and \<5% plasma cells in bone marrow aspirates. Stringent Complete Response is defined as complete response as noted previously plus normal free light chain (FLC) ratio and absence of clonal cells in bone marrow biopsy by immune-histochemistry. Partial Response is ≥50% reduction of serum M-protein plus reduction in 24 hour(h) urinary M-protein by ≥90% or to \<200 mg per 24 h. Very Good Partial Response is serum and urine M-protein detectable by immunofixation but not on electrophoresis or ≥90% reduction in serum M-protein plus urine M-protein level \<100 mg per 24 h.
次要结局
- Fraction of Participants Who Experience a Minimal Residual Disease Negative (MRDneg)Complete Response (CR) Using the Study Treatment(up to up to end of study for individual patient, an average of 11 months)
- Fluorodeoxyglucose (FDG) Avidity Positron-Emission Tomography/Computed Tomography (PET/CT) of Non-irradiated Extramedullary Lesions (Abscopal Effect) Compared to Baseline(End of study)
- Fraction of Participants Who Experience a Complete Response (CR) or Stringent Complete Response (sCR) Using the Study Treatment(up to end of study for individual patient, an average of 11 months)
- Number of Participants Overall Best Response(4 weeks)
- Percent Change in Aberrant Circulating Plasma Cells in the Peripheral Blood (PB) and Bone Marrow (BM) From Baseline(Baseline and up to end of study for individual patient, an average of 11 months)
- Percent Reduction in Size of On-irradiated Extramedullary Lesions(end of study)
- Number of Participants With Grade ≥1 Non-serious Adverse Events(Date treatment consent signed to date off study, approximately 14 months and 4 days.)
- Progression-free Survival (PFS)(End of study, an average of 11 months)
- Percentage of Participants With Overall Survival (OS)(Enrollment through end of study, an average of 11 months)
研究者
Mark Roschewski, M.D.
Principal Investigator
National Cancer Institute (NCI)