A Phase II Study of Elotuzumab in Combination With Pomalidomide, Bortezomib, and Dexamethasone in Relapsed and Refractory Multiple Myeloma
概览
- 阶段
- 2 期
- 干预措施
- Elotuzumab
- 疾病 / 适应症
- Multiple Myeloma
- 发起方
- Massachusetts General Hospital
- 入组人数
- 52
- 试验地点
- 6
- 主要终点
- Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
- 状态
- 进行中（未招募）
- 最后更新
- 3个月前
概览
简要总结
This research study is studying a combination of study drugs as a possible treatment for relapsed and refractory Multiple Myeloma. The interventions involved in this study are elotuzumab, pomalidomide, bortezomib, dexamethasone.
详细描述
This research study is a phase II clinical trial, the investigators are studying the safety and response rate of the combinations of elotuzumab, pomalidomide, bortezomib, dexamethasone (elo-PVD). The FDA (the U.S. Food and Drug Administration) has approved each of those drugs elotuzumab, pomalidomide, bortezomib, dexamethasone as a treatment option for Refractory or relapsed multiple myeloma. Pomalidomide is a drug that changes that enhances or suppresses your immune systems reaction to a stimulus.This change may help the body destroy tumor cells. Bortezomib is an inhibitor that targets how cells dispose of unneeded proteins. By blocking this process, bortezomib can help destroy unwanted cells. Dexamethasone is a steroid, that helps prevent inflammation in a wide variety of organs and acts against myeloma cells. Elotuzumab is a monoclonal antibody, Elotuzumab targets a protein that is highly common on the surface of multiple myeloma cells called SLAMF7. The combination of the drugs may provide an unique approach for treating the disease.
研究者
Andrew Yee, MD
MD
Massachusetts General Hospital
入排标准
入选标准
- •All laboratory assessments should be performed within 21 days of initiation of protocol therapy unless otherwise specified.
- •Participant has given voluntary signed written informed consent before performance of any study-related procedure that is not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to their future medical care.
- •Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 (see Appendix A).
- •Age ≥ 18 years
- •Measurable disease of multiple myeloma as defined by at least one of the following
- •Serum monoclonal protein ≥ 0.5 g/dL
- •≥ 200 mg of monoclonal protein in the urine on 24 hour electrophoresis
- •Serum free light chain ≥ 100 mg/L (10 mg/dL) and abnormal serum free kappa to serum free kappa light chain ratio
- •Previously treated relapsed and refractory multiple myeloma
- •Patients must have received at least one prior therapy with at least 2 cycles of lenalidomide and at least 2 cycles of a proteasome inhibitor (either in separate regimens or within the same regimen)
排除标准
- •Prior therapy with elotuzumab
- •Participants who have had chemotherapy or radiotherapy within 2 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events due to agents administered more than 2 weeks earlier. Patients may have received dexamethasone within 2 weeks prior to entering study.
- •Participants who are receiving any other investigational agents.
- •Concomitant high dose corticosteroids except patients may be on chronic steroids (maximum dose 10 mg/day prednisone equivalent) if they are being given for disorders other than myeloma, e.g. adrenal insufficiency, rheumatoid arthritis, etc.
- •Pregnant or lactating females
- •Prior history of malignancies, other than MM, unless the patient has been free of the disease for ≥ 3 years. Exceptions include the following:
- •Basal or squamous cell carcinoma of the skin
- •Carcinoma in situ of the cervix
- •Ductal carcinoma in situ of the breast
- •Incidental histologic finding of prostate cancer (T1a or T1b)
研究组 & 干预措施
Elotuzumab, pomalidomide, bortezomib, dex
Each cycle is 28 days. Elotuzumab will be administered by intravenous infusion. For cycles 1-2, elotuzumab will ge given weekly. For cycles 3-8, elotuzumab will be given every other week. For cycles 9+, elotuzumab will be given on day 1. Pomalidomide will be given orally on days 1-21. Bortezomib will be given weekly subcutaneously on days 1, 8, 15. Dexamethasone will be given as a combination orally and intravenously.
干预措施: Elotuzumab
Elotuzumab, pomalidomide, bortezomib, dex
Each cycle is 28 days. Elotuzumab will be administered by intravenous infusion. For cycles 1-2, elotuzumab will ge given weekly. For cycles 3-8, elotuzumab will be given every other week. For cycles 9+, elotuzumab will be given on day 1. Pomalidomide will be given orally on days 1-21. Bortezomib will be given weekly subcutaneously on days 1, 8, 15. Dexamethasone will be given as a combination orally and intravenously.
干预措施: Pomalidomide
Elotuzumab, pomalidomide, bortezomib, dex
Each cycle is 28 days. Elotuzumab will be administered by intravenous infusion. For cycles 1-2, elotuzumab will ge given weekly. For cycles 3-8, elotuzumab will be given every other week. For cycles 9+, elotuzumab will be given on day 1. Pomalidomide will be given orally on days 1-21. Bortezomib will be given weekly subcutaneously on days 1, 8, 15. Dexamethasone will be given as a combination orally and intravenously.
干预措施: Bortezomib
Elotuzumab, pomalidomide, bortezomib, dex
Each cycle is 28 days. Elotuzumab will be administered by intravenous infusion. For cycles 1-2, elotuzumab will ge given weekly. For cycles 3-8, elotuzumab will be given every other week. For cycles 9+, elotuzumab will be given on day 1. Pomalidomide will be given orally on days 1-21. Bortezomib will be given weekly subcutaneously on days 1, 8, 15. Dexamethasone will be given as a combination orally and intravenously.
干预措施: Dexamethasone
结局指标
主要结局
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
时间窗: 2 years
Overall response rate by International Myeloma Working Group criteria.
时间窗: 2 years
To evaluate the objective response rate (partial response or better) of elotuzumab in combination with pomalidomide, bortezomib, and dexamethasone in patients with relapsed and refractory multiple myeloma and who have received at least two prior therapies and are relapsed and/or refractory to both lenalidomide and bortezomib.
次要结局
- Progression Free Survival(2 Years)