Carfilzomib, Lenalidomide, and Dexamethasone in Newly Diagnosed Multiple Myeloma: Clinical and Correlative Phase II Study
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Number of Participants With Serious and Non-serious Adverse Events
研究概览
简要总结
Background:
- Carfilzomib is an experimental anti-cancer drug that has not yet been approved for treating multiple myeloma. Lenalidomide is a drug that may stop tumor growth and help the immune system kill cancer cells. Dexamethasone is a drug that helps stop inflammation. It is sometimes used to treat (alone or with other drugs) certain types of cancer, especially multiple myeloma. This combination of drugs has not been tested in people with multiple myeloma. Researchers want to see whether it is safe and effective for this group.
Objectives:
- To test the effectiveness of combined carfilzomib, lenalidomide, and dexamethasone in treating multiple myeloma.
Eligibility:
- People at least 18 years of age who have multiple myeloma that has not been treated.
Design:
- Participants will be screened with a medical history and physical exam. They will also have blood and urine tests, a bone marrow sample, and molecular imaging studies.
- Participants will have eight 28-day cycles of treatment. The combined study drugs will be given as tablets and injections. Those in the study will be monitored with frequent blood tests, bone marrow samples, and molecular imaging studies. In addition to current standard measures to determine clinical responses, molecular tests will be conducted to define evidence of minimal residual disease.
- After the first four cycles of therapy, those who are eligible for a stem cell transplant will have stem cells collected and stored for use if the cancer returns.
- After stem cell collection, participants will have the second four treatment cycles.
-, If the disease has improved or is stable at the end of eight cycles, those in the study may have another 12 cycles of low-dose (maintenance) lenalidomide alone.
- Participants will have regular follow-up visits after the end of the study chemotherapy.
详细描述
Background:
- Multiple myeloma (MM) is an incurable plasma cell neoplasm with a median survival of 3-4 years.
- Novel agent combinations with proteasome inhibitors demonstrate improved response rates while increasing survival in MM patients.
- A common debilitating side effect of the proteasome inhibitor bortezomib is neuropathy.
- Carfilzomib is a new proteasome inhibitor with potent anti-MM effects and decreased peripheral neuropathy
Objectives:
-Evaluate toxicity, including peripheral neuropathy, of carfilzomib, lenalidomide, and dexamethasone (CRd) in untreated MM patients
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 99 Years（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
研究组 & 干预措施
Carfilzomib, Lenalidomide, Dexamethasone
Patients will receive 8 cycles of induction combination therapy of carfilzomib, lenalidomide, and dexamethasone (CRd). Patients achieving stable disease or better after 8 cycles of CRd will receive lenalidomide extended dosing (phase I) for 12 cycles. After 12 cycles, patients will have the option to continue extended dosing (phase II) for one additional year
干预措施: Carfilzomib (Drug)
Carfilzomib, Lenalidomide, Dexamethasone
Patients will receive 8 cycles of induction combination therapy of carfilzomib, lenalidomide, and dexamethasone (CRd). Patients achieving stable disease or better after 8 cycles of CRd will receive lenalidomide extended dosing (phase I) for 12 cycles. After 12 cycles, patients will have the option to continue extended dosing (phase II) for one additional year
干预措施: Lenalidomide (Drug)
Carfilzomib, Lenalidomide, Dexamethasone
Patients will receive 8 cycles of induction combination therapy of carfilzomib, lenalidomide, and dexamethasone (CRd). Patients achieving stable disease or better after 8 cycles of CRd will receive lenalidomide extended dosing (phase I) for 12 cycles. After 12 cycles, patients will have the option to continue extended dosing (phase II) for one additional year
干预措施: Dexamethasone (Drug)
结局指标
主要结局
Number of Participants With Serious and Non-serious Adverse Events
时间窗: 4 years and 9 months and 2 days
Here is the number of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.
次要结局
- Overall Response Rate(48.3 months)
- Cluster of Differentiation 138 (CD138) + Plasma Cells Gene Expression Profiling on Pre and Post Carfilzomib Exposure Bone Marrow Samples(Cycle 1 Day 1, an average of 28 days ± 2 days)
- Progression Free Survival (PFS) at 48 Months(48 months)
- Overall Survival (OS) Rate(up to 6 months)
- Percentage of Responders With Duration of Response (DOR) at 48 Months(48 months)
- Rate of Minimal Residual Disease (MRD) by Flow Cytometry(Day 100)
- Complete Response (CR) and Minimal Residual Disease Neg (MRDneg) CR Rates at Treatment Intervals With Carfilzomib, Lenalidomide & Dexamethasone (CRd) in New Multiple Myeloma Patients After 8 Cycles of Induction, 1 Year Maintenance, and 2 Years Maintenance(up to 2 years)
研究者
Dickran Kazandjian, M.D.
Principal Investigator
National Cancer Institute (NCI)